(90 days)
Not Found
No
The 510(k) summary describes a personal moisturizer and lubricant, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found in this excerpt) point to a simple, non-technological product.
No
The device is described as a personal moisturizer and lubricant for sexual pleasure and ease of insertion of various items, not for treating a disease or condition.
No
Explanation: The device is intended for personal moisturization and lubrication, not for diagnosing any disease or condition.
No
The device description is not found, but the intended use clearly describes a "Personal Moisturizer" used for lubrication, 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 clearly states that the device is a personal moisturizer for the vaginal area and for lubricating sexual pleasure and insertion of various items into the rectal area. This is a topical application and lubrication, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided text, the WET® Light Personal Moisturizer is a personal lubricant and moisturizer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
WET® Light Personal Moisturizer is intended for whi Bight refections . It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.
Product codes
85 MMS, 85 HIS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal area, rectal
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Trigg Laboratories, Inc. % Mr. W. Patrick Noonan Regulatory Counsel W. Patrick Noonan Warner Center Plaza, Suite 840 21800 Oxnard Street WOODLAND HILLS CA 91367 Re: K013086
K013060
Trade/Device Name: WET® Light Personal Moisturizer Regulation Number: 21 CFR 880.6375 Regulation Name: Patient lubricant Regulatory Class: II Product Code: 85 MMS Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 12, 2001 Received: September 14, 2001
Dear Mr. Noonan:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(th) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Cherosule) to regally manation program date of the Medical Device American Co commerce prior to May 20, 1978, the enzordance with the provisions of the Federal Food, Drug, devices that have been reclassinod in acceraarroval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmelle Act (Act) that do not require approvide controls provisions of the Act. The You may, therefore, market the devices, bacted to annual registration, listing of general Controls provisions of the fisc labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classifica (see above) and stime major regulations affecting your device can be it may be subject to additional controlial shoulding may only of the 898. In addition, FDA may found in the Code of I sacrains concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 Issualled of a backware of a back other requirements of the Act that I DA has made a acterinations administered by other Federal agencies. You must of any Federal statures and roganitients, including, but not limited to: registration and listing comply with an the Act 3 requirements, in 801); good manufacturing practice requirements as set (21 CFR Patt 807), laocime (21 OFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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.
: 上
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
2
510(k) Number (if known):_KO 13086
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
WET® Light Personal Moisturizer is intended for whi Bight refections . It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off
Division of Reproductive, Assisted,
and Radiological Devices K013086
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)