(58 days)
Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided . Bone Regeneration
Synthetic Mineral -- Collagen Bone Graft Matrix is a composite of synthetic calcium phosphate based granules and type I collagen. The calcium phosphate mineral has an apatite structure similar to that of natural bone. The type I collagen is derived from bovine Achilles tendon. The composite material is a resorbable, porous, osteoconductive bone graft matrix. The product is supplied in granular or block/plug form, and it is sterile, non-pyrogenic, and for single use only.
The provided text describes a 510(k) premarket notification for a medical device called "Synthetic Mineral - Collagen Bone Graft Matrix." This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving effectiveness through a standalone clinical study with specific acceptance criteria that lead to performance metrics, as would be typical for a new device.
Therefore, the specific details requested in the prompt, such as acceptance criteria based on performance studies, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth methodologies, are not explicitly present in this type of submission.
Instead, the "effectiveness" section states: "The characteristics of the Synthetic Mineral – Collagen Bone Graft Matrix meet the design requirements for an effective bone grafting material in dental surgery." This implies that the device's inherent properties and its resemblance to predicate devices are considered sufficient to meet the general design requirements for bone grafting materials.
Here's how the available information relates to your request:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility and Safety (based on FDA Blue Book tests) | Passed "all selected FDA Blue Book" tests. |
| Effectively functions as a bone grafting material in dental surgery | "The characteristics... meet the design requirements for an effective bone grafting material." |
| Substantial Equivalence to Predicate Devices | "found that Synthetic Mineral – Collagen Bone Graft Matrix is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral with Collagen." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission does not describe a clinical study with a "test set" in the context of device performance metrics. Its effectiveness is based on material characteristics and comparison to predicate devices, not on direct clinical performance data from a specific patient cohort for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The submission does not involve a "test set" for which ground truth would be established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. There is no "test set" or adjudication method described.
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-powered diagnostic device, and therefore, an MRMC study with human readers assisting or being assisted by AI is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a bone grafting material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is based on the established regulatory standards for biocompatibility (FDA Blue Book tests) and the material characteristics that are demonstrably similar to legally marketed predicate devices. There is no "ground truth" derived from patient outcomes or expert consensus on diagnostic interpretations for this type of device.
8. The sample size for the training set:
- Not Applicable. The submission does not describe a "training set" in the context of machine learning or an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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FEB 1 2 2009
510(k) Summary of Safety and Effectiveness
Applicant Name and Address: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417
Peggy Hansen, RAC Contact Person: Sr. Director, Clinical, Regulatory, and QA Tel: (201) 405-1477 Fax: (201) 405-1355
December 12, 2008 Date of Summary:
Bone Grafting Material Device Common Name:
Synthetic Mineral - Collagen Bone Graft Matrix Device Trade Name:
Device Classification Name:
Bone Grafting Material, Synthetic 872.3930 LYC Class II
Predicate Device(s):
SynOss™ Synthetic Bone Graft Material K072397 OsteoGuide™ Anorganic Bone Mineral Products K043034 FOUNDATION™ Bone Filling Augmentation Material K040783
Description of the Device
Synthetic Mineral -- Collagen Bone Graft Matrix is a composite of synthetic calcium phosphate based granules and type I collagen. The calcium phosphate mineral has an apatite structure similar to that of natural bone. The type I collagen is derived from bovine Achilles tendon. The composite material is a resorbable, porous, osteoconductive bone graft matrix. The product is supplied in granular or block/plug form, and it is sterile, non-pyrogenic, and for single use only.
Intended Use
Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge �
- Elevation of maxillary sinus floor .
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- Filling of periodontal defects in conjunction with products intended for Guided � Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided . � Bone Regeneration
Summary/Comparison of Technical Characteristics
Synthetic Mineral – Collagen Bone Graft Matrix and its predicates have the same Gynthello Mineral - Seriatics. In particular, the Synthetic Mineral - Collagen Bone Graft Matrix and its predicates are the same with respect to intended use, material characterization, and product forms.
Safety
Synthetic Mineral – Collagen Bone Graft Matrix has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book to assess to oalery.blooompanisms.com the biological evaluation of medical devices.
Effectiveness
The characteristics of the Synthetic Mineral – Collagen Bone Graft Matrix meet the design requirements for an effective bone grafting material in dental surgery.
Conclusion
The results of the in vitro product characterization studies, in vitro and in vivo The Tesults of the in Vitro product than Synthetic Mineral – Collagen Bone Graft Matrix is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral with Collagen.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2009
Ms. Peggy Hansen President, Clinical, Regulatory, QA, and Marketing Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K083742
Trade/Device Name: Synthetic Mineral - Collagen Bone Graft Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC, NPM Dated: December 12, 2008 Received: December 16, 2008
Dear Ms. Hansen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Hansen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony D. Orain
Ginette V. Michaud, M.D.
Ginette Y. Michaud, M Acting 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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Indications for Use
510(k) Number (if known):
Device Name: _ Synthetic Mineral - Collagen Bone Graft Matrix
Indications for Use:
Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery ... The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR :
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Tunne
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devicess
510(k) Number: K083742
Page 1 of
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.