Climax Personal Lubricant

K171044 · Wsm Investment, LLC, Dba Topco Sales · NUC · Nov 21, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K171044
• Device Name: Climax Personal Lubricant
• Applicant: Wsm Investment, LLC, Dba Topco Sales
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Climax Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Story

Climax Personal Lubricant is a non-sterile, water-soluble, viscous liquid personal lubricant. It is applied topically to the penis or vagina to moisturize and lubricate, enhancing comfort during intimate sexual activity. The device is intended for over-the-counter use by consumers. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is supplied in 5 fl. oz. and 6.5 fl. oz. PET bottles. It functions by providing a physical barrier and reducing friction during sexual intercourse, thereby supplementing the body's natural lubrication.

Clinical Evidence

No clinical data. Performance testing included biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), condom compatibility (per ASTM D7661-10), and shelf-life testing. All results confirmed the device meets specifications and is biocompatible.

Technological Characteristics

Water-based lubricant; ingredients include purified water, glycerin, propylene glycol, hydroxyethylcellulose, diazolidinyl urea, methylparaben, propylparaben. Packaged in PET bottles. Tested per ISO 10993-1:2009, ISO 10993-10:2010, ISO 10993-11:2006, and ASTM D7661-10. Microbial testing per USP <61>, <62>, and <51>.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex, polyurethane, and polyisoprene 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

• Astroglide Sensual Strawberry (K140590)

Submission Summary (Full Text)

{0}------------------------------------------------

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

November 21, 2017

WSM Investment LLC, dba Topco Sales Julie Casagrande Quality Control Manager 3990 Suite B Heritage Oak Court Simi Valley, CA 93063

Re: K171044 Trade/Device Name: Climax Personal Lubricant Regulation Number: 21 CFR\$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 23, 2017 Received: October 23, 2017

Dear Julie Casagrande:

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. 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.

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.

{1}------------------------------------------------

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K171044

Device Name Climax Personal Lubricant

Indications for Use (Describe)

Climax Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary K171044

#### General Information

- WSM Investments dba Topco Sales 510(k) Owner: 3990-B Heritage Oak Court Simi Valley, CA, 93063 Telephone: [phone]
- Julie Casagrande Contact Person(s): QC/Regulatory Manager 3390-B Heritage Oak Court Simi Valley, CA 93063 Phone: [phone]
- Summary Preparation Date: November 20, 2017

#### Device Information

| Device Trade Name: | Climax Personal Lubricant |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom<br>(21 CFR 884.5300, Class II, Product Code: NUC (lubricant, personal)) |

#### Predicate Device

Device Name: Astroglide Sensual Strawberry 510(k) Clearance Number: K140590

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

#### Device Description

Climax Personal Lubricant is a non-sterile, water soluble, viscous liquid which is intended to be used as a personal lubricant. The ingredients are Purified Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben. The product specifications include appearance, color, odor, pH, viscosity, specific gravity, osmolality, total aerobic microbial count per USP <61>, total yeast and mold count per USP <61>, absence of pathogenic organisms per USP <62>, and antimicrobial effectiveness per USP <51>. Climax Personal Lubricant is packaged in 5 fl. oz, and 6.5 fl. oz. bottles.

#### Indications for Use

Climax Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

The subject and predicate device have the same intended use.

{4}------------------------------------------------

#### Technological Characteristics

| | K171044 | K140590 | Comments |
|--------------------------------|----------------------------------------------------------------|------------------------------------------------------------------|----------|
| General Device Characteristics | Subject | Predicate | |
| Trade Name | Climax Personal Lubricant | Astroglide Sensual Strawberry | N/A |
| Submitter | WSM Investment LLC, dba Topco<br>Sales | BioFilm Inc. | N/A |
| Regulation Number | 884.5300 | 884.5300 | Same |
| Product Code | NUC | NUC | Same |
| Device Class | Class II | Class II | Same |
| Condom Compatibility | Natural Rubber Latex (NRL),<br>Polyurethane, and Polyisoprene | Natural Rubber Latex (NRL),<br>Polyurethane, and<br>Polyisoprene | Same |
| Base Type | Water | Water | Same |
| Primary Ingredients | Water<br>Glycerin<br>Propylene Glycol<br>Hydroxyethylcellulose | Water<br>Glycerin<br>Propylene Glycol<br>Hydroxyethylcellulose | Same |
| Packaging | polyethylene terephthalate<br>(PET) bottle with pump | polyethylene terephthalate<br>(PET) bottle with flip top | Same |

The subject and predicate device have differences in technological characteristics, including formulation and specifications. However, those differences do not raise new questions on safety or effectiveness.

#### Performance Testing

#### Biocompatibility

Climax Personal Lubricant has undergone biocompatibility testing including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing per ISO 10993-1:2009, ISO 10993-10:2010 and ISO 10993-11:2006. The testing found that Climax Personal Lubricant is biocompatible.

#### Condom Compatibility

Climax Personal Lubricant was tested for condom compatibility per ASTM D7661-10 and was found to be compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

## Shelf Life

The results of shelf life testing demonstrate that the subject device maintains its specifications over the duration of their proposed shelf life.

#### Conclusion

The results of performance testing demonstrate that the subject and predicate device are substantially equivalent.