Coconu Water Based Personal Lubricant

K210814 · Coconu, LLC · NUC · Jun 14, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K210814
• Device Name: Coconu Water Based Personal Lubricant
• Applicant: Coconu, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Coconu 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Coconu Water Based Personal Lubricant is a non-sterile, water-based gel applied topically to penile and/or vaginal areas to supplement natural lubrication and enhance comfort during sexual activity. The device is packaged in a 3 oz MDPE tube for over-the-counter use. It functions as a physical lubricant; it does not contain active pharmaceutical ingredients. The user applies the lubricant manually as needed. The product is compatible with natural rubber latex and polyisoprene condoms but incompatible with polyurethane condoms. Clinical benefit is derived from reduced friction during intimate activity, improving comfort for the user.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, dermal sensitization, vaginal irritation, acute systemic toxicity) confirmed the device is non-sensitizing, non-irritating, and non-systemically toxic. Condom compatibility verified per ASTM D7661-10. Shelf life of 8.5 months validated via accelerated aging per ASTM F1980-16.

Technological Characteristics

Water-based gel; ingredients include water, coconut fruit juice, sodium benzoate, potassium sorbate, xanthan gum, lactic acid, sodium dehydroacetate, and sodium carboxymethylcellulose. pH 4.0-5.0; viscosity 2,800-4,500 cps; osmolality 42.0-46.0 mOsm/kg (1:10 dilution). Packaged in MDPE tube. Non-sterile. Complies with USP <51> (antimicrobial effectiveness), USP <61>/<1111> (microbial limits), and USP <62> (pathogen absence).

Indications for Use

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

• Coconut Infused Hybrid Personal Lubricant (K180712)

Submission Summary (Full Text)

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June 14, 2021

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

Re: K210814

> Trade/Device Name: Coconu Water Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 11, 2021 Received: March 17, 2021

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,

# Monica D. Garcia -S

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) K210814

Device Name Coconu Water Based Personal Lubricant

### Indications for Use (Describe)

Coconu 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 and polyisoprene condoms. This product is not compatible with 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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### 510(k) Summary K210814 Coconu Water Based Personal Lubricant

### Submitter Information l.

| Applicant: | COCONU, LLC. |
|------------------|---------------------------------------|
| Company Address: | 1968 E. ASHLEY MESA LANE |
| | SANDY, UT 84092 USA |
| Company Phone: | [phone] |
| Company Contact: | Taylor Warnick |
| Contact Person: | Louie Goryoka |
| | Sr. Regulatory and Quality Consultant |
| | Med-Device Consulting, Inc. |
| | Email: [e-mail] |
| | [phone] |

- ll. Date Prepared June 11, 2021
### lll. Device Information

| Trade Name: | Coconu Water Based Personal 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

| Trade Name: | Coconut Infused Hybrid Personal Lubricant |
|----------------|-------------------------------------------|
| 510(k) Number: | K180712 |
| Manufacturer: | United Consortium |
| Common Name: | Personal Lubricant |
| Device Class: | Class II |
| Product Code: | NUC (lubricant, personal) |

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

### V. Device Description

Coconu Water Based Personal 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Its formulation consists of water, Coconut) fruit juice, Microcare SB (water, sodium benzoate, potassium sorbate), Keltrol CG (xanthan gum), Purac FCC 50 (water, lactic acid), Geogard 111S (sodium dehydroacetate), CMC 7H3SF PHARM (sodium carboxymethylcellulose).

