(177 days)
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.
The provided text describes the 510(k) summary for the Aongen™ Dental Collagen Matrix. It outlines the device description, indications for use, and a summary of tests conducted to demonstrate biocompatibility and performance. However, this document does not contain information typically associated with acceptance criteria or study details for a device whose performance is measured in terms of metrics like sensitivity, specificity, or accuracy, which would be relevant for software or diagnostic devices.
The Aongen™ Dental Collagen Matrix is a physical medical device (resorbable matrix for dental surgical procedures) and its evaluation focuses on biocompatibility and substantial equivalence to predicate devices, rather than performance metrics of an AI or diagnostic algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the type of device and study described in this 510(k) summary.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (collagen matrix), acceptance criteria are typically related to safety profiles like biocompatibility and sterility, rather than analytical performance metrics common in AI or diagnostic systems. The "reported device performance" here refers to meeting these safety standards.
| Acceptance Criterion (Test) | Reported Device Performance (Result) |
|---|---|
| Agar Diffusion Test | Non-cytotoxic |
| Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay | Not mutagenic |
| Rodent Bone Marrow Micronucleus Assay | Non-clastogenic |
| Hemolysis – Rabbit Blood | Non-hemolytic |
| Intramuscular Implantation Test | No local toxic effects after implantation |
| Intracutaneous Injection Test | Negligible irritant |
| Kligman Maximization Test | No sensitization |
| Rabbit Pyrogen Test | Non-pyrogenic |
| Systemic Injection Test | No toxic effects |
| Heavy Metal Test | Within acceptance level |
| Sterility Test | Sterile |
| LAL Test | <0.5 EU/mL |
2. Sample size(s) used for the test set and the data provenance
This is not applicable as the device is a physical collagen matrix, not a software or AI device requiring a "test set" in the context of data or image analysis. The tests performed are laboratory-based biocompatibility studies, which would use biological samples or animal models, but the specific "sample sizes" (e.g., number of cells, animals) for each test are not detailed in this summary document. Data provenance as "country of origin" or "retrospective/prospective" is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This concept is relevant for algorithm-based devices where human experts define ground truth for training/testing data. For a physical device, testing involves standardized laboratory assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for resolving disagreements in expert annotations for diagnostic or AI algorithm testing.
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. MRMC studies are designed for evaluating diagnostic devices/AI where human readers interpret cases. This device is a surgical material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the "ground truth" is defined by the established scientific protocols and standards for each specific test (e.g., "non-cytotoxic," "not mutagenic," "sterile"). These are objective laboratory measurements against predefined thresholds, not expert consensus or pathology in a diagnostic sense.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it's not an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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KI12568
510(k) Summary
MAR - 1 2012
Submitter Name and Address:
Aeon Astron Europe B.V. Niels Bohrweg 11-13, 2333 CA Leiden, The Netherlands
Contact Person:
Horng Ji Lai C.E.O. Tel: +31-71-3322280 Fax: +31-71-3322281
Date Prepared:
February 23, 2012
Device Information:
| Proprietary Name: | Aongen™ Dental Collagen Matrix |
|---|---|
| Product Code: | MGQ |
| Device Class: | Unclassified |
| Review Panel: | General & Plastic Surgery |
Predicate Device:
| Predicate #1 | |
|---|---|
| Proprietary Name: | OTA Collagen Biomaterial |
| Common Name: | Collagen dental membrane |
| Product Code: | NPL |
| 510(k) Number: | K073685 |
| 510(k) Submitter: | Osseous Technologies of America, Inc. |
Predicate #2
| Proprietary Name: | Integra Meshed Bilayer Wound Matrix |
|---|---|
| Common Name: | N/A |
| Product Code: | FRO |
| 510(k) Number: | K081635 |
| 510(k) Submitter: | Integra Lifesciences Corp. |
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Device Description:
Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.
Indications for Use:
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
Summary of Tests:
Tests were conducted to evaluate the biocompatibility and performance of Aongen™ Dental Collagen Matrix. The results of these tests demonstrate that Aongen™ Dental Collagen Matrix is safe and biocompatible.
| Biocompatibility Tests | Result |
|---|---|
| Agar Diffusion Test | Non-cytotoxic |
| Salmonella Typhimurium and EscherichiaColi Reverse Mutation Assay | Not mutagenic |
| Rodent Bone Marrow Micronucleus Assay | Non-clastogenic |
| Hemolysis – Rabbit Blood | Non-hemolytic |
| Intramuscular Implantation Test | No local toxic effects after implantation |
| Intracutaneous Injection Test | Negligible irritant |
| Kligman Maximization Test | No sensitization |
| Rabbit Pyrogen Test | Non-pyrogenic |
| Systemic Injection Test | No toxic effects |
| Heavy Metal Test | Within acceptance level |
| Sterility Test | Sterile |
| LAL Test | <0.5 EU/mL |
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Comparison with the Predicates:
| Device Name | Aongen™ Dental CollagenMatrix | Integra Meshed Bilayer WoundMatrix |
|---|---|---|
| Submitter | Aeon Astron Europe B.V. | Integra Lifesciences Corp. |
| 510(k) No. | K081635 | |
| Similarities | Both devices are comprised of a Collagen-GAG matrix whichcreates a suitable environment for wound healing process. | |
| Differences | Integra Meshed Bilayer Wound Matrix has an extra layer oftemporary semi-permeable silicone membrane. |
| Device Name | Aongen™ Dental CollagenMatrix | OTA Collagen Biomaterial |
|---|---|---|
| Submitter | Aeon Astron Europe B.V. | Osseous Technologies ofAmerica, Inc. |
| 510(k) No. | K073685 | |
| Similarities | Both devices are applied as an onlay to cover wound defects. | |
| Differences | The source of collagen is different in these two devices.Aongen™ Dental Collagen Matrix is sourced from porcine, andOTA Collagen Biomaterial is sourced from bovine. |
Conclusion of Tests:
The results of product characterization studies and biocompatibility studies demonstrate that Aongen™ Dental Collagen Matrix is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The symbol is black, and the text is also in a dark color, likely black or a dark shade of gray.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012
Mr. Horng Ji Lai CEO Aeon Astron Europe B.V. Niels Bohrweg 11-13 Leiden NETHERLANDS 2333 CA
Re: K112568
Trade/Device Name: Aongen™ Dental Collagen Matrix Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MQN Dated: February 23, 2012 Received: February 27, 2012
Dear Mr. Lai:
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. Lai
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.
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 /ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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106/
Indications for Use
510(k) Number (if known):
Device Name: Aongen™ Dental Collagen Matrix
Indications for Use:
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
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)
Susan Runne
Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K112576
N/A