(188 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen matrix, with no mention of AI or ML.
Yes
The device is intended for the management of oral wounds and sores, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device description and intended use indicate it is a collagen matrix for wound management, not for diagnosing conditions.
No
The device description clearly states that Collacare Dental is a "collagen matrix," which is a physical material, not software.
Based on the provided information, Collacare Dental is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of Collacare Dental is for the management of oral wounds and sores. This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a collagen matrix used for wound healing. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples, detect biomarkers, or provide diagnostic information.
Therefore, Collacare Dental is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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 the | ||
| management of oral wounds and | |||
| sores, including: | |||
| denture sores oral ulcers (non-infected or | |||
| viral) periodontal surgical | |||
| wounds suture sites burns surgical wounds traumatic wounds | Collacara 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 traumatic wounds | Collagen Wound Dressing-Oralis | ||
| indicated for the management of oral | |||
| wounds and sores, including: | |||
| Denture sores Oral ulcers (non-infected or | |||
| viral) Periodontal surgical | |||
| 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 | ||
| 5cm | Matrix: 3.6cm x 1.8cm 2.5cm x 2.5cm and | ||
| 2.5cm x 5cm | |||
| Plug: Height-17mm Top - 10mm Bottom - 14mm | Matrix. 2.5cm x 7.5cm, 2.0cm x 4cm | ||
| Plug. 1cm x 2 cm | |||
| Storage | |||
| Conditions | Room temperature less than 25°C | Room temperature less than 25°C | The product should be stored at room |
| temperature. Avoid excessive heat and | |||
| humidity. |
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