(73 days)
Not Found
Not Found
No
The summary describes a hydrogel burn dressing and blanket, which are passive, non-electronic devices. There is no mention of any software, image processing, AI, or ML terms.
Yes
The device is intended to treat burns by cooling, soothing, and moisturizing the affected area, which aligns with the definition of a therapeutic device.
No
The device is described as a first aid product to cool, soothe, and moisturize burn areas. It does not perform any diagnostic function.
No
The 510(k) summary describes physical burn dressings and blankets, 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 BURN-AID products are for "pre-medical first aid for first and second degree burns and scalds to cool, soothe and moisturize the burn area." This describes a topical application for treating a physical injury.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting.
IVDs are used to perform tests on samples taken from the body to diagnose or monitor conditions. The BURN-AID products are applied to the body to treat a physical injury.
N/A
Intended Use / Indications for Use
The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first and second degree burns and scalds to cool, soothe and moisturize the burn area.
Product codes
MGQ
Device Description
Burn-aid Hydrogel, Burn-aid Dressing, Burn-aid Burn Blanket
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
pre-medical first aid
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN 28 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ivor Duncan EmOx 911 CC Post Office Box 79 Somerset West, South Africa 7129
Re: K984082
Trade Name: Burn-aid Hydrogel, Burn-aid Dressing, Burn-aid Burn Blanket Regulatory Class: Unclassifed Product Code: MGQ Dated: November 11, 1998 Received: November 16, 1998
Dear Mr. Duncan:
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 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).
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.
1
Page 2 - Mr. Ivor Duncan
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,
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
INOR DUNCAN
510(k) Number (if known): 984082
Device Name: BURN-AID Hydrogel BURN-AID Burn Dressing BURN-AID Burn Blanket
Indications for use: The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first and second degree burns and scalds to cool, soothe and moisturize the burn area.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE: ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Prescription use | Division of General Restorative Devices the counter Use |
| (Per 21 CFR 801.109 | 510(k) Number: 984082 |