(174 days)
Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.
AMI intends to reprocess all brands of used disposable surgical saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.
Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.
AMI intends to market used disposable surgical blades, burs, bits and taps that have been reprocessed. Reprocessing blades, burs, bits and taps is performed by AMI to AMI protocol Number 40014. "Reprocessed," means all operations performed to render a contaminated singleuse device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals).
AMI is a "third party reprocessor" and reprocesses used single-used medical devices.
Used blades, burs, bits and taps that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the item is not reprocessed at all) or anytime during subsequent reprocessings.
AMI believes that used single-use blades, burs, bits and taps can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.
AMI reprocessed blades, burs, bits and taps are composed of the same materials as currently marketed blades, burs, bits and taps sold new.
Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) are reprocessed by Adven Medical, Inc.
The information provided does not contain details about specific acceptance criteria or a study that evaluates device performance against such criteria. The document is a 510(k) summary for reprocessed surgical blades, burs, bits, and taps, outlining the manufacturer's intent to market these reprocessed devices and asserting their substantial equivalence to new, disposable devices already on the market.
Instead of performance metrics, the key aspects discussed are:
- Substantial Equivalence: The primary claim is that the reprocessed devices are substantially equivalent to new disposable devices. This is based on their ability to withstand cleaning and sterilization, their material composition (same as new devices), and their intended use.
- Reprocessing Protocol: Adven Medical, Inc. (AMI) has a specific protocol (Number 40014) for reprocessing these devices, and devices that do not meet this protocol are rejected. This protocol itself acts as a form of internal acceptance criteria for reprocessing.
- Regulatory Compliance: The FDA review confirms that the device is substantially equivalent for the stated indications of use and can be marketed under general controls provisions of the Act.
Therefore, I cannot populate the requested tables and information based on the provided text, as it does not describe a performance study with acceptance criteria in the typical sense for a medical device. It focuses on the process of reprocessing and the assertion of equivalence to existing devices, rather than a standalone performance evaluation with specific numerical targets.
If there were a study, one might expect to see:
- Mechanical testing (e.g., sharpness, torque, tensile strength) before and after reprocessing.
- Biocompatibility testing to ensure no harmful residues.
- Sterility assurance level (SAL) validation.
None of these are present in the provided text.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.