(180 days)
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
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.
The provided text discusses the Collacare Dental device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Summary for a medical device submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a dedicated study.
Here's a breakdown of what is and isn't present in relation to your request:
Information NOT present in the document:
- Acceptance Criteria for Device Performance: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, healing rates, etc.) with corresponding acceptance thresholds.
- Study Proving Acceptance Criteria: There is no description of a study designed to test the Collacare Dental device against performance acceptance criteria.
- Reported Device Performance: Since there are no acceptance criteria or a study, there's no reported performance data against such metrics.
- Sample Size for Test Set: No test set is mentioned, thus no sample size.
- Data Provenance: No data from specific tests are presented.
- Number of Experts/Qualifications for Ground Truth: Not applicable as there's no performance study described.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
- Standalone Performance Study: No standalone performance study details are provided.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- Ground Truth Establishment for Training Set: Not applicable.
What the document does describe instead of a performance study against acceptance criteria:
The document focuses on demonstrating Substantial Equivalence based on:
- Materials of Construction: It explicitly states, "Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403), Salicept Oral Patch (K012126)..." and later, "...the materials of construction and finished product material match that of Collagen Sponge (K092805)."
- Intended Use: The intended uses for Collacare Dental are listed and are presumed to be similar to the predicate devices.
- Biocompatibility: It states, "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." This implies a biocompatibility assessment was done, but it's not a performance study of the device's efficacy against specific clinical outcomes.
Conclusion:
Based on the provided text, the device Collacare Dental gained market clearance through substantial equivalence to existing predicate devices, primarily by demonstrating similar materials of construction, intended use, and a satisfactory biocompatibility assessment. The document does not describe specific performance acceptance criteria or a study designed to prove the device meets such criteria through quantitative performance metrics.
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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: +353 (0) 9066 90661 Fax: +353 (0) 9066 34895
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
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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 (800) 638-2041 or (301) 796-7100 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
4 - 1
N/A