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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "Passion Natural Water Based Lubricant" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Appearance	Clear, viscous liquid	Clear, viscous liquid
Color	Colorless	Colorless
Odor	Odorless	Odorless
Viscosity @ 25°C (Spindle LV#3hu @ 60rpm)	700 cps – 900 cps	700 cps – 900 cps
Specific Gravity @ 25°C	1.00 – 1.20	1.00 – 1.20
pH	4.0 – 5.0	4.0 – 5.0
Osmolality (1:10 dilution)	92.5 - 192.5 mOsm/kg	92.5 - 192.5 mOsm/kg
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<100 cfu/g	<100 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	<10 cfu/g
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products (bacteria: >= 2.0 log reduction at 14 days, no increase from 14-day count at 28-day count; yeast/molds: no increase from initial calculated count at 14 and 28 days)	Meets USP <51> acceptance criteria for Category 2 products.
Presence of Pathogenic organisms ( S. aureus, P. aeruginosa, C. albicans) per USP <62>	Absent	Absent
Biocompatibility (Cytotoxicity)	Non-cytotoxic	Non-cytotoxic
Biocompatibility (Sensitization)	Non-sensitizing	Non-sensitizing
Biocompatibility (Vaginal Irritation)	Non-irritating	Non-irritating
Biocompatibility (Acute Systemic Toxicity)	Non-systemically toxic	Non-systemically toxic
Condom Compatibility	Compatible with polyisoprene condoms; not compatible with natural rubber latex and polyurethane condoms	Compatible with polyisoprene condoms; not compatible with natural rubber latex and polyurethane condoms
Shelf Life	Maintain all defined device specifications at all time points out to 8.5 months	Met all device specifications at all time points for 8.5 months.

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state a separate "test set" sample size in the context of an algorithm or AI model evaluation. The non-clinical performance testing described seems to refer to standard product testing rather than algorithm validation.

Sample Size: Not specified for individual tests beyond general descriptions (e.g., "results showed that Passion Natural Water Based Lubricant...").
Data Provenance: Not specified. It's implied to be internal testing conducted by or for the manufacturer (XR, LLC). The document does not indicate country of origin for the data or if it's retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The product is a personal lubricant, and the "ground truth" for its performance is established through laboratory and in-vivo (animal) biocompatibility testing, chemical/physical specification testing, and condom compatibility testing against established ASTM and USP standards, not through expert human review of data like in an imaging AI study.

4. Adjudication Method for Test Set

This information is not applicable for this type of device. The evaluation relies on standardized tests with objective pass/fail criteria, not on human adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. This device is a physical product, not an AI system.

6. Standalone Performance Study (Algorithm Only)

No standalone algorithm performance study was done. This document pertains to a physical medical device (personal lubricant), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

Laboratory measurements and assays: For properties like appearance, color, odor, viscosity, specific gravity, pH, osmolality, and microbial counts.
In-vivo (animal) testing: For biocompatibility (sensitization, vaginal irritation, acute systemic toxicity).
Established
standard test methods: Such as ASTM D7661-10 for condom compatibility, USP <61>, <62>, <51>, <1111> for microbial limits and effectiveness, and ISO 10993 series for biocompatibility.
Accelerated aging studies (ASTM F1980-16): For shelf-life determination.

8. Sample Size for Training Set

This information is not applicable. There is no AI model or algorithm being developed or "trained" for this device.

9. How Ground Truth for Training Set Was Established

This information is not applicable as there is no training set for an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

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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 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-regulatoryinformation/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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

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

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Indications for Use

510(k) Number (if known) K202017

Device Name Passion Natural Water Based Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Applicant:	XR LLC.
Company Address:	5251 PIPELINE LANEHUNTINGTON BEACH, CA 92649
Company Phone:	(714) 907-1034
Company Contact:	Gerardo Ramos
Contact Person:	Louie GoryokaSr. Regulatory and Quality ConsultantMed-Device Consulting, Inc.Email: mdci@m-dci.us(818) 585-7488
Date Prepared:	January 7, 2021
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)
Predicate Device:	Pulse H20h!

510(k) number: K152628

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

V. Device Description

ll.

III.

IV.

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

Device specifications are listed in the Table below

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Osmolality	92.5 - 192.5 mOsm/kg (1:10 dilution)
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<100 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products. 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 aeruginosa , and Candida albicans per USP <62>)	Absent

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:

Characteristic/Feature	Passion Natural Water BasedLubricant (K202017)	Pulse H20h! (K152628)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	Passion Natural Water BasedLubricant is a personal lubricantfor penile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with polyisoprenecondoms. This product is notcompatible with natural rubberlatex and polyurethane condoms.	The Pulse H2Oh!Personal lubricant isintended for vaginaland/or penileapplication to moisturizeand lubricate, enhancethe ease and comfort ofintimate sexual activity,and supplement thebody's naturallubrication. Thispersonal lubricant iscompatible with naturalrubber latex andpolyisoprene condoms.This product is notcompatible withpolyurethane condoms.
Water Soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Purified Water, Propanediol,Xanthan Gum, Methocel, SodiumBenzoate, Potassium Sorbate,Citric Acid, Hydroxyethylcellulose(HEC).	Purified water,Propanediol/ZemeaPropanediol,Hydroxyethylcellulose/Natrosol 250H Pharm,Potassium Sorbate, ChiaSeed Extract, Citric Acid.
Over-the-Counter Use	Yes	Yes
Labeled condom compatible	Yes	Yes
Condom Compatibility	Polyisoprene	Natural Rubber Latex,Polyisoprene
Biocompatibility Tested	Yes	Yes
pH	4.0 - 5.0	4.8 - 5.2
Osmolality	92.5 mOsm - 192.5 mOsm (1:10dilution)	Tested - specificationnot stated in predicatesummary
Microbial Limits	Total mold/yeast count <10 cfu/g Total aerobic microbial count <100 cfu/g Absence of pathogens ( Candida albicans ,Pseudomonas aeruginosa ,Staphylococcus aureus )	Parameters Tested –specifications not statedin predicate summary
Antimicrobial EffectivenessTested (USP <51> Category 2Product)	Yes	Yes
Viscosity	700 cps - 900 cps	Tested - specificationnot stated in predicatesummary
The product is not acontraceptive and does notcontain spermicide	Yes	Yes
Non-Sterile	Yes	Yes
Shelf life	8.5 months	2 years

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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:

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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.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.