(27 days)
Not Found
Not Found
No
The provided 510(k) summary describes a wound dressing and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The intended use statement indicates that the device is for the "wet management" of various types of wounds, including chronic wounds like pressure ulcers and diabetic ulcers, which classifies it as a therapeutic device.
No
The document describes "TenderWet® active and TenderWet® active Cavity" as products for "wet management of ... wounds." This indicates a therapeutic or wound care function, not a diagnostic one. There is no mention of assessing, identifying, or diagnosing medical conditions using this device.
No
The 510(k) summary describes a wound dressing product, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being for the "wet management of dry, light and moderately exudating partial and full thickness wounds". This is a therapeutic application, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information about a patient's health status or disease.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Technologies: There is no mention of image processing, AI, DNN, or ML, which are sometimes associated with diagnostic devices, although their absence doesn't definitively rule out an IVD.
In summary, the device's function is to manage wounds, which is a treatment or care activity, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
MGQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (under the direction of a health care professional for chronic wounds)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
2
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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