H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two 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 and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Device Description

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with 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. These devices are composed of water (aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Capsicum Frutescens Fruit Extract and PEG-60 Hydrogenated Castor Oil.

AI/ML Overview

This document describes the validation of several personal lubricants for over-the-counter use. The products are H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, and #LubeLife Sensations Pleasure Kit for Two.

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Semi-viscous liquid	Semi-viscous liquid (implied by meeting other specifications)
Color	Colorless	Colorless (implied by meeting other specifications)
Odor	Odorless	Odorless (implied by meeting other specifications)
Viscosity (cps) per USP <911>	2150 - 4000	Met (tested at 0, 1, 2, and 3 years)
pH per USP <971>	3.50 - 4.50	Met (tested at 0, 1, 2, and 3 years)
Specific Gravity per USP <841>	1.010 - 1.030	Met (tested at 0, 1, 2, and 3 years)
Osmolality per USP <785>	950 – 1100 mOsm/kg (1:1 dilution with purified water)	Met (tested at 0, 1, 2, and 3 years)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.	Met (tested at 0, 1, 2, and 3 years)
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g	Met (tested at 0, 1, 2, and 3 years)
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Met (tested at 0, 1, 2, and 3 years)
Pseudomonas aeruginosa	Absent	Absent (tested at 0, 1, 2, and 3 years)
Staphylococcus aureus	Absent	Absent (tested at 0, 1, 2, and 3 years)
Salmonella/Shigella	Absent	Absent (tested at 0, 1, 2, and 3 years)
Escherichia coli	Absent	Absent (tested at 0, 1, 2, and 3 years)
Candida albicans	Absent	Absent (tested at 0, 1, 2, and 3 years)
Biocompatibility	Pass cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity	Passed (demonstrated biocompatible)
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.
Shelf life	3 years	Met (demonstrated through real-time aging study)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a distinct "test set" in the context of a dataset for an AI/algorithm study. The performance data is derived from various laboratory tests and a real-time aging study of the physical lubricant products themselves. Therefore, information on sample size and data provenance in terms of country of origin or retrospective/prospective for a test set is not applicable here.

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

This information is not applicable as there is no mention of a test set requiring expert ground truth in the context of an AI/algorithm study. The "ground truth" for the device specifications and biocompatibility is established through adherence to recognized scientific standards (USP, ISO, ASTM) and laboratory testing by presumably qualified personnel in those fields.

4. Adjudication Method for the Test Set

This information is not applicable as there is no test set requiring adjudication in the context of an AI/algorithm study.

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

An MRMC comparative effectiveness study was not done. This document concerns the performance of personal lubricants, not an AI or imaging device that would involve human readers.

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

A standalone performance study for an algorithm was not done. This document is about physical personal lubricant products.

7. The type of ground truth used

The ground truth for the device's performance is based on:

Established scientific standards and pharmacopeial monographs: USP (United States Pharmacopeia) for viscosity, pH, specific gravity, osmolality, antimicrobial effectiveness, and microbial counts.
International standards: ISO 10993 for biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), and ASTM D7661-10 for condom compatibility.
Laboratory test results: Derived from direct measurements and analyses of the lubricant's physical and chemical properties, as well as its interaction with biological systems (biocompatibility) and condoms.
Real-time aging study: For shelf-life determination.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" in the context of an AI/algorithm study for these personal lubricants. The product formulation development and testing would constitute the "development" phase, but it's not described as a training set for an AI.

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

This information is not applicable as there is no "training set" in the context of an AI/algorithm study. The composition and characteristics of the lubricants were developed and confirmed through standard chemical formulation, analytical testing, and quality control processes.

Summary

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June 10, 2021

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

Re: K210972

Trade/Device Name: H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 30, 2021 Received: March 31, 2021

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 (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,

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) K210972

Device Name H2O Warming Personal Lubricant H2O Anal Warming Personal Lubricant JO 2 To Tango for You

JO 2 To Tango Couples Pleasure Kit #LubeLife Sensations Warming #LubeLife Sensations Pleasure Kit for Two

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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Image /page/3/Picture/0 description: The image shows a logo with two stylized letters that appear to be "CC". To the right of the letters, the word "WELLNESS" is written in a smaller, sans-serif font. The overall design is simple and elegant, suggesting a brand identity for a wellness-related business or service. The letters are connected by a swooping line.

