URGOCLEAN ABSORBENT WOUND DRESSING

K123219 · Laboratoires Urgo · FRO · Mar 18, 2013 · SU

Device Facts

• Record ID: K123219
• Device Name: URGOCLEAN ABSORBENT WOUND DRESSING
• Applicant: Laboratoires Urgo
• Product Code: FRO · SU
• Decision Date: Mar 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.

Device Story

Urgoclean Absorbent Wound Dressing; sterile non-woven absorbent pad coated with soft-adherent lipido-colloid layer. Interface contacts wound exudates/slough; forms gel; creates moist environment; prevents maceration; allows painless, one-piece removal. Used in clinical settings for wound management; applied by healthcare providers. High tensile strength facilitates removal. Biocompatibility tested for permanent contact (>30 days).

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993 for permanent contact (>30 days), including cytotoxicity, primary skin irritation, sensitization, genotoxicity (bacterial reverse mutation, chromosomal aberration, mouse bone marrow micronucleus), and 28-day systemic toxicity studies.

Technological Characteristics

Sterile non-woven fiber pad; lipido-colloid coating. Absorption/gelling mechanism via fiber-exudate interaction. Biocompatibility per ISO 10993. No electronic components or software.

Indications for Use

Indicated for patients with exuding wounds, including chronic wounds (venous, arterial, pressure stage II-IV, diabetic ulcers), surgical wounds, donor sites, dermatological wounds, partial thickness burns, and wounds prone to bleeding requiring debridement.

Predicate Devices

• Aquacel® Hydrofiber® Wound Dressing (K982116, K063271, K080383)

Submission Summary (Full Text)

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K123219
page 1 of 3
K123219

MAR 1 8 2013

## 5. 510(k) Summary

Premarket Notification Summary

- Sponsor Information: 】.
Laboratoires URGO 42 Rue de Longvic 21300 Chenove France

Contact Person: Sophie Fortin Regulatory Affairs Manager Phone: [phone] +33.3.80.44.71.40 Fax:

- 2. Device Name:
Common or Usual Name: Absorbent Wound Dressing Proprictary Name: Urgoclean Absorbent Wound Dressing Classification Name: Dressing, Wound, Hydrophilic

- 3. Predicate Devices:
Aquacel® Hydrofiber® Wound Dressing (K982116, K063271, K080383), Convatec.

- Description of Device 4.
Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent pad coated with a soft-adherent lipido-colloid layer on the dressing/wound interface. In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, allowing a one piece and painless removal. It is supplied sterile in an individual pouch.

- ર. Indications for Usc
Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers: . surgical wounds (post-operative, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.

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K123219

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

Urgoclean Absorbent Wound Dressing is used for 1 to 2 days but may be replaced by the same dressing. It may therefore be employed for more than 30 days Thus biocompatibility tests were conducted in accordance with standards ISO 10993 for a product considered as being in permanent contact with an altered surface (> 30 days):

- Cytotoxicity test -
- -Primary Skin Irritation test
- Sensitization test ﯿ
- ା Genotoxicity tests: Bacterial reverse mutation study, chromosomal aberration study, Mouse bone marrow micronucleus study
- 28-day systemic toxicity study -

### Substantial Equivalence

Both products are fibers-based and have visually similar aspects:

Image /page/1/Figure/11 description: The image shows two different types of wound dressings. On the left is an "Urgoclean Absorbent Wound Dressing", and on the right is an "Aquacel Hydrofiber Wound Dressing". The Urgoclean dressing is white and folded, and the Aquacel dressing is also white and appears to be a square shape.

Moreover both products have similar properties & claims, leading to similar indications.

Key properties of both dressings are

- Absorption of exudates/body fluids by fibers => gel formation -
- Creation of a moist environment to enhance healing , while avoiding maceration of peri-wound skin
- Non-sticking => pain-free removal 1
- -Conformability to the wound
- -Sterility

In addition Urgoclean Absorbent Wound Dressing can claim a possible "one-piece removal" due to its higher resistance / tensile strength.

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K123219

When compared to Aquace19 Hydrofiber® Wound Dressing, it was demonstrated that Urgoclean Absorbent Wound Dressing have similar properties such as, both are made of sterile fibers and have comparable absorption and gelling properties leading to comparable indications for use.

Thus we conclude that Urgoclean Absorbent Wound Dressing and Aquacel® Hydrofiber® Wound Dressing are substantially equivalent.

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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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the top of the logo.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18. 2013

Laboratoires Urgo % Ms. Sophie Fortin Regulatory Affairs Director Excellence 2000 2 Avenue De Strasbourg Chevigny Saint Sauveur, France 21801

Re: K123219

Trade/Device Name: Urgoclean Absorbent Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 07, 2013 Received: January 16, 2013

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. Drue, 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. 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

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Page 2 - Ms. Sophie Fortin

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 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 yours, FOR

# Peter Day Mimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known):

Device Name: Urgoclean Absorbent Wound Dressing

Indications For Use:

- Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.
Prescription Use X AND/OR (Part 21 CFR 801 Subpari D)

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)

JiyoungDàng -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123219