The Milliken Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. Milliken Silver Wound Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

Device Description

Milliken's Silver Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressing consists of a nylon, lycra, and polyester continuous filament Jersey knit textile substrate which is pad coated with an aqueous suspension of silver sodium hydrogen zirconium phosphate (AlphaSan® RC-2000) and a polyurethane binder to provide an antimicrobial coating to the fabric. The textile substrate has a nylon face and polyester back providing a moisture affinity gradient across the thickness of the dressing.

Milliken Silver Wound Dressings are offered in several configurations including the following: 2" x 2", 4.25" x 4.25", 6" x 6", 1" x 24" and 4" x 48" (wrap).

AI/ML Overview

Here's an analysis of the provided text regarding the Milliken Silver Wound Dressings, structured according to your request. Please note that the document is a 510(k) summary for a medical device cleared by the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance against predefined acceptance criteria through a full-fledged clinical study in the way a novel drug or a high-risk AI algorithm might.

This document describes a wound dressing, which is a relatively low-risk device. The "performance testing" described is primarily to support the claim of substantial equivalence and safety, not to establish a precise performance metric like sensitivity or specificity.

Acceptance Criteria and Study Details for Milliken Silver Wound Dressings

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a wound dressing, the "acceptance criteria" are not framed as specific numerical performance targets like sensitivity/specificity for an AI algorithm. Instead, the acceptance criteria are implicitly that the device is substantially equivalent to legally marketed predicate devices, demonstrating comparable safety and effectiveness.

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance (as demonstrated by testing)
Biocompatibility: Suitable for intended use (non-toxic, non-irritating).	Results: Biocompatibility testing performed in accordance with ISO recommendations demonstrated the device is suitable for its intended use. Specifically, the animal study indicated the test articles were "nonirritant as compared to the negative and comparative controls."
Antimicrobial Barrier Effectiveness: Provides an effective microbial barrier to the dressing itself.	Results: Antimicrobial testing performed showed that the Milliken Wound Dressings provide an effective microbial barrier to the dressing itself. This aligns with the intended use statement: "provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing." The document references "zone-of-inhibition antimicrobial" testing, which is a standard method to demonstrate antimicrobial activity of substances.
Wound Healing Characteristics: Does not impede normal wound healing.	Results: A full thickness wound healing study conducted using swine found that "All wounds appeared to heal without complication." Microscopically, "the test articles were considered nonirritant as compared to the negative and comparative controls." This indicates that the dressing did not negatively impact the healing process and was well-tolerated.
Substantial Equivalence: Design, function, and intended use are similar to predicate devices, and differences do not affect safety and effectiveness.	Claim: Milliken believes that the data, including technical characteristics, physical properties, silver extraction, zone-of-inhibition antimicrobial and animal testing, demonstrates substantial equivalence to Argentum Medical LLC Silverlon® Wound Contact Dressing (K023612) and Westaim Biomedical Acticoat™ 7 Dressing (K001519). The FDA ultimately concurred with this claim, issuing the 510(k) clearance (K051445).

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

Sample Size:
- Biocompatibility: Not specified beyond "testing was performed."
- Full Thickness Wound Healing Study (Swine): The specific number of swine or wounds is not explicitly stated. It mentions "swine in order to characterize the healing process."
- Antimicrobial Testing (Zone-of-Inhibition): Not specified.
Data Provenance: The wound healing study was conducted using swine (animal data). Other tests (biocompatibility, antimicrobial) are general lab tests. There is no human clinical data presented in this summary.

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

Experts: Not explicitly mentioned in the context of establishing "ground truth" for the test results. For the animal study, the microscopic evaluation of irritation would typically be performed by a veterinary pathologist, but their number and qualifications are not specified nor is it described as "ground truth" in the AI sense.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This document does not describe a process involving human judgment on diagnostic output, but rather laboratory and animal study results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed or described. This type of study is typically relevant for diagnostic imaging or AI algorithms where human readers interpret results.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Standalone Performance: Not applicable. The device is a physical wound dressing, not a diagnostic algorithm. Therefore, "standalone performance" in the context of AI is not relevant. The device implicitly performs its function (antimicrobial barrier, wound healing support) "standalone" without human-in-the-loop interaction for its primary function once applied.

