The Silver Wound Pad is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic).

Device Description

The Silver Wound Pad is a sterile, single-use wound care dressing for use in moist wound management. The Silver Wound Pad is offered in several configurations including 24" x 36" and 36 " x 36" The dressings are comprised of 5 layers, each performing a specific function; an occlusive synthetic bottom layer (not in contact with patient), two absorbent layers, a layer of a knitted composite fabric (containing polyester on one side and nylon on the other side; coated with 15 ± 5% Antimicrobial AlphaSan® RC 2000 contained in a polyurethane binder) and a contact layer of apertured polyethylene film. These layers are then stitched or heat-sealed together along the edge.

AI/ML Overview

The provided text is a 510(k) summary for the Silver Wound Pad, focusing on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria, detailed device performance metrics in the way typically seen for AI/ML device studies, or the specific study design elements requested (like sample sizes for test/training sets, expert details for ground truth, or MRMC studies).

The "Performance Testing" section broadly states that "Biocompatibility testing was performed... Results... demonstrate that the device is suitable for its intended use. Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against gram-positive and gram-negative bacteria." However, it does not provide quantitative acceptance criteria or detailed results of these tests.

Therefore, many of the requested fields cannot be directly extracted from the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Study Details for Silver Wound Pad

Information Requested	Details from the Document
1. Table of Acceptance Criteria & Reported Performance	Acceptance Criteria: Not explicitly stated in terms of quantitative metrics. The overall acceptance criterion appears to be "substantially equivalent" to the predicate device, implying that the safety and effectiveness are comparable. Reported Performance: - Biocompatibility: "Results of the biocompatibility tests demonstrate that the device is suitable for its intended use." - Antimicrobial Activity: "Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against gram-positive and gram-negative bacteria." No specific numerical performance metrics (e.g., reduction percentage, zone of inhibition sizes) are provided.
2. Sample Size (Test Set) and Data Provenance	Not applicable. This device is a wound dressing, not an AI/ML diagnostic. The "testing" mentioned refers to laboratory performance tests (biocompatibility, antimicrobial), not a clinical 'test set' in the AI sense. No information on sample sizes or data provenance for these lab tests is provided.
3. Number of Experts & Qualifications (Ground Truth)	Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic test set.
4. Adjudication Method (Test Set)	Not applicable.
5. MRMC Comparative Effectiveness Study	Not applicable. This is not an AI/ML device and therefore no MRMC study would be applicable.
6. Standalone (Algorithm Only) Performance	Not applicable. This is a physical wound dressing and does not have an algorithm component.
7. Type of Ground Truth Used	Not applicable. The "ground truth" for this device would be established by validated laboratory assays for biocompatibility and antimicrobial efficacy.
8. Sample Size for Training Set	Not applicable. This is not an AI/ML device.
9. How Ground Truth for Training Set was Established	Not applicable.

Summary of the Study:

The "study" or "performance testing" described in the 510(k) submission for the Silver Wound Pad primarily consists of two types of laboratory tests:

Biocompatibility Testing: Performed in accordance with International Organization for Standardization (ISO) recommendations. The results indicated the device's suitability for its intended use. No specific ISO standards or detailed results are provided.
Antimicrobial Testing: Performed to demonstrate efficacy against gram-positive and gram-negative bacteria. The results showed the Silver Wound Pad "provides efficacy" against these bacteria. No specific test methods or quantitative results (e.g., bacterial reduction percentages or zones of inhibition) are mentioned.

The overarching "study" in the context of this 510(k) is the demonstration of substantial equivalence to the predicate device (Smith & Nephew Exu-Dry® Non-Permeable Pad). The biocompatibility and antimicrobial tests served to support the claim that the addition of a silver-based preservative does not negatively impact safety and effectiveness, and indeed provides an additional functional benefit (antimicrobial control) while maintaining overall equivalence in design, function, and intended use as a wound dressing. The acceptance criteria essentially boil down to passing these standard laboratory tests to a level that supports safety and efficacy for the stated intended use, and ultimately, allowing the FDA to determine substantial equivalence.

Summary

{0}------------------------------------------------

510(k) Summary for Silver Wound Pad

APR 1 6 2009

1. SPONSOR

Milliken Chemical 920 Milliken Rd., M-333 Spartanburg, SC 29303 Contact Person: John D. Bruhnke, Ph.D.

Telephone:864-503-2844 Date Prepared: March 9, 2009

2. DEVICE NAME

Proprietary Name: Silver Wound Pad Wound Dressing Common/Usual Name: Classification Name: Dressing

3. PREDICATE DEVICES

Smith & Nephew Exu-Dry® Non-Permeable Pad (K864011) .

4. DEVICE DESCRIPTION

{1}------------------------------------------------

5. INTENDED USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Technological characteristics of the Silver Wound Pad and the predicate product are substantially equivalent in that they are both dressings suitable for use on partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic). The Silver Wound Pad substantially equivalent in design, function and intended use to the Smith & Nephew Exu-Dry® Non-Permeable Pad (K864011). The only significant difference between the Silver Wound Pad and the predicate device is that Silver Wound Pad contains a silver-based preservative in a polyurethane coating for control of microorganisms.

{2}------------------------------------------------

7. PERFORMANCE TESTING

Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use. Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against grampositive and gram-negative bacteria. Milliken believes that the data included in this submission including the technical characteristics and physical properties demonstrate that Silver Burn Pad is substantially equivalent in design, function and intended use to Exu-Dry®.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Milliken & Company % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

APR 1 6 2009

Re: K083659 ·

Trade/Device Name: Silver Wound Pad Regulation Name: Unclassified Product Code: FRO Dated: March 31, 2009 Received: April 1, 2009

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to

{4}------------------------------------------------

Page 2 - Ms. Mary McNamara-Cullinane, RAC

premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, J

F.of P.ol.V
O.R

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

Enclosure

{5}------------------------------------------------

Indications for Use

K083659 510(k) Number (if known):

Silver Wound Pad Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel D. Kime for MXM

(Division Sign-Off) (Division Sign Of General, Restorative, Division rological Devices

510(k) Number K083659

Regulation Number and Section

N/A