COLLACARE DENTAL

K133290 · Innocoll Pharmaceuticals · KGN · May 1, 2014 · SU

Device Facts

• Record ID: K133290
• Device Name: COLLACARE DENTAL
• Applicant: Innocoll Pharmaceuticals
• Product Code: KGN · SU
• Decision Date: May 1, 2014
• 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, resorbable collagen matrix derived from bovine Achilles tendon; supplied as dental sponges or cones for single use. Device acts as a wound dressing for oral applications. Used in clinical settings by dental professionals to manage various oral wounds; provides a scaffold for healing. Benefits include biocompatibility and conformability to oral wound sites. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity. Collagen type and purity were evaluated to ensure no denaturing during manufacturing. Viral reduction assessments were conducted to demonstrate viral deactivation within acceptable safety ranges.

Technological Characteristics

Material: Purified Type I collagen from bovine Achilles tendon. Form factor: Dental sponges and cones. Sterilization: Irradiation. Properties: Resorbable, biocompatible, non-pyrogenic. Standalone device; no software or energy source.

Indications for Use

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

Predicate Devices

• Collacare Dental (K110388)
• Collagen Wound Matrix-Oral (K122115)

Submission Summary (Full Text)

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### MAY 0 1 2014

# Pharmaceutic

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

#### 510(k) Summary

Date Prepared: Submitter:

30" April 2014 Innocoll Pharmaceuticals, Midland Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath, Ireland.

Submission Correspondent: Aaron Wyse Senior 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

Predicate devices:

Collacare Dental (K110388) Collagen Wound Matrix-Oral (K122115)

Collacare Dental 510k 510k Summary

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#### 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 collagen matrix, conformable and resorbable, 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. Sizes available include the following:

Dental Sponges: 3.6cm x 1.8cm, 2.5cm x 2.5cm and 2.5cm x 5cm Dental Cone: Height-17mm Ø Top - 10mm Ø Bottom - 14mm

#### Statement of Substantial Equivalence:

Collacare Dental is substantially equivalent in materials of construction and indications to Collacare Dental (K110388) and Collagen Wound Matrix-Oral (K122115)

| Feature | Collacare Dental | Collacare Dental | Collagen Wound Dressing-Oral |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Syntacoll GmbH | Syntacoll GmbH | Collagen Matrix Inc. |
| 510(k) number | K110388 | K133290 | K122115 |
| Indications for Use | Collacara Dental is indicated for the<br>management of oral wounds and<br>sores, including:<br>denture sores oral ulcers (non-infected or<br>viral) periodontal surgical<br>wounds suture sites burns surgical wounds traumatic wounds | Collacara Dental is indicated for the<br>management of oral wounds and sores,<br>including:<br>denture sores oral ulcers (non-infected or viral) periodontal surgical wounds suture sites burns surgical wounds traumatic wounds | Collagen Wound Dressing-Oralis<br>indicated for the management of oral<br>wounds and sores, including:<br>Denture sores Oral ulcers (non-infected or<br>viral) Periodontal surgical<br>wounds Suture sites Burns Extraction sites Surgical wounds Traumatic wounds |
| Materials | Type I Collagen | Type I Collagen | Type I Collagen |
| Collagen Source | Bovine Achilles tendon | Bovine Achilles tendon | Porcine Achilles tendon |
| Biodegradable | Yes | Yes | Yes |
| Biocompatible | Yes | Yes | Yes |
| Non-Pyrogenic | Yes | Yes | Yes |
| Sterile | Yes - Irradiation | Yes - irradiation | Yes - irradiation |
| Sizes | Matrix: 2.5cm x 2.5cm and 2.5cm x<br>5cm | Matrix: 3.6cm x 1.8cm 2.5cm x 2.5cm and<br>2.5cm x 5cm<br>Plug: Height-17mm Top - 10mm Bottom - 14mm | Matrix. 2.5cm x 7.5cm, 2.0cm x 4cm<br>Plug. 1cm x 2 cm |
| Storage<br>Conditions | Room temperature less than 25°C | Room temperature less than 25°C | The product should be stored at room<br>temperature. Avoid excessive heat and<br>humidity. |

#### Summary of Performance Testing:

Collacare Dental 510k 510k Summary

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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 Collacare Dental (K110388). Biocompatibility testing undertaken included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity.

Collagen type and purity evaluated to show no denaturing during manufacturing process

Viral reduction assessments conducted to show viral deactivation within acceptable safety range.

#### 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.

Collacare Dental 510k 510k Summary

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20943-0002

May 1, 2014

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

Re: K133290

Trade/Device Name: Collacare Dental Regulatory Class: Unclassified Product Codc: KGN Dated: March 20, 2014 Received: April 1, 2014

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.

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 (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.

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Page 2 - Mr. Wyse

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

## Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental 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): K133290

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)

# Sheena A. Green -S 2014.04.30 14:44:23 -04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Collacare Dental 510k Indications for Use

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