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K Number
K982825
Device Name
BRENNEN MEDICAL BETA GLUCAN GEL
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
1998-11-06

(87 days)

Product Code
MGQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Brennen Medical Beta Glucan Gel

AI/ML Overview

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.

N/A