January 8, 2021

XR, LLC
℅ Louie Goryoka
Sr. QA/RA Consultant
Med-Device Consulting, Inc.
5804 Rainbow Hill Road
Agoura Hills, CA 91301

Re: K202017
Trade/Device Name: Passion Natural Water Based Lubricant
Regulation Number: 21 CFR§ 884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: NUC
Dated: November 25, 2020
Received: December 1, 2020

Dear Louie Goryoka:

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 (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
located 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.

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.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.22
Silver Spring, MD 20993
www.fda.gov
K202017 - Louie Goryoka Page 2

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
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,

Michael T. Bailey -S
For
Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (ifknown)

K202017

Device Name
Passion Natural Water Based Lubricant

Indications for Use (Describe)

Passion Natural Water Based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to
moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural
lubrication. This product is compatible with polyisoprene condoms. This product is not compatible with natural rubber
latex and polyurethane condoms.

Type of Use (Select one or both, as applicable)

F Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number"

FORM FDA 3881 (6120) Page 1 of 1 PSC PublisAing Servics (301) 443-6740 EF
 510(K) SUMMARY K202017
Page 1 of 4
K202017
Passion Natural Water Based Lubricant

I. Submitter Information

Applicant: XR LLC.
Company Address: 5251 PIPELINE LANE
HUNTINGTON BEACH, CA 92649

Company Phone: (714) 907-1034

Company Contact: Gerardo Ramos

Contact Person: Louie Goryoka

Sr. Regulatory and Quality Consultant
Med-Device Consulting, Inc.
Email: mdci@m-dci.us
(818) 585-7488

II. Date Prepared: January 7, 2021

III. Device Information

Trade name: Passion Natural Water Based Lubricant

Common Name: Personal Lubricant
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: Class II
Product Code: NUC (lubricant, personal)

IV. Predicate Device: Pulse H20h!

510(k) number: K152628

The predicate device has not been subject to a design‐related recall.

V. Device Description
The Passion Natural Water Based Lubricant is a non-sterile, water-based personal lubricant that is
intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and
comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is
compatible with polyisoprene condoms, and is not compatible with natural rubber latex and
polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum,
methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion
Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap.
Passion Natural Water Based Lubricant is a personal lubricant for over-the-counter (OTC) use.

Device specifications are listed in the Table below

Property Specification
Appearance Clear, viscous liquid
Color Colorless
Odor Odorless
Viscosity@25°C 700 cps – 900 cps
Spindle LV#3hu@60rpm (cps)
Specific Gravity@25°C 1.00 – 1.20
pH 4.0 – 5.0
 K202017
Page 2 of 4
Osmolality 92.5 – 192.5 mOsm/kg (1:10 dilution)
Total aerobic microbial count
(TAMC) per USP <61> and <100 cfu/g
<1111>
Total yeast and mold count
(TYMC) per USP <61> and <10 cfu/g
<1111>
Antimicrobial effectiveness per Meets USP <51> acceptance criteria for Category 2 products.
USP <51> Category 2, bacteria should show not less than 2.0 log
reduction at 14 days and no increase from 14-day count at
the 28-day count. Yeast and molds should show no increase
from the initial calculated count at 14 and 28 days
Presence of Pathogenic
organisms (Staphylococcus
aureus, Pseudomonas Absent
aeruginosa, and Candida
albicans per USP <62>)

VI. Indications for Use

Passion Natural Water Based Lubricant is a personal lubricant for penile and/or vaginal application,
intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and
supplement the body's natural lubrication. This product is compatible with polyisoprene condoms.
This product is not compatible with natural rubber latex and polyurethane condoms.

