(1030 days)
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.
This document describes a medical device, the Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail, and its sterilization validation, not the performance of an AI or diagnostic device that would typically have acceptance criteria related to accuracy or other performance metrics.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC study, standalone performance, training set details) are not applicable to this document.
This document focuses on:
- Device Description: A tibial nail for stabilizing fractures.
- Material: Titanium-6Aluminum-7Niobium.
- Sterilization Method: Gamma radiation.
- Sterilization Validation: Biological Indicator - Overkill Method, following AAMI guidelines, ensuring a sterility assurance level in excess of 10^-6.
- Packaging: Double sterility barrier using PETG plastic trays and Tyvek lids.
- Radiation Dose: 2.5 - 3.2 MegaRads (validation minimum dose range per AAMI is 1.8 - 2.6 MegaRads).
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KC93330
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Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(215) 647-9700 Contact: Diane Cochet-Wynant May 12, 1993
Device: Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail, as compared to Synthes Unreamed Tibial Nail (stainless steel)
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia. It is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.
Synthes Unreamed Tibial Nail is also indicated for fractures of the tibia.
To facilitate insertion and anatomic fit, the Unreamed Tibial Nail was modified (e.g., locking hole number/placement, material) to make the Titanium-6Aluminum-7Niobium Unreamed Tibial Nail.
The method used to sterilize the Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is gamma radiation, as recognized by the United States Pharmacopeia.
The method used to validate the sterilization cycle was the Biological Indicator - Overkill Method for Low Bioburden Medical Devices per guidelines established by the Association for Advancement of Medical Instrumentation (AAMI). Synthes applied the guidelines appearing in "Process Control Guidelines for Gamma Radiation Sterilization of Medical Devices," AAMI, October 18, 1991.
The AAMI Biological - Overkill Method dictates a sterility assurance level in excess of 10-6 which assures a 12 logarithmic reduction in a possible micro-organism population.
The packaging system used to maintain device sterility consists of two sealed trays, one within the other, providing a double sterility barrier. The packaging trays and lids are manufactured from industry accepted components for EO and gamma radiation, namely, medical grade, blue tint, 6763 PETG plastic for the trays and Tyvek 1073 B for the lids. The sealed trays are placed in a paperboard shipping carton and shrink wrapped.
The radiation dose used to insure sterility basis, is 2.5 - 3.2 MegaRads. The validation minimum dose range, per AAMI, is 1.8 - 2.6 MegaRads.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.