The Acticoat® Moisture Control dressing, an addition to the Acticoat® Dressing line of products is intended as an absorbent dressing which provides an effective barrier to bacterial penetration. Acticoat® Moisture Control Dressing is indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Acticoat® Moisture control may be used over debrided and partial thickness wounds.

Device Description

The absorbent, antimicrobial barrier dressing consists of three layers. An outer blue polyurethane film layer, a central polyurethane foam layer and a nanocrystalline silver coated polyurethane film wound contact layer. The layers are heat laminated together to form a single dressing. The dressing can be cut to size and maintains its antimicrobial activity for up to 7 days.

AI/ML Overview

This 510(k) premarket notification for K050030, the Acticoat® Moisture Control Dressing, is for a wound dressing and as such, does not involve the typical software-driven device acceptance criteria and studies you might expect for an AI/ML product. The submission is focused on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not applicable to this type of device submission.

Instead, the "acceptance criteria" for this submission are met by demonstrating the following:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Description of Acceptance	Reported "Device Performance" (as evidence of substantial equivalence)
Intended Use	Identical to predicate device.	The labeled indications of the Acticoat Moisture Control Dressing (light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites) are identical to those of the predicate device Acticoat Foam (K000051).
Design, Materials & Manufacturing Methods	Comparable to predicate device and do not raise new safety/effectiveness issues.	The absorbent, antimicrobial barrier dressing consists of three layers: an outer blue polyurethane film, a central polyurethane foam, and a nanocrystalline silver coated polyurethane film wound contact layer. These layers are heat laminated. The nanocrystalline silver layer is applied by physical vapor deposition, an identical manufacturing process approved for the predicate device Acticoat Foam (K000051) and other Acticoat brand dressings. The materials (polyurethane foam, polyurethane film, nanocrystalline silver) are comparable to the predicate and similar existing devices (Allevyn, Hydrasorb).
Biocompatibility	No additional safety risk over predicate device.	Biocompatibility has been demonstrated through appropriate in vivo and in vitro tests and previous tests on individual components, in accordance with ANSI/AAMI/ISO 10993. The product introduces no additional safety risk over the predicate device Acticoat Foam (K000051).
Directions for Use	Equivalent to predicate device.	The directions for use are equivalent to those of the predicate device Acticoat Foam (K000051).
Antimicrobial Activity	Maintains antimicrobial activity for specified duration.	The dressing maintains its antimicrobial activity for up to 7 days. (This is an inherent feature of the silver coating, proven in predicate devices, rather than a new performance claim requiring a specific study for this submission beyond equivalence).
Absorbency	Functions as an absorbent dressing.	The device is described as an "absorbent dressing." (This is a functional characteristic inherent in the polyurethane foam layer, comparable to the predicate).
Barrier to Bacterial Penetration	Provides effective barrier.	The device is intended to provide an "effective barrier to bacterial penetration." (This is attributed to the presence of nanocrystalline silver, validated in predicate Acticoat devices).

Regarding the specific questions which are NOT applicable to this 510(k) submission for a wound dressing:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a wound dressing substantial equivalence submission. Performance data for a direct animal or human study for this specific claim of equivalence is not detailed in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of AI/ML models is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device.
The sample size for the training set: Not applicable. There is no AI/ML model for which a training set would be used.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document demonstrates substantial equivalence by comparing the new device's intended use, technological characteristics (materials, design, manufacturing), and biocompatibility to a predicate device (Acticoat® Foam Dressing K000051) which has already been deemed safe and effective. The FDA's acceptance of this submission means they agreed that the Acticoat® Moisture Control Dressing is substantially equivalent to the predicate and does not raise new questions of safety or effectiveness.

Summary

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K050030

510k SUMMARY OF SAFETY AND EFFECTIVENESS

1. Trade (Proprietary) Name

Acticoat® Moisture Control Dressing

2. Common/Classification Name

Common name: Silver coated Antimicrobial Barrier Foam Dressing/Wound or Burn Dressing

Classification Name: KMF

3. Applicant's Name & Address

Smith & Nephew Inc 11775 Starkey Road, PO Box 1970, Largo, Florida, FL 33779-1970

4. Device classification and Panel

A classification for wound/burn dressings has not been implemented. The device category is considered unclassified.

