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 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.

AI/ML Overview

This document describes the premarket notification (510(k)) and summary for a personal lubricant, "Climax Personal Lubricant." It is not for a medical device that uses AI or complex algorithms requiring extensive performance testing with clinical data, ground truth establishment, or multi-reader studies.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment cannot be provided from this document as it is not relevant to the type of device (personal lubricant) being discussed.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

Indications for Use: Same as predicate.
Technological Characteristics: Largely similar to predicate, with differences not raising new safety/effectiveness questions.
Performance Testing:
- Biocompatibility: Tested per ISO 10993 standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
- Condom Compatibility: Tested per ASTM D7661-10 with natural rubber latex, polyurethane, and polyisoprene condoms.
- Shelf Life: Demonstrated maintenance of specifications over proposed shelf life.

The acceptance criteria here are based on meeting these standardized tests rather than clinical performance metrics typical for diagnostic or AI-powered devices. No "ground truth" in the clinical sense (e.g., disease presence/absence determined by pathology) is applicable here.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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

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Indications for Use

510(k) Number (if known) K171044

Device Name Climax Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| 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 K171044

General Information

WSM Investments dba Topco Sales 510(k) Owner: 3990-B Heritage Oak Court Simi Valley, CA, 93063 Telephone: 805-842-9197
Julie Casagrande Contact Person(s): QC/Regulatory Manager 3390-B Heritage Oak Court Simi Valley, CA 93063 Phone: 805-842-9197
Summary Preparation Date: November 20, 2017

Device Information

Device Trade Name:	Climax Personal Lubricant
Common Name:	Personal Lubricant
Classification Name:	Condom(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

Indications for Use

The subject and predicate device have the same intended use.

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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 TopcoSales	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),Polyurethane, and Polyisoprene	Natural Rubber Latex (NRL),Polyurethane, andPolyisoprene	Same
Base Type	Water	Water	Same
Primary Ingredients	WaterGlycerinPropylene GlycolHydroxyethylcellulose	WaterGlycerinPropylene GlycolHydroxyethylcellulose	Same
Packaging	polyethylene terephthalate(PET) bottle with pump	polyethylene terephthalate(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.

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.