LifeStyles® Smooth™ 2-in-1 Massage & 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® Smooth™ 2-in-1 Massage & Lubricant is a non-sterile, water-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. The formula is a non-staining, non-sticky, biocompatible gel-like liquid, with a strawberry aroma, 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 a 510(k) submission for a personal lubricant, not an AI-powered medical device. Therefore, the questions related to AI device performance, training sets, ground truth, expert opinions, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through various physical, chemical, and biological compatibility tests.

If this were an AI medical device submission, the following information would be required:

Acceptance Criteria and Device Performance for an AI-Powered Medical Device

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
[Specific AI Metric 1]	[Threshold/Range for Metric 1]	[Actual Device Performance for Metric 1]
[Specific AI Metric 2]	[Threshold/Range for Metric 2]	[Actual Device Performance for Metric 2]
[Specific AI Metric 3]	[Threshold/Range for Metric 3]	[Actual Device Performance for Metric 3]
(Add more rows as needed for all relevant metrics)

2. Sample Size and Data Provenance

Test Set Sample Size: [Number] of cases (e.g., images, patient records).
Data Provenance:
- Country of Origin: [List of countries where data was collected]
- Retrospective/Prospective: [State whether the data was retrospective, prospective, or a mix of both. If mixed, specify proportions or characteristics of each.]

3. Experts for Ground Truth Establishment

Number of Experts: [Number]
Qualifications of Experts: [Detailed qualifications for each expert or group of experts, e.g., "Board-certified radiologists with an average of 15 years of experience in oncologic imaging, including sub-specialty training in breast MRI interpretation."]

4. Adjudication Method for Test Set Ground Truth

Adjudication Method: [Describe the method used, e.g., "2+1 consensus (two initial reads, third expert resolves disagreement)," "3+1 (three initial reads, majority rules, fourth expert resolves persistent disagreement)," "Majority vote," "No adjudication, single expert reads."]

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? [Yes/No]
If Yes:
- Effect Size of Human Reader Improvement (AI vs. Without AI Assistance): Human readers showed an improvement of [Quantifiable metric, e.g., "X% increase in AUC," "Y reduction in false positives per case," "Z% increase in sensitivity while maintaining specificity"] when assisted by AI compared to unassisted reads.

6. Standalone Algorithm Performance

Was a standalone (algorithm only) performance study done? [Yes/No]
If Yes, Report Standalone Performance: [Report relevant metrics for the algorithm alone, e.g., "Standalone sensitivity was X% and specificity was Y%," "Standalone AUC was Z."]

7. Type of Ground Truth Used

Type of Ground Truth: [Specify the definitive source of truth for the test set, e.g., "Expert consensus," "Histopathology/Pathology results," "Longitudinal patient outcomes data," "Clinical follow-up," "Hybrid (e.g., expert consensus confirmed by pathology for a subset)."]

8. Training Set Sample Size

Training Set Sample Size: [Number] of cases.

9. Ground Truth Establishment for Training Set

Method for Establishing Ground Truth: [Describe how the ground truth for the training data was established. This can be similar to the test set ground truth methods but often involves more automated or scalable approaches, e.g., "Labeling by expert radiologists (same qualifications as test set experts)," "Programmatic labeling based on EMR data and pathology reports," "Crowdsourcing with expert review," "Hybrid approach combining automated extraction with targeted expert review."]

Summary

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K122476

Image /page/0/Picture/2 description: The image shows the word "Ansell" in a bold, sans-serif font. The word is in all capital letters and is black. There is a horizontal line underneath the word, which appears to be a stylized underline.

Traditional 510(k) Ansell Healthcare Products, LLC

510(k) SUMMARY

Applicant:

Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, AL 36303, USA Phone: (334) 615-2563 Fax: (334) 615-2574

Robert Mahler, Regulatory Affairs Director, Americas Contact Person:

Date Prepared: January 28, 2012

510(k) Number: K122476

LifeStyles® Smooth™ 2-in-1 Massage & Lubricant Proprietary Name:

Common Name: Personal Lubricant

Classification Name: Lubricant, patient, vaginal, latex compatible (Class II, 21 CFR 884.5300, Product Code NUC)

Predicate Device: Durex Play™ Temptations Assorted Lubricants (K060098)

Device Description:

Indications for Use:

Technological Characteristics:

LifeStyles® Smooth™ 2-in-1 Massage & Lubricant contains a similar blend of water and water soluble ingredients as the predicate device. Testing per ASTM D7661 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. The osmolality of the device was tested. Real-time and accelerated aging tests indicate a 3 year shelf-life for the lubricant.

Summary:

LifeStyles® Smooth™ 2-in-1 Massage & 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem. The seal is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

March 7, 2013

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

Re: K122476

Trade/Device Name: LifeStyles® Smooth™ 2-in-1 Massage & Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 29, 2013 Received: February 1, 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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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,

HerbertP.Lerner -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

K122476 510(k) Number (if known):

Device Name: LifeStyles® Smooth™ 2-in-1 Massage & Lubricant

Indications for Use: LifeStyles® Smooth™ 2-in-1 Massage & 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 PD & erner -S

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inn Sign-Of uctive. Gastro-Renal, and

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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.