(190 days)
Durex Play™ 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™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
The provided text is a 510(k) Premarket Notification summary for Durex Play™ Personal Lubricant and the FDA's clearance letter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study proving the device meets acceptance criteria.
The information present in the document pertains to:
- Device Description: Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
- 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.
- Predicate Devices: K-Y Jelly Personal Lubricant (K955648) and AstroGlide (K935299).
- Substantial Equivalence: Durex Play™ is substantially equivalent to the predicate devices in intended use and similar in composition. All products are marketed as personal lubricants, safe to use with condoms, water soluble, and sold Over-the-Counter.
In summary, this document describes a regulatory filing based on substantial equivalence, not a clinical or performance study with the detailed aspects requested in the prompt.
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JAN 1 6 2004
Image /page/0/Picture/1 description: The image shows the logo for SSL Americas, Inc. The letters "SSL" are in large, bold font, followed by "Americas, Inc." in a smaller, thinner font. A curved line runs above and below the text, creating a swoosh effect.
Office of Requlatory Affairs 3585 Engineering Drive, Suite 200 Norcross, GA 30092-9214 Tel: 7 /0-582-2222 Fax: 770-582-2204
KO32124
Durex Play™, 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: Kathleen Harris, Regulatory Affairs Manager, SSL Americas Date of Summary: July 4, 2003
Section VIII.2 General Device Information
Device Trade Name: Durex Play™ 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™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
Section VIII.5 Intended Use
Indications: Durex Play™ 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™ 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.
Image /page/0/Picture/17 description: The image contains two brand logos, "durex" and "SILIPOS". The "durex" logo is enclosed in a rounded rectangle. The "SILIPOS" logo is to the right of the "durex" logo and has a small triangle to the right of the word.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 16 2004
Ms. Kathleen Harris Regulatory Manager SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K032124
Trade/Device Name: Durex Play Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: October 16, 2003 Received: October 21, 2003
Dear Ms. Harris:
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.
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) 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
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.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
Page 2
to proceed to the market.
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Indications for Use
510(k) Number (if known): K032124
Device Name: Durex Play Personal Lubricant
Indications For Use: Durex Play™ 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) ANDYOR
Over-The-Counter Use X (21 CFR 807 Subpart C)
*(PEEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadben
(Division Sign-Off Division of Reproductive, Abdom and Radiological Device
510(k) Number K032124
Page 1 of 1
§ 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.