(155 days)
Durex Play™ Warmer™ 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.
Durex Play Warmer™ is a clear colorless personal lubricant composed of Purified Water, Hydroxyethyl Cellulose (Natrosol 250), Propylene Glycol, Benzoic Acid, Sodium Hydroxide, Sodium Saccharin, Glycerol.
This 510(k) summary for Durex Play Warmer™ personal lubricant does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are typically not required for Class II devices seeking substantial equivalence via the 510(k) pathway.
The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or meeting specific performance criteria through a standalone study.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: Composition and general characteristics.
- Intended Use: What the lubricant is designed for.
- Substantial Equivalence: Comparison to existing predicate devices (K-Y Jelly and AstroGlide) based on intended use, composition, and marketing.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or ground truth establishment.
- Expert involvement or adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithmic performance.
- Ground truth types or training set details.
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Ko42563
FEB 2 3 2005
Durex Play Warmer™, Premarket Approval [510(k)] Summary
Section VIII.1 Submitter Information
SSL. Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233 Contact person: Chris Robinson, Regulatory Affairs Manager, SSL Americas Date of Summary: June 6th 2004
Section VIII.2 General Device Information
Device Trade Name: Durex Play Warmer™ Device Common Name: Personal lubricant Classification: Patient lubricant
Section VIII.3 Predicate Devices
K-Y Jelly Personal Lubricant (K955648) AstroGlide (K935299)
Section VIII.4 Device Description
Durex Play Warmer™ is a clear colorless personal lubricant composed of Purified Water, Hydroxyethyl Cellulose (Natrosol 250), Propylene Glycol, Benzoic Acid, Sodium Hydroxide, Sodium Saccharin, Glycerol.
Section VIII.5 Intended Use
Indications: Durex Play Warmer™ 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.
Section VIII.6 Substantial Equivalence
Durex Play Warmer™ is substantially equivalent in intended use to K-Y Jelly personal lubricant and AstroGlide and similar in composition. All products are marketed as personal lubricants, safe to use with condoms, water soluble and sold Over-the-Counter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Robinson Controller Head of Global Regulatory Affairs SSL Americas, Inc. 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-2222
Re: K042563
Trade/Device Name: Durex Play™ Warmer™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: 85 HIS Regulatory Class: II Regulation Number: 21 CFR §880.6375 Regulation Name: Patient lubricant Product Code: 80 KMJ Dated: February 3, 2005 Received: February 9, 2005
Dear Mr. Robinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have 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 the cherolsare) to regardy man date of the Medical Device Amendments, or to devices that have been May 20, 1970, the channing in 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 do not require apply a work of the Act. The general controls provisions of the Act de recreation and go 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I ippice 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. 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter whilanow you to organization of substantial equivalence of your device to a legally premarked nouncation: "The PDF mixing strenges and thus, permits 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 If you ucane specific acview to: your de retter 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" (21 CFR Also, please note the regulation enners in formation on your responsibilities under the Act from the 807.97). Tou may obtain other gulternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use
K042563 510(k) Number (if known):
Durex Play Warmer Personal Lubricant Device Name:
Indications For Use:
Durex Play™ Warmer™ 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel h. Syam
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.