H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit

K210986 · CC Wellness, LLC · NUC · Jun 10, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K210986
• Device Name: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit
• 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 Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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

Clear, semi-viscous personal lubricants; applied topically to penile, anal, or vaginal areas to supplement natural lubrication and enhance comfort during sexual activity. Packaged in PET cylinder bottles with disc tops; hermetically sealed. Used by consumers in home settings (OTC). Formulation includes water, glycerin, polysorbate 20, propylene glycol, hydroxyethylcellulose, chlorphenesin, peppermint leaf extract, and sodium hydroxide. Provides cooling sensation. Benefits include reduced friction and increased comfort during intercourse. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). Condom compatibility tested per ASTM D7661-10. Shelf-life validated via real-time aging study (3 years). Antimicrobial effectiveness tested per USP <51>.

Technological Characteristics

Water-based personal lubricant. Ingredients: Aqua, Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita Leaf Extract, Sodium Hydroxide. Viscosity: 2150-4000 cps (USP <911>); pH: 3.50-4.50 (USP <971>); Osmolality: 1000-1100 mOsm/kg (USP <785>). Non-sterile. Packaging: PET bottles. Condom compatibility tested per ASTM D7661-10.

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 Cooling Personal Lubricant (K200894)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 10, 2021

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

Re: K210986

> Trade/Device Name: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling, #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: April 1, 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K210986

| Device Name |
|-------------------------------------|
| H2O Cooling Personal Lubricant |
| H2O Anal Cooling Personal Lubricant |
| JO 2 To Tango for Me |

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

#### Indications for Use (Describe)

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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)

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Image /page/3/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". To the right of the letters, the word "WELLNESS" is written in a simple, sans-serif font. The overall design is minimalist and elegant.

510(k) Summary – K210986

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

K210986 Page 1 of 5

| 510(k) Owner: | CC Wellness LLC |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 |
| Contact Person: | Marlent Perez<br>Quality/Regulatory Affairs Specialist<br><br>Bruce Albert<br>Chief Scientific Officer |
| Contact Numbers: | Phone: [phone], ext. 1007<br>Phone: [phone], ext. 231 |
| Summary Preparation Date: | May 25, 2021 |
| Trade Name: | H2O Cooling Personal Lubricant<br>H2O Anal Cooling Personal Lubricant<br>JO 2 To Tango for Me<br>JO 2 To Tango Couples Pleasure Kit<br>#LubeLife Sensations Cooling<br>#LubeLife Sensations Pleasure Kit for Two |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom<br>Regulation Number: 21 CFR § 884.5300<br>Product Code: NUC (lubricant, personal)<br>Device Class: Class II |
| Predicate Device: | Product Name: Agape Cooling Personal Lubricant<br>510(k) Number: K200894<br>Manufacturer: CC Wellness LLC<br>Product Code: NUC (lubricant, personal)<br>Device Class: Class II |

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

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#### 510(k) Summary - K210986

Image /page/4/Picture/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. Below the letters, the word "WELLNESS" is written in smaller, sans-serif letters. The overall design is simple and elegant, suggesting a focus on health and well-being. The logo is in black and white.

#### K210986 Page 2 of 5

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

### Device Description:

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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.

H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 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 1 fl. oz./30 mL size bottles are capped with natural disc tops. 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.

H2O Anal Cooling 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 Me 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 Cooling 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.

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#### 510(k) Summary - K210986

Image /page/5/Picture/1 description: The image shows a logo for "CC Wellness". The logo features two stylized, cursive letters "C" connected by a flowing line. The word "WELLNESS" is written in small, sans-serif letters below the two "C"s.

#### K210986 Page 3 of 5

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

The individual bottles are hermetically sealed during the production process.

These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.

The devices specifications are listed in the table below:

| Table 1: Device Specifications for H2O Cooling Personal Lubricant, H2O Anal Cooling |
|-----------------------------------------------------------------------------------------|
| Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife |
| Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two |

| Property | Specification |
|--------------------------------------------------------------|-------------------------------------------------------------|
| Appearance | Semi-viscous liquid |
| Color | Colorless |
| Odor | Peppermint |
| 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> | 1000 – 1100 (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 Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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 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 flowing lines of the cursive letters.

#### 510(k) Summary – K210986

# H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/

JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two

| Feature | H2O Cooling Personal Lubricant<br>H2O Anal Cooling Personal Lubricant<br>JO 2 To Tango for Me<br>JO 2 To Tango Couples Pleasure Kit<br>#LubeLife Sensations Cooling<br>#LubeLife Sensations Pleasure Kit for<br>Two | Agape Cooling Personal<br>Lubricant<br>(K200894) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | H2O Cooling Personal Lubricant, H2O<br>Anal Cooling Personal Lubricant, JO 2 To<br>Tango for Me, JO 2 To Tango Couples<br>Pleasure Kit, #LubeLife Sensations<br>Cooling 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<br>lubrication. These products are<br>compatible with natural rubber latex and<br>polyisoprene condoms. These products<br>are not compatible with polyurethane<br>condoms. | Agape Cooling 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, Glycerin, Polysorbate 20, Propylene<br>Glycol, Hydroxyethylcellulose,<br>Chlorphenesin, Mentha Piperita<br>(Peppermint) Leaf Extract and Sodium<br>Hydroxide | Aqua, Propanediol,<br>Gluconolactone,<br>Hydroxyethylcellulose,<br>Sodium Benzoate,<br>Polysorbate 20, Citric<br>Acid and Mentha<br>Piperita (Peppermint)<br>Leaf Extract |
| 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 |

### Table 2: Comparator Table for Subject and Predicate Device

The subject and predicate devices have similar indications for use statements 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

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#### 510(k) Summary - K210986

Image /page/7/Picture/1 description: The image shows a logo for a wellness company. The logo features a stylized, cursive font. The word "WELLNESS" is written in smaller, block letters below the cursive letters.

#### K210986 Page 5 of 5

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

Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing 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 10993-1:2019 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 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 D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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 Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are safe and effective as the predicate device and supports a determination of substantial equivalence.