Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.

Device Description

Acticoat™ silver coated dressing is a 3-ply 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 barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat™ silver coated dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content, abrasion resistance and adhesion, and tensile strength.

AI/ML Overview

I am sorry, but I cannot provide an answer based on the context you provided. The provided text is a 510(k) summary for a medical device (a silver-coated wound dressing) and discusses substantial equivalence to a predicate device, as well as various performance tests like silver dissolution, absorptivity, tensile strength, and antimicrobial activity. However, it does not contain the specific information required to answer your questions about acceptance criteria, a study that proves the device meets them, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a training set. This type of information is typically associated with the evaluation of artificial intelligence/machine learning (AI/ML) driven medical devices, which is not what this document describes.

Summary

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K925453

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ATTACHMENT 9

510(k) SUMMARY FOR WEST SIM TECHNOLOGIES, INC.' ACTICOAT™ SILVER COATED DRESSIN

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

Westaim Technołogies Inc. 10101 - 114 Street Fort Saskatchewan, Alberta T8L 3W4 CANADA

Phone: (403) 992-5380 Facsimile: (403) 992-5325

Contact Person: Robert Burrell, Ph.D. Phone: (403) 992-5380 Facsimile: (403) 992-5325

Jonathan S. Kahan, Esq. Regulatory Counsel for Westaim Technologies Inc. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910

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and the comments of

Date Prepared: November 7, 1995

Name of Device and Name/Address of Sponsor

Acticoat™ silver coated dressing

Sponsor

Westaim Technologies Inc. 10101 - 114 Street Fort Saskatchewan, Alberta T8L 3W4 CANADA

Phone: (403) 992-5380 Facsimile: (403) 992-5325

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Robert Burrell, Ph.D. Contact Person: Phone: (403) 992-5380 Facsimile: (403) 992-5325

Common or Usual Name

Silver coated dressing

Classification Name

Wound and burn dressing

Predicate Devices

The Company's Acticoat™ silver coated dressing covered by this submission is substantially equivalent to other legally marketed burn and wound dressings. Specifically, Acticoat™ silver coated dressing is substantially equivalent to Vitaphore Corporation's Silver Foam Dressing (K914579).

Intended Use

Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.

Technological Characteristics and Substantial Equivalence

Description of the Acticoat™ Silver Coated Dressing A.

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Substantial Equivalence of the Acticoat™ Silver Coated Dressing B.

The predicate device also provides the same or similar functions, characteristics, and accessories as described above for the Acticoat™ silver coated dressing. Both dressings have the same intended use and are recommended for the same indications (e.g., ulcers, first and second degree burns, trauma wounds, surgical wounds, abrasion, lacerations, and donor
sites). sites).

Like the Acticoar™ dressing, the predicate Vitaphore dressing consists of an absorbent material, and the dressing releases silver ions into and around the wound site when activated by moisture. Both products are provided sterile to the user, and both have an sentimierobial effect. Additionally, both dressings are non-toxic, non-irritating, and non-irritating, and non-Similar to the Acticoat™ device, the predicate Vitaphore dressing is gas permeable and has a soft. pliable, cushioning texture.

Both the Acticoat™ dressing and its predicate are effective over similar periods of time (i.e., between dressing changes). Additionally, both wound dressing devices are secured to the wound site via traditional dressing methods such as tape, gauze, are elastic bandage. The predicate Vitaphore dressing, like the Acticoat™ dressing, also has been shown to have low adhesivity to the wound site.

Although there are some differences between the Acticoat™ product and its predicate Vitaphore Silver Foam Wound Dressing, bese differences are minor and its
new questions of safety or effectiveness . Fijm the and its and its new questions of safety or effectiveness. First, the predicate Vitaphore dressing is described as a 1-ply dressing with a silver-outaining collagen-derived gel, whereas the Acticoar™ dressing is a 3-ply dressing whose upper and lower layers of mesh are coated with a silver Additionally, the labeling for the prodicate Vitaphore dressing suggests that the film. that more frequent changes are necessers during than 24 hours, but also indicates that more frequent changes are necessary during the initial wound healing stages and that the frequency of dressing changes should be determined by a medical practitioner. On the other hand, the Acticat™ dressing is recommended to be replaced at least once every 24 hours. The predicate Vitaphore dressing also is sterilized with an ethylene oxide ("EtO)" process. while the Actical™ dressing is sterilized using gamma radiation. However, these few differences in technological characteristics between the Acticoae™ dressing and its predicate device are minor and do not present any new issues of safety or effectiveness.

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Performance Data

The Acticoat™ silver coated dressing was subjected to the following performance testing:

Silver dissolution .
Absorbtivity and moisture content .
Abrasion resistance and adhesion .
Tensile strength .
. Biocompatibility studies (including skin irritation, sensitization ( and cytotoxicity)
. Silver ion exposure levels
In vitro and in vivo studies of antimicrobial activity ◆
Shelf life testing .

In all instances, the Acticoat™ silver coated dressing functioned as intended. These test results demonstrated that the Acticoat™ silver coated dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate device.

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.