K Number
K172473
Device Name
LifeStyles® SKYN® Intimate Moments Personal Lubricant
Manufacturer
Date Cleared
2017-12-15

(122 days)

Product Code
Regulation Number
884.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The device description and performance studies focus on the chemical composition, physical properties, biocompatibility, and condom compatibility of a personal lubricant. There is no mention of AI or ML technology in the provided text.

No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or cure a medical condition.

No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose a medical condition.

No

The device description clearly indicates it is a physical personal lubricant made of various chemical components, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosing, monitoring, or treating diseases or conditions.
  • Device's Intended Use: The intended use of LifeStyles® SKYN® Intimate Moments Personal Lubricant is 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."
  • Mechanism of Action: The device works by providing physical lubrication and moisture to the external or internal reproductive organs. It does not analyze biological samples or provide diagnostic information.

The information provided clearly describes a personal lubricant for topical application during sexual activity, which falls under a different regulatory category than IVDs.

N/A

Intended Use / 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.

Product codes

NUC

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, total yeast and mold count per USP, absence of specific microorganisms per USP, and antimicrobial effectiveness per USP .

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

penile and/or vaginal application

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K120751

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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

1

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

2

Indications for Use

510(k) Number (if known) K172473

Device Name

LifeStyles® SKYN® Intimate Moments Personal Lubricant

Indications for Use (Describe)

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.

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:

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, total yeast and mold count per USP, absence of specific microorganisms per USP, and antimicrobial effectiveness per USP .

4

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.

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 DevicePredicate Device
Trade NameLifeStyles® SKYN® Intimate
Moments Personal LubricantTROJANT™ LUBRICANTS
Continuous Silkiness Personal
Lubricant
510(k) NumberK172473K120751
SubmitterSXWELL USA LLCChurch & Dwight Co., Inc
Product CodeNUCNUC
Regulation Number21 CFR 884.530021 CFR 884.5300
Regulation NamePersonal LubricantPersonal Lubricant
Indications for UseLifeStyles® 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.[Continuous Silkiness – Warm &
Tingling] [Continuous Silkiness] 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 natural
rubber latex and polyisoprene
condoms. Not compatible with
polyurethane or other condoms.
Prescription or Over-
The-Counter UseOver-The-Counter UseOver-the-Counter Use

5

Subject DevicePredicate Device
IngredientsPropylene glycol, water,
cyclopentasiloxane, dimethicone/
vinyl dimethicone crosspolymer,
hydroxyethyl acrylate/sodium
acryloyl dimethyl taurate copolymer,
cyclohexasiloxane, 1,2-hexanediol,
caprylyl glycol and fragrance (aroma).Propylene glycol, water,
dimethicone, dimethicone/ vinyl
dimethicone crosspolymer,
hydroxyethyl acrylate, sodium
acryloyl dimethyl taurate
copolymer, methylparaben and
propylparaben.
Condom CompatibilityCompatible with commercially
available polyisoprene condoms. Not
compatible with natural rubber latex
and polyurethane condomsCompatible with commercially
available natural rubber latex
and polyisoprene condoms
SterilizationNon-sterileNon-Sterile
Shelf Life3 years2 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.