5. Predicate device

Acticoat® Foam Dressing (K000051)

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6. Other similar devices

Allevyn® Hydrophillic Dressing (K963096) and Hydrasorb Sterile Dressing (K973260) are similar to the subject device with respect to materials and construction. Both of these similar dressings possess an absorbent polyurethane foam layer and polyurethane film lacking while are equivalent to the corresponding layers of the subject device, however, neither the Allevyn nor Hydrasorb dressings possess a wound contact layer with an antimicrobial silver coating.

6. Performance Standards

No applicable performance standards have been established under Sec. 514 of the FD&C Act.

7. Intended use and Device Description

The Acticoat Moisture Control dressing, an addition to the Acticoat® Dressing line of products is intended as an absorbent dressing which provides an effective barrier to bacterial penetration. Acticoat® Moisture Control Dressing is indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Acticoat® Moisture control may be used over debrided and partial thickness wounds.

The nanocrystalline silver layer is applied by a process known as physical vapor deposition which is identical manufacturing process approved for use in the manufacture of the predicate device Acticoat Foam (K000051). The same process is also approved as the method for

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applying a silver coating for all other Acticoat brand dressings as described in the following cleared premarket notifications:

Acticoat Dressings Foam (K000051) .
Acticoat Moisture Control (K010447) .
Acticoat 7 Dressing (K001519) .
Acticoat Alginate Absorbent (K002896) ◆
Acticoat Primary -- Burn (K99222) ●

8. Biocompatability

The biocompatibility of Acticoat Moisture Control has been demonstrated through appropriate in vivo and in vitro tests as well as previous tests on individual components. The product has been assessed in accordance with ANSVAAMI/ISO 10993. The product does not introduce any additional safety risk over the predicate device Acticoat Foam (K000051)

9. Summary of Substantial Equivalence1

The labeled indications of the Acticoat Moisture Control Dressing are identical to those of the predicate device Acticoat Foam (K000051). The directions for use are equivalent to those of the predicate device Acticoat Foam (K000051). The design, materials and manufacturing methods of the dressings are comparable to those of the predicate dressing and do not raise any new issues of safety and effectiveness.

' Any statement made in conjunction with this submitiel courselved any other product only colars to whether the ' Any statement made in confinent with this submitted to any becalled and be increated as a notal production of the local is cvidence in patent infringement litigation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

Public Health Service

APR 2 1 2005

Food and Drug Adrninistration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terry C. McMahon Manager, Regulatory Affairs- Devices Smith and Nephew, Inc. Wound Management 11775 Starkey Road Largo, Florida 33773

Re: K050030

Trade/Device Name: Acticoat® Moisture Control Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 11, 2005 Received: April 12, 2005

Dear Mr. McMahon:

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 – Mr. Terry C. McMahon

This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will and w you'ls cognifinating of substantial equivalence of your device to a legally premative nouried.com "> 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 If you desire specific acresliance at (240) 276-0115 . Also, please note the regulation entitled, Connect the Office of Coan to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Echoral 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/cdrl/industry/support/index.html.

Sincerely yours,

Ekh

_Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ACTICOAT® MOISTURE CONTROL DRESSING

510(k) Number:

Device Name: Acticoat® Moisture Control Dressing

Indications for Use:

The Acticoat® Moisture Control Dressing is indication for use in light to moderately exuding partial thickness wounds including decubitus ulcers, 1st and 2nd degree burns, and donor sites. Acticoat Moisture Control may be used over debrided and partial thickness wounds

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription
(Per 21 CFR 801.109)

Over the Counter Use

(Optional Format 1-2-96)

E.H.H

Aca Sign-Cit) vision of General, Restorative d Neurological Devices

KOS0030

Regulation Number and Section

N/A