Premium 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, polyisoprene and polyurethane condoms.

Premium Anal Cooling 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, polyisoprene and polyurethane condoms.

Device Description

Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and polyurethane condoms. These devices are non-sterile personal lubricants 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.

Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is 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.

Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of Dimethicone, Dimethiconol and Menthol.

AI/ML Overview

The provided FDA 510(k) summary document for "Premium Cooling Personal Lubricant" and "Premium Anal Cooling Lubricant" is for a personal lubricant, not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) are not applicable to this document.

However, I can extract the acceptance criteria and study information for this non-AI/ML medical device from the document.

Acceptance Criteria and Reported Device Performance

Property	Specification (Acceptance Criteria)	Reported Device Performance
Appearance	Semi-viscous liquid	Not explicitly stated as "met", but implied by description
Color	Colorless	Not explicitly stated as "met", but implied by description
Odor	Odorless	Not explicitly stated as "met", but implied by description
Viscosity (cps) per USP <911>	800 to 1,075	Met (implied by "The subject device met the device specifications at all time points" for shelf-life)
Specific Gravity per USP <841>	0.875 to 1.020	Met (implied by "The subject device met the device specifications at all time points" for shelf-life)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.	Met (explicitly stated "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	Met (explicitly stated "Less than 100 cfu/g")
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Met (explicitly stated "Less than 10 cfu/g")
Presence of Pathogens per USP <62>	Pseudomonas aeruginosa: AbsentStaphylococcus aureus: AbsentSalmonella/Shigella: AbsentEscherichia coli: AbsentCandida albicans: Absent	Met (explicitly stated "Absent" for all listed pathogens)
Biocompatibility - Cytotoxicity	Passing reactivity score (non-cytotoxic)	"only slightly cytotoxic with a passing reactivity score"
Biocompatibility - Sensitization	Non-sensitizing	"non-sensitizing"
Biocompatibility - Vaginal Irritation	Non-irritating	"non-irritating"
Biocompatibility - Acute Systemic Toxicity	Non-systemically toxic	"non-systemically toxic"
Shelf-Life	Maintain all device specifications for 3 years	"met the device specifications at all time points" (0, 1, 2, and 3 years)
Condom Compatibility	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms	"are compatible with natural rubber latex, polyisoprene and polyurethane condoms"

Study Information (for non-AI/ML device):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility Studies: Not specified in terms of sample size for living organisms. The tests performed are standard in vitro and in vivo toxicology tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). Data provenance is not mentioned.
- Shelf-Life Study: Samples were tested at 0, 1, 2, and 3 years. The number of individual product units tested at each time point is not specified. Data provenance is not mentioned.
- Condom Compatibility Study: Evaluated in accordance with ASTM D7661-18. The number of condoms or lubricant samples tested is not specified. Data provenance is not mentioned.
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 as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Performance is assessed against scientific/regulatory standards and specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML diagnostic device.
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 as this is not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device. The device itself is the "standalone" product being evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here refers to established scientific and regulatory standards/specifications (e.g., USP monographs for viscosity, microbial limits, and antimicrobial effectiveness; ISO standards for biocompatibility; ASTM standards for condom compatibility).
The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires training data.
How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device that requires training data.

Summary

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June 3, 2020

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

Re: K200602

Trade/Device Name: Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 5, 2020 Received: March 9, 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.

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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 (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

Jason R. Roberts, 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)

K200602

Device Name Premium Cooling Personal Lubricant Premium Anal Cooling Lubricant

Indications for Use (Describe)

Premium Anal Cooling Lubricant is a personal lubricant for 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, polyisoprene and 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 - K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant

510(k) Owner:	CC Wellness LLC
Street Address:	29000 N. HancockParkway Valencia, CA91355
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:	May 29, 2020
Trade Name:	Premium Cooling Personal LubricantPremium Anal Cooling Lubricant
Common Name:	Personal Lubricant
Device Classification:	Common Name:Regulation Name:Regulation Number:Product Code:Device Class:	Personal LubricantCondom21 CFR § 884.5300NUC (lubricant,personal) Class II
Predicate Device:	Product Name:	Trojan Chain Reaction PersonalLubricant
	510(k) Number:	K161544
	Sponsor:	Church & Dwight Co., Inc
	Product Code:	NUC (lubricant,personal) Class II
	Device Class:	NUC (lubricant,personal) Class II

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

Device Description:

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510(k) Summary - K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant

These devices are composed of Dimethicone, Dimethiconol and Menthol.

The device specifications are listed in the table below:

Table 1: Device Specifications for Premium Cooling Personal Lubricant and Premium
Anal Cooling Lubricant
Property	Specification
Appearance	Semi-viscous liquid
Color	Colorless
Odor	Odorless
Viscosity (cps) per USP <911>	800 to 1,075
Specific Gravity per USP <841>	0.875 to 1.020
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

Indications for Use:

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Image /page/5/Picture/1 description: The image shows a logo with two stylized cursive letters, possibly 'CC', connected by a flourish. Below the letters, the word 'WELLNESS' is written in smaller, sans-serif font. The logo has a clean and elegant design, suggesting a brand related to health, beauty, or lifestyle.

510(k) Summary – K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant

Predicate Device Comparison:

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

Table 2: Comparator Table for Subject Device – Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant and Predicate Device – Trojan Chain Reaction Personal Lubricant

Feature	Premium Cooling Personal LubricantPremium Anal Cooling Lubricant	Trojan Chain Reaction PersonalLubricant (K161544)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	Premium Cooling Personal Lubricantis a personal lubricant for penile, analand/or vaginal application, intendedto lubricate and moisturize, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubber latex,polyisoprene and polyurethanecondoms.Premium Anal Cooling PersonalLubricant is a personal lubricant forpenile, anal and/or vaginalapplication, intended to lubricate andmoisturize, to enhance the ease andcomfort of intimate sexual activityand supplement the body's naturallubrication. This product iscompatible with natural rubber latex,polyisoprene and polyurethanecondoms.	Trojan Chain Reaction PersonalLubricant is a personal lubricantfor penile and/or vaginalapplication, intended to lubricateand moisturize, to enhance theease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. Not compatible withpolyurethane condoms.
Water soluble	No	No
Ingredients	DimethiconeDimethiconolMenthol	DimethiconeDimethiconolSensate
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex, Polyisopreneand Polyurethane	Natural Rubber Latex andPolyisoprene

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Image /page/6/Picture/1 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 - K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant

Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	2 years

The subject and predicate devices have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the primary intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate devices have different technological characteristics; for example, different formulations. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness questions.

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 10993-1:20019 as follows:

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 lubricants are only slightly cytotoxic with a passing reactivity score, non-irritating, non-sensitizing and nonsystemically toxic.

Shelf-Life:

The subject devices are non-sterile personal lubricants 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 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.

Condom Compatibility:

The compatibility of the subject devices with natural rubber latex, polyisoprene and polyurethane condoms were 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 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are 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.