On June 14, 2023, FDA issued a guidance titled “Content of Premarket Submissions for Device

Software Functions.”1 This final guidance supersedes the Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices, issued on May 11, 2005. The final
guidance issued on June 14, 2023, provides information regarding the recommended
documentation sponsors should include in premarket submissions for FDA’s evaluation of the
safety and effectiveness of device software functions. In particular, the final guidance includes
information to help determine a device’s Documentation Level (formerly known as Level of
Concern). The purpose of the Documentation Level is to help identify the minimum amount of
information that would support a premarket submission that includes device software functions.
Within the framework of the superseded guidance, electrosurgical devices intended for use in
general surgery were considered a device with a Major Level of Concern. Based on the device’s
risk in the context of the device’s intended use, as discussed in the final guidance “Content of
Premarket Submissions for Device Software Functions,” electrosurgical devices intended for use
in general surgery should generally address the recommendations for an Enhanced
Documentation Level. The actual Documentation Level for your device may vary based on the
specifics of your device. For more information about the Documentation Level and
recommended documentation for a premarket submission, sponsors are encouraged to review the
guidance “Content of Premarket Submissions for Device Software Functions.”

1
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-
submissions-device-software-functions.
 Contains Nonbinding Recommendations

Premarket Notification (510(k))

Submissions for Electrosurgical
Devices for General Surgery
Guidance for Industry and Food and
Drug Administration Staff
Document issued on March 9, 2020.

Document originally issued on August 15, 2016.

The draft of this document was issued on March 24, 2014.

For questions about this document, contact OHT4: Office of Surgical and Infection Control
Devices/ DHT4A: Division of General Surgery Devices, 301-796-6970.

U.S. Department of Health and Human Services

Food and Drug Administration
Center for Devices and Radiological Health

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Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
http://www.regulations.gov. Submit written comments to the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD
20852. Identify all comments with the docket number FDA-2014-D-0217. Comments may not be
acted upon by the Agency until the document is next revised or updated.

Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document
number 19029 and complete title of the guidance in the request.

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Table of Contents
I. Introduction ...................................................................................................................... 4
II. Scope ................................................................................................................................ 5
III. Device Description........................................................................................................... 6
A. Indications for Use ..................................................................................................... 6
B. Device Design ............................................................................................................ 6
IV. Predicate Comparison ...................................................................................................... 7
V. Software ........................................................................................................................... 9
VI. Biocompatibility ............................................................................................................ 10
VII. Sterility........................................................................................................................... 11
VIII. Reprocessing .................................................................................................................. 12
IX. Pyrogenicity ................................................................................................................... 12
X. Shelf Life ....................................................................................................................... 13
XI. Performance Data........................................................................................................... 14
A. ESU .......................................................................................................................... 14
B. Active Components/Accessories .............................................................................. 14
C. Neutral Electrodes .................................................................................................... 15
D. Miscellaneous Components/Accessories ................................................................. 15
E. System Testing ......................................................................................................... 15
XII. Electrical Safety and Electromagnetic Compatibility .................................................... 18
XIII. Clinical Testing .............................................................................................................. 19
XIV. Labeling ......................................................................................................................... 20
A. Instructions for Use (User Manual) .......................................................................... 21
B. Device Labels ........................................................................................................... 23
C. Package Labels ......................................................................................................... 23
D. Labeling for Specific Components ........................................................................... 23
Appendix A. Glossary of Terms ............................................................................................ 26

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Premarket Notification (510(k))

Submissions for Electrosurgical
Devices for General Surgery
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements
of the applicable statutes and regulations. To discuss an alternative approach, contact the
FDA staff or Office responsible for this guidance as listed on the title page.

I. Introduction
FDA has developed this guidance document to assist industry in preparing premarket notification
(510(k)) submissions for electrosurgical devices intended for use in general surgery. These
devices are designed to cut and/or remove tissue and control bleeding through the use of high-
frequency electrical current. For the purpose of this guidance, electrosurgical devices may also
be called radiofrequency (RF) devices or high-frequency (HF) devices.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the
FDA Recognized Consensus Standards Database. 1 For more information regarding use of
consensus standards in regulatory submissions, refer to the FDA guidance titled “Appropriate
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” 2

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidance means that something is suggested or
recommended, but not required.

1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
2
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices.

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II. Scope
The scope of this document is limited to the Class II electrosurgical devices and accessories
classified under the following regulation number:

Section 878.4400 Electrosurgical cutting and coagulation device and accessories.

An electrosurgical cutting and coagulation device and accessories is a device intended to
remove tissue and control bleeding by use of high-frequency electrical current.

Electrosurgical devices under this regulation are indicated for general tissue cutting and/or
coagulation. If your device has specific indications, it may require additional information (e.g.,
additional bench and/or clinical data) or may be found to have a new intended use. For more
information on this topic, refer to FDA’s “Guidance for Industry: General/Specific Intended
Use.” 3

There are electrosurgical devices that have been classified under other medical panels (e.g., 21
CFR part 872 for dental devices). This guidance is not applicable to devices classified under the
following regulations:

• Section 872.4920 Dental electrosurgical unit and accessories

• Section 876.4300 Endoscopic electrosurgical unit and accessories
• Section 882.4400 Radiofrequency lesion generator
• Section 882.4725 Radiofrequency lesion probe
• Section 884.4150 Bipolar endoscopic coagulator-cutter and accessories
• Section 884.4160 Unipolar endoscopic coagulator-cutter and accessories
• Section 886.4100 Radiofrequency electrosurgical cautery apparatus
• Section 886.4115 Thermal cautery unit

This guidance is applicable to electrosurgical devices that may have multiple uses or indications,
if one of those indications includes tissue cutting and/or coagulation. In addition, some
electrosurgical devices may include both open and minimally invasive uses; in those cases, this
guidance document would apply. This guidance also applies to devices that may include an
arthroscopic indication. In addition, please be aware that there is supplemental guidance for
electrosurgical devices for other specific indications (e.g., RF vessel sealers). In such instances,
the supplemental guidance may provide additional recommendations or supersede this guidance.
We recommend that you search FDA’s guidance database 4 for any device specific supplemental
guidance or contact the Division of General Surgery Devices for more information.