7. Type of Ground Truth Used

Ground Truth: The "ground truth" here is based on biological outcomes (wound healing, non-irritation) and laboratory measurements (antimicrobial activity, biocompatibility metrics).
- For the wound healing study: The observation that "All wounds appeared to heal without complication" and microscopic findings that "the test articles were considered nonirritant" serve as the "ground truth" for the dressing's impact on healing in the animal model.
- For antimicrobial activity: The "zone-of-inhibition" results directly measure the antimicrobial efficacy, serving as ground truth for that specific property.
- For biocompatibility: The results from ISO-compliant tests establish the biological safety.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Training Set Ground Truth Establishment: Not applicable, as there is no training set for a physical wound dressing.

Summary

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510(k) Summary for Milliken Silver Wound Dressings

1. SPONSOR

Milliken Chemical 920 Milliken Rd. PO Box 1927, M-209 Spartanburg, SC 29304 Contact Person: John D. Bruhnke, Ph.D.

864-503-2844 Telephone: Date Prepared: August 10, 2005

2. DEVICE NAME

Proprietary Name:	Milliken Silver Wound Dressings
Common/Usual Name:	Wound Dressing
Classification Name:	Dressing

3. PREDICATE DEVICES

. Argentum Medical LLC Silverlon® Wound Contact Dressing (K023612)
Westaim Biomedical Acticoat™ 7 Dressing (K001519) .

DEVICE DESCRIPTION 4.

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Milliken Silver Wound Dressings are offered in several configurations including the following: 2" x 2", 4.25" x 4.25", 6" x 6", 1" x 24" and 4" x 48" (wrap).

5. INTENDED USE

Milliken Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

Milliken Silver Wound Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Technological characteristics of the Milliken Silver Wound Dressings and the predicate products are substantially equivalent in that they are all dressings suitable for use on pressure sores, leg ulcers, post-operative wounds, superficial wounds and abrasions. The Milliken Silver Wound Dressings are substantially equivalent in design, function and intended use to the Argentum Medical LLC Silverlon® Wound Contact Dressing (K023612) and the Westaim Biomedical Acticoat™ 7 Dressing (K001519). The Milliken Silver Wound Dressings and the predicate devices contain silver, which provides an effective barrier to microbial activity in the dressing itself. The Milliken dressings are manufactured from a silver coated nylon, lycra and polyester fabric whereas the predicate Silverlon® dressing is made from nylon fabric with a metallic silver coating, and the Acticoat™ 7 is made from multi-layer fabrics comprised of rayon/polyester nonwoven layers and silver coated high density polyethylene mesh. Differences between the Milliken Silver Wound Dressings and the predicate devices include slightly different silver concentrations. These differences are minor and do not affect safety and effectiveness of the device, as demonstrated by the animal and biocompatibility testing performed on the Milliken Silver Wound Dressings and the specific construction of the fabric base.

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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. A full thickness wound healing study was conducted using swine in order to characterize the healing process following treatment with the Milliken Silver Wound Dressings. All wounds appeared to heal without complication. Microscopically, the test articles were considered nonirritant as compared to the negative and comparative controls. Antimicrobial testing was performed which showed that the Milliken Wound Dressings provide an effective microbial barrier to the dressing itself. Milliken believes that the data included in this submission including the technical characteristics, physical properties, silver extraction, zone-of-inhibition antimicrobial and animal testing demonstrates that the Milliken Silver Wound Dressings are substantially equivalent in design, function and intended use to the Argentum Medical LLC Silverlon® Wound Contact Dressing (K023612) and the Westaim Biomedical Acticoat™ 7 Dressing (K001519).

S/3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2005

Milliken Chemical c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K051445

Trade/Device Name: Milliken Silver Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: August 12, 2005 Received: August 15, 2005

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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.

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Page 2- Ms. Mary McNamara-Cullinane, RAC

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Barbara Buchms
for

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

510(k) Number (if known): K051445

Milliken Silver Wound Dressings Device Name:

Indications for Use:

Prescription Use × (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)

Barbara Brielund for mxy
(Division Sign-off)

Division of General, Restorative, and Neurological Devices

510(k) Number K051445

August 12, 2005

Regulation Number and Section

N/A