INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant

K242645 · Project Chemistry, Inc. · NUC · Dec 6, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K242645
• Device Name: INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
• Applicant: Project Chemistry, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

INA Moisturizing Intimate Water-Based 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 natural rubber latex, polyurethane, and polyisoprene condoms.

Device Story

INA Moisturizing Intimate Water-Based Personal Lubricant is a non-sterile, water-based personal lubricant intended for penile and/or vaginal application to enhance comfort during sexual activity. It supplements natural lubrication and is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is sold as an over-the-counter (OTC) product in a 3 fl. oz. (90 mL) polyethylene vinyl alcohol bottle with a polypropylene flip cap. Users apply the lubricant topically as needed. The product is formulated with various ingredients including deionized water, aloe vera gel, and sodium hyaluronate. By reducing friction, the lubricant enhances ease and comfort, potentially benefiting the patient by preventing discomfort during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) demonstrated the device is non-irritating, non-sensitizing, and not systemically toxic. Condom compatibility testing performed per ASTM D7661-10 confirmed compatibility with natural rubber latex, polyisoprene, and polyurethane condoms. Shelf-life established at 6 months via real-time aging.

Technological Characteristics

Water-based personal lubricant. Ingredients: Deionized Water, Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Sea Buckthorn Oil. Physical properties: Translucent viscous gel, pH 4.3-5.3, viscosity 8,000-10,400 cps, osmolality 1394-1428 mOSm/kg. Non-sterile. Packaging: Polyethylene vinyl alcohol bottle with polypropylene flip cap.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity; compatible with natural rubber latex, polyurethane, and polyisoprene 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

• The Sex Gel Personal Lubricant (K181078)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2024

Project Chemistry, Inc. % Louie Goryoka Sr. Consultant RA/QA Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K242645

> Trade/Device Name: INA Moisturizing Intimate Water-Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 4, 2024 Received: September 9, 2024

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 (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.

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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).

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 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-reportingcombination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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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,

# 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

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## Indications for Use

510(k) Number (if known) K242645

#### Device Name

INA Moisturizing Intimate Water-Based Personal Lubricant

#### Indications for Use (Describe)

INA Moisturizing Intimate Water-Based 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 natural rubber latex, polyurethane, and polyisoprene 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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#### 510(K) SUMMARY

#### Submitter Information

| A. Company Name: | Project Chemistry |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| B. Company Address: | 18241 Gothard St.<br>Huntington Beach, CA 92648 |
| C. Company Phone: | [phone] |
| D. Company Contact | Jessica Graham – Sr. Director, Product Development |
| E. Submission Correspondent: | Louie Goryoka<br>Sr. VP. Regulatory and Quality Consultant<br>Med-Device Consulting, Inc.<br>Email: [e-mail]<br>[phone] |

#### F. Summary Preparation Date: December 4, 2024

#### Device Identification

| A. Device Trade Name: | INA Moisturizing Intimate Water-Based Personal Lubricant |
|-----------------------|----------------------------------------------------------|
| B. Common Name: | Personal Lubricant |
| C. Regulation Name: | Condom |
| D. Regulation Number: | 21 CFR §884.5300 |
| E. Device Class: | Class II |
| F. Product Code: | NUC (lubricant, personal) |
| H. Predicate Devices | The Sex Gel Personal Lubricant, K181078. |

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

#### Indications for Use Statement

INA Moisturizing Intimate Water-Based Personal 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 natural rubber latex, polyurethane, and polyisoprene condoms.

#### Device Description

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane

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condoms. The device is for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box.

This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.

The device specifications are listed in the table below:

| Property | Specification |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Translucent Viscous Gel |
| Color | Straw |
| Odor | None |
| Viscosity | 8,000 - 10,400 cps |
| pH | 4.3 - 5.3 |
| Osmolality (mOSm/kg) | 1394 - 1428 mOSm/kg |
| 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 a log reduction of less than 2.0 at 14 days and no increase from the 14-day count to the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days |
| Presence of Pathogens per USP <62> | Specification |
| Absence of pathogenic organisms ( <i>Staphylococcus aureus</i> , <i>Pseudomonas aeruginosa</i> , <i>Candida albicans</i> , <i>E. coli</i> , coliforms, <i>Salmonella</i> , and enrichment pathogens) per USP <62> | Absent |

#### Table 1: Device Specifications for INA Moisturizing Intimate Water-Based Personal Lubricant

## Comparison of Intended Use and Technological Characteristics with Predicate Device:

The table below lists the comparative intended use and technological characteristics of the subject and predicate device.

