Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are personal lubricants 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. These products are compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Device Description

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

All-In-One Warming is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 4 fl. oz./120 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 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Dimethicone, Dimethiconol and Capsicum Frutescens Fruit Extract.

AI/ML Overview

The provided text describes the 510(k) summary for the Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, and All-In-One Warming. This document is a regulatory submission to the FDA, and as such, it presents performance data to demonstrate substantial equivalence to a predicate device, rather than a "study that proves the device meets acceptance criteria" in the context of an AI/algorithm-driven device.

Given that this document is for a personal lubricant (a physical product, not an AI/algorithm), most of the requested information (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this type of device and submission.

However, I can extract the acceptance criteria and reported device performance from the provided "Device Specifications" table and the "Summary of Performance Data."

Here's the information that can be extracted, and where applicable, a note on why certain requested fields are not relevant for this device type:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Appearance	Semi-viscous liquid	Semi-viscous liquid (implied, as it meets specification)
Color	Colorless	Colorless (implied, as it meets specification)
Odor	Odorless	Odorless (implied, as it meets specification)
Viscosity (cps) per USP <911>	800 to 1,075	Meets specification (actual value not provided, but within range)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.	Meets USP <51> acceptance criteria for Category 2 products.
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g	Less than 100 cfu/g (implied, as it meets specification)
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Less than 10 cfu/g (implied, as it meets specification)
Presence of Pathogens per USP <62> (Pseudomonas aeruginosa)	Absent	Absent (implied, as it meets specification)
Presence of Pathogens per USP <62> (Staphylococcus aureus)	Absent	Absent (implied, as it meets specification)
Presence of Pathogens per USP <62> (Salmonella/Shigella)	Absent	Absent (implied, as it meets specification)
Presence of Pathogens per USP <62> (Escherichia coli)	Absent	Absent (implied, as it meets specification)
Presence of Pathogens per USP <62> (Candida albicans)	Absent	Absent (implied, as it meets specification)
Biocompatibility	Pass (based on ISO standards)	The subject lubricant is biocompatible.
Shelf-Life	3 years (maintaining all device specifications)	3 years (met device specifications at 0, 1, 2, and 3 years)
Condom Compatibility	Compatible with natural rubber latex, polyisoprene and polyurethane condoms (per ASTM D7661-18)	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Regarding the studies conducted, the following information is available:

Biocompatibility Studies:
- Tests performed: Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity, and Sensitization Testing.
- Standards: ISO 10993-1:2016, ISO 10993-1:20019, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
- Outcome: "The results of this testing demonstrated that the subject lubricant is biocompatible."
Shelf-Life Study:
- Design: Real-time aging study.
- Duration: 3 years.
- Testing points: 0, 1, 2, and 3 years.
- Parameters tested: All device specifications listed in Table 1 (Appearance, Color, Odor, Viscosity, Antimicrobial effectiveness, Microbial counts, Pathogen presence).
- Outcome: "The subject device met the device specifications at all time points."
Condom Compatibility Study:
- Standard: ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Results: "Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are compatible with natural rubber latex, polyisoprene, and polyurethane condoms."

The following requested information is NOT APPLICABLE or NOT PROVIDED for this type of medical device (personal lubricant) in this regulatory submission:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical product; refers to software/AI. The "test set" here would refer to the physical samples of the lubricant subjected to the various chemical, microbiological, and physical tests. The document does not specify the number of units tested for each specific criterion but implies standard laboratory practices were followed.
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 to a physical product; refers to AI/algorithm performance evaluation. Ground truth for these tests comes from established scientific methods, not expert consensus in the diagnostic sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; refers to AI/algorithm. Laboratory tests have defined endpoints and pass/fail criteria.
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; refers to AI/algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; refers to AI/algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical product, "ground truth" is established through standardized laboratory testing methods (e.g., USP monographs for microbial testing, ISO standards for biocompatibility, ASTM for condom compatibility).
The sample size for the training set: Not applicable; refers to AI/algorithm.
How the ground truth for the training set was established: Not applicable; refers to AI/algorithm.

Summary

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May 22, 2020

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

Re: K200457

Trade/Device Name: Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 21, 2020 Received: February 25, 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.

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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 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 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.

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)

K200457

Device Name Premium Warming Personal Lubricant Premium Anal Warming Lubricant All-In-One Warming

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 – K200457

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:	May 4, 2020
Trade Name:	Premium Warming Personal LubricantPremium Anal Warming LubricantAll-In-One Warming
Common Name:	Personal Lubricant
Device Classification:	Common Name: Personal LubricantClassification Name: CondomClassification Number: 21 CFR § 884.5300Product Code: NUC (lubricant, personal)Device Class: Class II
Predicate Device:	Product Name: JO Premium Personal Lubricant510(k) Number: K132954Manufacturer: United ConsortiumProduct Code: NUC (lubricant, personal)Device Class: Class II

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

Device Description:

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This device is composed of Dimethicone, Dimethiconol and Capsicum Frutescens Fruit Extract.

The device specifications are listed in the table below:

Table 1: Device Specifications for Premium Warming Personal Lubricant, Premium Anal
Warming Lubricant and All-In-One Warming

Property	Specification
Appearance	Semi-viscous liquid
Color	Colorless
Odor	Odorless
Viscosity (cps) per USP <911>	800 to 1,075
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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condoms.

Predicate Device Comparison:

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

Table 2: Comparator Table for Subject Device – Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming and Predicate Device – JO Premium Personal Lubricant

Feature	Premium Warming Personal LubricantPremium Anal Warming LubricantAll-In-One Warming(K200457)	JO Premium Personal Lubricant(K132954)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	Premium Warming PersonalLubricant, Premium Anal WarmingLubricant and All-In-One Warmingare personal lubricants for penile,anal and/or vaginal application,intended to lubricate andmoisturize, to enhance the ease andcomfort of intimate sexual activityand supplement the body's naturallubrication. These products arecompatible with natural rubberlatex, polyisoprene andpolyurethane condoms.	JO Premium Personal Lubricant isa personal lubricant for penileand/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	No	No
Ingredients	Dimethicone, Dimethiconol andCapsicum Frutescens Fruit Extract	Dimethicone,Cyclopentasiloxane,Cyclotetrasiloxane,Dimethiconol
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex, Polyisoprene andPolyurethane	Latex, Polyisoprene
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	3 years

The subjects and predicate device 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 types of safety and effectiveness questions.

Summary of Performance Data:

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Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization Testing 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 lubricant is biocompatible.

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 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 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming 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.