Agape Cooling 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

Agape Cooling Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

This device is a non-sterile personal lubricant for penile, anal 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.

The device is provided in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.

AI/ML Overview

The document describes the regulatory approval for "Agape Cooling Personal Lubricant" and includes details about its acceptance criteria and the studies performed to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Physical/Chemical Specifications
Appearance	Semi-viscous liquid	Meets specification (implied, as part of overall compliance)
Color	Colorless	Meets specification (implied, as part of overall compliance)
Odor	Peppermint	Meets specification (implied, as part of overall compliance)
Viscosity (cps) per USP <911>	2150 to 4000	Meets specification (implied, as part of overall compliance)
pH per USP <971>	3.50 to 4.50	Meets specification (implied, as part of overall compliance)
Specific Gravity per USP <841>	1.010 to 1.030	Meets specification (implied, as part of overall compliance)
Osmolality per USP <785> (1:2 dilution)	500 to 750 mOsm/kg	Meets specification (implied, as part of overall compliance)
Microbiological Specifications
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	Meets specification
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g	Meets specification
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Meets specification
Presence of Pathogens per USP <62>	Absent	Absent
Pseudomonas aeruginosa	Absent	Absent
Staphylococcus aureus	Absent	Absent
Salmonella/Shigella	Absent	Absent
Escherichia coli	Absent	Absent
Candida albicans	Absent	Absent
Biocompatibility
Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Non-cytotoxic
Sensitization (ISO 10993-10:2010)	Non-sensitizing	Non-sensitizing
Vaginal Irritation (ISO 10993-10:2010)	Non-irritating	Non-irritating
Acute Systemic Toxicity (ISO 10993-11:2006)	Non-systemically toxic	Non-systemically toxic
Shelf-Life	Maintain all device specifications for 3 years	All device specifications met at Time 0 and end of 3-year shelf-life
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 Data Provenance

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., biocompatibility, condom compatibility, microbiological tests, or shelf-life). The data provenance is not specified in terms of country of origin, but the studies were conducted to comply with US FDA guidance and international ISO standards. All studies appear to be prospective as they are testing the product prior to its market release.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth. The acceptance criteria and testing methods refer to internationally recognized standards (e.g., USP, ISO, ASTM), implying that expert consensus is embedded within these standards, but individuals involved in performing or interpreting these tests are not detailed.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (e.g., 2+1, 3+1). The testing process relies on standardized laboratory methods (USP, ISO, ASTM) and the results are reported as meeting or not meeting these standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically associated with imaging algorithms or diagnostic devices where human readers interpret cases. The device in question is a personal lubricant, and its performance evaluation does not involve human readers interpreting cases.

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

This question is not applicable. The device is a personal lubricant, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tests conducted are "standalone" in the sense that they evaluate the lubricant itself against physical, chemical, and biological criteria, without human interaction as part of the primary performance metric.

7. The Type of Ground Truth Used

The ground truth for the performance tests is based on:

Established industry standards and regulatory guidelines: USP (United States Pharmacopeia), ISO (International Organization for Standardization), and ASTM (American Society for Testing and Materials) standards define the acceptable limits and methodologies for testing.
Scientific measurement and observation: Laboratory tests measure properties like viscosity, pH, osmolality, microbial counts, and observe biological responses (cytotoxicity, irritation, sensitization).
Predicate device comparison: The device's safety and effectiveness are also framed in comparison to a legally marketed predicate device (Premium Cooling Personal Lubricant K200602), showing substantial equivalence despite some formulation differences.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product (personal lubricant), not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this type of device.

