(292 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The product is intended to moisturize and lubricate to enhance ease and comfort during intimate sexual activity, which is not considered a therapeutic purpose.
No
Explanation: This device is a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity, not to diagnose a medical condition.
No
The device description clearly states it is a "personal lubricant," which is a physical substance, 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 during sexual activity, applied to the vagina or penis. This is a topical application for physical comfort and ease, not for diagnosing a condition or examining a sample taken from the body.
- Device Description: The description details a lubricant for external or internal (vaginal) application, not a reagent or instrument used to test biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Diagnosing, monitoring, or predicting a disease or condition
- Using reagents or analytical methods
The device is clearly described as a personal lubricant, which falls under a different regulatory category than IVDs. The predicate devices listed are also personal lubricants, further supporting this conclusion.
N/A
Intended Use / Indications for Use
Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, 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 only.
Product codes
NUC
Device Description
Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Durex Play™ personal lubricant (K032124), Durex Play™ Assorted Temptations lubricants (K060098), Durex Play™ Warmer lubricant (K042563), KY liquid (K955648), Lifestyles (K033076)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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Section VIII: Durex Play Soft & Sensual Lubricant Premarket approval [510(k)] Application Summary.
Section VIII.1 Submitter Information
APR - 1 2008
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 SSL Americas. Date of summary: 31st March 2008
Section VIII.2 General Device Information
Device trade Name: Durex Play Soft & Sensual Device common name: Personal Lubricant Classification: Patient Lubricant , Patient lubricant, vaginal, latex compatible.
Section VIII.3 Predicate devices
Durex Play™ personal lubricant (K032124) Durex Play™ Assorted Temptations lubricants (K060098) Durex Play™ Warmer lubricant (K042563) KY liquid (K955648) Lifestyles (K033076)
Section VIII.4 Device Description
Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.
Section VIII.5 Intended Use
Indications: Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, 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 only.
Section VIII.6 Substantial Equivalence
The product; Durex Play™ Soft & Sensual Lubricant is substantially equivalent in intended use to Durex Play™ personal lubricant, Durex Play™ Assorted Temptations lubricants, Durex Play™ Warmer lubricant, KY liquid
1
(K955648) & Lifestyles (K033076). The proposed and predicate devices are non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms. In addition, the proposed labelling is substantially equivalent to that previously approved for the SSL predicate devices, and all are intended to be available over the counter.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2008
Mr. Chris Robinson Head of Regulatory Compliance SSL Americas, Inc. 3585 Engineering Dr., Suite 200 NORCROSS GA 30092-9214
K071626 Re:
Trade Name: Durex Play™ Soft & Sensual™ Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 17, 2008 Received: March 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.
3
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 Actor 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 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 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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Section IV.3 Indications for Use
510(k) Number (if known). K071626
Durex Play Soft & Sensual Device Name:
Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, 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 only.
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices |
510(k) Number K071624