(27 days)
TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "TenderWet® Active." This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/software device that requires extensive performance studies against acceptance criteria in the manner you've outlined.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.
This document solely confirms that the FDA has reviewed the submission (K040517) for the TenderWet® Active device and determined it is substantially equivalent to existing devices, allowing it to be marketed. It does not contain primary study data or performance metrics against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2004
Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060
Re: K040517
Trade/Device Name: TenderWet® Active Regulatory Class: Unclassified Product Code: MGQ Dated: February 26, 2004 Received: February 27, 2004
Dear Ms. Haferkamp:
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 markcted predicate devices markcted 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 (Spccial 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 detcrmination 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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Page 2 - Mr. Jay M. Patel
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040517
Device Name: TenderWet® active
Indications For Use:
TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.
Prescription Use X ============================================================================================================================================================================ AND/OR Over-Thie-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
/ Mark A. Mikkelson
Division Sign-Off
Division of General, Restorative,
and Neurological Devices
510(k) Number K040517
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