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| Characteristic/Feature | INA Moisturizing Intimate<br>Lubricant Water-Based<br>Personal Lubricant<br>Subject Device (K242645) | The Sex Gel Water-Based<br>Personal Lubricant<br>Predicate Device (K181078) |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | INA Moisturizing Intimate<br>Water-Based Personal<br>Lubricant is a personal<br>lubricant, for penile<br>and/or vaginal<br>application, intended to<br>moisturize and lubricate,<br>to enhance the ease and<br>comfort of intimate sexual<br>activity and supplement<br>the body's natural<br>lubrication. This product<br>is compatible with natural<br>rubber latex,<br>polyurethane, and<br>polyisoprene condoms. | The Sex Gel is a personal<br>lubricant, for penile and/or<br>vaginal 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 natural latex,<br>polyisoprene, and polyurethane<br>condoms. |
| Water-Based Lubricant | Yes | Yes |
| Over the Counter | Yes | Yes |
| Non-sterile | Yes | Yes |
| Odor | Odorless | Characteristic |
| Viscosity | 8,000 cps - 10,400 cps | 3,000 cps - 5,000 cps |
| pH | 4.3 -5.3 | 4.0 - 5.0 |
| Osmolality | 1394 – 1428 mOsm/kg | 435-535 mOsm/kg |
| Microbial Limits | Total mold/yeast count<br><10 cfu/g<br>Total aerobic microbial<br>count <100 cfu/g<br>Absence of pathogenic<br>organisms | Total mold/yeast count <10 cfu/g<br>Total aerobic microbial<br>count <10 cfu/g<br>Absence of pathogenic organisms |
| Antimicrobial<br>Effectiveness<br>Testing<br>(USP<51> Category 2) | Yes | Yes |
| Condom Compatibility | Compatible with natural<br>latex, | Compatible with natural latex,<br>polyisoprene, and polyurethane |
| Primary ingredients | Deionized Water, Organic<br>Certified Aloe Vera Gel,<br>Madecassoside,<br>Asiaticoside, Centella<br>Asiatica Leaf Extract,<br>Propanediol, Sclerotium<br>Gum, Sodium<br>Hyaluronate, Tremella<br>Fuciformis Sporocarp<br>Extract, Xanthan Gum,<br>Lactic Acid, Red Alga Gel<br>EC, Sodium Benzoate,<br>Potassium Sorbate,<br>Moringa Oleifera Seed Oil,<br>Cariborg Sea Buckthorn<br>Oil Refined. | Water, aloe barbadensis leaf<br>juice, sorbitol,<br>hydroxyethylcellulose,<br>allantoin, lactic acid/tocopherols<br>(vitamin E), sodium hyaluronate,<br>sodium benzoate & potassium<br>sorbate |
| Sterile | No | No |
| Shelf life | 6 months | 6 months |

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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 variations and specifications (e.g., pH, osmolality, etc.). The differences in the technological characteristics of the subject and predicate do not raise different questions of safety and effectiveness.

## Performance Data

## Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2023 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", as follows:

- Cytotoxicity (ISO 10993-5:2009/(R)2014)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021)
- Vaginal Irritation (ISO 10993-23: 2021)
- Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrate that the subject lubricant is non-irritating, nonsensitizing, and not systemically toxic.

## Condom Compatibility

Condom compatibility studies were performed per ASTM-D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant and was determined to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

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#### Shelf Life Testing

The INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is shown to have a 6 month shelf life utilizing real time aging. Testing on samples showed that the subject device specifications listed in Table 1 above across the device shelf-life.

#### Conclusion

The results of the performance testing described above demonstrate that the INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.