LifeStyles® Warm Lovin'™ 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

LifeStyles® Warm Lovin'™ Personal Lubricant is a non-sterile, personal lubricant designed to moisturize and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a clear, nonstaining, long-lasting, warming and biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.

AI/ML Overview

The provided text describes the 510(k) summary for the LifeStyles® Warm Lovin'™ Personal Lubricant, detailing its non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe a study involving a device that uses a machine learning algorithm or AI.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this document.

Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing performed:

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

Acceptance Criteria / Test	Reported Device Performance (LifeStyles® Warm Lovin'™)
Condom Compatibility (ASTM D 7661)	Compatible with condoms (natural rubber latex, polyurethane, polyisoprene)
Biocompatibility (ISO 10993)	Biocompatible (tested for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity)
Non-staining	Non-staining
Viscosity	Appropriate viscosity (for substantial equivalence to predicate)
pH	Appropriate pH (for substantial equivalence to predicate)
Specific Gravity	Appropriate specific gravity (for substantial equivalence to predicate)
Appearance	Appropriate appearance (clear, gel-like liquid)
Color	Appropriate color (for substantial equivalence to predicate)
Odor	Appropriate odor (for substantial equivalence to predicate)
Microbial Quality (USP)	Microbial quality (tested for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness)
Shelf-life	3-year shelf-life (indicated by real-time and accelerated aging tests)

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 describes non-clinical bench testing and biocompatibility studies. Specific sample sizes for these tests are not provided in the summary. The studies are described as "non-clinical testing" and are likely performed in a laboratory setting, not on human subjects where data provenance (country, retrospective/prospective) would typically apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The tests performed are laboratory-based and follow established standards (e.g., ASTM, ISO, USP). "Ground truth" in the context of expert consensus is not relevant for this type of device and testing.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert review processes for medical image interpretation or similar tasks, which is not relevant to the described non-clinical testing.

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 is not applicable. This document describes a personal lubricant and its non-clinical performance; it does not involve AI or human readers for diagnostic tasks.

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

This is not applicable. The device is a personal lubricant, not an algorithm.

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

For the non-clinical testing:

Condom compatibility: Established by adherence to ASTM D 7661 standards.
Biocompatibility: Established by adherence to ISO 10993 standards.
Physical/Chemical properties (viscosity, pH, specific gravity, appearance, color, odor, non-staining): Established through bench testing against internal specifications and comparison to the predicate device.
Microbial Quality: Established by adherence to USP testing standards.
Shelf-life: Established by real-time and accelerated aging tests against pre-defined stability criteria.

These are objective, quantifiable measures against established scientific and regulatory standards, rather than subjective "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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

This is not applicable. There is no ground truth for a training set as this is not an AI/ML device.

Summary

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Ansell

Page 1 of 2 Traditional 510(k) Summary

510(k) SUMMARY

FEB 2 2 2013

Applicant:	Ansell Healthcare Products, LLC
	1635 Industrial Road,
	Dothan, AL 36303
	USA
	Phone: (334) 615-2563
	Fax: (334) 615-2574
Contact Person:	Robert Mahler, Regulatory Affairs Director, Americas
Date Prepared:	February 8, 2013
510(k) Number:	K122720
Proprietary Name:	LifeStyles® Warm Lovin'TM Personal Lubricant
Common Name:	Personal Lubricant
Classification Name:	Lubricant, patient, vaginal, latex compatible (Class II, 21 CFR884.5300, Product Code NUC)
Predicate Device:	K Y ® Brand Warming Liquid Personal Lubricant (K021492)

Device Description:

Indications for Use:

Technological Characteristics:

LifeStyles® Warm Lovin'™ Personal Lubricant contains a similar blend of ingredients as the predicate device that create a warming gel lubricant. Like the predicate, the lubricant formulation is compatible with condoms and biocompatible, and has appropriate characteristics (i.e. viscosity, pH, specific gravity, appearance, color , odor, microbial quality) for a personal lubricant.

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510(k) SUMMARY (Continued)

Non-Clinical Testing:

Testing per ASTM D 7661 indicated that, like the predicate, the lubricant formulation is compatible with condoms. As with the predicate, testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity in accordance with ISO 10993 indicated device biocompatibility. Bench testing indicated that the lubricant is non-staining and that it has an appropriate viscosity, pH, specific gravity, appearance, color and odor for substantial equivalence to the predicate. USP testing for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality. Real-time and accelerated aging tests indicate a 3-year shelf-life for the lubricant.

Summary:

LifeStyles® Warm Lovin™ Personal Lubricant has the same intended use and basic technological characteristics as the predicate device. This lubricant is as safe and effective as the predicate device.

END

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2013

Ansell Healthcare Products, LLC % Ms. Donna Di Gangi Principal Consultant DiGangi Consulting 4 Los Verdes Drive SAN LUIS OBISPO CA 93401

Re: K122720

Trade/Device Name: LifeStyles® Warm Lovin'™ Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 11, 2013 Received: February 12, 2013 ·

Dear Ms. Di Gangi:

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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Page 2 – Ms. Donna Di Gangi

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

HerbertPLerner-S

for 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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Traditional 510(k) Ansell Healthcare Products, LLC

Indications for Use

510(k) Number (if known):

K122720

Device Name: LifeStyles® Warm Lovin'TM Personal Lubricant

Indications for Use: LifeStyles® Warm Lovin'™ 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert R. Deliner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122720 510(k) Number

Page 1 of 1

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.