SURESKIN SILVER BANDAGES

K081274 · Euromed, Inc. · FRO · May 28, 2008 · SU

Device Facts

• Record ID: K081274
• Device Name: SURESKIN SILVER BANDAGES
• Applicant: Euromed, Inc.
• Product Code: FRO · SU
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

SureSkin Silver Bandage is a sterile, single-use wound dressing; consists of silver-containing hydrocolloid adhesive bonded to an outer polyurethane film cover. Hydrocolloid adhesive interacts with wound moisture to form a gel, creating a moist healing environment. Silver in the adhesive activates upon moisture contact to provide an antimicrobial barrier against microbial colonization and penetration. Used in home or clinical settings for first aid; applied by patients or caregivers. Output is a physical barrier and antimicrobial effect; aids healing of minor wounds. Benefits include infection prevention and accelerated healing compared to standard bandages.

Clinical Evidence

Bench testing only. In vitro laboratory testing demonstrated antimicrobial effectiveness against Staph aureus (MRSA), E. coli, and P. aeruginosa. Microbial barrier testing confirmed effectiveness. Biocompatibility testing performed.

Technological Characteristics

Sterile, single-use adhesive dressing. Materials: silver-containing hydrocolloid adhesive, polyurethane film backing. Mechanism: occlusive barrier with silver-based antimicrobial effect. Sterilization: Gamma irradiation.

Indications for Use

Indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters, and scalds in patients requiring wound protection.

Predicate Devices

• Euromed SureSkin III with Silver Wound Dressings (K050032)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### Contact Person at EuroMed Inc.

Subhash Chander Regulatory Affairs Manager Phone: [phone] ext. 321 Email: [e-mail]

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
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## 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 Silver<br>Bandage | SureSkin III with<br>Silver Wound<br>Dressing |
| 510 (k) Number | Not assigned | K050032 |
| Form | Adhesive Dressing | Adhesive Dressing |
| Is the device provided<br>sterile? | ✓ | ✓ |
| Is the device intended for<br>single 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 801<br>Subpart 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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-<br>0115 |
|------------------------------------------------------------------------------------|------------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-<br>0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-<br>0115 |
| General Hospital Devices Branch | 240-276-<br>0115 |
| General Surgery Devices Branch | 240-276-<br>0115 |
| Division of Enforcement B | 240-276-<br>0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-<br>0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and<br>Radiological Devices | 240-276-<br>0120 |

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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