The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

The SureSkin III with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.

The SureSkin™ III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.

The SureSkin™ III with Silver wound dressings are also indicated for use on second degree burns and donor sites.

Device Description

The SureSkin III with Silver Wound Dressings are identical to the SureSkin II products with the exception that the formulation has been slightly modified to include silver. The SureSkin III formulation includes the same well-known materials that are used in other hydrocolloid wound dressings. Polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing. The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (wound dressing), not an AI/ML powered device. As such, most of the requested information regarding AI/ML study design, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable or not present in the provided document.

However, I can extract information related to the device's performance testing and acceptance criteria as described for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Antimicrobial Effectiveness	Antimicrobial effectiveness testing (USP Methods)	"showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad."
Microbial Barrier	Microbial Barrier testing (USP Methods)	"showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad."
Biocompatibility	Biocompatibility testing (International Organization for Standardization recommendations)	"Results of the biocompatibility tests demonstrate that the device is suitable for its intended use."
Substantial Equivalence	Comparison to Predicate Devices (SureSkin II, Contreet, Xylos Cell Antimicrobial)	"The SureSkin III with Silver Wound Dressings... are identical in design, function and intended use to the commercially available predicate SureSkin II wound dressings. The only difference is the slight change in formulation of the materials... The only differences between the new SureSkin III with Silver products and the predicate devices are slightly different formulations, which are minor and do not affect safety and effectiveness of the device."

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

Not Applicable (N/A) for AI/ML powered device studies.
For the performance testing mentioned (Antimicrobial effectiveness, Microbial Barrier, Biocompatibility), the document does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective). These are typically laboratory-based tests following specific protocols, not clinical studies with human subjects.

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

N/A for AI/ML powered device studies.
Ground truth as typically understood in AI/ML validation (e.g., expert consensus on image annotations) is not relevant here. The "ground truth" for this device's performance is established by the results of standardized laboratory tests and comparisons to predicate devices.

4. Adjudication method for the test set

N/A for AI/ML powered device studies.
Adjudication methods (like 2+1, 3+1) are common in clinical trials or expert review of AI outputs. This document describes laboratory testing; arbitration or adjudication of results would follow standard laboratory quality control and protocol adherence, not a multi-expert consensus process as implied by the question.

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

No, an MRMC comparative effectiveness study was not done. This is not an AI/ML powered device.

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

N/A. This is not an AI/ML powered device with an algorithm. Performance tests were done on the physical device itself.

7. The type of ground truth used

For this device, the "ground truth" is established by:
- Standardized Test Methods: Adherence to established USP methods for antimicrobial and microbial barrier testing.
- International Standards: Compliance with International Organization for Standardization (ISO) recommendations for biocompatibility.
- Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices based on design, function, intended use, and material composition.

8. The sample size for the training set

N/A for AI/ML powered device studies.
There is no training set mentioned, as this is not an AI/ML device.

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

N/A for AI/ML powered device studies.
There is no training set for this device.

Summary

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510(k) Summary

for

Euromed SureSkin III with Silver Wound Dressings

1. SPONSOR
  MAY 17 2003

KO50032

1 3

Euromed, Inc. 411 Clinton Ave Northvale, NJ 07647

Contact Person: Mr. Jarl Jensen 201-750-1840 Telephone:

January 6, 2005 Date Prepared:

DEVICE NAME 2.

Proprietary Name:	SureSkin™ III with Silver Border Wound DressingSureSkin™ III with Silver Thin Wound Dressing
Common/Usual Name:	Wound Dressing
Classification Name:	Occlusive Wound and Burn Dressing

PREDICATE DEVICES 3.

• Contreet Antimicrobial Wound Dressing	K013525
• Xylos Corporation Cell Antimicrobial Wound Dressing	K024054
• SureSkin II Wound Dressings	K992363

DEVICE DESCRIPTION 4.

510(k) Summary · Page 1

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page 2 of 3

Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.

ട്. INTENDED USE

The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

The SureSkin III with Silver Wound Dressings are sterile hydrocolloid wound dressings indicated for the management of lightly to heavily exudating wounds such as pressure sores and leg ulcers, and for the management of dry to lightly exudating wounds such as dermal ulcers, post-operative wounds, superficial wounds, and abrasions. The SureSkin III with Silver Wound Dressings are also suitable for use on second degree burns and donor sites.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The SureSkin III with Silver Wound Dressings manufactured by Euromed, Inc. are composed of a hydrocolloid material and silver, which are in contact with the wound, and an occlusive polyurethane backing. The dressings are identical in design, function and intended use to the commercially available predicate SureSkin II wound dressings. The only difference is the slight change in formulation of the materials.

The technological characteristics of the SureSkin III with Silver Wound Dressings and the predicate products are identical in that they are all dressings that contain a silver component suitable for use on pressure sores, leg ulcers, post-operative wounds, superficial wounds and abrasions. The only differences between the new SureSkin III with Silver products and the predicate devices are slightly different formulations, which are minor and do not affect safety and effectiveness of the device.

7. PERFORMANCE TESTING

Antimicrobial effectiveness and Microbial Barrier testing was performed according to the USP methods and showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad. Biocompatibility testing was performed in accordance with the International Organization for Standardization

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Page 3 of 3

recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Euromed Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Staff Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K050032

Trade/Device Name: Euromed SureSkin III with Silver Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: March 29, 2006 Received: March 30, 2006

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 yours,

Herbert Remmering

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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Indications for Use

510(k) Number (if known): Ko 500 32

Euromed SureSkin III with Silver Wound Dressings_ Device Name: ____

Indications for Use:

The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

The SureSkin III with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.

The SureSkin™ III with Silver wound dressings are also indicated for use on second degree burns and donor sites.

Prescription Use X (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)

Richard Lesner us

Division of General, Restorative. and Neurological Devices

510(k) Number K050032

Euromed, Inc. 510(k) SureSkin III with Silver Wound Dressings

January 6, 2005

CONFIDENTIAL Page vi

Regulation Number and Section

N/A