(87 days)
Brennen Beta Glucan Gel 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 graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.
Brennen Glucan Gel provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
Brennen Medical Beta Glucan Gel
Unfortunately, the provided text is a 510(k) clearance letter from the FDA for a medical device called "Brennen Medical Beta Glucan Gel." This letter grants clearance for the device to be marketed based on substantial equivalence to a predicate device, but it does not contain the detailed study results, acceptance criteria, or performance data that would be necessary to answer your request.
The FDA 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with predefined acceptance criteria and performance reports in the same way a PMA (Premarket Approval) submission would.
Therefore, I cannot extract the information you've requested from these documents. The provided text only states:
- Device Name: Brennen Medical Beta Glucan Gel
- Regulatory Clearance: 510(k) clearance (K982825)
- Indications for Use: To aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin. It provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
- Limitations on Labeling: Not for third-degree burns, no claims of accelerating wound healing, not a long-term/permanent/artificial skin dressing, not a treatment or cure.
To get the information you asked for (acceptance criteria and detailed study data), you would typically need to consult the original 510(k) submission summary, which sometimes contains more detail on performance studies (though often not as extensive as a PMA). This information is not present in the brief FDA clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Mr. Kenneth B. Herland Director, Regulatory Affairs & Quality Assurance Brennen Medical, Inc. 1290 Hammond Road St. Paul. Minnesota 55110
Re: K982825
Trade Name: Brennen Medical Beta Glucan Gel Regulatory Class: Unclassified Product Code: MGQ Dated: October 16, 1998 Received: October 19, 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 vour device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
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- This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
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- 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
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Page 2 - Mr. Kenneth B. Herland
misbranding and adulteration.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Sallie McWane, Ph.D., M.D.
Ita 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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Page 1 of 1
510(k) Number (If Known): K982825
Device Name: Brennen Medical Beta Glucan Gel
INDICATIONS FOR USE:
Brennen Beta Glucan Gel 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 graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.
Brennen Glucan Gel provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of SAll, Value in Device Evaluation (VDL)
Prescription Use J (Per 21 CFR 801.109) OR
Over-The Counter-Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982825
Brennen Medical, Inc. Beta Glucan Gel 510(K) Submission
N/A