Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.

Device Description

Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.

The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".

AI/ML Overview

This premarket notification (K050086) for Brennen Medical, Inc.'s Silver Glucan Wound Dressing does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way modern medical device submissions typically do for AI/ML devices.

Instead, this 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use, and presents a list of general performance tests conducted. The "acceptance criteria" here are implied by the successful completion of these tests and the determination of substantial equivalence (rather than specific quantitative thresholds).

Therefore, I will extract the information available and note where specific details are not provided in this document format.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance(s)
Biocompatibility	No adverse tissue reactions (irritation, sensitization, cytotoxicity).	Studies conducted: skin irritation, sensitization, and cytotoxicity. Outcome: Device is effective for intended use and functions in a substantially equivalent manner.
Wound Healing	Supports or does not impede wound healing.	Animal Wound Healing Study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner.
Silver Dissolution	Controlled and appropriate release of silver ions.	Silver dissolution study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner.
Tensile Strength	Sufficient mechanical integrity for intended use.	Tensile strength study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner.
Barrier Efficacy	Effective barrier to bacterial and candida penetration.	Barrier efficacy study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. The indication for use explicitly states it is "an effective barrier to bacterial and candida penetration."
Antimicrobial Activity	Zone of inhibition demonstrating antimicrobial effect.	Zone of inhibition study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner.
Stability	Maintains integrity and performance over shelf life.	Stability testing conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner.
Substantial Equivalence	Device is as safe and effective as predicate devices.	Reviewed against Acticoat Silver Coated Wound Dressing (K955453) and Silverlon Contact Wound Dressing (K981299), and others. Conclusion: Found substantially equivalent in design, materials, function, intended use, and does not raise new questions of safety or effectiveness.

Missing Information: Specific quantitative thresholds for "acceptance criteria" (e.g., minimum tensile strength in Newtons, specific cytotoxicity scores, exact zone of inhibition measurements) are not detailed in this summary. The summary broadly states that the device "is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This 510(k) summary does not describe specific "test sets" in the context of an algorithm or AI model evaluation. The "studies" mentioned (Biocompatability, Animal Wound Healing, Silver Dissolution, Tensile Strength, Barrier Efficacy, Zone of Inhibition, Stability) are laboratory or animal-based performance tests, not clinical evaluations with human patient data or AI algorithm testing with a specific test set.

Sample Size for Test Set: Not applicable/not specified for a "test set" in the context of an AI/ML device. The underlying details of the sample sizes for each specific performance study (e.g., number of animals in the wound healing study, number of samples for tensile strength) are not provided in this summary.
Data Provenance: Not applicable/not specified for an AI/ML device test set. The provenance of the data for the performance studies (e.g., which lab conducted the tests, what species for animal studies) is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. This 510(k) pertains to a wound dressing, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth on a test set. The listed studies are laboratory and preclinical performance tests.

4. Adjudication Method for the Test Set

This information is not applicable. There is no AI/ML test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an imaging or diagnostic AI/ML system that would typically undergo such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies refers to the direct measurement or observation of the physical, chemical, or biological properties and effects of the wound dressing.

Biocompatibility: In-vitro (cytotoxicity, sensitization assays) and in-vivo (irritation, sensitization on animals/humans) test results.
Wound Healing: Clinical and histological assessment of wound closure, tissue regeneration, inflammation in an animal model.
Silver Dissolution: Analytical chemistry measurements of silver release.
Tensile Strength: Physical testing measurements of material strength.
Barrier Efficacy: Microbiological challenge tests demonstrating reduction of bacterial/fungal penetration.
Zone of Inhibition: Microbiological growth assays on agar plates.
Stability Testing: Comparison of pre- and post-aging performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI/ML algorithm that is "trained."

Summary

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K050086

Page 1 of 2

FEB 1 7 2006

510(K) Summary For Brennen Medical, Inc.'s Silver Glucan Wound Dressing

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Date Prepared: January 27, 2006

1.	Submitter	Brennen Medical, Inc.1290 Hammond RoadSt. Paul, MN 55110
		Kenneth HerlandV.P. Regulatory Affairs and Q.A.651-429-7413
2.	Device Name

Proprietary Name: Common Name: Classification Name: Regulatory Class:

Silver Glucan Wound Dressing (TBD) Dressing Dressing Unclassified

Intented Usc 3.

