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 · CC Wellness, LLC · NUC · Jun 10, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: 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
• Applicant: CC Wellness, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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 Story

Personal lubricants applied topically to penile, anal, or vaginal areas to reduce friction and enhance comfort during sexual activity. Formulated as clear, semi-viscous liquids containing water, glycerin, propylene glycol, hydroxyethylcellulose, chlorphenesin, Capsicum frutescens fruit extract, and PEG-60 hydrogenated castor oil. Packaged in PET cylinder bottles with disc tops. Intended for over-the-counter use by consumers. Provides supplemental lubrication to assist in sexual activity; compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). Shelf-life validated via real-time aging study (3 years). Condom compatibility tested per ASTM D7661-10.

Technological Characteristics

Water-based, semi-viscous personal lubricant. Ingredients: water, glycerin, propylene glycol, hydroxyethylcellulose, chlorphenesin, Capsicum frutescens fruit extract, PEG-60 hydrogenated castor oil. pH 3.50-4.50; viscosity 2150-4000 cps; osmolality 950-1100 mOsm/kg. Packaged in PET bottles. Non-sterile. Tested per USP <51>, <61>, <62>, <785>, <841>, <911>, <971>.

Indications for Use

Indicated for individuals requiring personal lubrication for penile, anal, and/or vaginal application to enhance comfort during intimate sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Agape Warming Personal Lubricant (K200208)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 Parkway<br>Valencia, CA 91355 | |
| Contact Person: | | Marlent Perez<br>Quality/Regulatory Specialist | |
| | | Bruce Albert<br>Chief Scientific Officer | |
| Contact Numbers: | | Phone: [phone], ext. 1007<br>Phone: [phone], ext. 231 | |
| Summary Preparation Date: | | May 24, 2021 | |
| Trade Name: | | H2O Warming Personal Lubricant<br>H2O Anal Warming Personal Lubricant<br>JO 2 To Tango for You<br>JO 2 To Tango Couples Pleasure Kit<br>#LubeLife Sensations Warming<br>#LubeLife Sensations Pleasure Kit for Two | |
| Common Name: | | Personal Lubricant | |
| Device Classification: | | Regulation Name:<br>Regulation Number:<br>Product Code:<br>Device Class: | Condom<br>21 CFR § 884.5300<br>NUC (lubricant, personal)<br>Class II |
| Predicate Device: | | Product Name:<br>510(k) Number:<br>Manufacturer:<br>Product Code:<br>Device Class: | Agape Warming Personal Lubricant<br>K200208<br>CC Wellness LLC<br>NUC (lubricant, personal)<br>Class II |

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

## 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

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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:

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.

## 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 H2O<br>Anal Warming Personal Lubricant<br>JO 2 To Tango for You<br>JO 2 To Tango Couples Pleasure Kit<br>#LubeLife Sensations Warming<br>#LubeLife Sensations Pleasure Kit for<br>Two | Agape Warming Personal<br>Lubricant<br>(K200208) |
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | H2O Warming Personal Lubricant, H2O<br>Anal Warming Personal Lubricant, JO 2 To<br>Tango for You, JO 2 To Tango Couples<br>Pleasure Kit, #LubeLife Sensations<br>Warming and #LubeLife Sensations<br>Pleasure Kit for Two are personal<br>lubricants for penile, anal and/or vaginal<br>application, intended to lubricate and<br>moisturize, to enhance the ease and<br>comfort of intimate sexual activity and<br>supplement the body's natural lubrication.<br>These products are compatible with<br>natural rubber latex and polyisoprene<br>condoms. These products are not<br>compatible with polyurethane condoms. | Agape Warming Personal<br>Lubricant is a personal<br>lubricant for penile, anal<br>and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the<br>ease and comfort of<br>intimate sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible<br>with polyurethane condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Aqua<br>Glycerin<br>Propylene Glycol<br>Hydroxyethylcellulose<br>Chlorphenesin<br>Capsicum Frutescens Fruit Extract<br>PEG-60 Hydrogenated Castor Oil | Water (Aqua)<br>Propanediol<br>Gluconolactone<br>Hydroxyethylcellulose<br>Sodium Benzoate<br>Polysorbate 20<br>Citric Acid<br>Capsicum 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.