BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD

• K Number: K990179
• Device Name: BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
• Manufacturer: NORTRADE MEDICAL, INC.
• Date Cleared: 1999-08-13 ( 205 days)
• Product Code: MGQ , MGO
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

1. For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions.
2. Relieves Pain.
3. Cools and Soothes.
4. Moistens.
5. Non-Irritating
6. Bacteriostatic

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Burnfree Sterile Wound and Burn Dressing" and "Burnfree Pain Relieving Gel" products. It confirms that the devices are substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

This document does not contain information about:

1. Acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or details of a study.
3. Number of experts, their qualifications, or adjudication methods.
4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines emanating from the head, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1999

Mr. Jay W. Taylor Executive Vice President Nortrade Medical, Inc. 9382 South 670 West Sandy, Utah 84070

Re: K990180 Trade Name: Burnfree Sterile Wound and Burn Dressing K990179 Trade Name: Burnfree 1/8 oz. Sterile Pain Relieving Gel, Model SD K990178 Trade Name: Burnfree Pain Relieving Gel, Model 4B Regulatory Class: Unclassified Product Code: MGO Dated: July 20, 1999 Received: July 26, 1999

Dear Mr. Taylor:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 devices 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.

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Page 2 – Mr. Jay W. Taylor

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 [phone] 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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Form B

Indications for Use Form

510 (k) Number (if known):

Device Name: BURNFREE 1/8 oz. STERILE PAIN RELIEVING GEL SD

Indications for Use:

• 1. For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions.
• 2. Relieves Pain.
• 3. Cools and Soothes.
• 4. Moistens.
• 5. Non-Irritating
• 6. Bacteriostatic

Instructions:

Apply a generous layer to affected area. Do not rub in - the gel is most effective when applied in a thick layer.

Warning:

For external use only. Seek medical attention if condition persists.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or

Over-the-Counter Use X

Pcoellef

79

Regulation Number and Section

N/A