Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming

K200457 · CC Wellness, LLC · NUC · May 22, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K200457
• Device Name: Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
• Applicant: CC Wellness, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: May 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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 Story

Personal lubricants (Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming) formulated with Dimethicone, Dimethiconol, and Capsicum Frutescens Fruit Extract; intended for penile, anal, and vaginal application to enhance comfort during sexual activity. Products are non-sterile, over-the-counter (OTC) liquids packaged in PET bottles. Users apply topically to supplement natural lubrication. Compatibility with natural rubber latex, polyisoprene, and polyurethane condoms confirmed via ASTM D7661-18. Benefits include reduced friction and increased comfort during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5, -10, and -11 (cytotoxicity, sensitization, vaginal/penile irritation, acute systemic toxicity). Shelf-life validated via real-time aging study (3 years). Condom compatibility tested per ASTM D7661-18. All specifications met.

Technological Characteristics

Formulation: Dimethicone, Dimethiconol, Capsicum Frutescens Fruit Extract. Physical state: semi-viscous liquid. Viscosity: 800-1,075 cps (USP <911>). Packaging: PET bottles. Non-sterile. Biocompatibility per ISO 10993. Antimicrobial effectiveness per USP <51>.

Indications for Use

Indicated for individuals requiring lubrication for penile, anal, and/or vaginal intimate sexual activity. Compatible with natural rubber latex, polyisoprene, and 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

• JO Premium Personal Lubricant (K132954)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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.

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 Parkway<br>Valencia, CA 91355 |
| Contact Person: | Marlent Perez<br>Quality Specialist |
| | Bruce Albert<br>Head of Technical Services |
| Contact Numbers: | Phone: [phone], ext. 1007<br>Phone: [phone], ext. 231 |
| Summary Preparation Date: | May 4, 2020 |
| Trade Name: | Premium Warming Personal Lubricant<br>Premium Anal Warming Lubricant<br>All-In-One Warming |
| Common Name: | Personal Lubricant |
| Device Classification: | Common Name: Personal Lubricant<br>Classification Name: Condom<br>Classification Number: 21 CFR § 884.5300<br>Product Code: NUC (lubricant, personal)<br>Device Class: Class II |
| Predicate Device: | Product Name: JO Premium Personal Lubricant<br>510(k) Number: K132954<br>Manufacturer: United Consortium<br>Product Code: NUC (lubricant, personal)<br>Device Class: Class II |

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

# 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.

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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.

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 2<br>products. |
| Total aerobic microbial count (TAMC) per USP<br><61> and <1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP <61><br>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:

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

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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 Lubricant<br>Premium Anal Warming Lubricant<br>All-In-One Warming<br>(K200457) | JO Premium Personal Lubricant<br>(K132954) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Premium Warming Personal<br>Lubricant, Premium Anal Warming<br>Lubricant and All-In-One Warming<br>are personal lubricants for penile,<br>anal and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the ease and<br>comfort of intimate sexual activity<br>and supplement the body's natural<br>lubrication. These products are<br>compatible with natural rubber<br>latex, polyisoprene and<br>polyurethane condoms. | JO Premium Personal Lubricant is<br>a personal lubricant for penile<br>and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with natural<br>rubber latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. |
| Water soluble | No | No |
| Ingredients | Dimethicone, Dimethiconol and<br>Capsicum Frutescens Fruit Extract | Dimethicone,<br>Cyclopentasiloxane,<br>Cyclotetrasiloxane,<br>Dimethiconol |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene and<br>Polyurethane | 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.