The Durex Play™ Tingling aqueous based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is only compatible with natural rubber latex condoms.

Device Description

Durex Play™ Tingling aqueous based personal lubricant is a slightly hazy/clear, water soluble personal lubricant.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a personal lubricant, not a medical device that would require the typical performance studies described in your request. Therefore, most of the requested information regarding acceptance criteria, study findings, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable to this type of submission.

This submission focuses on demonstrating substantial equivalence to a predicate device, Durex Play™ Personal Lubricant (K032124), rather than proving specific performance metrics against defined acceptance criteria for a diagnostic or therapeutic device. The key elements for this type of submission are typically:

Intended Use Compatibility: Ensuring the new device's intended use is substantially equivalent to the predicate.
Material Compatibility: Proving the formulation and materials are safe and compatible with intended use (e.g., condom compatibility).
Biocompatibility (if applicable): Testing for irritation or sensitization.
Performance (functional): Ensuring the lubricant functions as expected (e.g., lubrication properties).

Given the nature of the device (a personal lubricant), the "acceptance criteria" and "study" are not presented in the format one would expect for a diagnostic AI device. The approval is based on "substantial equivalence" to a predicate device.

Here's an attempt to address your points based on the provided text, highlighting what is and isn't available:

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

Acceptance Criteria: Not explicitly stated as quantitative metrics in the provided text. The FDA's acceptance is based on the determination of "substantial equivalence" to the predicate device. This implies that the device must perform similarly and safely for its intended use as the predicate. The crucial "performance" for a lubricant typically involves:
- Lubrication effectiveness: Enhancing ease and comfort of intimate sexual activity.
- Moisturizing properties.
- Condom compatibility: "This product is compatible with natural rubber latex condoms."
- Safety: Not causing irritation or adverse reactions.
Reported Device Performance: The text states the device's intended use is "to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." It also explicitly states, "This product is compatible with natural rubber latex condoms." The implication (by FDA approval) is that the submission provided data demonstrating these claims were met, and no significant differences from the predicate device were found. Specific quantitative performance data is not included in this summary.

Acceptance Criteria (Implied from Intended Use & Predicate Equivalence)	Reported Device Performance (Implied by 510(k) Clearance)
Enhances ease & comfort of intimate sexual activity.	Device is intended to achieve this.
Supplements body's natural lubrication.	Device is intended to achieve this.
Moisturizes.	Device is intended to achieve this.
Compatible with natural rubber latex condoms.	Product is compatible with natural rubber latex condoms.
Safe for penile and/or vaginal application.	Deemed safe through substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not provided: The provided 510(k) summary does not contain information about specific test sample sizes or data provenance for performance testing. For a device like a lubricant, testing often involves bench testing (e.g., viscosity, pH, osmolality, condom compatibility testing) and biocompatibility studies, which would have their own sample sizes but are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This type of medical device (personal lubricant) does not involve ground truth establishment by experts in the sense of diagnostic interpretation (e.g., radiologists reviewing images). The assessment is based on physical/chemical properties and biological safety.

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

Not Applicable: Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging or clinical trials with ambiguous endpoints. This is not pertinent to a personal lubricant's evaluation for substantial equivalence.

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

No: This is entirely irrelevant to a personal lubricant. MRMC studies and AI assistance are typically for diagnostic imaging or similar interpretation tasks.

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

No: This is irrelevant as there is no algorithm associated with a personal lubricant.

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

Not Applicable / Ground Truth by Proxy: For a lubricant, "ground truth" would be established by laboratory standards for material properties (e.g., pH, viscosity, osmolality), standardized biocompatibility testing (e.g., cytotoxicity, irritation, sensitization assays), and validated methods for condom compatibility. This isn't "ground truth" in the diagnostic sense but rather objective compliance with established performance standards for such products.

8. The sample size for the training set

Not Applicable / No Training Set: There is no "training set" for an AI algorithm in the context of a personal lubricant.

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

Not Applicable / No Training Set: There is no "training set" for an AI algorithm in the context of a personal lubricant.

Summary

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K672236

Durex Play™ Tingling Aqueous Based Lubricant Premarket Approval 510(K) Application.

MAY - 7 2008

Section VIII: Durex Play™ Tingling Lubricant Premarket approval [510(k)] Application Summary.

Section VIII.1 Submitter Information

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. Alternative contact person: Janice Jose, Associate Regulatory Controller Date of summary: July 2007.

Section VIII.2 General Device Information

Device trade Name: Durex Play™ Tingling aqueous based lubricant. Device common name: Personal Lubricant Classification: Patient Lubricant

Section VIII.3 Predicate devices.

Durex Play™ Personal Lubricant (K032124)

Section VIII.4 Device Description

Durex Play™ Tingling aqueous based personal lubricant is a slightly hazy/clear, water soluble personal lubricant.

Section VIII.5 Intended Use

Indications: The Durex Play ™Tingling aqueous based lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and Jubricate, 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.

Page 71 of 72

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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2008

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

Re: K072236

Trade/Devices Name: Durex Play Tingling Aqueous Based Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Dated: April 18, 2008 Received: April 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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Page 2

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 max 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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Durex Play™ Tingling Aqueous Based Lubricant Premarket Approval 510(K) Application.

Section IV.3 Indications for Use

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Durex Play™ Tingling aqueous based Lubricant

This product is only compatible with natural rubber latex condoms.

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)

ion of Renroductive. Andominal and Radiological Dey 510(k) Number

Page 15 of 72

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.