PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING

K071552 · Medline Industries, Inc. · FRO · Apr 25, 2008 · SU

Device Facts

• Record ID: K071552
• Device Name: PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
• Applicant: Medline Industries, Inc.
• Product Code: FRO · SU
• Decision Date: Apr 25, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of: - Full thickness and partial thickness wounds - Pressure ulcers - Venous ulcers - Ulcers caused by mixed vascular etiologies - Diabetic ulcers - First and second degree burns - Donor sites and other bleeding surface wounds - Abrasions - Trauma wounds healing by secondary intention - Dehisced wounds - Surgical wounds - Dehisced surgical wounds These dressings may be cut to size and may be layered for the management of deep wounds.

Device Story

Puracol Plus Ag MicroScaffold Wound Dressing is a collagen-based wound dressing containing silver. It is applied topically to various wound types to manage exudate and support healing. The dressing is designed to be cut to size or layered for deep wounds. It is intended for use under the supervision of a healthcare professional. The device provides a scaffold for wound healing while the silver component provides antimicrobial properties. It is not a substitute for treating underlying infections. Clinical benefit is derived from the physical properties of the collagen scaffold and the presence of silver in the wound environment.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Collagen-based wound dressing containing silver. Form factor is a scaffold dressing that can be cut or layered. Intended for topical application.

Indications for Use

Indicated for management of full/partial thickness wounds, pressure/venous/diabetic/mixed vascular ulcers, 1st/2nd degree burns, donor sites, abrasions, trauma wounds, and surgical wounds. Contraindicated for patients with collagen or silver allergies and 3rd degree burns.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

Medline Industries, Inc. % Mr. Matt Clausen One Medline Place Mundelein, Illinois 60060

Re: K071552

Trade/Device Name: Puracol Plus Ag Collagen Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 17, 2008 Received: April 18, 2008

Dear Mr. Clausen:

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.

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 - Mr. Matt Clausen

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 yours.

Mark N Millican

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):

K071552

Device Name: Puracol® Plus Ag MicroScaffold™ Wound Dressing

Indications for Use:

Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of:

- Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- First and second degree burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Trauma wounds healing by secondary intention
- Dehisced wounds
- Surgical wounds
- Dehisced surgical wounds

These dressings may be cut to size and may be layered for the management of deep wounds.

## PRECAUTIONS:

Puracol® Plus Ag wound dressings are suitable for use under compression therapy with healthcare professional supervision. Wounds with diagnosed infection may be managed with Puracol® Plus Ag dressings only when the causes of infection are being treated in parallel by medical professionals. The dressing is not intended for the treatment of infected wounds, and cannot be considered to be a substitute for proper management of infections.

## CONTRAINDICATIONS:

Puracol® Plus Ag cannot be used on patients who are allergic to collagen or silver. Product use should be discontinued should signs of sensitization occur. The product is not indicated for the treatment of third degree burns.

Prescription Use XX (Per 21 CFR 801.109)

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

(PLEASE DO NOT WRITE BELOW THIS ANOTHER PAGE IF NEEDED) 11552 Concurrence of CDRH, Office of Device Evaluation (ODE)