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Coconu Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box. Coconu Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.

| Property | Specification |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Opaque Flowable Gel |
| Color | Off-White - Light Yellow |
| Odor | None |
| Viscosity@25°C | 2,800 cps - 4,500 cps |
| Spindle #RVS@20rpm (cps) | |
| Specific Gravity@25°C | 0.90-1.11 |
| pH @ 25° | 4.0 to 5.0 |
| Osmolality (mOSm/kg) (1:10 dilution) per<br>USP<785> | 42.0 mOsm/kg - 46.0 mOsm/kg |
| Total aerobic microbial count (TAMC) per<br>USP <61> and <1111> | <100 cfu/g |
| Total yeast and mold count (TYMC) per<br>USP <61> and <1111> | <10 cfu/g |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for<br>Category 2 products. Category 2, bacteria<br>should show not less than 2.0 log reduction<br>at 14 days and no increase from 14-day<br>count at the 28-day count. Yeast and molds<br>should show no increase from the initial<br>calculated count at 14 and 28 days |
| Presence of Pathogens per USP <62><br>(Pseudomonas aeruginosa, Staphylococcus<br>aureus, Salmonella/Shigella, Escherichia<br>coli and Candida albicans per USP <62>) | Absent |

## Device specifications are listed in the Table below:

### VI. Indications for Use

Coconu 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

### VII. Predicate Device Comparison

A comparison of the intended use and technological characteristics of the subject and predicate device is summarized in the table below:

| Characteristic/Feature | Coconu Water Based Personal<br>Lubricant – Subject Device | Coconut<br>Personal Lubricant<br>(Predicate Device) | Infused<br>Hybrid<br>K180712 | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|
| Indications for Use | Coconu Water Based Lubricant<br>is a personal lubricant for<br>penile and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort<br>of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is | Coconut Infused Hybrid Personal<br>Lubricant is a water-based<br>personal lubricant for penile,<br>anal and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This | Similar | |
| | compatible with natural rubber<br>latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | | |
| Water-Based Lubricant | Yes | Yes | Same | |
| Over the Counter | Yes | Yes | Same | |
| Non-sterile | Yes | Yes | Same | |
| Odorless | Yes | Yes | Same | |
| Viscosity (cps) | 2,800 - 4,500 | 20,000 - 31,000 | Different | |
| pH | 4.0 - 5.0 | 5.7 - 6.3 | Different | |
| Osmolality (mOsm/kg) | 42.0 - 46.0 (1:10 dilution) | 450 – 900 | Different | |
| Condom Compatibility | Natural rubber latex and<br>polyisoprene condoms only. | Natural rubber latex and<br>polyisoprene condoms only. | Same | |
| Primary Ingredients | Water (Aqua), Cocos Nucifera<br>(Coconut) Fruit Juice, Microcare<br>SB (Water, Sodium Benzoate,<br>Potassium Sorbate), Keltrol CG<br>(Xanthan Gum), Purac FCC 50<br>(Water, Lactic Acid), Geogard<br>111S (Sodium Dehydroacetate),<br>CMC 7H3SF PHARM (Sodium<br>Carboxymethylcellulose) | Water (Aqua), Propylene Glycol,<br>Caprylic/Capric Triglyceride,<br>Cocos Nucifera (Coconut) Oil,<br>Flavor (Aroma),<br>Phenoxyethanol, Polyacrylate<br>13, Cellulose Gum (Sodium<br>Carboxymethylcellulose),<br>Raphanus Sativus (Radish) Seed<br>Extract, Polyisobutene,<br>Polysorbate 20, PEG-45M | Different | |
| Shelf life | 8.5 months | 3 years | Different | |

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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, viscosity, pH, osmolality, 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

Coconu Water Based Personal 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:

- Cytotoxicity Direct Contact Method, ISO 10993-5:2009/(R)2014 ●

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- Dermal Sensitization Guinea Pig Maximization Sensitization, ISO 10993-10:2010/(R)2014 ●
- Vaginal Irritation - Vaginal Mucosa Irritation Test, ISO 10993-10:2010/(R)2014
- . Acute Systemic Toxicity - ISO 10993-11:2017

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

### Condom Compatibility

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

### Shelf Life Testing

Coconu Water Based Personal 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 specifications at all time points.

### IX. Conclusion

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