May 28, 2024
Sibel Health Inc.
Sarah Coughlin
Regulatory Affairs Manager
2017 N Mendell St.
Suite 2SE
Chicago, Illinois 60614
Re: K240305
Trade/Device Name: ANNE Limb
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA, FLL
Dated: May 7, 2024
Received: May 7, 2024
Dear Sarah Coughlin:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.06.10
Silver Spring, MD 20993
www.fda.gov
K240305 - Sarah Coughlin Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
510(K) Summary
I. Submitter:
Sibel Health Inc.
2017 N Mendell St. Suite 2SE Chicago, IL 60614
Tel: (224) 251-8859
Official Correspondent:
Sarah Coughlin, Regulatory Affairs Manager
2017 N Mendell St. Suite 2SE Chicago, IL 60614
Tel: (224) 251-8859
Date Prepared: 04/26/2024
II. Device Information
Name of Device: ANNE Limb
510K Number: K240305
Classification Name: Oximeter
Regulation: 21 CFR §870.2700
Regulatory Class: Class II
Product Classification Code: DQA, FLL
III. Predicate Device
Trade Name: ANNE One
510(k): K223711
Device Manufacturer: Sibel Health Inc.
IV. Device Description
The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals
including photoplethysmography (PPG) and temperature. The ANNE Limb sensor has
on-device processing of raw data for the calculation of SpO2 and pulse rate. The sensor
communicates via Bluetooth to the Sibel SDK, which may be integrated within software
applications for the display and storage of data.
V. Indications for Use
The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional
oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE
510(k) Summary Page 1 of 5
K240305
Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient
undergoes significant motion or is active. The ANNE Limb Sensor communicates with
compatible software applications for the display, storage, and analysis of data. The device is
indicated for use as an aid to diagnosis and treatment by healthcare professionals in general
care patients who are 12 years of age or older in clinical and home environments. The device is
not intended for use on critical care patients.
VI. Performance Data
The following consensus standards and bench testing were used to evaluate the safety and
performance of ANNE Limb:
● Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI
ES60601-1:2005/(R)2012 and IEC 60601-1-2 Edition 4.0 2014 standards. Electrical
safety testing in the home healthcare environment per IEC 60601-1-11:2015.
● Biocompatibility testing according to ISO 10993-5:2009 and ISO 10993-10:2010 for
patient contacting materials.
● Wireless coexistence testing according to ANSI IEEE C63.27-2017.
● Software verification and validation testing according to IEC 62304:2015 and the FDA
guidance document, Content of Premarket Submissions for Software Contained in
Medical Devices.
● Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC
60601-2-47:2012.
● Shelf life testing of the adhesive to demonstrate safety and performance over the
intended device life cycle.
● Bench testing to demonstrate the mechanical durability of the sensors.
● Usability testing in accordance with the FDA guidance document, Applying Human
Factors and Usability Engineering to Medical Devices.
● Performance testing of pulse rate and skin temperature.
● Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in
Medical Devices: Quality System Considerations and Content of Premarket Submissions
VII. Clinical Studies
SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas
analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to
Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions
[510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013.
Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker
skin pigmentation (Fitzpatrick 5). The average root mean square error (ARMS) was 2.31%,
meeting the requirements of the above-mentioned standard.
510(k) Summary Page 2 of 5
K240305
VIII. Conclusion
The results of the substantial equivalence assessment, taken together with safety and
performance testing data, demonstrate that ANNE Limb’s performance characteristics are
substantially equivalent to the predicate device in both technology and intended use.
Subject device Predicate device Variances / Equivalence
Sibel Health Inc. Sibel Health Inc.
Trade Name ANNE Limb ANNE One
510(k) Number K223711
Class II II Equivalent
Product Code DQA, FLL DRG, DQA, FLL, KMI, MWI, Similar
MWJ The MWJ, MWI, KMI, and
DRG product codes represent
functionalities supported by the
ANNE One predicate device
that are not part of the
intended use of the subject
device.
Both devices share the DQA
and FLL product codes.
Regulation 870.2700 870.2910 Different
Number and Oximeter Transmitters and Receivers, The primary product codes are
Regulation Physiological Signal, different. The predicate device
Name Radiofrequency also has the DQA product code
for oximetry.
