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

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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a first aid product for minor skin injuries and does not mention any computational or analytical capabilities, let alone AI/ML.

Therapeutic

Yes
The device is intended for first aid use on minor burns, cuts, scrapes, and abrasions, and states it "Relieves Pain," "Cools and Soothes," and "Moistens," which are therapeutic claims.

Diagnostic

No
Explanation: The device is described as being for first aid use on minor burns, cuts, and scrapes, and provides relief, cooling, soothing, and moistening. None of these functions involve diagnosing a condition.

SaMD (Software as a Medical Device)

No

The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a physical product for topical application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for first aid on minor burns, cuts, scrapes, and abrasions, focusing on pain relief, cooling, soothing, and moistening. This is a topical application for external use.
• Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body.
• Device Description (Not Found): While the description is missing, the intended use strongly suggests a non-diagnostic product.
• No Mention of Biological Specimens: The intended use is applied directly to the affected area, not to biological samples like blood, urine, or tissue.

IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's intended use falls outside of that scope.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes

MGO

Device Description

Not Found

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

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

Not Found

Regulation Number and Section

N/A

Summary

0

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

2

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

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