EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS

K050032 · Euromed, Inc. · FRO · May 17, 2006 · SU

Device Facts

• Record ID: K050032
• Device Name: EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
• Applicant: Euromed, Inc.
• Product Code: FRO · SU
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

SureSkin III with Silver Wound Dressings are sterile hydrocolloid dressings incorporating silver for antimicrobial properties. The device consists of a hydrocolloid material layer and an occlusive polyurethane film backing, which is impermeable to water and bacteria. The dressing is applied topically to the wound site to manage exudate and provide an antimicrobial barrier. It is intended for use by healthcare professionals or patients in clinical or home settings. The dressing maintains a moist wound environment and can remain in place for up to seven days depending on exudate levels. By providing a physical and antimicrobial barrier, the dressing protects the wound from microbial colonization and penetration, facilitating healing of various wound types including ulcers, burns, and surgical sites.

Clinical Evidence

Bench testing only. Antimicrobial effectiveness and microbial barrier testing performed per USP methods demonstrated an effective microbial barrier. Biocompatibility testing performed in accordance with ISO recommendations confirmed suitability for use.

Technological Characteristics

Hydrocolloid wound dressing with silver component; occlusive polyurethane film backing (impermeable to water/bacteria). Beveled edges on border dressing for adherence. Sterile. Standalone application.

Indications for Use

Indicated for management of lightly to heavily exudating wounds (pressure sores, leg ulcers) and dry to lightly exudating wounds (dermal ulcers, post-operative wounds, superficial wounds, abrasions). Also indicated for second degree burns and donor sites.

Predicate Devices

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

Submission Summary (Full Text)

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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 Dressing<br>SureSkin™ 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.

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

510(k) Summary · Page 1

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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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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 [phone]. 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 [phone] or [phone] 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 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.

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