BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET

• K Number: K984082
• Device Name: BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
• Manufacturer: EMOX 911 CC
• Date Cleared: 1999-01-28 ( 73 days)
• Product Code: MGQ
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Burn-aid Hydrogel, Burn-aid Dressing, Burn-aid Burn Blanket". It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for the specific details you asked for, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on the regulatory clearance process, defining the permissible indications for use and outlining limitations on labeling claims to ensure substantial equivalence with existing products. It mentions "general controls provisions of the Act" and "Good Manufacturing Practices (GMP)" but does not detail performance-based acceptance criteria or validation studies beyond the substantial equivalence determination.

Summary

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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.
• 3. 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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

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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

Regulation Number and Section

N/A