(37 days)
Not Found
Not Found
No
The 510(k) summary describes a hydrogel wound dressing, a passive medical device, and contains no mention of AI, ML, image processing, or any other computational technology.
Yes
The device is indicated for the management of partial thickness wounds, burns, and other superficial injuries. The term "management" implies therapeutic action for these conditions.
No
Explanation: The provided text describes the device as a "hydrogel dressing" intended for the "management of partial thickness wounds, first and second degree burns," and other superficial injuries. Its function is to manage wounds, not to diagnose them. There is no mention of it being used to identify, detect, or analyze conditions.
No
The device description clearly states it is a "hydrogel dressing," which is a physical, material-based 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 clearly states that this is a wound dressing for the management of various types of wounds and burns. This is a topical application for direct treatment of the body surface.
- Device Description: The description reinforces that it is a sterile wound dressing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This hydrogel dressing is used in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries.
Ad-HealTM Hydrogel Dressing is indicated for:
First and Second Degree Burns
Partial Thickness Wounds
Donor Sites
Pressure Ulcers
Abrasions
Note: Ad-HealM is not indicated for full thickness or infected wounds or for third degree burns.
Product codes
MGQ
Device Description
This is a disposable, short term (less than 72 hours between changes) device for single patient use
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
Not Found
Indicated Patient Age Range
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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)
Not Found
Reference Device(s)
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
§ 878.4022 Hydrogel wound dressing and burn dressing.
(a)
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 parallel lines forming the body and wings. The bird is facing towards the upper right. 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
Mr. Patrick A. Malia Manager, Quality Assurance/Regulatory Affairs Ludlow-Technical Products ---Two Ludlow Park Drive, PO Box 297 Chicopee, Massachusetts 01021-0297
Re: K972646 Ad-Heal™ Hydrogel Dressing, various sizes Regulatory Class: Unclassified Product Code: MGQ Dated: July 11, 1997 Received: July 15, 1997
AUG 2 1 1997
Dear Mr. Malia:
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 of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
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).
1
Page 2 - Mr. Patrick A. Malia
The general controls provisions of the Act include requirements for annual 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 vour 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,
folly
Celia M. Witten, Ph.D., M.D.
ia 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
ATTACHMENT # 7 Page 1 of 1
Revised 08/01/97
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Indications For Use Form
510(k) Number (if known): K972646
Device Name: Ad-Heal Bd Heal Dressing
Indications for use:
This liydroge! dressing is a sterile wound dressing for the management of partial This hydrogel dressing is a sterle would dressing for and superficial injuries.
thickness wounds, first and second degree burns, donor sites and superficial injuries.
Ad-Heal™ Bydrogel Dressing is indicated for:
First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions
Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns.
This is a disposable, short term (less than 72 hours between changes) device for single patient use
(BLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANGILIER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K-972646 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | ----------------------------------------- |
OR
| Over-The Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)