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 2, 2020

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

K200894 Re: Trade/Device Name: Agape Cooling Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 2, 2020 Received: April 3, 2020

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. 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

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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-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 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, Ph.D. Acting 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)

K200894

Device Name Agape Cooling 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 – K200894Agape Cooling Personal Lubricant
510(k) Owner:	CC Wellness LLC
Street Address:	29000 N. Hancock ParkwayValencia, CA 91355
Contact Person:	Marlent PerezQuality Specialist
	Bruce AlbertHead of Technical Services
Contact Numbers:	Phone: (661) 295-1700, ext. 1007Phone: (661) 295-1700, ext. 231
Summary Preparation Date:	June 29, 2020
Trade Name:	Agape Cooling Personal Lubricant
Common Name:	Personal Lubricant
Device Classification:	Regulation Name:Regulation Number:Product Code:Device Class:	Condom21 CFR § 884.5300NUC (lubricant, personal)Class II
Predicate Device:	Product Name:510(k) Number:Manufacturer:Product Code:Device Class:	Premium Cooling Personal LubricantK200602CC Wellness LLCNUC (lubricant, personal)Class II

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

Device Description:

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Image /page/4/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". Below the letters, the word "WELLNESS" is written in a smaller, sans-serif font. The overall design is simple and elegant, with a focus on the company's name and its association with wellness.

510(k) Summary - K200894 Agape Cooling Personal Lubricant

oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.

The device specifications are listed in the table below:

Property	Specification
Appearance	Semi-viscous liquid
Color	Colorless
Odor	Peppermint
Viscosity (cps) per USP <911>	2150 to 4000
pH per USP <971>	3.50 to 4.50
Specific Gravity per USP <841>	1.010 to 1.030
Osmolality per USP <785> (1:2 dilution)	500 to 750 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2products.
Total aerobic microbial count (TAMC) per USP<61> and <1111>	Less than 100 cfu/g
Total yeast and mold count (TYMC) per USP <61>and <1111>	Less than 10 cfu/g
Presence of Pathogens per USP <62>	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Salmonella/Shigella	Absent
Escherichia coli	Absent
Candida albicans	Absent

Table 1: Device Specifications for Agape Cooling Personal Lubricant

Indications for Use:

Predicate Device Comparison:

The table below lists the comparative indications for use and technological characteristics of the subject and predicate devices.

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Image /page/5/Picture/0 description: The image shows a logo for a business called "Wellness". The logo features a stylized, cursive font. The word "Wellness" is written in smaller letters to the right of the cursive letters. The logo is simple and elegant, and it is likely used to represent a business that focuses on health and well-being.

Table 2: Comparator Table for Subject Device – Agape Cooling Personal Lubricant and Predicate Device – Premium Cooling Personal Lubricant

Feature	Agape Cooling PersonalLubricant	Premium Cooling PersonalLubricant (K200602)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	Agape Cooling Personal Lubricant isa personal lubricant for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatible withpolyurethane condoms.	Premium Cooling PersonalLubricant is a personal lubricant forpenile, anal and/or vaginalapplication, intended to lubricateand moisturize, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex, polyisoprene andpolyurethane condoms.
Water soluble	Yes	No
Contains water	Yes	No
Ingredients	Water, Propanediol, Gluconolactone,Hydroxyethylcellulose, SodiumBenzoate, Polysorbate 20, Citric Acidand Mentha Piperita (Peppermint)Leaf Extract	Dimethicone, Dimethiconoland Menthol
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex andPolyisoprene	Natural Rubber Latex, Polyisopreneand Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	3 years

The subject and predicate device indications for use are not identical as the predicate device indications for use also states that it is compatible with polyurethane condoms. This difference does not represent a new intended use as the intended use of the subject device is the same as the predicate device, i.e., provides lubrication during intimate sexual activity. In addition, the subject and predicate devices have different technological characteristics; for example, different formulations, water solubility, condom compatibility, etc. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

Summary of Performance Data:

Biocompatibility

Biocompatibility studies were performed in accordance with the 2016 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" and ISO 10993-1:2018 as follows:

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Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010)
Vaginal Irritation (ISO 10993-10:2010)
Acute Systemic Toxicity (ISO 10993-11:2006) ●

The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing and non-systemically toxic.

Shelf-Life:

The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at Time 0 and at the end of the three-year shelf-life. The subject device met the device specifications at all time points assessed.

Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane 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 indicated that Agape Cooling Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that Agape Cooling 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.