Agape Warming 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 Warming Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. 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 and supplement the body's natural lubrication. This product is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in a clear polyethylene terephthalate (PET) cylinder bottle. 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 Capsicum Oleoresin.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a personal lubricant. It does not describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer your questions about acceptance criteria, study details, ground truth establishment, or expert consensus related to AI/ML device performance.

The document focuses on the substantial equivalence of the "Agape Warming Personal Lubricant" to a predicate device, based on standard physical, chemical, and biological testing relevant to personal lubricants.

Here's why your questions cannot be answered from this document:

AI/ML Device: The product is a personal lubricant, not an AI/ML-driven diagnostic or therapeutic device.
Performance Metrics: The acceptance criteria and performance data relate to physical properties (viscosity, pH, osmolality), antimicrobial effectiveness, biocompatibility, and condom compatibility, not to AI/ML performance metrics like sensitivity, specificity, AUC, or reader performance improvement.
Ground Truth: Ground truth for a lubricant is established by laboratory assays and physical tests, not by expert consensus on images or outcomes data in the way it would be for an AI diagnostic.
Training/Test Sets: There are no training or test sets in the AI/ML sense, as there is no algorithm being trained or evaluated for pattern recognition.
Experts/Adjudication/MRMC Studies: These concepts are relevant to the evaluation of AI systems, particularly in medical imaging, where human readers interact with AI or human expert consensus is needed to establish a "truth" for complex interpretations. They are not applicable to the evaluation of a personal lubricant.

In summary, the provided text does not contain any information about an AI/ML device, and thus cannot be used to answer questions pertaining to its acceptance criteria or validating study.

Summary

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April 27, 2020

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

Re: K200208

Trade/Device Name: Agape Warming Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 23, 2020 Received: January 28, 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

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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. 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) K200208

Device Name

Agape Warming Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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	K200208Agape Warming Personal Lubricant	K200208Page 1 of 4
510(k) Owner:	CC Wellness LLC
Street Address:	29000 N. Hancock ParkwayValencia, CA 91355
Contact Person:	Marlent PerezQuality SpecialistBruce AlbertHead of Technical Services
Contact Numbers:	Phone: (661) 295-1700, ext. 1007Phone: (661) 295-1700, ext. 231
Summary Preparation Date:	April 24, 2020
Trade Name:	Agape Warming Personal Lubricant

510(k) Summary

Device Classification:	Common Name:	Personal Lubricant
	Regulation Name:	Condom
	Regulation Number:	21 CFR 884.5300
	Product Code:	NUC (lubricant, personal)
	Device Class:	Class II
Predicate Device:	Product Name:	JO Agape Original PersonalLubricant
	510(k) Number:	K183384
	Manufacturer:	CC Wellness LLC
	Product Code:	NUC (lubricant, personal)
	Device Class:	Class II

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

Device Description:

This product is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size

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CC
WELLNESS

Agape Warming Personal Lubricant

K200208 Page 2 of 4

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 Capsicum Oleoresin.

The device specifications are listed in the table below:

Table 1: Device Specifications for Agape Warming Personal Lubricant
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Property	Specification
Appearance	Semi-viscous liquid
Color	Clear
Odor	Odorless
Viscosity (cps) per USP <911>	2,150 to 4,000
pH per USP <971>	3.40 to 4.50
Specific Gravity per USP <841>	0.950 to 1.035
Osmolality per USP <785>	575 to 750 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.

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

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 with two stylized cursive letters that appear to be "CC". Below the letters, in a smaller, sans-serif font, is the word "WELLNESS". The overall design is simple and elegant, suggesting a brand identity focused on health and well-being.

510(k) Summary K200208 Agape Warming Personal Lubricant

Feature	Subject DeviceAgape Warming PersonalLubricantK200208	Predicate DeviceJO Agape Original PersonalLubricantK183384
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	Agape Warming Personal Lubricantis a personal lubricant for penile,anal and/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.	JO Agape Original PersonalLubricant is a water-basedpersonal lubricant for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Water (Aqua), Propanediol,Gluconolactone,Hydroxyethylcellulose, SodiumBenzoate, Polysorbate 20, Citric Acidand Capsicum Oleoresin	Water (Aqua), Propanediol,Gluconolactone,Hydroxyethylcellulose, SodiumBenzoate, Citric Acid
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex, Polyisoprene	Latex, Polyisoprene
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	3 years

Table 2: Comparator Table for the Subject and Predicate Devices

The subject and predicate device have similar indications for use, and the same intended use (i.e., lubrication during intimate sexual activity). The subject and predicate devices have different technological characteristics; for example, different formulations, including ingredients to provide a warming sensation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

Summary of Performance Data:

Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation, Penile Irritation, Cytotoxicity and Sensitization 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 10993-1:20019 as follows:

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Image /page/6/Picture/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. The letters are connected by a flowing line that extends from the left side of the first "C" to the right side of the second "C". Below the letters, the word "WELLNESS" is written in smaller, sans-serif font. The logo is simple and elegant, and the use of cursive and sans-serif fonts creates a contrast that is both visually appealing and easy to read.

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

The results of this testing demonstrated that the subject lubricant is only slightly cytotoxic with a passing reactivity score, non-irritating, non-sensitizing and nonsystemically toxic.

Shelf-Life:

The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of real-time and accelerated aging studies. All device specifications listed in Table 1 were tested and met the device specifications across the shelf-life duration.

Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that Agape Warming 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 Warming 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.