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 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). 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Coconu Water Based Personal Lubricant. It contains information about the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Opaque Flowable Gel	Opaque Flowable Gel (implied by meeting specification)
Color	Off-White - Light Yellow	Off-White - Light Yellow (implied by meeting specification)
Odor	None	None (implied by meeting specification)
Viscosity@25°C Spindle #RVS@20rpm	2,800 cps - 4,500 cps	2,800 cps - 4,500 cps (implied by meeting specification)
Specific Gravity@25°C	0.90-1.11	0.90-1.11 (implied by meeting specification)
pH @ 25°	4.0 to 5.0	4.0 to 5.0 (implied by meeting specification)
Osmolality (mOSm/kg) (1:10 dilution) per USP <785>	42.0 mOsm/kg - 46.0 mOsm/kg	42.0 mOsm/kg - 46.0 mOsm/kg (implied by meeting specification)
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<100 cfu/g	<100 cfu/g (implied by meeting specification)
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	<10 cfu/g (implied by meeting specification)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products: 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.	Meets USP <51> acceptance criteria for Category 2 products (explicitly stated).
Presence of Pathogens per USP <62>	Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli and Candida albicans)	Absent (implied by meeting specification)
Biocompatibility: Cytotoxicity	Non-cytotoxic	Non-cytotoxic (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.")
Biocompatibility: Dermal Sensitization	Non-sensitizing	Non-sensitizing (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.")
Biocompatibility: Vaginal Irritation	Non-irritating	Non-irritating (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.")
Biocompatibility: Acute Systemic Toxicity	Non-systemically toxic	Non-systemically toxic (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.")
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms.	Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. (explicitly stated)
Shelf Life	All device specifications listed in Section V (the table above) met at all time points for 8.5 months.	All device specifications listed in Section V met at all time points for 8.5 months (explicitly stated).

2. Sample size used for the test set and the data provenance

The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective). Instead, it lists various non-clinical performance tests, each likely having its own sample size and methodology defined by the respective ASTM or USP standard. For example:

Biocompatibility: The specific ISO standards (10993-5, 10993-10, 10993-11) would define the sample sizes for these tests (e.g., number of cells for cytotoxicity, number of guinea pigs for sensitization, number of animals for irritation/systemic toxicity).
Condom Compatibility: Tested in accordance with ASTM D7661-10. This standard would dictate the number of condoms and lubricant applications required.
Shelf Life Testing: Per ASTM F1980-16 (accelerated aging). This standard defines the methodology, but specific sample sizes are not provided in this summary.
Microbial Testing: USP <61>, <1111>, <51>, <62> define the methods, which include specific sample weights or volumes for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device submission. The Coconu Water Based Personal Lubricant is not an AI/ML device, nor is it a diagnostic device that requires expert review or ground truth labeling of medical images or patient data. The "ground truth" for this device's performance is established through adherence to standardized laboratory testing protocols (e.g., ASTM, USP, ISO).

4. Adjudication method for the test set

Not applicable. As noted above, this submission relies on standardized laboratory testing protocols rather than human adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for Coconu Water Based Personal Lubricant is established through:

Physical and Chemical Property Measurement: Direct measurements of properties like viscosity, pH, specific gravity, osmolality, appearance, color, and odor using calibrated laboratory equipment and standard analytical methods.
Microbiological Testing: Standardized microbiological culture and identification techniques following USP guidelines.
Biocompatibility Standards: In vivo and in vitro biological tests conducted in accordance with ISO 10993 series for medical devices.
Material Compatibility Standards: Testing against a specific ASTM standard (D7661-10) for condom compatibility.
Accelerated Aging Studies: Conducted per ASTM F1980-16 to determine shelf-life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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:	(801) 550-8611
Company Contact:	Taylor Warnick
Contact Person:	Louie Goryoka
	Sr. Regulatory and Quality Consultant
	Med-Device Consulting, Inc.
	Email: mdci@m-dci.us
	(818) 585-7488

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

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) perUSP<785>	42.0 mOsm/kg - 46.0 mOsm/kg
Total aerobic microbial count (TAMC) perUSP <61> and <1111>	<100 cfu/g
Total yeast and mold count (TYMC) perUSP <61> and <1111>	<10 cfu/g
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria forCategory 2 products. Category 2, bacteriashould show not less than 2.0 log reductionat 14 days and no increase from 14-daycount at the 28-day count. Yeast and moldsshould show no increase from the initialcalculated count at 14 and 28 days
Presence of Pathogens per USP <62>(Pseudomonas aeruginosa, Staphylococcusaureus, Salmonella/Shigella, Escherichiacoli and Candida albicans per USP <62>)	Absent

Device specifications are listed in the Table below:

VI. Indications for Use

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 PersonalLubricant – Subject Device	CoconutPersonal Lubricant(Predicate Device)	InfusedHybridK180712
Indications for Use	Coconu Water Based Lubricantis a personal lubricant forpenile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product is	Coconut Infused Hybrid PersonalLubricant is a water-basedpersonal lubricant for penile,anal and/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. This	Similar
	compatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.	product is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatible withpolyurethane 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 andpolyisoprene condoms only.	Natural rubber latex andpolyisoprene condoms only.	Same
Primary Ingredients	Water (Aqua), Cocos Nucifera(Coconut) Fruit Juice, MicrocareSB (Water, Sodium Benzoate,Potassium Sorbate), Keltrol CG(Xanthan Gum), Purac FCC 50(Water, Lactic Acid), Geogard111S (Sodium Dehydroacetate),CMC 7H3SF PHARM (SodiumCarboxymethylcellulose)	Water (Aqua), Propylene Glycol,Caprylic/Capric Triglyceride,Cocos Nucifera (Coconut) Oil,Flavor (Aroma),Phenoxyethanol, Polyacrylate13, Cellulose Gum (SodiumCarboxymethylcellulose),Raphanus Sativus (Radish) SeedExtract, Polyisobutene,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.

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.