For a new device that combines an electrosurgical device with another device(s) (e.g.,
mechanical massager or low level light source) into a single system, and is designed to operate
simultaneously or in sequence to achieve a desired clinical effect in tissue, additional data are

3
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-
guidance-industry.
4
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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usually necessary to demonstrate that the new device is substantially equivalent to the predicate
devices working independently. We recommend that you contact the Agency through the Q-
submission process to obtain further guidance for data recommendations in such cases. For
information on the Q-submission process, see FDA’s guidance, “Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program.” 5

III. Device Description

We recommend that you identify your device by the applicable regulation number described in
Section II and include the following information:

Indications for Use

You should provide a clear statement of your device’s Indications for Use. The
Indications for Use as stated on the Indications for Use Statement page should be
identical to that in the 510(k) Summary (if provided in lieu of a 510(k) Statement) and the
device labeling. You should also state if the device is a prescription (including home use)
or over-the-counter (OTC) device, and indicate this accordingly on the Indications for
Use Statement page.

Device Design
You should provide a brief description of the device’s operating principle(s) and
mechanism of action for achieving the intended effects. If the device will be labeled for
use with multiple components or accessories, and the components/accessories are part of
the submission, you should provide a list of all components/accessories with
accompanying model numbers and/or part numbers. For the purpose of this guidance,
components/accessories of electrosurgical devices refer to the electrosurgical unit (ESU),
active component/active accessory, neutral electrode, and miscellaneous
components/accessories. If there are components/accessories that have received prior
510(k) clearance or are exempted from the 510(k) requirement, you should provide the
510(k) numbers or indicate their exemption status, respectively.

You should provide the following information regarding device design:

1. Device Components
We recommend you provide a brief description of all major components or
accessories where applicable to your submission:
• ESU (i.e., the generator and control console) major functions, performance
specifications, and physical specifications

5
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program.

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• Active components/active accessories (generally comprised of one or more

active electrode(s), active connector or cables, and active handle or hand
piece) design, physical specifications, and patient contacting materials

• Neutral electrodes (also commonly called dispersive electrodes, grounding

pads, patient return electrodes, or passive/plate electrode) design, physical
specifications, and patient contacting materials

• Miscellaneous accessories such as foot pedal, irrigation pumps, suction or

smoke evacuation, etc.

2. Submission for Specific Components/Accessories

If your submission is requesting clearance for a specific component or accessory, but
not the entire electrosurgical device, you should describe the component/accessory.
You should discuss how you intend or expect this component/accessory to be used.
For example, if the submission is for an active electrode and will only be labeled for
use with your own legally marketed devices, you should provide performance testing
(see Section XI, Performance Data) to demonstrate compatibility with your own
legally marketed devices. Also, you should address the potential that this active
electrode could be used with other manufacturers’ electrosurgical devices and identify
the associated risk(s). In your risk assessment, you should identify whether you have
incorporated into your device design a way to prevent using your active electrode
with other manufacturers’ devices for which compatibility has not been established.
Based on your risk assessment, you may need to provide additional performance
testing to demonstrate this component will be safe and effective when used with other
manufacturers’ devices.

3. Photograph and/or Drawing of the Device

We recommend you provide high-level drawings, diagrams, and/or photographs of
the device that can help explain the functions and features. We also recommend you
provide an exploded or assembly view diagram or connection diagram, including all
components clearly labeled.

IV. Predicate Comparison

For devices reviewed under the 510(k) process, manufacturers must compare their new device to
a similar legally marketed predicate device to support its substantial equivalence (section 513(i)
(21 U.S.C. 360c(i)) of the FD&C Act; 21 CFR 807.87(f)). This comparison should provide
information to show how your device is similar to and different from the predicate. Side-by-side
comparisons for each major component using a tabular format such as shown in Table 1,
whenever possible, are desirable. See below for an example of how this information may be
organized. For each identified difference, you should provide further discussion of the difference
compared to the predicate and why this difference will not significantly affect safety or
effectiveness. You may need to provide performance data to support that, even with significant
differences, the device is as safe and effective as the predicate.

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Table 1. Example Comparison Table

Description Your Device Predicate Device
Indications for Use
Prescription or OTC
ESU
• Major functions (e.g., bipolar,
monopolar, temperature sensors,
impedance monitor, continuity
monitor)
• Performance specifications (e.g.,
output frequency, waveform,
power output, voltage output,
crest factor)
• Physical specifications
Active accessory
• Monopolar or bipolar
• Physical dimensions and design
(e.g., size, length, connector
type)
• Rated voltage
• Materials (electrode, insulation,
coating, etc.)
Neutral electrodes
• Conductive or capacitive
• Physical specifications
• Materials
Miscellaneous accessories
• Functions
• Performance specifications
• Physical specifications
• Materials

When more than one predicate device is identified to establish substantial equivalence of your
device, you should provide justification for the use of each predicate. You should address why
the combination of features and/or functions into one device does not raise different types of
safety and effectiveness questions for each predicate identified. An example of where multiple
predicates could be used is if the device includes different technologies that can stand alone but
can also be used together for the intended use of cutting and coagulating tissue. If there is a
predicate device for each of the technologies, then the combination of these technologies,
assuming that the use of one of the functions does not interfere with the others, could be found
substantially equivalent. In such an instance, you may need to provide performance data to
support your justification. For more information on the appropriate use of multiple predicates,

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see FDA’s guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)].” 6

V. Software
Significance: Software in electrosurgical generators ensures that appropriate energy is delivered
to the patient. Adequate software performance testing provides assurance that the device is
operating within safe parameters.

