(521 days)
SYNERGY is intended for use in: Augmentation or reconstructive treatment of alveolar ridge Filling periodontal defects Filling defects after root resection, apicoectomy, and cystectomy Filling extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Synergy is a Xenograft of bovine origin. It contains macro and micro porous structures similar to Bio-Oss. Synergy is a purified osteoconductive mineral structure produced from bone in a multi-stage purification process. Synergy is chemically as well as structurally comparable to mineralized Bio Oss and Equimatrix. Synergy is used as an adjunctive therapy in restoring bony defects in the mouth. Synergy is produced from selected bovine bone. Physical and chemical analysis has demonstrated that the composition of Synergy is similar to the predicate devices which have been shown to be anorganic, osteoconductive hydroxyapatite bone mineral. The product is milled to generate granules of two sizes (0.30 - 0. 84 mm or 0.84 - 2.0 mm) which are put into glass vials and sterilized by gamma irradiation. Synergy has porous structure and composition, encouraging the formation and ingrowth of new bone at the implantation. In the course of time Synergy is partially remodelled by osteoclasts and osteoblasts (physiological remodelling).
The provided text describes a 510(k) premarket notification for a dental bone grafting material called "Synergy" (K123876). The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study designed to meet specific performance targets.
Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance or a study proving the device meets said criteria in the way a clinical trial or performance study report would.
The document primarily provides:
- Device description and intended use for Synergy, the predicate devices (Bio-Oss and Equimatrix™), and a comparison table.
- A statement of substantial equivalence to the predicate devices based on intended use, biocompatibility, sterility, physical and chemical testing, performance evaluation in an anatomically relevant animal model, and results of clinical cases (though the details of these cases or the animal study are not provided).
- Compliance with recognized standards (ISO 10993, ASTM F1088 - 04a, USP 31, ASTM F1185 - 03, ASTM F1581 - 08, Argentine Pharmacopeia) and FDA Special Controls Guidance Document for Dental Bone Grafting Material Devices.
Since the document does not present specific acceptance criteria or a detailed study to meet them, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, etc. Those details are typically found in a dedicated performance study report, which is not part of this 510(k) summary.
§ 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.