(36 days)
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No
The summary describes a hydrogel gauze dressing for wound care and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device, DermaMend™ Hydrogel Gauze Dressing, is intended "To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds", which clearly describes a medical function for treating wounds.
No
The device, DermaMend™ Hydrogel Gauze Dressing, is described as absorbing exudate and creating a moist environment for wounds, which are therapeutic functions, not diagnostic.
No
The device description clearly identifies it as a "Hydrogel Gauze Dressing," 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 a device applied externally to wounds to absorb exudate and maintain a moist environment. This is a therapeutic or wound care function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: "Hydrogel Gauze Dressing" further supports the idea of an external wound dressing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a patient's health status
Therefore, the DermaMend™ Hydrogel Gauze Dressing is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds; 1st and 2nd degree burns; cuts, abrasions, and other imitations of the skin.
Product codes
KMF
Device Description
DermaMend™ Hydrogel Gauze Dressing
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
972336
Ms. Maryanne Carroll President DermaRx Corporation 400 S. Colorado Boulevard, Suite 420 Denver, Colorado 80222
JUL 2 9 1997
K972336 DermaMend™ Hydrogel Gauze Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 23, 1997 Received: June 23, 1997
Dear Ms. Carroll:
Re:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate 2. of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of 4. wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual
1
Page 2 - Ms. Maryanne Carroll
registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fo
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page --/ of /
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
DermaMend™ Hydrogel Gauze Dressing Device Name:
Indications For Use:
- To absorb exudate and to create and maintain a moist environment for partial and full -To absorb exudate and to create and manual a more estasis ulers; dermal wounds;
thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds;
thickness thickness wounds including pressure alocre, busers, and other imitations of the skin.
1ª and 2ª degree burns; cuts, abrasions, and other imitations of the skin.
(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 General Restorative Devices | |
| 510(k) Number | K972336 |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)