Device Description 4.

The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".

గ్ Predicate Device Comparision

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K050086

Brennen Medical, Inc. believes the Silver Glucan to be substantially equivalent in design, materials, function, and intended use as Acticoat Silver Coated Wound Dressing, a wownd dressing that is in commercial distribution and is presently marketed by Westain Medical (now under the name of Smith-Nephew) and previously reviewed by ODE under 510(k) K955453; and Silverlon Contact Wound Dressing reviewed on K981299. Both were found substantially equivalent.

Also, the following predicate device(s) contain silver or glucan and have been reviewed by ODE and found substantially equivalent

The predicate devices are: 1. Acticoat Silver Coated Dressing (K983833, K992221, K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan II Wound Dressing (K964241).

The predicate devices are all sterile, single use coverings for wounds. Each of the silver predicate devices, as well as this new device, employ silver metal on a support material.

The support matrix varies for each of the products. Acticoat silver coated dressing is a 3ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver-coated high density polyethylene mesh designed to be a banner against microbial infections of a wound. Silverlon and Silver Glucan are composed of a polymeric material (nylon). While the support matrixes vary for each product the role it provides is the same; to provide a physical barrier to the wound and provide a substrate for Ag.

The differences between the new Silver Glucan device and its predicate devices are minor and raise no new questions of safety or effectiveness. All of the products have the same intended use and are sterile and for single use.

Biocompatibility 6.

The Silver Glucan Wound Dressing was subjected to the following performance tests:

Biocompatability studies (including skin irritation, sensitization, and cytotoxicity)
Animal Wound Healing Study .
Silver dissolution .
Tensile strength .
Barrier efficacy .
Zone of inhibition .
Stability testing ●

In all instances, the Silver Glucan Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

Mr. Kenneth B. Herland Vice President Regulatory Affairs and Quality Assurance Brennen Medical, Inc. 1290 Hammond Road Saint Paul, Minnesota 55110

Re: K050086

K050080
Trade/Device Name: Brennen Medical Silver Glucan Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 6, 2006 Received: January 9, 2006

Dear Mr. Herland:

We have reviewed your Section 510(k) premarket notification of intent to narket the indication we nave reviewed your becasin 3 ro(s) presses is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regars neatment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Face to Fre commence prior to May 20, 1978, the exactions of the Federal Food, Drug, devices mall have been recurse in accee approval of a premarket approval application (PMA). and Costlience Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merciole, mance the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 acover) includes affecting major regulations affecting your device it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Obas of ements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I DTC issualite or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally it catal statutes and regaratents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic forth in the quality bystells (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and will you to organizal equivalence of your device of your device to a legally

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Page 2 - Mr. Herland

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), please
r the regulation and 11, 2011 and 11, 276, 11:55 and resealeries entitled if you desire specific advice for your ac not the ray a suggest note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the may ab contact the Office of Compliance at (216) 216 - 11 - 11 - 17 Part 807.97). You may obtain "Misbranding by reletence to premance nouthead.com of the Act from the Division of Small other general miormation on your responsion.com at its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer Fibelance or or corph/industry/support/index.html.

Sincerely yours,
Mark A. Mellkerson

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known)

Device Name: Brennen Medical Silver Glucan Wound Dressing

Indications for Use

Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penerration. The dressing may be used for partial and full thickness wounds including decabitus ulcers, venous stasis ulcers, diabelix ulcers. first and second degree burns, donor sites, and surgical wounds. Silver Glassis dicers, may be used over partial thickness wounds, and as a temporary covering for full thickness and grafted wounds.

Presemption Use X

(Per 21 CFR 801.109)

()[ર

Over the Counter Use

(Optimal Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)

Concurrence of CDRH,	(ODH)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K050086

Regulation Number and Section

N/A