The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.

Device Description

Acticoat® Composite Wound Dressing is a 3-ply dressing consisting of an absorbent rayon core with an upper layer of polyurethane film and a lower layer of silvercoated 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® Composite Wound Dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content. abrasion resistance, adhesion, and tensile strength.

AI/ML Overview

The Westaim Corporation's Acticoat® Composite Wound Dressing is a medical device. Here's an analysis of its acceptance criteria and the study that proves its performance, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Acticoat® Composite Wound Dressing are centered around demonstrating that it is substantially equivalent to legally marketed predicate devices, particularly in its performance characteristics and intended use. The performance data presented in the 510(k) summary are essentially the evidence that these criteria have been met.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Material Properties	Silver dissolution	"both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
	Absorptivity and moisture content	"similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content." and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
	Drop penetration and vapor transmission	"both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
	Tensile strength	"similar to those found in untreated gauze-based dressings in the areas of... tensile strength." and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
Biocompatibility	Skin irritation	"non-irritating" (implied through substantial equivalence to predicate) and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
	Sensitization	"non-sensitizing" (implied through substantial equivalence to predicate) and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
	Cytotoxicity	"non-toxic" (implied through substantial equivalence to predicate) and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
	Silver ion exposure levels	"both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
Antimicrobial Activity	In vitro studies of antimicrobial activity	"both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
Intended Use Equivalence	Barrier to bacterial penetration	"effective barrier to bacterial penetration." and "The barrier function of the dressing may help reduce infection..."
General Equivalence	Similar functions, characteristics, and accessories to predicate devices	"The predicate devices also provide the same or similar functions, characteristics, and accessories as described above for the Acticoat® Composite Wound Dressing." and "The dressings have the same intended use and are recommended for the same indications..."
	Non-toxic, non-irritating, non-sensitizing	"Additionally, both dressings are non-toxic, non-irritating, and non-sensitizing." (referring to both the subject device and predicate silver-coated dressing)
	Gas permeable, soft, pliable, cushioning texture	"Similar to the subject device, the silver coated dressing is gas permeable and has a soft, pliable, cushioning texture."
	Effective over similar periods of time	"Both the subject dressing and its predicates are effective over similar periods of time (i.e., between dressing changes)."
	Low adhesivity to wound site	"The predicate dressings, like the composite wound dressings, also have been shown to have low adhesivity to the wound site."

The Study that Proves the Device Meets Acceptance Criteria:

The document describes a series of performance tests conducted on the Acticoat® Composite Wound Dressing. These tests were designed to compare the new device's performance against established benchmarks and predicate devices.

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

The document does not explicitly state the sample sizes used for the various performance tests (e.g., silver dissolution, absorptivity, biocompatibility). It simply lists the types of tests performed.

The data provenance is not explicitly stated beyond the tests being performed by "The Westaim Corporation." There's no information regarding the country of origin of data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a wound dressing, these tests would typically be laboratory-based (in-vitro) or animal studies for biocompatibility, rather than human clinical trials for substantial equivalence.

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

This information is not applicable in the context of this 510(k) submission. The "ground truth" for a wound dressing in this type of submission is typically based on established physical properties, chemical analyses, and standardized biological tests rather than expert consensus on diagnostic images or clinical outcomes. The performance tests themselves generate the data that is then compared to accepted standards or predicate device performance.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the tests are largely objective measurements of material properties and biological responses (e.g., cytotoxicity tests under defined conditions), there wouldn't be a need for an adjudication method like 2+1 or 3+1 that is common in clinical imaging studies for establishing ground truth. The results of the tests would be reported directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The Acticoat® Composite Wound Dressing is a physical wound dressing, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. As mentioned above, this is not an AI-powered device.

7. The Type of Ground Truth Used:

The "ground truth" for the acceptance criteria and performance evaluation of the Acticoat® Composite Wound Dressing is based on established scientific and engineering standards and the performance of legally marketed predicate devices.

Predicate Device Performance: The primary ground truth is the performance characteristics (e.g., absorptivity, tensile strength, antimicrobial effect, biocompatibility) of the Acticoat® Antimicrobial Barrier Dressing (K955453) and Bioderm's Composite Wound Dressing, as well as Conformant 28 Wound Dressing for the wound contact layer. The new device must demonstrate "substantial equivalence" to these.
Scientific and Engineering Standards: For tests like silver dissolution, absorptivity, tensile strength, and biocompatibility, there are likely industry-standard test methods and acceptance limits that serve as a form of ground truth or benchmark for performance.
In Vitro/Laboratory Data: The performance tests conducted and reported (e.g., silver dissolution, in vitro antimicrobial activity) provide objective data that is compared to expected or desired outcomes based on these standards and predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

This information is not applicable for the same reason as point 8.

