JO CUMPLAY Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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

JO CUMPLAY Personal Lubricant is a non-sterile, water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.

Its formulation consists of Water (Aqua), Propylene Glycol, Dimethicone, Dimethiconol, Lauryl Glucoside, Aloe Barbadensis Leaf Powder, Vitamin E Acetate, Hydroxyethylcellulose, PEG-90M, Hydrogenated Polydecene, Acrylic Copolymer, Sodium Acrylates/Beheneth-25 Metharylate Crosspolymer, and Chlorphenesin.

JO CUMPLAY Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in a 4 fl. Oz./120 mL polyethylene terephthalate bottle and capped with matte black Polypropylene (PP) pump closure.

AI/ML Overview

The provided document is a 510(k) Summary for a personal lubricant, not a study involving AI or human readers for comparative effectiveness. Therefore, many of the requested categories related to AI performance, expert ground truth, and MRMC studies are not applicable to this document.

However, I can extract the acceptance criteria and the results of the studies conducted for the device.

Here's the information based on the provided text:

Device: JO CUMPLAY Personal Lubricant

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Specification)	Reported Device Performance/Results
Appearance	Viscous liquid	Viscous liquid (as per device specifications)
Color	White to off-white	White to off-white (as per device specifications)
Odor	Odorless	Odorless (as per device specifications)
Viscosity (per USP<911>)	7800 - 8800 cps	(Tested to be within this range, implied by "maintains its specifications")
pH (per USP<791>)	6.8 – 8.0	(Tested to be within this range, implied by "maintains its specifications")
Osmolality (per USP<785>)	700 – 1000 mOsm/kg	(Tested to be within this range, implied by "maintains its specifications")
Total Aerobic Microbial Count (TAMC, per USP <61>)	<100 cfu/g	(Tested to be within this limit, implied by "maintains its specifications")
Total Yeast and Mold Count (TYMC, per USP <61>)	<10 cfu/g	(Tested to be within this limit, implied by "maintains its specifications")
Presence of Pathogens (per USP <62>)	Pseudomonas aeruginosa: Absent Staphylococcus aureus: Absent Candida albicans: Absent Escherichia coli: Absent Salmonella/Shigella: Absent	Absent (implied by "maintains its specifications" and "Absence of Pathogenic Organisms: Yes")
Antimicrobial Effectiveness Testing (per USP <51>)	Bacteria: Meets USP <51> criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days Yeast and Molds: No increase from the initial calculated count at 14 and 28 days	Meets USP <51> criteria (implied by "Antimicrobial Effectiveness Tested: Yes")
Biocompatibility	Acceptable results for Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity as per ISO 10993 standards.	Results of testing support the biocompatibility of the device materials.
Shelf-Life	Device maintains specifications for the claimed shelf-life.	2.5 years (results from real-time testing demonstrated maintenance of specifications).
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.

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

Test Set Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for viscosity, pH, etc.). However, for condom compatibility, the test method is ASTM D7661-10(R) 2017, which would define the sample size.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical performance testing conducted by the manufacturer or a contracted lab. The studies are prospective in the sense that they were conducted specifically for this device submission to demonstrate its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a physical and chemical product, not an AI or diagnostic device that requires expert-established ground truth. The "ground truth" for these tests comes from established international standards (e.g., USP, ISO, ASTM) and analytical methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring human adjudication of results. The tests are based on objective chemical and physical measurements.

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 device is a personal lubricant, not an AI system.

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

Not applicable. This device is a personal lubricant, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the physical, chemical, and microbiological properties, the "ground truth" is defined by the established specifications and validated test methods from recognized standards (e.g., USP, ISO, ASTM).
For biocompatibility, the ground truth is determined by the results of standardized biological tests that evaluate the material's interaction with biological systems according to ISO 10993 series.
For condom compatibility, the ground truth is determined by the results of the specific ASTM standard test method.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 20, 2022

CC Wellness LLC Marlent Perez Quality/Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K221908

Trade/Device Name: JO CUMPLAY Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 27, 2022 Received: June 30, 2022

Dear Marlent Perez:

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) K221908

Device Name JO CUMPLAY 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 K221908 JO CUMPLAY Personal Lubricant

1. Submitter Information

Applicant: CC Wellness LLC Contact: Marlent Perez Regulatory Affairs Specialist Bruce Albert Chief Scientific Officer Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: (661) 481-6390 Phone: (661) 295-1700, ext. 231

2. Correspondent Information

Contact: Marlent Perez Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: (661) 481-6390 Email: mperez@ccwellness.com

3. Date prepared: August 26, 2022

4. Subject Device Information

Device Trade Name: JO CUMPLAY Personal Lubricant Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: NUC (lubricant, personal) Device Class: Class II

5. Predicate Device Information

Device Name: Coconut Infused Hybrid Personal Lubricant 510(k) Number: K180712 Manufacturer: United Consortium

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

6. Device Description

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Device specifications for the JO CUMPLAY Personal Lubricant are listed in Table 1.

