(188 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 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
This document is a 510(k) Pre-market Notification for Collacare Dental, a collagen dental matrix. It's a regulatory submission to the FDA, not a study report with acceptance criteria and performance metrics in the typical sense for an AI/CADe device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present and not applicable to this type of document.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of features and a summary of performance testing related to biocompatibility and viral reduction. It doesn't report on specific clinical performance metrics (e.g., sensitivity, specificity, accuracy) of the device in treating oral wounds or sores, as it's a medical device composed of material rather than a diagnostic algorithm.
Here's a breakdown based on the provided document, addressing what is present and what is not applicable:
1. Table of acceptance criteria and the reported device performance
This document does not define specific quantitative "acceptance criteria" for clinical performance (e.g., statistical thresholds for wound healing rates, reduction in pain, etc.) nor does it report on such device performance. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices.
The reported "performance" is more about the device's characteristics and safety aspects, rather than clinical efficacy metrics:
| Feature / Test | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity) | No new biocompatibility issues compared to predicate (Collacare Dental K110388). | Testing undertaken, demonstrating no new issues as materials match predicate. |
| Collagen Type and Purity | No denaturing during manufacturing process. | Evaluated to show no denaturing. |
| Viral Reduction | Viral deactivation within acceptable safety range. | Assessments conducted, showing deactivation within acceptable range. |
| Materials (Type I Collagen, Bovine Achilles Tendon) | Identical to predicate device (K110388). | Matches predicate. |
| Biodegradable, Biocompatible, Non-pyrogenic, Sterile (Irradiation) | Identical to predicate devices. | All match predicate specifications. |
| Intended Use | Consistent with predicate devices. | Matches predicate. |
| Physical Sizes | Similar to predicate devices, with some variations. Demonstrated by listing the sizes. | New sizes (3.6cm x 1.8cm, Height-17mm, etc.) listed and accepted. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document is a 510(k) for a medical device (collagen matrix), not an AI/CADe device. There is no "test set" in the context of diagnostic performance evaluation. The "testing" mentioned is laboratory-based (biocompatibility, viral inactivation) on the device material itself, not human subjects data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/CADe device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the biocompatibility and viral reduction tests, the "ground truth" would be established by validated laboratory assays and recognized safety standards for those specific tests, rather than clinical consensus or pathology.
8. The sample size for the training set
- Not Applicable. This is a medical device, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study (as described in the document):
The "study" in this context is a series of laboratory-based tests to demonstrate the safety and material properties of the Collacare Dental device, primarily by showing it is substantially equivalent to existing, legally marketed predicate devices.
- Biocompatibility Testing: Included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity. The conclusion was that there were no new biocompatibility issues compared to the predicate device (Collacare Dental K110388).
- Collagen Type and Purity Evaluation: Conducted to ensure no denaturing occurred during the manufacturing process.
- Viral Reduction Assessments: Performed to demonstrate viral deactivation within an acceptable safety range.
The purpose of these tests was to support the claim of substantial equivalence to predicate devices, thereby meeting the regulatory requirements for premarket notification as defined in CFR21, Part 807. The FDA acknowledged this in the letter dated May 1, 2014, stating that the device is "substantially equivalent."
{0}------------------------------------------------
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: +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
Predicate devices:
Collacare Dental (K110388) Collagen Wound Matrix-Oral (K122115)
Collacare Dental 510k 510k Summary
{1}------------------------------------------------
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 themanagement of oral wounds andsores, including:denture sores oral ulcers (non-infected orviral) periodontal surgicalwounds suture sites burns surgical wounds traumatic wounds | Collacara Dental is indicated for themanagement of oral wounds and sores,including:denture sores oral ulcers (non-infected or viral) periodontal surgical wounds suture sites burns surgical wounds traumatic wounds | Collagen Wound Dressing-Oralisindicated for the management of oralwounds and sores, including:Denture sores Oral ulcers (non-infected orviral) Periodontal surgicalwounds 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 x5cm | Matrix: 3.6cm x 1.8cm 2.5cm x 2.5cm and2.5cm x 5cmPlug: Height-17mm Top - 10mm Bottom - 14mm | Matrix. 2.5cm x 7.5cm, 2.0cm x 4cmPlug. 1cm x 2 cm |
| StorageConditions | Room temperature less than 25°C | Room temperature less than 25°C | The product should be stored at roomtemperature. Avoid excessive heat andhumidity. |
Summary of Performance Testing:
Collacare Dental 510k 510k Summary
{2}------------------------------------------------
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
{3}------------------------------------------------
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.
{4}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
{5}------------------------------------------------
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
4 - 1
N/A