(59 days)
BurnFree Hydrogel, Dressing & Blanket, Burnshield Hydrogel, Dressing & Blanket
Not Found
No
The summary describes a hydrogel-based burn dressing and blanket with antiseptic properties, and there is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as pre-medical first aid for burns to cool, soothe, and moisturize the burn area, indicating a therapeutic effect.
No
Explanation: The device is indicated for use as a "pre-medical first aid" to "cool, soothe and moisturize the burn area." It does not claim to diagnose any condition or disease.
No
The device description clearly outlines physical components (hydrogel, foam sheet, wool blanket) and does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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.
- Device Description: The device is a hydrogel, dressing, and blanket applied externally to the skin. It contains ingredients like tea tree oil for antiseptic properties.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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
Not Found
Device Description
BURN-AID Hydrogel is a water-based gel containing extract of Melaleuca alternifolia (tea tree oil) and various stabilizers, emulsifiers and preservatives. The tea tree oil acts as an antiseptic. This gel is available in single-use packets for direct application to the skin. The BURN-AID Burn Dressing is composed of a soft foam sheet impregnated with the BURN-AID Hydrogel. The BURN-AID Burn Blanket is composed of pure virgin wool saturated with the BURN-AID Hydrogel.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
BurnFree Hydrogel, Dressing & Blanket, Burnshield Hydrogel, Dressing & Blanket
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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I. General Information
Image /page/0/Picture/4 description: The image shows a sequence of handwritten characters. The characters are 'K961067'. The characters are written in a bold, cursive style. -
A. Submitted By: MedTrak International, nc. 9841 Broken Land Parkway, Suite 107 Columbia, MD 21406 Tel: (410) 381-6488 Fax: (410) 381-6496
MAY 1 6 1996
Contact Person: Harold Jaynes at address above
| B. | Device Trade Name: | BURN-AID Hydrogel |
|---|---|---|
| BURN-AID Hydrogel Burn Dressing | ||
| BURN-AID Hydrogel Burn Blanket | ||
| Common Name: | Burn Dressing, Blanket, & Gel | |
| Classification Name: | Burn Dressing, Blanket, & Gel | |
| C. | Predicate Device: | BurnFree Hydrogel, Dressing & Blanket |
| Burnshield Hydrogel, Dressing & Blanket |
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D. Device Description:
BURN-AID Hydrogel is a water-based gel containing extract of Melaleuca alternifolia (tea tree oil) and various stabilizers, emulsifiers and preservatives. The tea tree oil acts as an antiseptic. This gel is available in single-use packets for direct application to the skin. The BURN-AID Burn Dressing is composed of a soft foam sheet impregnated with the BURN-AID Hydrogel. The BURN-AID Burn Blanket is composed of pure virgin wool saturated with the BURN-AID Hydrogel. -
E. 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. -
F. Device Comparison:
The BURN-AID products are substantially equivalent to various other currently legally marketed burn products, including those marketed under the name BurnFree and Burnshield. Each of these products are available as a
1
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hydrogel containing tea tree oil, as a burn dressing impregnated with the hydrogel, or as a burn blanket impregnated with the hydrogel.
- II. Testing: No additional testing necessary