Durex Play ™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.

Device Description

Durex Play™ Massage gel personal lubricant is a clear, colorless, water soluble personal lubricant.

AI/ML Overview

This document is a 510(k) premarket notification for a personal lubricant, Durex Play™ Massage gel. It focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study with acceptance criteria and device performance evaluation in the typical sense of a medical diagnostic device.

Therefore, the requested information elements related to clinical study design, test sets, ground truth establishment, and expert involvement are not applicable in this context. The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of intended use, technological characteristics, and performance data if relevant to safety or effectiveness claims.

Here's a breakdown of the available information based on your request, highlighting what is not applicable (N/A) given the nature of a 510(k) for a personal lubricant:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (N/A for 510(k) for this device type)	Reported Device Performance (Focus on Substantial Equivalence)
N/A - No specific quantitative performance acceptance criteria are mentioned for this lubricant in the provided text, as this is a 510(k) submission for substantial equivalence.	Intended Use: As a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. Compatibility with natural rubber latex and synthetic polyisoprene condoms.
N/A	Formulation: Very similar to existing Durex Play™ formulations (Durex Play™ and Durex Play Warmer™).
N/A	Safety & Effectiveness: Considered substantially equivalent to predicate devices (K-Y Jelly Personal lubricant, Astroglide, Durex Play™ Warmer lubricant, Durex Play™ Personal Lubricant) based on intended use and formulation similarity.
N/A	Biocompatibility: Implied through substantial equivalence to legally marketed predicates.
N/A	Condom Compatibility: Explicitly stated to be compatible with natural rubber latex and synthetic polyisoprene condoms.

2. Sample size used for the test set and the data provenance:

N/A. The provided document does not describe a "test set" in the context of a performance study for this device. The submission focuses on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a test set of data.

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

N/A. No expert ground truth establishment for a test set is described. The FDA's review process and the determination of substantial equivalence are made by regulatory experts based on the submitted documentation and comparison to predicate devices, rather than through expert review of a clinical test set for this product type.

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

N/A. No test set or adjudication method is described.

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:

N/A. This device is a personal lubricant, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

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

N/A. This device is a personal lubricant, not an algorithm. Standalone performance as described is irrelevant.

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

N/A. The concept of "ground truth" as typically applied in diagnostic device studies (e.g., pathology for cancer detection) is not applicable here. The "truth" in this 510(k) submission is the demonstration of substantial equivalence to already legally marketed devices based on intended use, technological characteristics, and safety profiles.

8. The sample size for the training set:

N/A. As this is not an AI/algorithm-based device, there is no "training set."

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

N/A. Not applicable, as there is no training set for this device.

In summary, for a 510(k) submission for a personal lubricant, the primary "study" is the comparison to predicate devices to demonstrate substantial equivalence. The provided document indicates that the device's formulation is "very similar" to existing Durex Play™ products and shares the same intended use as other legally marketed lubricants (K-Y Jelly, Astroglide, etc.). The FDA's issuance of the 510(k) clearance signifies their agreement that the Durex Play™ Massage gel lubricant is substantially equivalent to these predicate devices for its intended use.

Summary

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Durex Play ! M Massage Lubricant Pre-market Notitication 510(k) submission.

Section VIII: Durex Play™ Massage gel lubricant Premarket approval [510(k)] Application Summary.

Section VIII.1 Submitter Information

SSL Americas 3585 Engineering Drive Suite 200 Norcross GA 30092-9214. Fax: 770-582-2233 Phone: 770-582-2222 Contact Person: Chris Robinson, Controller Head of Regulatory Affairs, SSL Americas. Date of summary: original 1 November 2006 , amended 10 March 2008.

Section VIII.2 General Device Information

Device trade Name: Durex Play™ Massage gel Device common name: Personal Lubricant Classification: Patient Lubricant

Section VIII.3 Predicate devices.

K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play™ Warmer lubricant (K042563) Durex Play™ Personal Lubricant (K032124)

Section VIII.4 Device Description

Durex Play™ Massage gel personal lubricant is a clear, colorless, water soluble personal lubricant.

Cont.

Ko63385

MAR 1 0 2008

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Section VIII.5 Intended Use

Indications: Durex Play ™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.

Section VIII.6 Substantial Equivalence

The product Durex Play ™ Massage gel is substantially equivalent in intended use to K-Y Jelly, Astroglide and Durex Play ™ personal lubricants. The formulations are very similar to the existing Durex Play™ formulations Durex Play™ and Durex Play Warmer™ All these products are sold Over-the-Counter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2008

Mr. Chris Robinson Controller-Head of Global Regulatory Affairs SSL Americas. Inc. 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-2891

K063385 Re:

Trade/Device Name: Durex Play™ Massage Gel Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 19, 2008 Received: February 29, 2008

Mr. Chris Robinson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section IV.3

Indications for Use

510(k) Number (if known):

Device Name: Durex Play™ Massage Gel Lubricant

Durex Play™Massage gel lubricant is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

This lubricant has been shown to be compatible only with condoms made of natural rubber latex and synthetic polyisoprene.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Lense

(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.