510(k) Summary — K210972 H2O Warming Personal Lubricant/H2O Anal Warming Personal Lubricant/JO 2 To Tango for You/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Warming/ #LubeLife Sensations Pleasure Kit for Two

K210972 Page 1 of 5

510(k) Summary

510(k) Owner:	CC Wellness LLC
Street Address:	29000 N. Hancock ParkwayValencia, CA 91355
Contact Person:	Marlent PerezQuality/Regulatory Specialist
	Bruce AlbertChief Scientific Officer
Contact Numbers:	Phone: (661) 295-1700, ext. 1007Phone: (661) 295-1700, ext. 231
Summary Preparation Date:	May 24, 2021
Trade Name:	H2O Warming Personal LubricantH2O Anal Warming Personal LubricantJO 2 To Tango for YouJO 2 To Tango Couples Pleasure Kit#LubeLife Sensations Warming#LubeLife Sensations Pleasure Kit for Two
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:	Agape Warming Personal LubricantK200208CC 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/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. To the right of 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 letters and the word "WELLNESS".

H2O Warming Personal Lubricant/H2O Anal Warming Personal Lubricant/JO 2 To Tango for You/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Warming/ #LubeLife Sensations Pleasure Kit for Two

K210972 Page 2 of 5

that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with 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.

H2O Warming Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL, 4 fl. oz./120 mL and 8 fl. oz./240 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, 4 fl. oz./120 mL and 8 fl. oz./240 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

H2O Anal Warming Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. 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.

JO 2 To Tango for You is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. 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.

JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. 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.

#LubeLife Sensations Warming is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of water (aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Capsicum Frutescens Fruit Extract and PEG-60 Hydrogenated Castor Oil.

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Image /page/5/Picture/0 description: The image shows a logo with the letters "CC" in a stylized, cursive font. To the right of 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 letters and the word "WELLNESS".

H2O Warming Personal Lubricant/H2O Anal Warming Personal Lubricant/JO 2 To Tango for You/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Warming/ #LubeLife Sensations Pleasure Kit for Two

The device specifications are listed in the table below:

Table 1: Device Specifications for H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two

Property	Specification
Appearance	Semi-viscous liquid
Color	Colorless
Odor	Odorless
Viscosity (cps) per USP <911>	2150 - 4000
pH per USP <971>	3.50 - 4.50
Specific Gravity per USP <841>	1.010 - 1.030
Osmolality per USP <785>	950 – 1100 mOsm/kg (1:1 dilution with purified water)
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:

Comparison of Intended Use and Technological Characteristics to the Predicate Device:

The table below lists a comparison of the intended use and technological characteristics of the subject and predicate devices.

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Image /page/6/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "C"s, connected by a flowing line. Below the letters, the word "WELLNESS" is written in a simple, sans-serif font, with the letters spaced out.

H2O Warming Personal Lubricant/H2O Anal Warming Personal Lubricant/JO 2 To Tango for You/ JO 2 To Tango Couples Pleasure Kit/

#LubeLife Sensations Warming/ #LubeLife Sensations Pleasure Kit for Two

Table 2: Comparator Table for Subject Device and Predicate Device
Feature	H2O Warming Personal Lubricant H2OAnal Warming Personal LubricantJO 2 To Tango for YouJO 2 To Tango Couples Pleasure Kit#LubeLife Sensations Warming#LubeLife Sensations Pleasure Kit forTwo	Agape Warming PersonalLubricant(K200208)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	H2O Warming Personal Lubricant, H2OAnal Warming Personal Lubricant, JO 2 ToTango for You, JO 2 To Tango CouplesPleasure Kit, #LubeLife SensationsWarming and #LubeLife SensationsPleasure Kit for Two are personallubricants for penile, anal and/or vaginalapplication, intended to lubricate andmoisturize, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's natural lubrication.These products are compatible withnatural rubber latex and polyisoprenecondoms. These products are notcompatible with polyurethane condoms.	Agape Warming PersonalLubricant is a personallubricant for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance theease and comfort ofintimate sexual activity andsupplement the body'snatural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	AquaGlycerinPropylene GlycolHydroxyethylcelluloseChlorphenesinCapsicum Frutescens Fruit ExtractPEG-60 Hydrogenated Castor Oil	Water (Aqua)PropanediolGluconolactoneHydroxyethylcelluloseSodium BenzoatePolysorbate 20Citric AcidCapsicum Annuum Resin
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex and Polyisoprene	Latex and 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 and have the same intended use – to provide lubrication 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:

Biocompatibility

Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and

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Image /page/7/Picture/1 description: The image shows a logo with the text "Wellness" in a stylized font. The logo features two cursive letters, possibly "C"s, connected by a decorative flourish. The word "WELLNESS" is written in smaller, sans-serif letters to the right of the cursive letters. The overall design is simple and elegant, suggesting a focus on health and well-being.

H2O Warming Personal Lubricant/H2O Anal Warming Personal Lubricant/JO 2 To Tango for You/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Warming/ #LubeLife Sensations Pleasure Kit for Two

acute systemic toxicity were 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" and ISO 10993-1:2009 as follows:

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 this testing demonstrated that the subject lubricants are 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 the devices specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the devices 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 D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are 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.