Recommendation: Refer to the FDA guidance, “Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices” 7 for a discussion of the software
documentation that you should provide in your submission. The software guidance outlines the
type of documentation to be provided based on the “level of concern” associated with the device.
FDA generally considers the software for electrosurgical device generators that are intended for
general surgery indications to present a “major” level of concern. If you believe that the software
in your device presents a lower level of concern (e.g., “moderate” or “minor”) as defined in the
software guidance, you should provide a scientific justification that supports your rationale of the
level of concern based on the possible consequences of software failure.

We recommend that you provide a full description of the software/firmware supporting the
operation of the subject device following the software guidance, commensurate with the
appropriate level of concern. This recommendation applies to original device/systems as well as
to any software/firmware changes made to already-marketed devices. Changes to software must
be re-validated and re-verified in accordance with Design Controls, 21 CFR 820.30(i), and
documented in the Design History File (see 21 CFR 820.30(j)). Some software changes may
warrant the submission of a new 510(k). In such cases, it is recommended that you consult the
FDA guidance, “Deciding When to Submit a 510(k) for a Software Change to an Existing
Device.” 8

As appropriate, you should also provide information on the cybersecurity aspects of your device,
including, but not limited to, the following facets of information security with respect to
communications features of your device and associated software: confidentiality, integrity,
availability and accountability.

Confidentiality assures that no unauthorized users have access to the information.

Integrity is the assurance that the information is correct—that is, it has not been improperly
modified.

6
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-
equivalence-premarket-notifications-510k.
7
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
submissions-software-contained-medical-devices.
8
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
software-change-existing-device.

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Availability suggests that the information will be available when needed.

Accountability is the application of identification and authentication to assure that the

prescribed access process is being done by an authorized user.

The FDA guidance, “Content of Premarket Submissions for Management of Cybersecurity in

Medical Devices,” 9 provides additional information regarding cybersecurity and medical
devices.

If the device includes off-the-shelf software, you should provide the additional information as
recommended in the FDA guidance titled “Off-The-Shelf Software Use in Medical Devices” 10
and “Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS)
Software.” 11

Overall, the documentation related to the software contained in the medical device should
provide sufficient evidence to describe the role of the software included in the device, and
performance testing to demonstrate that the software functions as designed.

VI. Biocompatibility
Significance: Electrosurgical devices contain patient-contacting materials that, when used as
intended, i.e., given the contact type and duration, may induce a harmful biological response.

Recommendation: You should determine the biocompatibility of all patient-contacting materials

present in your device. For polymeric materials, you should identify each material by trade name
and manufacturer. If your materials are identical in composition and processing methods to
materials used in a predicate device or another device with the same contact type and duration
(e.g., tissue contacting, less than 24 hours) for electrosurgical applications, you may reference
previous testing experience in lieu of new testing.

We recommend that you follow the FDA guidance, “Use of International Standard ISO 10993-1,
‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process,’” 12 which identifies the types of biocompatibility assessments that should
be considered and recommendations regarding how to conduct related tests.

Differences in formulation, processing, sterilization, or device surface properties that could affect
biocompatibility of the final product may warrant additional biocompatibility testing.

9
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-
management-cybersecurity-medical-devices-0.
10
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices.
11
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-healthcare-
organizations-about-fdas-guidance-industry-cybersecurity-networked-medical.
12
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.

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Most active electrodes should be considered external devices that contact tissue/bone/dentin for a
limited contact duration (less than 24 hours). As a result, we recommend evaluation for:

• Cytotoxicity (see ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests
for in vitro cytotoxicity);

• Intracutaneous reactivity (see ISO 10993-10, Biological evaluation of medical devices –

Part 10: Tests for irritation and skin sensitization);

• Delayed type sensitivity (see ISO 10993-10, Biological evaluation of medical devices –
Part 10: Tests for irritation and skin sensitization); and

• Consideration of acute systemic toxicity testing, either by inclusion of the testing or a

rationale for its omission (see ISO 10993-11, Biological evaluation of medical devices –
Part 11: Tests for systemic toxicity).

Most neutral electrodes should be considered surface devices that contact only intact skin for a
limited contact duration (less than 24 hours). As a result, we recommend evaluation for:

• Cytotoxicity (see ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests
for in vitro cytotoxicity);

• Dermal irritation (see ISO 10993-10, Biological evaluation of medical devices – Part 10:
Tests for irritation and skin sensitization); and

• Delayed type sensitivity (see ISO 10993-10, Biological evaluation of medical devices –
Part 10: Tests for irritation and skin sensitization).

For biocompatibility testing conducted using extraction samples, we recommend that you:

• Determine the appropriate amount of test material as outlined in ISO 10993-12,

Biological evaluation of medical devices – Part 12: Sample preparation and reference
materials, or an equivalent method, using surface area to extractant volume ratios (mass
to extractant volume ratios should only be used if surface area cannot be calculated);

• Use both polar and nonpolar extractants;

• Describe the condition of the extraction vehicle (e.g., color, presence of any particles);

• Explain any changes in the post-extraction vehicle (compared to pre-extraction); and

• Describe the details of storage conditions, if applicable.

VII. Sterility
Significance: Electrosurgical devices for general surgery indications come in contact with blood
and body tissue and should be adequately sterilized to minimize infections and related
complications.

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Recommendation: For electrosurgical devices labeled as sterile, we recommend that you provide
sterility information for the finished device. For information on sterility information in 510(k)
submissions for devices labeled as sterile, see the FDA guidance, “Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as
Sterile.” 13 You should sterilize the device to a sterility assurance level (SAL) of 1x10-6. Please
note that your sterilization process must be validated in accordance with the Quality System
Regulation (21 CFR part 820).

VIII. Reprocessing
Significance: The patient contacting components of electrosurgical devices that are reused
should be adequately cleaned, disinfected, and sterilized between uses to minimize infections and
prevent device degradation.

Recommendation: Under FDA labeling regulations (21 CFR part 801), a device must have
adequate directions for use, which include instructions on preparing a device for use. Instructions
on how to reprocess a reusable device or a single-use device that is provided non-sterile to the
user are critical to ensure that a device is appropriately prepared for its initial and/or subsequent
uses. For information on the development and validation of reprocessing instructions in your
proposed device labeling, see FDA’s guidance, “Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling.” 14

IX. Pyrogenicity
Significance: Pyrogenicity testing is used to help protect patients from the risk of febrile
reaction due to gram-negative bacterial endotoxins and/or chemicals that can leach from a
medical device (e.g., material-mediated pyrogens).

