COLLACARE DENTAL

K110388 · Innocoll Pharmaceuticals, Ltd. · KGN · Aug 9, 2011 · SU

Device Facts

• Record ID: K110388
• Device Name: COLLACARE DENTAL
• Applicant: Innocoll Pharmaceuticals, Ltd.
• Product Code: KGN · SU
• Decision Date: Aug 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collacare Dental is indicated for the management of oral wounds and sores, including: denture sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, surgical wounds and traumatic wounds.

Device Story

Collacare Dental is a sterile, non-pyrogenic, single-use collagen matrix derived from purified bovine Achilles tendon type I collagen. It is designed for the management of various oral wounds and sores, including denture sores, ulcers, and surgical sites. The device is applied topically to the wound site to provide a conformable matrix. It functions as a wound dressing to support the management of oral lesions. It is intended for use in clinical or dental settings by healthcare professionals.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on materials of construction and biocompatibility testing performed in accordance with ISO 10993-1.

Technological Characteristics

Conformable matrix composed of purified type I collagen derived from bovine Achilles tendon. Supplied sterile and non-pyrogenic for single use. Biocompatibility evaluated per ISO 10993-1.

Indications for Use

Indicated for management of oral wounds and sores, including denture sores, non-infected or viral oral ulcers, periodontal surgical wounds, suture sites, burns, and surgical or traumatic wounds in patients requiring oral wound care.

Predicate Devices

• Collagen Sponge (K092805)
• Collagen Wound dressing - Oral (K040403)
• Salicept Oral Patch (K012126)

Submission Summary (Full Text)

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K110388

AUG --- 9 2011

Image /page/0/Picture/2 description: The image shows the logo for "Innocoll Pharmaceuticals". The word "Innocoll" is written in a bold, sans-serif font, with a stylized "O" that appears to be drawn with multiple lines. Below the word "Innocoll", the word "Pharmaceuticals" is written in a smaller, sans-serif font.

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

# 510(k) Summary

Date Prepared: Submitter:

27th June 2011 Innocoll Pharmaceuticals, Midland Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath, Ireland.

Aaron Wyse Submission Correspondent: Director of Regulatory Affairs Tel: [phone] Fax: [phone]

Proprietary Name:

Collacare Dental

Common Name:

Collagen dental matrix

## Device Classification:

Product Code: Classification Name: Regulatory Class:

KGN Wound Dressing, Collagen Unclassified

# Statement of Substantial Equivalence:

Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403), Salicept Oral Patch (K012126) is a hydrogel containing non-collagen materials.

Collacare Dental 510(k) 510(k) Summary

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110388

# Intended Use:

Collacare Dental is indicated for the management of oral wounds and sores, including:

- denture sores •
- oral ulcers (non-infected or viral) .
- periodontal surgical wounds .
- suture sites .
- burns ·
- surgical wounds and traumatic wounds ,

## Description:

Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.

# Biocompatibility:

There are no new biocompatibility issues arising with the use of Collacare Dental as the materials of construction and finished product material match that of Collagen Sponge (K092805). A complete biocompatibility evaluation was undertaken in line with the requirements of ISO 10993-1.

#### Conclusion:

Collacare Dental is substantially equivalent to the predicate devices delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected, flowing shapes. The logo is rendered in black and white.

Public Health Service

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

Mr. Aaron Wyse Director of Regulatory Affairs Innocoll Pharmaceuticals, Limited Midland Innovation and Research Centre, Dublin Road. Athlone, Co. Westmeath, IRELAND

AUG - 9 2011

Re: K110388

Trade/Device Name: Collacare Dental Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: KGN Dated: July 25, 2011 Received: July 28, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director · Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

# Enclosure

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# K 110388

# Statement of Indications for Use

510(k) Number (if known):

Device Name: Collacare Dental

Indications For Use:

Collacare Dental is indicated for the management of oral wounds and sores, including:

- denture sores ·
- oral ulcers (non-infected or viral) .
- periodontal surgical wounds .
- suture sites .
- . burns
- surgical wounds and traumatic wounds .

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 Dewise Evaluation (ODE)

Susan Rumer

(Division Sign-On)
Division of Anesthesiology, General Hospit
Infection Control and Dental Devices
\$10(k) Number
E 1028

Collacare Dental 510k Indications for Use

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