Passion Natural Water Based Lubricant

K202017 · Xr, LLC · NUC · Jan 8, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K202017
• Device Name: Passion Natural Water Based Lubricant
• Applicant: Xr, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jan 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended 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.

Device Story

Passion Natural Water Based Lubricant is a non-sterile, water-based personal lubricant for over-the-counter use. It is applied topically to the penis or vagina to provide lubrication and moisture during intimate sexual activity. The device is packaged in 4 oz polyethylene terephthalate bottles. It is not a contraceptive and contains no spermicide. The lubricant is intended to enhance comfort and supplement natural lubrication. It is compatible with polyisoprene condoms but incompatible with natural rubber latex and polyurethane condoms. The device is used by consumers in a home setting.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) showed the device is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic. Condom compatibility tested per ASTM D7661-10. Shelf-life of 8.5 months validated via accelerated aging per ASTM F1980-16. Microbial limits and antimicrobial effectiveness tested per USP <61>, <1111>, and <51>.

Technological Characteristics

Water-based lubricant formulation: purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, hydroxyethylcellulose. pH 4.0-5.0; viscosity 700-900 cps; osmolality 92.5-192.5 mOsm/kg. Packaged in 4 oz polyethylene terephthalate bottles. Non-sterile. Tested per ASTM D7661-10 for condom compatibility and ASTM F1980-16 for shelf-life.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity. Compatible with polyisoprene condoms; not compatible with natural rubber latex or polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Pulse H20h! (K152628)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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 LANE<br>HUNTINGTON BEACH, CA 92649 |
| Company Phone: | [phone] |
| Company Contact: | Gerardo Ramos |
| Contact Person: | Louie Goryoka<br>Sr. Regulatory and Quality Consultant<br>Med-Device Consulting, Inc.<br>Email: [e-mail]<br>[phone] |
| 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.

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.

| 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 ( <i>Staphylococcus aureus</i> , <i>Pseudomonas aeruginosa</i> , and <i>Candida albicans</i> 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 Based<br>Lubricant (K202017) | Pulse H20h! (K152628) |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Passion Natural Water Based<br>Lubricant is a personal lubricant<br>for penile and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with polyisoprene<br>condoms. This product is not<br>compatible with natural rubber<br>latex and polyurethane condoms. | The Pulse H2Oh!<br>Personal lubricant is<br>intended for vaginal<br>and/or penile<br>application to moisturize<br>and lubricate, enhance<br>the ease and comfort of<br>intimate sexual activity,<br>and supplement the<br>body's natural<br>lubrication. This<br>personal lubricant is<br>compatible with natural<br>rubber latex and<br>polyisoprene condoms.<br>This product is not<br>compatible with<br>polyurethane condoms. |
| Water Soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Purified Water, Propanediol,<br>Xanthan Gum, Methocel, Sodium<br>Benzoate, Potassium Sorbate,<br>Citric Acid, Hydroxyethylcellulose<br>(HEC). | Purified water,<br>Propanediol/Zemea<br>Propanediol,<br>Hydroxyethylcellulose/N<br>atrosol 250H Pharm,<br>Potassium Sorbate, Chia<br>Seed Extract, Citric Acid. |
| Over-the-Counter Use | Yes | Yes |
| Labeled condom compatible | Yes | Yes |
| Condom Compatibility | Polyisoprene | Natural Rubber Latex,<br>Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| pH | 4.0 - 5.0 | 4.8 - 5.2 |
| Osmolality | 92.5 mOsm - 192.5 mOsm (1:10<br>dilution) | Tested - specification<br>not stated in predicate<br>summary |
| Microbial Limits | Total mold/yeast count <10 cfu/g Total aerobic microbial count <100 cfu/g Absence of pathogens ( <i>Candida albicans</i> ,<br><i>Pseudomonas aeruginosa</i> ,<br><i>Staphylococcus aureus</i> ) | Parameters Tested –<br>specifications not stated<br>in predicate summary |
| Antimicrobial Effectiveness<br>Tested (USP <51> Category 2<br>Product) | Yes | Yes |
| Viscosity | 700 cps - 900 cps | Tested - specification<br>not stated in predicate<br>summary |
| The product is not a<br>contraceptive and does not<br>contain 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.