Recommendation: To address the risks associated with the presence of bacterial endotoxins,
electrosurgical devices labeled as “non-pyrogenic” should follow the recommendation in Section
VII, Sterility. Recommended pyrogen limit specifications have been identified in FDA’s
guidance, “Submission and Review of Sterility Information in Premarket Notification (510(k))
Submissions for Devices Labeled as Sterile.” 15

To address the risks associated with material-mediated endotoxins, it is recommended that you
follow the recommendations in the FDA guidance, “Use of International Standard ISO 10993-1,
‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process.’” 16

13
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled.
14
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling.
15
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled.
16
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.

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For devices intended to be labeled as “non-pyrogenic,” we recommend that both the bacterial
endotoxin and rabbit material-mediated pyrogen testing be conducted.

X. Shelf Life
Significance: Shelf life testing is conducted to support the proposed expiration date through
evaluation of the package integrity for maintaining device sterility and/or evaluation of any
changes to device performance or functionality.

Recommendation: With respect to package integrity for maintaining device sterility, you should
provide a description of the packaging, including how it will maintain the device’s sterility, a
description of the package integrity test methods, and a summary of the package integrity test
results. FDA recommends that package integrity test methods include simulated distribution and
associated package integrity, as well as simulated (and/or real-time) aging and associated seal
strength testing, to validate package integrity and shelf life claims. We recommend you follow
the methods described in the FDA-recognized series of consensus standards AAMI/ANSI/ISO
11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for
materials, sterile barrier systems and packaging systems and AAMI/ANSI/ISO 11607-2:
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for
forming, sealing and assembly processes.

With respect to evaluating the effects of aging on device performance or functionality, shelf life
studies should evaluate the critical physical and mechanical properties of the device that are
necessary to ensure it will perform adequately and consistently during the entire proposed shelf
life. To evaluate device functionality, we recommend that you assess each of the bench tests
described in Section XI, Performance Data, and repeat all tests that evaluate design components
or characteristics that are potentially affected by aging. For example, aging can affect the
performance of most polymeric materials used; therefore, tests that evaluate the integrity and
performance of the insulation should be repeated after aging. For those bench tests that you do
not repeat, you should provide a rationale explaining why the performance characteristics
assessed by the tests are not expected to be affected by aging.

We recommend that you provide a summary of the test methods used for your shelf life testing,
results and the conclusions drawn from your results. If you use devices subject to accelerated
aging for shelf life testing, we recommend that you specify the way in which the device was aged
and provide a rationale to explain how the results of shelf life testing based on accelerated aging
are representative of the results if the device were aged in real time. We recommend that you age
your devices as per the currently FDA-recognized version of ASTM F1980: Standard Guide for
Accelerated Aging of Sterile Barrier Systems for Medical Devices and specify the environmental
parameters established to attain the expiration date. For devices or components containing
polymeric materials, you should conduct testing on real-time aged samples to confirm the results
of the accelerated aging study. This testing should be conducted in parallel with 510(k) review
and clearance, with results documented to file in the design history file (i.e., the test reports do
not need to be submitted to FDA).

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XI. Performance Data

We recommend that nonclinical testing be performed to demonstrate that each individual
component of the device, as well as the electrosurgical device with all the components connected
(system), meets all the design and performance specifications. In the case where the 510(k)
submission is for one or more components of the electrosurgical device but not the entire
electrosurgical device (e.g., electrosurgical generator only or active electrodes only), nonclinical
testing as a system should be provided using legally marketed components with which your
device is labeled as compatible. Depending on the substantial equivalence comparison to the
predicate(s) above, nonclinical testing may be accomplished with bench testing alone, or an in
vivo or ex vivo animal model may be necessary. 17 The following are recommended nonclinical
tests for each major component and for the system.

ESU
For each mode, you should provide a graphical display of the output waveform at the
rated load, identifying the associated mode, amplitude, frequency, duty cycle, load used,
and crest factor.

For each mode, you should provide a graph displaying the power output at maximum and
half-of-maximum intensity over the range of expected loads (e.g., 100 Ω to 2000 Ω for
monopolar). This information should be derived from experimental test data and not
theoretical values, and it should include a comparison of these curves to the
corresponding mode of the predicate device(s).

Active Components/Accessories
Mechanical testing of electrosurgical instruments is important to minimize the risks
associated with mechanical failure and short circuiting. Although the methods will vary
based on the device design, you should assess the potential for damage to the device both
before use (e.g., drop tests of the instrument in its packaging) and during use (e.g.,
bending force). Different considerations will also be necessary for single-use instruments
versus reusable instruments. For reusable instruments, testing should demonstrate both
adequate mechanical strength and electrical performance (e.g., insulation integrity) after
multiple reuse and reprocessing cycles. For instruments with actuating parts, we
recommend simulated repeated-use testing of the actuating part, including grasping force
and force to jaw failure. Force to jaw failure is defined as the force required to cause the
articulating component to no longer be able to grasp or close on the target tissue. This
testing is important to ensure that the device can appropriately grasp the target tissue
under worst case scenarios. Testing of the cutting performance of any instrument that
includes a mechanical cutting function should also be performed, where applicable. For

17
FDA supports the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. We
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable,
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency
to an animal test method.

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 Contains Nonbinding Recommendations

reusable instruments, this testing should be conducted after the maximum number of
simulated use and reprocessing cycles.

Neutral Electrodes
Neutral electrode thermal performance, contact impedance, and adhesion testing should
be performed in accordance with the currently FDA-recognized version of IEC 60601-2-
2, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety
and essential performance of high frequency surgical equipment and high frequency
surgical accessories. If alternative test methods and test procedures are developed, a
detailed description of the testing and test results should be provided. In addition, you
should provide a discussion regarding why the testing and test results are comparable to
the currently FDA-recognized version of the IEC 60601-2-2 standard.

