URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER

K062559 · Laboratoires Urgo · FRO · Jan 29, 2007 · SU

Device Facts

• Record ID: K062559
• Device Name: URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
• Applicant: Laboratoires Urgo
• Product Code: FRO · SU
• Decision Date: Jan 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.

Device Story

Urgocell® Ag is a sterile, non-occlusive, non-adhesive antimicrobial wound dressing. It consists of three layers: a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers, and silver-containing Vaseline; a super-absorbent polyurethane foam pad; and a protective, semi-permeable polyurethane backing. The device is applied to the wound surface by a clinician to provide a barrier and release silver to reduce infection in exuding wounds. It facilitates painless removal due to its non-adhesive contact layer.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility studies (cytotoxicity, irritation, sensitization) and antimicrobial efficacy testing against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes, showing results comparable to predicate devices.

Technological Characteristics

Three-layer construction: polyester mesh contact layer impregnated with carboxymethylcellulose hydrocolloid, cohesion polymers, and silver-containing Vaseline; super-absorbent polyurethane foam pad; semi-permeable polyurethane backing. Sterile, non-occlusive, non-adhesive.

Indications for Use

Indicated for patients with moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, and donor and graft sites, to help reduce infection.

Predicate Devices

• Contreet-Foam Antibacterial wound Dressing (K022416)
• Urgotul® Ag Antimicrobial wound dressing with silver (K061220)

Submission Summary (Full Text)

{0}------------------------------------------------

### 5. 510(k) Summary

Premarket Notification Summary

JAN 2 9 2007

- Sponsor Information: 1. Laboratories URGO 42 Rue de Longvic 21300 Chenove France

| Contact Person: | Sophie Fortin |
|-----------------|-----------------------------|
| | Regulatory Affairs Manager |
| | Phone: [phone] |
| | Fax: [phone] |

- 2. Device Name: Common or Usual Name: Antimicrobial Wound Dressing with Silver Proprietary Name: Urgocell® Ag Classification Name: Unclassified
- 3. Predicate Devices:

Contreet-Foam Antibacterial wound Dressing (K022416), Coloplast Corp. Urgotul® Ag Antimicrobial wound dressing with silver (K061220), Laboratoires URGO

#### Description of Device 4.

Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.

Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.

Urgocell® Ag is composed of three layers :

- in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
- a non-sensitising, super-absorbent polyurethane foam pad, -
- a protective, semi-permeable polyurethane backing. -
- న్. Indications for Use

The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.

- 6. Description of Safety and Substantial Equivalence:
#### Safety Studies

A standard battery of safety and biocompatibility studies have been conducted including: Cytotoxicity -

{1}------------------------------------------------

K062559

Irritation study in rabbit

- Sensitization study in guinea pigs -
The results of the biocompatibility studies are considered to be comparable to predicate devices and other silver containing wound dressings.

Studies of the antimicrobial activity of Urgocell® Ag wound dressing have been conducted against MRSA, Pseudomonus aeruginosa, and Streptococcus pyogenes. Results demonstrated that the antibacterial activities are comparable to those of the predicate devices.

#### Substantial Equivalence

ー

Urgocell® Ag wound dressing compared to Contreet F and Urgotu19 Ag : all three contain silver as the active antimicrobial agent. All three provide comparable functions and indications for use. Urgocell® Ag wound dressing, Contreet® Foam and Urgotul® Ag are substantially equivalent.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with its wings spread. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laboratories URGO % Ms. Sophie Fortin Manager, Regulatory Affairs 42 Rue de Longvic 21300 Chenove France

JAN 2 9 2007

Re: K062559

Trade/Device Name: Urgocell AG Antimicrobial Wound Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: November 10, 2006 Received: November 16, 2006

Dear Ms. Fortin:

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.

{3}------------------------------------------------

Page 2 -- Ms. Sophie Fortin

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/industry/support/index.html.

Sincerely yours,

Mark N. Mellema

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

Enclosure

{4}------------------------------------------------

# Koh25

## Indications for Use

1062559 510(k) Number (if known):

Device Name: Urgocell® Ag

Indications For Use:

The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number