Property	Specification
Appearance	Viscous liquid
Color	White to off-white
Odor	Odorless
Viscosity (per USP<911>)	7800 - 8800 cps
pH (per USP<791>)	6.8 – 8.0
Osmolality (per USP<785>)	700 – 1000 mOsm/kg
Total Aerobic Microbial Count (TAMC, perUSP <61>)	<100 cfu/g
Total Yeast and Mold Count (TYMC, perUSP <61>)	<10 cfu/g
Presence of Pathogens (per USP <62>)	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Candida albicans	Absent
Escherichia coli	Absent
Salmonella/Shigella	Absent
Antimicrobial Effectiveness Testing (perUSP <51>	Specification
Bacteria	Meets USP <51> criteria for category 2.No less than 2.0 log reduction from initialcount at 14 days and no increase from the 14-day count at 28 days
Yeast and Molds	No increase from the initial calculated count at14 and 28 days

Table 1: Device Specifications for JO CUMPLAY Personal Lubricant

7. Indications for Use

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

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

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Table 2: Intended Use and Technological Characteristics Comparison of the Subject and Predicate Device

	JO CUMPLAY PersonalLubricantK221908Subject Device	Coconut Infused HybridPersonal LubricantK180712Predicate Device
Indications for Use	JO CUMPLAY Personal Lubricant is apersonal lubricant for penile, anal and/orvaginal application, intended to lubricateand moisturize, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.	Coconut Infused Hybrid PersonalLubricant is a water-based personallubricant for penile, anal and/orvaginal application, intended tolubricate and moisturize, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms
Base type	Water	Water
Primary ingredients	Water (Aqua), Propylene Glycol,Dimethicone, Dimethiconol, LaurylGlucoside, Aloe Barbadensis LeafPowder, Vitamin E Acetate,Hydroxyethylcellulose, PEG-90M,Hydrogenated Polydecene, AcrylicCopolymer, SodiumAcrylates/Beheneth-25 MetharylateCrosspolymer, Chlorphenesin	Water (Aqua), Propylene Glycol,Caprylic/Capric Triglyceride, CocosNucifera (Coconut) Oil, Flavor(Aroma), Phenoxyethanol,Polyacrylate 13, Cellulose Gum(sodium carboxymethylcellulose),Raphanus Sativus (Radish) SeedExtract, Polyisobutene, Polysorbate20, PEG-45M
Rx/OTC	OTC	OTC
Sterile	No	No
Appearance	Viscous liquid	Translucent, semi-viscous cream
Color	White to off-white	White to off-white
Odor	Odorless	Odorless
Viscosity	7,800 - 8800 cps	20,000 - 31,000 cps
pH	6.8 - 8.0	5.7 - 6.3
Osmolality	700 - 1000 mOsm/Kg	450-900 mOsm/kg
Total Aerobic Microbialcount (TAMC)	<100 cfu/g	<10 cfu/g
Total Yeast and Mold Count(TYMC)	<10 cfu/g	<10 CFU/g
Absence of PathogenicOrganisms	Yes	Yes
Antimicrobial EffectivenessTested	Yes	Yes
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms	Compatible with natural rubber latex and polyisoprene condoms
Biocompatibility Tested	Yes	Yes
Shelf life	2.5 years	3 years

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The subject and predicate device indications for use and intended use are the subject and predicate device have different technological characteristics, including formulations, shelf-life, and specifications for appearance, TAMC, viscosity, pH, and osmolality. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing was performed 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. " The following testing was conducted:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010) ●
Vaginal Irritation (ISO 10993-10:2010) ●
Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of testing support the biocompatibility of the device materials.

Shelf-Life

The subject device has a shelf-life of 2.5 years. Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

Condom Compatibility

The compatibility of JO CUMPLAY Personal Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed JO CUMPLAY Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed JO CUMPLAY Personal Lubricant not to be compatible with polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that JO CUMPLAY 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.