For reusable neutral electrodes, the above testing should be performed following
simulated reuse and reprocessing cycles according to the instructions for use.

Miscellaneous Components/Accessories
When your electrosurgical device also includes accessories such as a foot pedal,
irrigation pump, suction device, or smoke evacuation device, you should provide test
results to show that each of those accessories meets all of the design and performance
specifications.

If a component/accessory has been previously cleared by FDA, you may provide the
original 510(k) as a reference, rather than conducting additional tests for the referenced
component/accessory. However, compatibility between the component/accessory and the
proposed device should still be addressed.

System Testing
In addition to the component testing, testing of the electrosurgical device with all the
components and accessories working together as a system may be necessary. The
following are examples of system testing that may be needed for electrosurgical devices:

1. Thermal Effects on Tissue

For each mode and each representative active component or electrode, you should
provide a measurement (under magnification) of the size (length, width, and depth) of
the thermal damage zone, i.e., coagulation necrosis. This testing may be performed on
ex vivo animal tissue.

To support a specific soft tissue indications for use, testing should be performed in
tissues relevant to the specific indications for use. The target and surrounding tissues
should be used to provide the most clinically applicable thermal data. In some cases,
other tissue type(s) with comparable thermo-physiological properties may be
considered for testing if accompanied by a scientific justification.

15
 Contains Nonbinding Recommendations

To support a general soft tissue indication, testing should include at least three tissue
types. FDA recommends testing liver, kidney, and muscle tissue to cover a range of
tissue densities, but other tissue types may be appropriate based on the proposed
indicated treatment location. We recommend measuring thermal damage under
magnification using histology; however, if another method is used, a rationale for that
measurement method should be provided.

If active components or electrodes are grouped into a device family for test purposes,
you should provide the rationale for identifying a family representative or otherwise
pooling data from multiple active components in the test protocol. At a minimum,
each test should be performed in triplicate at the minimum, default, and maximum
power settings. We recommend providing the results in a chart and/or graph that
indicates the width and depth of thermally damaged zone in relation to the power
setting, and duration of activation for different tissue types.

Thermal damage is a function of spatial temperature distribution over time (i.e.,

“temperature-time history”), which involves heating as well as cooling. Therefore,
testing should be performed such that the tissue is exposed to relevant (best-case,
realistic-case, and worst-case) temperature-time history as expected in vivo. The
tissue should be maintained at the baseline temperature relevant for the indications for
use (e.g., core body temperature for internal tissues) prior to application of the active
component or electrode. After application of the device, the tissue should be allowed
to cool back down to baseline temperature as it would under clinical conditions of use
in order for the energy to flow and the thermal damage to develop.

The tissue under test should be such that the flow of energy and thus, the
development of thermal damage, is not impeded by the boundary conditions. For
example, during testing in ex vivo tissue, if the tissue sample is too small or too thin,
then the tissue would not be large enough for the thermal damage to fully develop.
Also, during ex vivo tissue testing if the tissue is kept at baseline temperature using a
water bath, but the flow rate in the water bath is set too high, the flow may impede the
development of thermal damage by removing the energy reaching the tissue
boundaries faster than what is typically permissible physiologically.

We recommend providing graphs of temperature versus time at relevant locations in

the tissue of interest to show that the thermal damage was produced in response to the
temperature-time history relevant for the clinical conditions of use. The temperature-
time history should be measured using temperature probes that are calibrated and that
have appropriate response time to be able to accurately measure the temperatures.
Data and/or justification should be provided regarding the appropriateness of the
temperature probes in measuring temperatures with sufficient spatial and temporal
resolution.

Thermal damage should be assessed using histological stains, such as Hematoxylin-

Eosin (H&E), lactate dehydrogenase (LDH), or triphenyl tetrazolium chloride (TTC).
Your choice of stain should be appropriate to fully assess the extent (depth, thickness,
width, and volume) of the adversely affected tissue region. You should provide data

16
 Contains Nonbinding Recommendations

and/or a scientific justification to show that your choice of stain(s) enables you to
accurately quantify the full extent of the adversely affected tissue region.

Note that for specific tissue and/or anatomic location type indications (e.g., lung,
colorectal tissue, skin, mucosa, neural tissue), additional testing may be necessary in a
chronic animal study. If you believe a chronic animal study is necessary, we highly
recommend that you contact the Agency through the Q-Submission process to obtain
early feedback on your study design considerations (see FDA guidance, “Requests for
Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program”). 18

2. Temperature Monitoring
For electrosurgical devices that include temperature sensing, you should provide
testing to demonstrate that this feature works as intended. Although the methods will
vary based on the device design, your testing should demonstrate that the temperature
sensing under simulated conditions meets your design specification and performance
requirements.

3. Contact Quality Monitoring (CQM) and/or Continuity Monitoring

For electrosurgical generators and neutral electrodes with contact quality and/or
continuity monitoring capabilities, you should provide testing to demonstrate that
these features work as intended. Although the methods will vary based on the
monitoring design, your testing should provide data on conditions where the
monitoring is effective in order to write adequate instructions for use.

4. Capacitive Coupling
If the proposed device design includes monopolar electrosurgical electrodes for use in
minimally invasive surgery, we recommend you test for active coupling resistance
between the subject device and a conductive cannula/trocar device under simulated
normal use conditions. This testing should be performed as recommended by the
currently FDA-recognized versions of IEC 60601-2-18, Medical electrical equipment
– Part 2-18: Particular requirements for the basic safety and essential performance
of endoscopic equipment and IEC 60601-2-2. For electrosurgical electrodes and
accessories, we also recommend you address the risks of leakage currents through
insulation as well as capacitive coupling with other surgical equipment (e.g., pulse
oximeter probes, invasive blood pressure transducers, temperature probes camera
systems) as a part of your risk management process (e.g., cross-coupling between
different HF patient circuits).

