(163 days)
Durex Play™ Tingling 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.
Durex Play™ Tingling personal Lubricant is a clear, colorless, spearmint scented personal lubricant composed of silicone fluid and sweetened spearmint aroma concentrate.
The provided text is a 510(k) premarket notification summary for a medical device, Durex Play™ Tingling Lubricant. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, a study validating performance against such criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.
Therefore, I cannot provide the requested table and information based on the given input, as the document focuses on regulatory submission for substantial equivalence rather than a detailed performance study. The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often without requiring new clinical trials or detailed performance studies if equivalence can be established through design, materials, and intended use.
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042958
APR 8 2005
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. 770-582-2222 Fax: 770-582-2233 Phone: Phone: Contact Person: Chris Robinson, Controller Head of Regulatory Affairs, SSL Americas. Date of summary: 30 September 2004.
Section VIII.2 General Device Information
Device trade Name: Durex Play™ Tingling lubricant. Device common name: Personal Lubricant Classification: Patient Lubricant
Section VIII.3 Predicate devices.
K-Y Jelly Personal lubricant (K955648) Astroglyde (K935299) Durex Spearmint scented condoms (K900679) Durex Play™ Personal Lubricant (K032124)
Section VIII.4 Device Description
Durex Play™ Tingling personal Lubricant is a clear, colorless, spearmint scented personal lubricant composed of silicone fluid and sweetened spearmint aroma concentrate.
Section VIII.5 Intended Use
Indications: Durex Play ™ Tingling 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.
Section VIII.6 Substantial Equivalence
Durex Play ™ Tingling Lubricant is substantially equivalent in intended use to K-Y Jelly, Astroglyde and Durex Play ™ personal lubricants and is the same composition as the lubricant on Durex Spearmint Scented lubricated condoms. All these products are sold Over-the-Counter and are condom compatible formulations.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features the department's name around the perimeter. In the center is an emblem of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with two snakes winding around it and a pair of wings at the top.
APR 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Robinson Controller-Head of Global Regulatory Affairs, Regulatory Affairs Manager SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K042958
Trade/Device Name: Durex Play™ Tingling Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 28, 2005 Received: March 7, 2005
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 (Premarket Approval), 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.
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 (OS) 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) premarket notification. The FDA finding of substantial equivalence of your device to 10(k) 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 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollon the Accurities (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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Section IV.3 Indications for Use
510(k) Number (if known):
Device Name: Durex Play™ Tingling Lubricant
Indications For Use: Durex Play™ Tingling 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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.
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§ 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.