LifeStyles® SKYN® Intimate Moments 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 polyisoprene condoms. This product is not compatible with natural rubber latex or polyurethane condoms.

Device Description

LifeStyles® SKYN® Intimate Moments Personal Lubricant is a non-sterile, propylene glycol/water/silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is made of propylene glycol, water, cyclopentasiloxane, dimethicone/ vinyl dimethicone crosspolymer, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer, cyclohexasiloxane, 1,2-hexanediol, caprylyl glycol and fragrance (aroma). The personal lubricant is packaged in a 100 mL tube or a 5 mL sample sachet.

The device specifications for the LifeStyles® SKYN® Intimate Moments Personal Lubricant include appearance, color, odor, viscosity, specific gravity, osmolality, pH, total aerobic microbial count per USP<61>, total yeast and mold count per USP<61>, absence of specific microorganisms per USP<62>, and antimicrobial effectiveness per USP <51>.

The device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with polyisoprene condoms but not compatible with natural rubber latex or polyurethane condoms.

AI/ML Overview

This document is a 510(k) summary for the LifeStyles® SKYN® Intimate Moments Personal Lubricant. It demonstrates the substantial equivalence of the subject device to a predicate device.

Here's an analysis of the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for a diagnostic or imaging device. Instead, it describes performance testing conducted to ensure safety and effectiveness, typical for a personal lubricant. The "acceptance criteria" here are implied by the successful completion of the tests and the device "maintaining its specifications."

Acceptance Criteria (Implied by Test Type)	Reported Device Performance (Summary)
Biocompatibility	The testing demonstrated that the LifeStyles® SKYN® Intimate Moments Personal Lubricant is biocompatible.
Condom Compatibility (Polyisoprene)	Compatible with Polyisoprene condoms.
Condom Compatibility (Natural Rubber Latex)	Not compatible with natural rubber latex condoms.
Condom Compatibility (Polyurethane)	Not compatible with polyurethane condoms.
Shelf Life (3 Years)	Maintains its specifications for the declared shelf life of three years (based on accelerated stability testing).
Device Specifications (Appearance, Color, Odor, Viscosity, Specific Gravity, Osmolality, pH, Microbial Counts, Antimicrobial Effectiveness)	Device specifications are maintained (implied by successful stability testing).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the non-clinical performance tests (biocompatibility, condom compatibility, shelf life). It only states that "testing was conducted" and "results... demonstrated." The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to this type of device and regulatory submission. Personal lubricants do not typically involve expert interpretation or "ground truth" establishment in the way medical imaging or diagnostic devices do. The performance is assessed through standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not part of the non-clinical testing for this personal lubricant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is not a study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests is derived from standardized laboratory testing and established analytical methods. For example:

Biocompatibility: In vitro and in vivo tests according to ISO standards.
Condom Compatibility: In vitro testing according to ASTM D7661-10.
Shelf Life: Accelerated stability testing measuring various physical and chemical device specifications.
Device Specifications: Laboratory measurements of properties like pH, viscosity, microbial counts, etc., against predefined acceptable ranges.

8. The sample size for the training set

This information is not applicable. This device does not involve machine learning or AI, and therefore, no "training set" in that context.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

In summary, the provided document is a regulatory submission for a personal lubricant, not a complex diagnostic or AI-driven medical device. Therefore, many of the requested data points related to clinical studies, expert-derived ground truth, and AI performance metrics are not relevant or present in this context. The "study" proving acceptance criteria here refers to the battery of non-clinical laboratory tests performed according to international standards (e.g., ISO, ASTM, USP) that demonstrated the product's safety and effectiveness for its intended use and supported its substantial equivalence claim.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 15, 2017

SXWELL USA LLC Robert Mahler Director, Regulatory Affairs for the Americas 111 Wood Avenue South, Suite 210 Iselin, New Jersey 08830

Re: K172473

Trade/Device Name: LifeStyles® SKYN® Intimate Moments Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: November 28, 2017 Received: November 30, 2017

Dear Robert Mahler:

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. 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

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manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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.