You should provide complete test reports for each test conducted. For information on
recommended content and format of test reports for non-clinical bench performance testing in

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
18

medical-device-submissions-q-submission-program.

17
 Contains Nonbinding Recommendations

premarket submissions, refer to FDA’s guidance, “Recommended Content and Format of Non-
Clinical Bench Performance Testing Information in Premarket Submissions.” 19

FDA recommends that complete test reports be provided for all tests performed because the IEC
60601-2-2 and IEC 60601-2-18 series of standards include general methods with multiple
options, and in some cases they do not include acceptance criteria or address assessment of
results. Therefore, when a declaration of conformity (DOC) is submitted with respect to IEC
60601-2-2 and IEC 60601-2-18, a copy of the supplemental information used to support the
declaration (e.g., a copy of the study test report) should be provided. For additional information
regarding the use of consensus standards and a DOC, refer to the FDA guidance, “Appropriate
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” 20

You should also provide an explanation of how the data generated from the test support a finding
of substantial equivalence. For any tests involving tissue effects, you should describe the clinical
relevance of the acceptance criteria for each test and explain why the test results demonstrate
acceptable clinical performance of your device. Nonclinical test conditions should simulate the
worst-case conditions that your device is likely to encounter during clinical use. For those
nonclinical tests that do not rely on FDA-recognized consensus standards, the results of the
testing on the proposed device should be compared to those of your predicate device(s).

XII. Electrical Safety and Electromagnetic Compatibility

Significance: Electrical safety is the ability of a device to operate properly in its intended use
environment without operating unexpectedly due to electrical fluctuations from either battery or
mains power. Electromagnetic compatibility (EMC) is the ability of a device to operate properly
in its intended use environment without operating unexpectedly due to electromagnetic
disturbances or introducing excessive electromagnetic disturbance into that environment.

Recommendation: All electrosurgical devices should undergo basic electrical, thermal, and
EMC testing to evaluate the potential for insufficient electrical safety and EMC. We recommend
that you conduct your testing and comply with the labeling provisions outlined in the currently
FDA-recognized versions of the 60601 series of standards listed below. Given the potential
variability in the test setup due to different designs and multiple components, you should submit
the complete test reports for your device in reference to these standards.

• AAMI/ANSI ES60601-1, Medical electrical equipment – Part 1: General requirements

for basic safety and essential performance

19
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket.
20
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices.

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 Contains Nonbinding Recommendations

• IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests

• IEC 60601-2-2, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories

Additionally, endoscopic/laparoscopic electrosurgical instruments should demonstrate

compliance with IEC 60601-2-18, Medical electrical equipment – Part 2-18: Particular
requirements for the basic safety and essential performance of endoscopic equipment.

For additional information on providing EMC information in a premarket review, please see the
FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of
Electrically-Powered Medical Devices.” 21

In addressing EMC, please be aware that according to IEC 60601-2-2, high frequency surgical
instruments are intentional emitters of electromagnetic energy and, therefore, emissions testing
to IEC 60601-1-2 is only needed for power generators in the idle state (i.e., powered on but
surgical energy not activated). However, even during idle testing, particular attention should be
paid to the effects of connected accessories and instruments, such as cord length (for resonant
frequency) and instruments that contain electronics. For instruments with different cord lengths,
connection types, or electronic components, it may not be appropriate to use a single
“representative” instrument model for testing purposes.

If your submission is for a specific component of the electrosurgical device, you are still
expected to evaluate your component while connected to other components of the electrosurgical
device system. This should be performed consistent with how you intend or expect your
component to be used and the intended environment of use.

If your electrosurgical device incorporates wireless technology including RFID (radio frequency
identification) technology, meeting the IEC 60601 standards is insufficient to demonstrate that
your device will not be susceptible to electromagnetic interferences and that your wireless
technology will perform reliably. Review FDA’s guidance, “Radio Frequency Wireless
Technology in Medical Devices,” 22 for a discussion on risks associated with wireless technology
and suggestions regarding how to address these risks.

XIII. Clinical Testing

Clinical data are generally not necessary to support 510(k) submissions for electrosurgical
devices that are intended for general surgery indications. However, if your device indications for
use or device technology and/or mechanism of action is significantly different when compared to

21
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-support-claim-
electromagnetic-compatibility-emc-electrically-powered-medical-devices.
22
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-
technology-medical-devices-guidance-industry-and-fda-staff.

19
 Contains Nonbinding Recommendations

the predicate device(s), and if nonclinical testing is insufficient to establish substantial

equivalence, clinical testing may be necessary to establish substantial equivalence to a predicate
device. For example, many electrosurgical devices for aesthetic use have utilized clinical data to
demonstrate that the devices are as safe and effective as the predicate. For additional information
regarding this topic, refer to Section F of the FDA guidance document, “The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” 23

If you believe that clinical data are necessary, or if you are uncertain, we highly recommend that
you contact the Agency through the Q-Submission process to obtain early feedback on study
design considerations (see the FDA guidance, “Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program”). 24

XIV. Labeling
The premarket notification must include labeling in sufficient detail to satisfy the requirements
of 21 CFR 807.87(e). Proposed labels, labeling, and advertisements sufficient to describe the
electrosurgical device, its intended use, and the directions for use must be provided with a
specific intended use statement and any warnings, contraindications, or limitations clearly
displayed as described in 21 CFR 807.87(e). Please consider the following suggestions for
assistance in preparing labeling that satisfies the requirements of 21 CFR 807.87(e). The
following suggestions are aimed at assisting you in preparing acceptable labeling.

Although final labeling is not required for 510(k) clearance, final labeling must comply with the
requirements of 21 CFR part 801 before a medical device is introduced into interstate commerce.
In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109.

As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate
directions for lay use. Labeling must, however, include adequate information for practitioner use
of the device, including indications, effects, routes, methods, frequency and duration of
administration and any relevant hazards, contraindications, side effects, and precautions (21 CFR
801.109(d)).

