SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect. The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.

AI/ML Overview

This is a 510(k) premarket notification for SureSkin Silver Bandage, which claims substantial equivalence to a predicate device. Therefore, a traditional acceptance criteria and study proving performance as one might expect for a novel device is not explicitly present in the provided document. The purpose of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

Instead of presenting an acceptance criteria table and a new clinical study to meet those criteria, the submission relies on demonstrating similarity to the predicate device and using non-clinical testing.

Here's a breakdown based on your request, focusing on what is provided and clarifying what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not explicitly present in the 510(k) submission as it would be for a de novo device or a PMA application. For a 510(k), acceptance criteria are implicitly tied to demonstrating equivalence to the predicate device.

The document states: "Antimicrobial effectiveness and Microbial Barrier testing was performed on the predicate device and showed that it provides an effective microbial barrier in the dressing. Biocompatibility testing was performed. Test results demonstrated that the device is suitable for its intended use."

The current device, SureSkin Silver Bandage, is stated to be "identical in formulation, packaging materials and produced under same manufacturing processes to the predicate device." Therefore, the acceptance is based on the assumption that if the predicate device met these performance criteria, and the new device is identical, then the new device also meets them.

Summary of what's provided related to "performance":

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (by Equivalence)
Antimicrobial effectiveness	Effective antimicrobial barrier in the dressing (based on predicate testing)
Microbial Barrier	Provides an effective microbial barrier (based on predicate testing)
Biocompatibility	Suitable for its intended use (based on predicate testing)

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

Test Set Sample Size: Not specified. This documentation refers to "in vitro laboratory testing" for antimicrobial effectiveness on the predicate device. The specific numbers of test samples, if any in a clinical sense, are not detailed as this is a non-clinical submission relying on equivalence for a Class I/unclassified device.
Data Provenance: The "in vitro laboratory testing" was done on the predicate device. No geographical information is provided, but it would have been conducted by or for the manufacturer (EuroMed Inc.). The data is retrospective in the sense that it relies on past testing of a predicate device.

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

This is not applicable or provided in this 510(k) submission. No human clinical studies or expert-driven test sets (e.g., for image interpretation or diagnosis) are described. The evaluation relies on laboratory testing and comparison to an existing device.

4. Adjudication Method for the Test Set

This is not applicable or provided. There is no "test set" in the context of human-interpreted data or clinical outcomes requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable or provided. This type of study is relevant for diagnostic devices involving human interpretation of results, often with AI assistance. The SureSkin Silver Bandage is a wound dressing, not a diagnostic device.

6. Standalone (Algorithm Only) Performance

This is not applicable or provided. The device is a physical wound dressing, not an algorithm. The "antimicrobial effectiveness" can be considered a standalone performance characteristic of the dressing itself, but it's not an algorithm's performance.

7. Type of Ground Truth Used

For the in vitro antimicrobial effectiveness testing on the predicate device:

Antimicrobial effectiveness: Likely based on standard microbiological methods (e.g., zone of inhibition, reduction in bacterial count) against specific bacterial strains (Staph aureus (MRSA), E. coli, and P. aeruginosa). The "ground truth" would be the measured reduction in bacterial growth or killing.
Microbial Barrier: Likely based on physical testing demonstrating the dressing's ability to prevent microbial penetration.
Biocompatibility: This would involve standard toxicology and irritation tests, with "ground truth" being the absence of adverse biological reactions.

8. Sample Size for the Training Set

This is not applicable or provided. There is no "training set" as this is not an AI/machine learning device.

9. How Ground Truth for the Training Set Was Established

This is not applicable or provided.

In summary: The provided document is a 510(k) premarket notification for a wound dressing. Its "acceptance criteria" are demonstrating substantial equivalence to a predicate device, which includes having similar performance characteristics as proven by in vitro laboratory testing on the predicate device and the new device being identical in composition and manufacturing. There are no clinical studies, expert-adjudicated test sets, or AI algorithm evaluations described in this type of submission.

Summary

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K081274
page 1 of 3

MAY 2 8 2008

Image /page/0/Picture/2 description: The image shows the logo for EuroMed. The logo consists of a medical symbol on the left, followed by the word "EuroMed" in a bold, sans-serif font. Below the word "EuroMed" is some smaller text that is difficult to read. The medical symbol appears to be a caduceus, which is a symbol of medicine.

510(k) Summary SureSkin Silver Bandage

Submitter's name, address, phone and fax numbers

EuroMed Inc. 25 Corporate Drive Orangeburg, NY 10962 USA Phone: 845 359 4039 Fax: 845 359 1315

Contact Person at EuroMed Inc.