Benjamin R. Fisher -S

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) K172473

Device Name

LifeStyles® SKYN® Intimate Moments Personal Lubricant

Indications for Use (Describe)

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

☐ Production Use (Part 21 CFR 601 Subpart B)	☑ Gene Therapy Use (21 CFR 601 Subpart C)
----------------------------------------------	-------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary

[K172473](https://510k.innolitics.com/search/K172473)

Submitter:

SXWELL USA LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830, USA Phone: 732-345-2174 Rob.mahler@ansell.com

Contact Person:

Robert S. Mahler Director Regulatory Affairs for the Americas Phone: 732-345-2174 Rob.mahler@ansell.com

Date Prepared: December 15, 2017

Device Name:	LifeStyles® SKYN® Intimate Moments Personal Lubricant
Common Name:	Personal Lubricant
Regulation:	21 CFR 884.5300, Condom
Device Class:	Class II
Product Code:	NUC (lubricant, personal)
Classification Panel:	Obstetrics/Gynecology

Primary Predicate Device:

510(K) Number: K120751 Device Name: TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant Manufacturer: Church & Dwight Co., Inc.

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

Device Description:

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Indications for Use:

LifeStyles® SKYN® Intimate Moments Personal Lubricant is a personal lubricant, for penile 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. This product is compatible with polyisoprene condoms. This product is not compatible with natural rubber latex or polyurethane condoms.

Predicate Comparison:

The following table compares the LifeStyles® SKYN® Intimate Moments Personal Lubricant to the predicate device with respect to the indications for use and technological characteristics:

	Subject Device	Predicate Device
Trade Name	LifeStyles® SKYN® IntimateMoments Personal Lubricant	TROJANT™ LUBRICANTSContinuous Silkiness PersonalLubricant
510(k) Number	K172473	K120751
Submitter	SXWELL USA LLC	Church & Dwight Co., Inc
Product Code	NUC	NUC
Regulation Number	21 CFR 884.5300	21 CFR 884.5300
Regulation Name	Personal Lubricant	Personal Lubricant
Indications for Use	LifeStyles® SKYN® Intimate MomentsPersonal Lubricant is a personallubricant, for penile and/or vaginalapplication, intended to lubricate andmoisturize, to enhance the ease andcomfort of intimate sexual activityand supplement the body's naturallubrication. This product iscompatible with polyisoprenecondoms. This product is notcompatible with natural rubber latexor polyurethane condoms.	[Continuous Silkiness – Warm &Tingling] [Continuous Silkiness] is apersonal lubricant, for penileand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. Not compatible withpolyurethane or other condoms.
Prescription or Over-The-Counter Use	Over-The-Counter Use	Over-the-Counter Use

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	Subject Device	Predicate Device
Ingredients	Propylene glycol, water,cyclopentasiloxane, dimethicone/vinyl dimethicone crosspolymer,hydroxyethyl acrylate/sodiumacryloyl dimethyl taurate copolymer,cyclohexasiloxane, 1,2-hexanediol,caprylyl glycol and fragrance (aroma).	Propylene glycol, water,dimethicone, dimethicone/ vinyldimethicone crosspolymer,hydroxyethyl acrylate, sodiumacryloyl dimethyl tauratecopolymer, methylparaben andpropylparaben.
Condom Compatibility	Compatible with commerciallyavailable polyisoprene condoms. Notcompatible with natural rubber latexand polyurethane condoms	Compatible with commerciallyavailable natural rubber latexand polyisoprene condoms
Sterilization	Non-sterile	Non-Sterile
Shelf Life	3 years	2 years

The LifeStyles® SKYN® Intimate Moments Personal Lubricant has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

Non-Clinical Performance Testing:

Biocompatibility

Biocompatibility testing was conducted in accordance with ISO-10993-1:2009, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), vaginal irritation (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2006). The testing demonstrated that the LifeStyles® SKYN® Intimate Moments Personal Lubricant is biocompatible.

Condom Compatibility

The results of condom compatibility testing per ASTM D7661-10 demonstrated that the LifeStyles® SKYN® Intimate Moments Personal Lubricant is compatible with Polyisoprene condoms only.

Shelf Life

The results of accelerated stability testing demonstrate that the LifeStyles® SKYN® Intimate Moments Personal Lubricant maintains its specifications for the declared shelf life of three years.

Clinical Performance Data:

Not Applicable

Conclusion:

Based on the comparison and analysis above, the LifeStyles® SKYN® Intimate Moments Personal Lubricant is substantially equivalent to the predicate device.

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.