(400 days)
No
The summary describes a passive wound dressing with antimicrobial properties. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is described as an effective barrier to bacterial and candida penetration used for various types of wounds, indicating it is intended to provide a therapeutic benefit by protecting and facilitating healing of injured tissue.
No
The device is a wound dressing designed to protect wounds from contamination and facilitate healing, not to diagnose medical conditions.
No
The device description clearly states it is a physical wound dressing made of nylon mesh coated with silver and oat glucan, and the performance studies focus on physical and biological properties of the dressing. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Silver Glucan Wound Dressing is a topical dressing applied directly to wounds. Its function is to act as a barrier to bacterial and candida penetration and facilitate wound healing. It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly describes its application to various types of wounds on the body.
- Device Description: The description details the physical components of the dressing and its mechanism of action on the wound surface.
- Performance Studies: The performance studies focus on biocompatibility, wound healing, physical properties of the dressing, and its barrier efficacy against microorganisms, all of which relate to its direct application to the wound.
Therefore, the Silver Glucan Wound Dressing is a medical device intended for direct application to the body for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be used 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.
Product codes
FRO
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".
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955453, K981299, K983833, K992221, K000051, K001519, K002466, K964241
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 Road
St. Paul, MN 55110 |
|----|-------------|---------------------------------------------------------------------|
| | | Kenneth Herland
V.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.
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 4.
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".
గ్ Predicate Device Comparision
1
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.
2
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
3
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
4
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) |
|---|---|
| ---------------------- | ------- |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K050086