Subhash Chander Regulatory Affairs Manager Phone: 845 359 4039 ext. 321 Email: schander@euromedinc.com

Date 510(k) Prepared

April 30, 2008

Name of the medical device

Trade Name: SureSkin Silver Bandage Common Name: Wound Dressing Classification Name: Occlusive wound dressing (21CFR878.4020)

Occlusive wound dressings with added drugs have not yet been classified by the FDA or given a Product Code. Occlusive wound dressings without drugs have been designated as Class I (general controls) with Product Code "NAD" and exempt from the pre-market notification 510(k) submission requirements. Other wound dressings with antimicrobial properties have not been classified but given the product code, 'FRO''.

Legally marketed device to which substantial equivalence is claimed

SureSkin Silver is substantially equivalent in function, construction, and chemical composition to Euromed SureSkin III with Silver Wound Dressings (Rx) cleared by FDA (K050032). The primary purpose of this 510(k) is to seek clearance for Over-The-Counter (OTC) marketing of this dressing with revised indications.

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K081274
page 2 of 3

Device Description

SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect.

The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages

Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.

In vitro laboratory testing has demonstrated the dressings antimicrobial effectiveness on fresh clinical isolates of Staph aureus (MRSA), E. coli, and P. aeruginosa.

Intended Use

The SureSkin Silver bandages provide an antimicrobial barrier to microbial colonization in the dressing and help eliminate microbial penetration through the dressing.

SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters, and scalds.

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K 0712-74
page 3 of 3

Comparison to predicate device

Company	Euromed, Inc.	Euromed, Inc.
Proprietary Name	SureSkin SilverBandage	SureSkin III withSilver WoundDressing
510 (k) Number	Not assigned	K050032
Form	Adhesive Dressing	Adhesive Dressing
Is the device providedsterile?	✓	✓
Is the device intended forsingle use?	✓	✓
Sterilization Method	Gamma irradiation	Gamma irradiation
Packaging	Pouch	Pouch
Intended Use	Over-the counter use	Prescription Use
	21 CFR 807 Subpart C	21 CFR 801Subpart D

Technological Characteristics comparison with Predicate Device

The SureSkin Silver Bandage is equivalent to the referenced predicate device in that it is composed of identical materials, same antimicrobial characteristics i.e. to provide barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing with an occlusive polyurethane backing.

Non-clinical and Performance Testing

Antimicrobial effectiveness and Microbial Barrier testing was performed on the predicate device and showed that it provides an effective microbial barrier in the dressing. Biocompatibility testing was performed. Test results demonstrated that the device is suitable for its intended use. SureSkin Silver Bandages are identical in formulation, packaging materials and produced under same manufacturing processes to the predicate device. Thus safety and effectiveness is not affected in any manner. The dressing under this submission is identical to the predicate device except over-the-counter use.

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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" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 2008

Euromed, Inc. % Subhash Chander Regulatory Affairs Manager 25 Corporate Drive Orangeburg, New York 10962

Re: K081274

Trade/Device Name: SureSkin Silver Bandage Regulatory Class: Unclassified Product Code: FRO Dated: April 30, 2008 Received: May 5, 2008

Dear Subhash Chander:

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. Iisting 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 - Subhash Chander

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark M. Mulhausen

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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Page 3 – Subhash Chander

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 (DGRND/PRSB) D.O. f/t:SRA:tlm:5-23-08

OC Numbers:

Division of Enforcement A	240-276-0115
Dental, ENT and Ophthalmic Devices Branch	240-276-0115
OB/GYN, Gastro. & Urology Devices Branch	240-276-0115
General Hospital Devices Branch	240-276-0115
General Surgery Devices Branch	240-276-0115
Division of Enforcement B	240-276-0120
Cardiovascular & Neurological Devices Branch	240-276-0120
Orthopedic, Physical Medicine & Anesthesiology Devices andRadiological Devices	240-276-0120

Last Updated: Brandi Stuart – 7/9/07

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Image /page/6/Picture/0 description: The image shows the logo for EuroMed Personalized Health Technologies. The logo consists of a caduceus symbol on the left and the word "EuroMed" on the right. Below the word "EuroMed" is the phrase "Personalized Health Technologies" in a smaller font. The logo is black and white.

Indications for Use

510(k) Number (if known): _ Ko 812 74

Device Name: SureSkin Silver Bandage

Indications for Use:

SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters and scalds.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nail R.P. Oglin for mxm
Division Sign Off

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K081274

Regulation Number and Section

N/A