As stated above in Section XII, Electrical Safety and Electromagnetic Compatibility, we

recommend that all electrosurgical device submissions demonstrate compliance with the labeling
sections of the currently FDA-recognized versions of the 60601 series of standards, including
AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and (when applicable) IEC 60601-2-
18. We also recommend that you include the information below in your labeling. Please note that
some of the recommended labeling content is already included in the standards but has been
repeated for emphasis. Other recommended content has been modified from the standards.

Electrosurgical systems generally consist of several different interchangeable components used

together to create the desired effect, including the ESU, active accessory, neutral electrodes,

23
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k.
24
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program.

20
 Contains Nonbinding Recommendations

footswitches, etc. Some of the labeling recommendations below may apply to only a single
component or to each component in a system. You should determine which labeling is
appropriate, depending on the indications for use, the individual component, and how the
components may be packaged (together or separately). If your submission is for a specific
component, your labeling should describe compatibility recommendations and results from your
risk assessment, as it relates to device compatibility.

The list below is not intended to be exhaustive of all the labeling requirements under part 801.

Instructions for Use (User Manual)

1. Indications for Use
Your labeling should clearly state the indications for use of your device as specified
in your Indications for Use Statement. This information should be prominently
located in the beginning of your directions for use. If your device consists of multiple
components with different indications, please specify this in your labeling.

2. Warnings
We recommend including the following warnings, as applicable, in the instructions
for use. Sample language is provided in italics. If you believe any of these warnings
are not applicable to your device, you should provide a justification for each
omission.

a. DO NOT USE in patients who have electronic implants such as cardiac

pacemakers without first consulting a qualified professional (e.g., cardiologist). A
possible hazard exists because interference with the action of the electronic
implant may occur, or the implant may be damaged.

b. DO NOT USE in the presence of flammable anesthetics or oxidizing gases (such

as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such
as ether or alcohol), as explosion may occur.

c. DO NOT place instruments near or in contact with flammable materials (such as

gauze or surgical drapes). Instruments that are activated or hot from use may
cause a fire.

d. When not using instruments, place them in a clean, dry, highly visible area not in
contact with the patient. Inadvertent contact with the patient may result in burns.

e. INSPECT instruments and cables for damage prior to each use, especially the
insulation of laparoscopic/endoscopic instruments. This may be done visually
under magnification or with a high voltage insulation testing device. Insulation
failures may result in burns or other injuries to the patient or operator.

f. The surface of the active electrode may remain hot enough to cause burns after
the RF current is deactivated.

21
 Contains Nonbinding Recommendations

g. Due to concerns about the carcinogenic and infectious potential of

electrosurgical byproducts (such as tissue smoke plume and aerosols), protective
eyewear, filtration masks, and effective smoke evacuation equipment should be
used in both open and laparoscopic procedures.

h. Connect adaptors and accessories to the electrosurgical unit only when the
energy is off. Failure to do so may result in an injury or electrical shock to the
patient or operating room personnel.

i. If the device is argon enhanced, you should include warnings and

recommendations regarding gas embolisms.

j. If the instrument is reusable, you should also include a warning that visual
inspection alone may not be sufficient to ensure that the insulation is intact.

k. DO NOT activate the instrument when not in contact with target tissue, as this
may cause injuries due to capacitive coupling with other surgical equipment.

The following additional warnings should be included for monopolar instruments:

l. ASPIRATE fluid from the area before activating the instrument. Conductive fluids
(e.g., blood or saline) in direct contact with or in close proximity to an active
electrode may carry electrical current or heat away from target tissues, which
may cause unintended burns to the patient.

m. DO NOT USE with hybrid trocar systems, i.e., a combination of metal and plastic,
when using monopolar active components. This may result in alternate site burns
due to capacitive coupling. Use only all-metal or all-plastic trocar systems.

n. Prior to increasing the intensity, check the adherence of the neutral electrode and
its connections. Apparent low output or failure of the device to function correctly
at the normal operating settings may indicate faulty application of the neutral
electrode or poor contact in its connections.

o. If the device uses a neutral electrode and does not have a CQM, you should
include a warning that loss of safe contact between the neutral electrode and the
patient will not result in an alarm.

p. If the device uses a neutral electrode and does have a CQM, you should include a
warning that loss of safe contact between the neutral electrode and the patient will
not result in an alarm unless a compatible monitoring neutral electrode is used.

3. Cautions
We recommend including the following cautions in the instructions for use. Sample
language is provided in italics.

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 Contains Nonbinding Recommendations

a. The intensity should be set as low as is necessary to achieve the desired effect.
[unless there is a risk associated with low settings, e.g., argon coagulation]

b. Keep the active electrodes clean. Build-up of eschar may reduce the instrument’s
effectiveness. Do not activate the instrument while cleaning. Injury to operating
room personnel may result.

4. Operating Information
Operating instructions should contain detailed information such that the practitioner
can set up and use the device safely and for the purposes for which it is intended. In
addition, we recommend that you include instructions concerning the proper selection
and use of accessories in order to avoid incompatibility and unsafe operation. In
particular, you should include advice concerning the compatibility between CQMs
and neutral electrodes and direct the user to verify that the generator’s output voltage
does not exceed the rated accessory voltage. For any accessories that may need to be
replaced (e.g., disposable electrodes), you should also provide instructions in your
labeling for obtaining replacements (e.g., model number and contact information).

Device Labels
In your submission, we recommend that you provide illustrations to show how each
component of your device is labeled to demonstrate that all controls, switches, and
connections (including those for hand switched active electrodes and foot switches) are
clearly, concisely, and permanently labeled to identify their function and other important
information (e.g., Type BF Applied Part). In the submission and the labeling, you should
also describe the color of any controls or connections (e.g., blue “coag” button) so that
the function of each is apparent.

Package Labels
We recommend that you provide draft package labels, which should include the
manufacturer, model number, and important information about device reuse, sterility,
shelf life, etc.