VII. Predicate Device Comparison

A comparison of the indications for use an technological characteristics of the subject and predicate
device is summarized in the table below:
Passion Natural Water Based
Characteristic/Feature Pulse H20h! (K152628)
Lubricant (K202017)
Device Classification Name Lubricant, Personal Lubricant, Personal
Product Code NUC NUC
Passion Natural Water Based The Pulse H2Oh!
Lubricant is a personal lubricant Personal lubricant is
for penile and/or vaginal intended for vaginal
application, intended to and/or penile
moisturize and lubricate, to application to moisturize
enhance the ease and comfort of and lubricate, enhance
intimate sexual activity and the ease and comfort of
supplement the body's natural intimate sexual activity,
lubrication. This product is and supplement the
Indications for Use
compatible with polyisoprene body's natural
condoms. This product is not lubrication. This
compatible with natural rubber personal lubricant is
latex and polyurethane condoms. compatible with naural
rubber latex and
polyisoprene condoms.
This product is not
compatible with
polyurethane condoms.
Water Soluble Yes Yes
Contains water Yes Yes
Traditional 510(k) (Confidential) Page 2 of 4
 K202017
Page 3 of 4
Purified water,
Purified Water, Propanediol, Propanediol/Zemea
Xanthan Gum, Methocel, Sodium Propanediol,
Primary ingredients Benzoate, Potassium Sorbate, Hydroxyethylcellulose/N
Citric Acid, Hydroxyethylcellulose atrosol 250H Pharm,
(HEC). Potassium Sorbate, Chia
Seed Extract, Citric Acid.
Over-the-Counter Use Yes Yes
Labeled condom compatible Yes Yes
Natural Rubber Latex,
Condom Compatibility Polyisoprene
Polyisoprene
Biocompatibility Tested Yes Yes
pH 4.0 – 5.0 4.8 – 5.2
Tested – specification
92.5 mOsm – 192.5 mOsm (1:10
Osmolality not stated in predicate
dilution)
summary
• Total mold/yeast count <10
cfu/g
• Total aerobic microbial count
<100 cfu/g Parameters Tested –
Microbial Limits • Absence of pathogens specifications not stated
(Candida albicans, in predicate summary
Pseudomonas aeruginosa,
Staphylococcus aureus)

Antimicrobial Effectiveness
Tested (USP <51> Category 2 Yes Yes
Product)
Tested – specification
Viscosity 700 cps – 900 cps not stated in predicate
summary
The product is not a
contraceptive and does not Yes Yes
contain spermicide
Non-Sterile Yes Yes
Shelf life 8.5 months 2 years

The subject and predicate device have similar indications for use and have the same intended use
(i.e., provides lubrication during intimate sexual activity). The subject and predicate device have
different technological characteristics, including different formulations, specifications (e.g., pH, etc.),
and shelf-life. The different technological characteristics of the subject device do not raise different
questions of safety and effectiveness as compared to the predicate device.

VIII. Summary of Non-Clinical Performance Testing

Biocompatibility

Passion Natural Water Based Lubricant has undergone biocompatibility testing in accordance with the
2020 FDA guidance document “Use of International Standard ISO 10993-1, Biological Evaluation of
Medical Devices – Part 1: Evaluation and testing within a risk management process.” Testing included:

Traditional 510(k) (Confidential) Page 3 of 4

 K202017
Page 4 of 4
• Cytotoxicity (ISO Direct Contact Method, ISO 10993‐5:2009)
• Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993‐10:2010)
• Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993‐10:2010)
• Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993‐11:2017)

The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, non-irritating,
and non-systemically toxic.

Condom Compatibility
Passion Natural Water Based Lubricant was tested in accordance with ASTM D7661-10 “Standard Test
Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.”
Results showed that Passion Natural Water Based Lubricant is compatible with polyisoprene
condoms. This product is not compatible with natural rubber latex and polyurethane condoms.

Shelf Life Testing

Passion Natural Water Based Lubricant has a shelf-life of 8.5 months, according to the results of an
accelerated aging study per ASTM F1980-16. All device specifications listed in Section V. Device
Description of this summary were evaluated in the shelf-life study. The subject device met the device
specificaitons at all time points.

IX. Conclusion
The results of performance testing described above demonstrate that the Passion Natural Water
Based Lubricant is as safe and effective as the predicate device and supports a determination of
substantial equivalence.

Traditional 510(k) (Confidential) Page 4 of 4