(146 days)
No
The summary describes a personal lubricant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a moisturizer for vaginal dryness and personal lubrication. These are therapeutic uses aimed at addressing a medical condition (vaginal dryness) or enhancing comfort during intimacy, which can be seen as a form of symptom relief or functional improvement. Additionally, it lists predicate devices that are personal lubricants, which are classified as therapeutic devices by the FDA.
No
The device is described as a personal lubricant intended to moisturize and facilitate comfort during sexual activity, not to diagnose any medical condition.
No
The device is a physical product (lubricant) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication and moisturizing vaginal dryness to enhance sexual activity and condom use. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description is of a personal lubricant, a substance applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
Product codes
NUC
Device Description
Durex Play™ Temptations Assorted personal lubricants are clear, colorless, water soluble personal lubricants.
The Tingle and Warming lubricants are already covered under K042958 and K042563 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal entry
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955648, K935299, K042563, K032124
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Durex Play™ Temptations Assorted Lubricants Premarket Approval 510(K) Application.
JUN - 8 2006
Section VIII: Durex Play™ Temptations Assorted lubricants 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 Phone: Fax: 770-582-2233 Contact Person: Chris Robinson, Controller Head of Regulatory Affairs, SSL Americas. Date of summary: 22nd December 2005.
Section VIII.2 General Device Information
Device trade Name: Durex Play™ Temptations Assorted lubricants. Device common name: Personal Lubricant Classification: Patient Lubricant
Section VIII.3 Predicate devices.
K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play™ Warmer lubricant (K042563) Durex Play™ Personal Lubricant (K032124)
Section VIII.4 Device Description
Durex Play™ Temptations Assorted personal lubricants are clear, colorless, water soluble personal lubricants.
The Tingle and Warming lubricants are already covered under K042958 and K042563 respectively.
Cont.
Page 168 of 169
1
Durex Play™ Temptations Assorted Lubricants Premarket Approval 510(K) Application.
Section VIII.5 Intended Use
Indications: Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers 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
The product Durex Play ™ Temptations Assorted Lubricants is substantially equivalent in intended use to K-Y Jelly, Astroglide and Durex Play ™ personal lubricants. The formulations are very similar to the existing Durex Play™ formulations Durex Play™ and Durex Play Warmer™ All these products are sold Over-the-Counter and are condom compatible formulations.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble an abstract representation of a human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 8 2006
Mr. Chris Robinson Head of Regulatory Compliance SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K060098
Trade/Device Name: Durex Play™ Temptations Assorted Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 11, 2006 Received: May 15, 2006
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.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the letters FDA in the center. The words "Centennial" and three stars are below the letters FDA. The text "Protecting and Promoting Public Health" is at the bottom of the image.
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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 yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Durex Play™ Temptations Assorted Lubricants Premarket Approval 510(K) Application.
Section IV.3 Indications for Use
510(k) Number (if known):
Durex Play™ Temptations Assorted Lubricants Device Name:
Durex Temptations Assorted Lubricants are 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 _____________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter Use X
(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)
Nancy C. Broodon
510/k) Numbe
Section V. Substantial Equivalence
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