COLLIEVA

K081782 · Innocoll Pharmaceuticals · KGN · Sep 30, 2008 · SU

Device Facts

• Record ID: K081782
• Device Name: COLLIEVA
• Applicant: Innocoll Pharmaceuticals
• Product Code: KGN · SU
• Decision Date: Sep 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collieva™ may be used for the management of wounds such as: - Pressure ulcers - Venous stasis ulcers - Diabetic ulcers - First and second degree burns - Partial and full thickness wounds - Superficial injuries

Device Story

Collieva™ is a clear collagen matrix film for topical wound management. Supplied sterile for single use. Applied topically to wounds to provide a protective matrix. Benefits include wound management for various ulcer types, burns, and superficial injuries. No complex electronics or software involved.

Clinical Evidence

No clinical data provided. Biocompatibility testing performed in accordance with ISO 10993-1:2003 requirements.

Technological Characteristics

Clear collagen matrix film; topical wound dressing; sterile; single-use. Biocompatibility tested per ISO 10993-1:2003.

Indications for Use

Indicated for management of pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, partial and full thickness wounds, and superficial injuries.

Predicate Devices

• CollaGuard™ (K061746)

Submission Summary (Full Text)

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K081782

### SEP 8 0 2008

Page 5 - 1

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Midlands Innovation and Research Centre Dublin Road. Athlone, Co. Westmeath, Irela Tel: + 353 (0)90 6486834 Fax: + 353 (0)90 6486835 www.innocoll-pharma.com

# 510(k) Summary

- June 13th , 2008 1. Date Prepared:
- Innocoll Pharmaceuticals 2. Submitter Midland Innovation and Research Centre Athlone Co. Westmeath Ireland. Tel: [phone] Fax: [phone]

Submission Aaron Wyse Correspondent: Director of Regulatory Affairs

- Collieva™ 3. Proprietary Name:
- 4. Common Name: Topical Wound Dressing
- 5. Device Classification: Product Code: KGN Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified

#### 6. Statement of Substantial Equivalence:

Collieva™ is substantially equivalent in materials of construction and intended use to CollaGuard™ (K061746) manufactured by Syntacoll GmbH.

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#### 7. Intended Use

Collieva™ may be used for the management of wounds such as:

- · Pressure ulcers
- Venous stasis ulcers
- · Diabetic ulcers
- · First and second degree burns
- · Partial and full thickness wounds
- · Superficial injuries

#### 8. Description

Collieva™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.

#### 9. Biocompatibility

Collieva™ - biocompatibility testing has been completed against the requirements of ISO 10993 -1:2003. Collieva™ has been shown to be biocompatible as a topical wound dressing.

#### 10. Conclusion

Collieva™ is substantially equivalent to the predicate device delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### SEP 3 0 2008

Innocoll Pharmaccuticals, Limited Mr. Aaron Wysc Director, of Quality and Regulatory Affairs Midlands Research and Innovation Centre, Dublin Road Athlonc, Colorado Westmeath IRELAND

Re: K081782

Trade/Device Name: Collieva Regulation Number: Unclassified Regulation Name: None Regulatory Class: Nonc Product Code: KGN Dated: June 13, 2008 Received: July 7, 2008

Dear Mr. Wyse:

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.

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Page 2 - Mr. Wyse

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 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. Millman

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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## Statement of Indications for Use

510(k) Number (if known): 160817 82

Device Name: Collieva

Indications For Use:

#### Indications:

Collieva may be used for the management of wounds such as:

- Pressure ulcers .
- Venous stasis ulcers ●
- Diabetic ulcers �
- First and second degree burns ◆
- Partial and full thickness wounds ●
- Superficial injuries .

Prescription Use (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)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: