Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile 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 condoms only.

Device Description

Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.

AI/ML Overview

This document describes a 510(k) premarket notification for a personal lubricant, not a medical device that requires clinical performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies in the way requested.

The submission for Durex Play Soft & Sensual Lubricant (K071626) primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on proving clinical effectiveness through detailed performance metrics against pre-defined acceptance criteria.

Therefore, the information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or not provided in this type of regulatory submission for this product.

Here's why and what information is relevant from the document:

Key Takeaways from the Document:

Device Type: Personal lubricant, classified as a Class II medical device (Regulation Number: 21 CFR §884.5300, Product Code: NUC).
Regulatory Pathway: 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Predicate Devices: Durex Play™ personal lubricant (K032124), Durex Play™ Assorted Temptations lubricants (K060098), Durex Play™ Warmer lubricant (K042563), KY liquid (K955648), and Lifestyles (K033076).
Basis for Substantial Equivalence: The document states the proposed and predicate devices are: "non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms." The intended use and labeling are also considered substantially equivalent.
"Acceptance Criteria" in a 510(k) Context: For this type of device and regulatory pathway, the "acceptance criteria" isn't a specific set of clinical performance metrics, but rather the demonstration that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparison of technical characteristics, intended use, and performance data if relevant (e.g., biocompatibility testing, lubricant compatibility with condoms), rather than complex clinical outcomes studies.

Regarding your specific questions:

Table of acceptance criteria and reported device performance: Not applicable. There are no clinical performance metrics or acceptance criteria presented in this type of 510(k) submission for a personal lubricant. The "performance" is demonstrated by its similarity to already approved lubricants.
Sample sizes used for the test set and data provenance: Not applicable for clinical performance. Any testing (e.g., for biocompatibility or condom compatibility) would have its own sample size, but that is not detailed here in the context of human clinical data for establishing performance.
Number of experts used to establish ground truth and qualifications: Not applicable. This type of submission does not involve expert review for clinical ground truth.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not a diagnostic device where human readers are interpreting results.
Standalone performance (algorithm only without human-in-the loop performance): Not applicable, as this is not an algorithm-driven device.
Type of ground truth used: Not applicable. For material performance (e.g., condom compatibility), the "ground truth" would be established by standardized laboratory testing methods, not clinical outcomes.
Sample size for the training set: Not applicable. This is not an AI/ML-driven device requiring training data.
How the ground truth for the training set was established: Not applicable.

Summary

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Section VIII: Durex Play Soft & Sensual Lubricant Premarket approval [510(k)] Application Summary.

Section VIII.1 Submitter Information

APR - 1 2008

SSL Americas 3585 Engineering Drive Suite 200 Norcross GA 30092-9214. Phone: 770-582-2174 Fax: 770-582-2226 Contact Person: Chris Robinson, Head of Regulatory Compliance SSL Americas. Date of summary: 31st March 2008

Section VIII.2 General Device Information

Device trade Name: Durex Play Soft & Sensual Device common name: Personal Lubricant Classification: Patient Lubricant , Patient lubricant, vaginal, latex compatible.

Section VIII.3 Predicate devices

Durex Play™ personal lubricant (K032124) Durex Play™ Assorted Temptations lubricants (K060098) Durex Play™ Warmer lubricant (K042563) KY liquid (K955648) Lifestyles (K033076)

Section VIII.4 Device Description

Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.

Section VIII.5 Intended Use

Indications: Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile 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 condoms only.

Section VIII.6 Substantial Equivalence

The product; Durex Play™ Soft & Sensual Lubricant is substantially equivalent in intended use to Durex Play™ personal lubricant, Durex Play™ Assorted Temptations lubricants, Durex Play™ Warmer lubricant, KY liquid

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(K955648) & Lifestyles (K033076). The proposed and predicate devices are non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms. In addition, the proposed labelling is substantially equivalent to that previously approved for the SSL predicate devices, and all are intended to be available 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2008

Mr. Chris Robinson Head of Regulatory Compliance SSL Americas, Inc. 3585 Engineering Dr., Suite 200 NORCROSS GA 30092-9214

K071626 Re:

Trade Name: Durex Play™ Soft & Sensual™ Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 17, 2008 Received: March 24, 2008

Dear Mr. 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 Actor 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 vours.

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). K071626

Durex Play Soft & Sensual Device Name:

This product is compatible with natural rubber latex condoms only.

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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K071624

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.