Summary

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K983833

ATTACHMENT 8

510(K) SUMMARY FOR THE WESTAIM CORPORATION'S ACTICOAT® COMPOSITE WOUND DRESSING

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

Westaim Biomedical Division The Westaim Corporation 10102 - 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 The Westaim Corporation Hogan & Hartson, L.L.P. 555 Thirteenth Street NW Washington, DC 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910

Date Prepared: March 1, 1998

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Name and Device and Name/Address of Sponsor

Acticoat® Composite Wound Dressing

Sponsor

Westaim Biomedical Division The Westaim Corporation 10102 - 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

Common or Usual Name

Composite wound dressing

Classification Name

Wound dressing

Predicate Devices

The Company's Acticoat® Composite Wound Dressing, covered by this submission, is substantially equivalent to other legally marketed wound dressings. Specifically, Actional Composite Wound Dressing is substantially equivalent The Westaim Corporation's Acticoat® Antimicrobial Barrier Dressing (K955453) and Bioderm's Composite Wound Dressing. The wound contact layer is also substantially equivalent to the Conformant 28 Wound Dressing.

WESTAIM

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Intended Use

The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat dressings may be used over debrided and grafted partial thickness wounds

Technological Characteristics and Substantial Equivalence

Description of the Acticoat® Composite Wound Dressing A.

Substantial Equivalence of the Acticoat® Composite Wound Dressing B.

The predicate devices also provide the same or similar functions, characteristics, and accessories as described above for the Acticoat® Composite Wound Dressing. The dressings have the same intended use and are recommended for the same indications (e.g., ulcers, trauma wounds, surgical wounds, abrasion, lacerations, and donor sites).

Like the subject composite wound dressing the Acticoat " Antimicrobial Barrier 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 antimicrobial effect. Additionally, both dressings are non-toxic, nonirritating, and non-sensitizing. Similar to the subject device, the silver coated dressing is gas permeable and has a soft, pliable, cushioning texture.

Both the subject dressing and its predicates are effective over similar periods of time (i.e., between dressing changes). Additionally, the dressings are secured to the wound site via traditional dressing methods such as tape, gauze, or elastic bandage. The predicate dressings, like the composite wound dressings, also have been shown to have low adhesivity to the wound site.

AWESTAIM

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Although there are some differences between the Acticoat® Composite Wound Dressing and its predicates, these differences are minor and raise no new questions of safety or effectiveness. First, the Bioderm device is described as a similar 3-ply gauze bandage without the silver coating on the lower layer of HDPE. Similarly, the Acticoat® Antimicrobial Barrier Dressing is described as a device similar to the subject dressing but lacks the occlusive polyurethane film and is not as absorptive. The labelling for all of the devices indicate that the frequency of dressing changes should be determined, in part, by the amount of wound exudate and general condition of the predicate silver coated dressing is also sterilized by gamma irradiation as is the subject composite wound dressing. These few differences in technological characteristics between the Acticoat® Composite Wound Dressing and its predicate devices are minor and do not present any new issues of safety or effectiveness.

Performance Data

The Acticoat® Composite Coated Dressing was subjected to the following performance tests:

Silver dissolution ●
Absorptivity and moisture content .
Drop penetration and vapour transmission .
Tensile strength
Biocompatibility studies (including skin irritation, sensitization and . cytotoxicity)
Silver ion exposure levels
In vitro studies of antimicrobial activity .

In all instances, the Acticoat Composite 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1998

Westaim Biomedical, Inc. c/o Jonathan S. Kahan Regulatory Counsel for The Westaim Corporation Hogan and Hartson L.L.P. 555 Thirteenth Street NW Washington, DC 20004

Re: K983833

Trade Name: Acticoat® Composite Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 30, 1998 Received: October 30, 1998

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

This device may not be labeled for use on third degree burns. 1.
This device may not be labeled as having any accelerating effect on the rate 2. of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure for any type of 4. wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Jonathan S. Kahan

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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iK983833

HOGAN & HARTSON LL.P.

510(k) Number (if known): __ K983833

Device Name: Acticoat@ Composite Wound Dressing

Indications For Use:

The Acticoat@ Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter OR Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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.