Indications for The ANNE Limb Sensor is a ANNE One is a wireless Similar
Use pulse oximeter intended for monitoring platform indicated The subject device utilizes the
continuous monitoring of for the measurement of same sensor and algorithms
for the calculation of SpO2,
functional oxygen saturation of electrocardiography (ECG)
pulse rate, and skin
arterial hemoglobin (SpO2), waveforms, heart rate, temperature as the Limb
pulse rate, and skin respiratory rate, functional Sensor of the predicate device,
temperature. The ANNE Limb oxygen saturation of arterial ANNE One. The ANNE One
Sensor is not intended to hemoglobin (SpO2), pulse rate, predicate had additional
monitor or measure SpO2 or activity, body position, fall outputs including ECG, heart
pulse rate while the patient detection, skin temperature, rate, respiratory rate, and body
position. This difference does
undergoes significant motion or and body temperature by
not affect the substantial
is active. The ANNE Limb qualified healthcare equivalence of the output
Sensor communicates with professionals in home and parameters indicated for use in
compatible software healthcare settings. ANNE One the subject device.
applications for the display, is compatible with third-party,
storage, and analysis of data. FDA-cleared devices for
The device is indicated for use noninvasive blood pressure,
as an aid to diagnosis and SpO2, pulse rate, and body
treatment by healthcare temperature measurements.
professionals in general care The device is indicated for
patients who are 12 years of monitoring ECG waveforms
age or older in clinical and and heart rate on ambulatory
510(k) Summary Page 3 of 5
K240305
home environments. The patients. The device is not
device is not intended for use intended to monitor or measure
on critical care patients. respiratory rate, SpO2, pulse
rate, or noninvasive blood
pressure while the patient
undergoes significant motion or
is active.
ANNE One continuously
monitors the orientation of
patients to aid in the prevention
of pressure ulcers for at-risk
patients. The system provides
visual notification when the
patient’s position has not
changed from a preset
threshold of time.
The device is intended for use
on general care patients who
are 12 years of age or older as
a general patient monitor to
provide continuous
physiological information as an
aid to diagnosis and treatment.
The data from ANNE One are
transmitted wirelessly for
display, storage, and analysis.
The device is not intended for
use on critical care patients.
Target 12 years of age and older 12 years of age and older Equivalent
Population
Use Home and healthcare settings Home and healthcare settings Equivalent
Environment
Reprocessing Reusable on multiple patients. Reusable on a single patient. Similar
The subject device is reusable
on multiple patients. Validation
of the cleaning process and
mechanical testing
demonstrate that this
difference does not impact
substantial equivalence.
Sensor Finger Finger and Chest Similar
Placement Placement of the ANNE Limb
sensor on the finger is the
same between the subject and
predicate devices. The
predicate device includes an
additional sensor, the ANNE
Chest Sensor, that is worn on
the chest. The ANNE Chest
sensor is not part of the scope
510(k) Summary Page 4 of 5
K240305
of the subject device.
Heart Rate Not Applicable 30-270 bpm Not Applicable
(the greater of ± 10% or ± 5
bpm)
Respiratory Not Applicable Accelerometer-derived Not Applicable
Rate 8 - 30 bpm
(± 3 bpm RMSE)
Skin 73.4°F - 109.4°F (±0.54°F) 73.4°F - 109.4°F (±0.54°F) Equivalent
Temperature 23°C - 43°C (±0.3°C) 23°C - 43°C (±0.3°C)
SpO2 ARMS ≤ 3% (range 70-100%) ARMS ≤ 3% (range 70-100%) Equivalent
Pulse Rate 30-300 bpm (±3 bpm RMSE) 30-300 bpm (±3 bpm RMSE) Equivalent
Activity Not Applicable Accelerometer Not Applicable
Posture Not Applicable Body Position Not Applicable
Fall Detection
Non-Invasive Not Applicable 0 - 300 mmHg Not Applicable
Blood Pressure (± 3 mmHg)
(NIBP)
Data Data is transmitted wirelessly Data is transmitted wirelessly Similar
via Bluetooth from the sensor via Bluetooth from the sensors The subject device allows
to the Sibel SDK, which may to a mobile device. Data may communication with compatible
be downloaded for later software applications for the
be integrated within software
storage and analysis. display, storage, and analysis
applications for the display and of data.
storage of data.
Notification No notification ability. Provides visual notification on Similar
patient orientation. The subject device provides a
visual notification on patient
orientation.
510(k) Summary Page 5 of 5
K240305
