The Allevyn Ag Dressings are 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. Allevyn Ag may be used over debrided and partial thickness wounds.

Device Description

Allevyn Ag has a trilaminate structure composed of a polyurethane top film, polyurethane central Silver Sulfadiazine (SSD) containing foam pad and polyurethane perforated wound contact film. This design allows Allevyn Ag to provide continual exudate absorption and barrier protection for up to seven days, while creating and maintaining a moist wound-healing environment in a presentation that is comfortable for the patient and easy to use, apply and remove for the user.

AI/ML Overview

This document is a 510(k) premarket notification for the Allevyn Ag Dressings. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or a specific study designed to prove the device meets such criteria in the way typically found for diagnostic or software-based medical devices. The performance information provided is related to "in-vitro testing studies" demonstrating antibacterial barrier characteristics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Antibacterial Barrier Characteristics (Implied acceptance criteria: device demonstrates barrier to common bacterial strains to support its function as an antibacterial barrier dressing)	In-vitro testing studies showed that Allevyn Ag dressing has demonstrated to have barrier characteristics to bacterial strains: - P. aerunginosa - S. aureus - E. coli - K. pneumoniae - A. calcoaceticus - S. pyogenes - E. faecalis - MRSA - C. perfringens - B. fragilis - P. melaninogenica
Biocompatibility (Implied acceptance criteria: device is biocompatible and does not introduce additional safety risk)	Biocompatibility of Allevyn Ag has been demonstrated through appropriate in vivo and in vitro tests on the foam as well as a literature review for the use of SSD. - Assessed in accordance with ANSI/AAMI/ISO 10993. - Does not introduce any additional safety risk over the predicate devices (Acticoat Moisture Control K050030 or Allevyn Foam K963096).
Performance (Exudate absorption, barrier protection, moist wound-healing) and User Comfort (Implied acceptance based on design and comparison to predicate devices)	Design allows Allevyn Ag to provide: - Continual exudate absorption - Barrier protection for up to seven days - Creation and maintenance of a moist wound-healing environment - Comfortable for the patient - Easy to use, apply and remove for the user

2. Sample size used for the test set and the data provenance

The document mentions "in-vitro testing studies" for antibacterial barrier characteristics and "in vivo and in vitro tests" for biocompatibility. However, it does not specify the sample sizes used for these tests. There's no mention of specific data provenance (country of origin, retrospective/prospective clinical study) as these appear to be laboratory-based performance and safety studies rather than clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to the provided document. The studies mentioned are laboratory-based performance and safety evaluations (e.g., antibacterial activity, biocompatibility), which typically do not involve human experts establishing ground truth in the context of diagnostic output or subjective assessments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable to the provided document. Adjudication methods are typically used in clinical studies or expert review processes, which are not detailed here for these specific performance tests.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a wound dressing, not a diagnostic or AI-assisted device, so such a study would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. The Allevyn Ag Dressing is a physical medical device (a wound dressing) and does not involve algorithms or AI for standalone performance evaluation in the way a software device would.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the antibacterial barrier characteristics, the "ground truth" would likely be based on standard microbiological assays and laboratory techniques to determine bacterial viability and growth in the presence of the dressing.

For biocompatibility, the ground truth would be established by standardized laboratory tests (e.g., cytotoxicity, sensitization, irritation studies) as per ANSI/AAMI/ISO 10993 guidelines, which define acceptable biological responses.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific performance claims in this document.

8. The sample size for the training set

This section is not applicable. This is a physical medical device and does not involve machine learning algorithms that require a "training set" in the computational sense.

9. How the ground truth for the training set was established

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

Summary

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5063835
page 1 of 3

510(k) SUMMARY

AUG - 3 2007

1. Trade (Proprietary) Name

Allevyn Ag Dressings

2. Common/Classification Name

Common Name: Silver Sulfadiazine Containing Antibacterial Barrier Dressings

Classification Name: Dressing

Classification Code: FRO

3. Applicant's Name & Address

Smith & Nephew Inc 11775 Starkey Road, PO Box 1970, Largo, Florida, FL 33779-1970 Phone: 727-392-1261 Fax: 727-399-3468

4. Contact Information

Terry McMahon Regulatory Affairs Manager Phone: 727-399-3785 Email: terry.momahon@smith-nephew.com

Date Prepared: 01 August 2007

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5. Device classification and Panel

A final classification for "Dressing" has not been implemented; however, a Class II classification has been proposed by the General and Plastic Surgery Devices Panel. At this time however, Classification Code FRO is unclassified.

6. Predicate devices

Allevyn Ag is similar in form and function to Acticoat Moisture Control Dressing (K050030) while being a modification of the Allevyn Foam Dressing (K963096) via the incorporation of Silver Sulfadiazine (SSD) within the absorbent foam core. Allevyn Ag has all the features and benefits associated with an absorbent foam dressing as well as the added benefit of an antibacterial barrier dressing. In-vitro testing studies showed that Allevyn Ag dressing has demonstrated to have barrier characteristics to bacterial strains: P. geruginosa, S. aureus, E. coli, K. pneumoniae, A. calcoaceticus, S. pyogenes, E. faccalis, MRSA, C. perfringens, B. fragilis, and P. melaninogenica.

7. Performance Standards

No applicable performance standards have been established under Section 514 of the FD&C Act. Biocompatibility tests were done in conformance with relevant requirements of ANSI/AAMI/ISO-10993.

8. Indications for Use:

The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1ª and 2ª degree burns, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.

Date Prepared: 01 August 2007

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9. Device Description

10. Biocompatability

The biocompatibility of Allevyn Ag has been demonstrated through appropriate in vivo and in vitro tests on the foam as well as a literature review for the use of SSD. The product has been assessed in accordance with ANSI/AAMI/ISO 10993 and does not introduce any additional safety risk over the predicate devices Acticoat Moisture Control (K050030) or Allevyn Foam (K963096).

11. Summary of Substantial Equivalence *

Allevyn Ag is comparable to Allevyn Foam and Acticoat Moisture Control in design, materials and manufacturing methods and does not raise any additional risks in terms of safety or performance; which is supported by product specifications and testing. This is further reflected in the similar labelled indications and directions for use for that of Allevyn Ag and the predicate devices.

Date Prepared: 01 August 2007

I Any statement made in conjunction with this submits to any other product only other product only relates the product can be lawfully market without premarket approval or classification and is not to be interpreted as an admission or used as evidence in patent infringement litigation.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2007

Smith & Nephew % Mr. Terry McMahon Manager Regulatory Affairs P.O. Box 1970 11775 Starkey Road Largo, Florida 33779-1970

Re: K063835 Trade/Device Name: Allevyn Ag Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 26, 2007

Dear Mr. McMahon:

Received: June 27, 2007

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 McMahon

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mckenna

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

Enclosure

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Dossier Reference: Allevyn Ag

smith&nephew

Page 12 of 141 Ko63835

ALLEVYN AG DRESSING

KO63828 510(k) Number:

Device Name: Allevyn Ag Dressing

Indications for Use:

X Prescription (Per 21 CFR 801.109)

Over the Counter Use

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Miller

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

N/A