BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO

• K Number: K980962
• Device Name: BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
• Manufacturer: BRENNEN MEDICAL, INC.
• Date Cleared: 1998-07-29 ( 135 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

MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.

MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

For external use only. Do not use on patients with known allergies to plants such as gum oat.

Device Description

Brennen Medical Beta Glucan Cream, "MacroPro"

AI/ML Overview

This document is a Premarket Notification (510(k)) decision letter from the FDA for the "Brennen Medical Beta Glucan Cream, 'MacroPro'". It focuses on regulatory approval and substantial equivalence, not on the performance of the device against specific acceptance criteria from a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document does not describe any specific performance criteria, a study design, sample sizes, expert qualifications, or ground truth establishment related to the device's efficacy or safety. It primarily outlines the allowed indications for use and disclaimers for labeling.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jul 29 1998

Mr. Kenneth B. Herland Director, Regulatory Affairs & Quality Assurance Brennen Medical, Inc. 1290 Hammond Road St. Paul, Minnesota 55110

Re: K980962

Trade Name: Brennen Medical Beta Glucan Cream, "MacroPro" Regulatory Class: Unclassified Product Code: MGQ Dated: May 21, 1998 Received: May 22, 1998

Dear Mr. Herland:

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:

• 1. This device may not be labeled for use on third degree burns.
• 2. This device may not be labeled as having any accelerating effect on the rate of 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.
• 4. This device may not be labeled as a treatment or a cure for any type of wound.

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. Kenneth B. Herland

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,

M. Witten, Ph.D., M.D.

. ".

Cel

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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JUL-13-98 MON 13:50

FAX NO. 4298020
K980962

Page 1 of 1

510(k) Number (If Known): K980962

Device Name: Brennen Medical Beta Glucan Cream, MacroPro

INDICATIONS FOR USE:

MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.

MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

For external use only. Do not use on patients with known allergies to plants such as gum oat.

(PLEASE DO NOT WRITE BELOW THIS I.INE-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
(Optional Format 1-2-96)

on Sign-Off)
ion of General Restorative Devices 4 8996f 2

Livision of General Re 510(k) Number

Regulation Number and Section

N/A