Labeling for Specific Components

1. ESU
Your directions for use should include information on the output specifications of
your device so that the user can easily understand the energy that is being delivered.
We recommend including the following information for each output mode of your
device:

a. Graphs or tables illustrating the actual power output (under a specified

impedance). These graphs or tables should be provided for each intensity setting
if multiple intensity settings are available.

23
 Contains Nonbinding Recommendations

b. Graphs displaying the power output at maximum and half-of-maximum intensity

over the range of expected impedances.

c. The maximum output voltage and instructions regarding selecting accessories

with appropriate voltage ratings.

2. Active components and active accessories

Your directions for use should include information on the compatibility of your active
electrodes with other components of the electrosurgical device. We recommend
including the following information:

a. The rated accessory voltage.

b. The compatible generator model or adequate instructions and criteria for the user
to identify an adequate generator.

c. The limitations on generator output settings and duration of activation.

d. A statement referring users to the generator and neutral electrode user manuals for
additional instructions.

e. If the instrument is monopolar, clearly communicate to the user that the hand
piece is a monopolar device, and that a neutral electrode should be used with the
generator to prevent burns/injury to the patient.

f. For ablation of tissue, the labeling should include a recommended ablation time
per lesion size, a lesion size and shape range for which the device is effective,
directions on how to perform multiple ablations on a single lesion including how
you relocate the probe in a lesion, a time versus temperature versus lesion size
created chart to inform users of the expected performance, and directions on how
the user knows when an ablation is complete.

3. Neutral Electrodes
For monopolar devices, your directions for use should include information on the
compatibility of your neutral electrodes with other components of the electrosurgical
device. We recommend including the following information:

a. The surface area and size.

b. Adequate instructions for the user to identify a compatible CQM or a warning that
it is not compatible with CQMs.

c. The compatible generator model or adequate instructions and criteria for the user
to identify an adequate generator.

d. The limitations of generator output settings and typical, tested, or demonstrated

times.

24
 Contains Nonbinding Recommendations

e. The appropriate patient population (e.g., size, weight).

f. Detailed instructions on how to apply the electrode to the patient, including

recommendations for application site selection and preparation, warnings and
precautions, and pre-application tests.

4. Components and Accessories

Your directions for use should include information on the compatibility for each of
your accessories with the electrosurgical device. For some accessories, such as
suction/irrigation pumps and smoke evacuation devices, separate instructions for use
should be considered.

5. Reusable Devices
For any reusable components and accessories, you should provide adequate
reprocessing instructions and information, as recommended in Section VIII.

25
 Contains Nonbinding Recommendations

Appendix A: Glossary of Terms

The following terms are defined for the purpose of this guidance only and may or may not
correspond to their broader usage.

Active accessory – The component of the electrosurgical device used by the operator to produce
surgical effects at the intended site on the patient. Generally comprised of an active handle,
the cord or cable, and the active electrode (monopolar or bipolar).

Active electrode – The conductive portion of the electrosurgical device that delivers high
density electrical current to the patient at the surgical site. This may or may not be
removable from the active handle.

Argon beam coagulator – An electrosurgical device that combines the uses of argon gas with
RF current to form a plasma at the surgical site to effect hemostasis in bleeding tissue.
Besides argon gas, other gases (e.g., nitrogen) have been used.

Bipolar – An electrosurgical device in which the current flows between two active electrodes
placed in close proximity.

Coagulation – The change of a liquid, especially blood, to a solid. This is considered separate
from coagulation necrosis.

Coagulation necrosis – Necrosis in which the affected cells or tissue are converted into a dry,
opaque, fairly homogenous eosinophilic mass as a result of the coagulation of protein.

Contact quality monitor (CQM) – A component of a monopolar electrosurgical system that

monitors the contact between the neutral electrode and the patient. The CQM produces an
alarm if the contact becomes insufficient and the patient is at risk for burns.

Continuity monitor – A component of a monopolar electrosurgical system that monitors the

connection between the neutral electrode and the generator. The continuity monitor
produces an alarm if the connection is lost, but it cannot detect if there may be a high
current density through the neutral electrode.

Electrocautery – The use of electric current to heat an instrument, which is applied to tissue to
create an effect. The current passes through the instrument only and not through the
patient’s tissue.
NOTE: The term electrocautery is often used incorrectly to refer to electrosurgical devices.
To prevent confusion, FDA recommends that you avoid misuse of this term.
Electrosurgical device – A device that passes high-frequency electrical current through soft
tissues for the purpose of removing tissue or controlling bleeding.

Electrosurgical system – A complete electrosurgical system includes the ESU, active

accessories, neutral electrodes (if applicable), and miscellaneous accessories.

26
 Contains Nonbinding Recommendations

ESU – Abbreviation for electrosurgical unit. This term refers to the generator and control
console.

Generator – The component of the electrosurgical system that produces the high-frequency
current waveform that is delivered to tissues via the connecting cable(s), instrument(s), and
electrode(s).

Hyfrecator – A type of monopolar electrosurgical device in which the current flows from a
single active electrode at the surgical site and returns to earth (ground) through the patient’s
own body capacitance.

Instrument – The component of the electrosurgical system that is manipulated by the operator
and applied to the surgical site, generally consisting of the handle and active electrode.

Monopolar – An electrosurgical technique in which the current flows from a single active
electrode at the surgical site, through the patient, to a relatively distant neutral electrode.

Neutral electrode – An electrode connected to the patient, in an anatomical location away from
the surgical site, to provide a return path for the high-frequency current. The neutral
electrode has a large area relative to the active electrode in order to provide a low current
density. Also known as: patient plate, ground pad, return electrode, dispersive electrode,
inactive electrode, passive electrode, indifferent electrode, etc.

Radiofrequency (RF) – Generally refers to frequencies ranging from 100 kHz to 5 MHz. This is
intended to exclude other frequencies (e.g., microwave ablation devices) that may
technically fall within the radiofrequency portion of the electromagnetic spectrum but
operate in a fundamentally different manner.

Vessel sealer – An electrosurgical device intended to seal isolated blood and lymphatic vessels
for hemostasis, as an alternative to ties. Usually bipolar.

27