(52 days)
Not Found
No
The summary describes a synthetic bone graft material and its intended uses in dental surgery. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The device is a physical material, not a software or imaging-based device that would typically incorporate AI/ML.
No.
The device is a bone graft material used in dental surgery to fill defects and enhance tissue preservation, which is a structural or restorative function, not a therapeutic treatment of a disease or condition.
No
Explanation: The device is a bone graft material used in dental surgery to augment or reconstruct bone, fill defects, or preserve the alveolar ridge. It is a therapeutic material, not a device used to diagnose a condition or disease.
No
The device description clearly states it is a "calcium phosphate based bone graft material" supplied in "granular form," indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in dental surgery for procedures like bone grafting and filling defects. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a synthetic bone graft material, which is a physical implant/material used in surgery. It does not describe a reagent, instrument, or system used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a therapeutic material used in a surgical procedure.
N/A
Intended Use / Indications for Use
SynOss Synthetic Bone Graft Material 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
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
SynOss™ Synthetic Bone Graft Material is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. The product is supplied in granular form, and it is sterile, non-pyrogenic, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
The characteristics of the SynOss Synthetic Bone Graft Material meet the design requirements for an effective bone grafting material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 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.
0
K07-2397
2007
510(k) Summary of Safety and Effectiveness
| Applicant Name and Address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, New Jersey 07417 | OCT 1 8 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Peggy Hansen, RAC
Sr. Director, Clinical, Regulatory, and QA
Tel: (201) 405-1477
Fax: (201) 405-1355 | |
| Date of Summary: | August 24, 2007 | |
| Device Common Name: | Bone Grafting Material | |
| Device Trade Name: | SynOss™ Synthetic Bone Graft Material | |
| Device Classification Name: | Bone Grafting Material, Synthetic
872.3930
LYC
Class II | |
| Predicate Device(s): | OsteoGuide™ Anorganic Bone Mineral Products
K043034 | |
Description of the Device
SynOss™ Synthetic Bone Graft Material is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. The product is supplied in granular form, and it is sterile, non-pyrogenic, and for single use only.
Intended Use
SynOss Synthetic Bone Graft Material 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
1
Collagen Matrix, Inc. 510(k) Summary of Safety and Effectiveness SynOss™ Synthetic Bone Graft Material
Summary/Comparison of Technical Characteristics
SynOss Synthetic Bone Graft Material and its predicate have the same technological characteristics. In particular, the both SynOss and its predicate are the same with respect to intended use, material structure, material characterization, form, and sizes.
Safety
SynOss Synthetic Bone Graft Material has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
Effectiveness
The characteristics of the SynOss Synthetic Bone Graft Material meet the design requirements for an effective bone grafting material.
Conclusion
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that the SynOss Synthetic Bone Graft Material is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral Granules.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, along with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Ms. Peggy Hansen Senior Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K072397
Trade/Device Name: SynOss™ Synthetic Bone Graft Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 24, 2007 Received: August 27, 2007
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.
3
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sautie y. Michino mD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Device Name: SynOss™ Synthetic Bone Graft Material
Indications for Use:
SynOss Synthetic Bone Graft Material 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, apicocectorny, and cystectorny ●
- 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)
Suss Juara
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"sion of Anesthesiology, General Hospital, Imaginon Control, Dental Devices
ber: K67R317
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