(266 days)
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.
The acceptance criteria and study proving the device meets them can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: | Demonstrated through extensive comparison of technological characteristics: |
| - Indications for Use | The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures. (Stated as substantially equivalent to predicate devices, expanding on previous indications). |
| - Intended Use | Cutting soft tissue and bone (Similar to predicate devices). |
| - Controller | Console with foot pedal (Similar to predicate devices). |
| - Energy Source | Electrical (Similar to predicate devices). |
| - Speed Indication | Digital (Similar to predicate devices). |
| - Functions | Drill and Microdebrider (Similar to predicate devices). |
| - Drill Motor Speed | Max 80,000 rpm (Similar to predicate devices). |
| - Irrigation | 1 peristaltic pump integrated into console for irrigation (Similar to predicate devices). |
| - Sterilization (Micromotors, Handpieces) | Steam Autoclave, AAMI TIR 12, ISO 17664, ISO 17665 (Similar to predicate devices). |
| - Direct Contact Material (for the proposed device, considering the additional diamond grit) | Stainless Steel / Diamond Grit (Differences in direct contact material related to diamond grit were addressed by biocompatibility testing, demonstrating no impact on safety or effectiveness). |
| Safety and Effectiveness: | |
| - Compliance with Internal Functional Specifications (including software) | Verification/validation testing demonstrated that the device is safe and effective, and performs comparably to and is substantially equivalent to the predicate devices. This included traceability of verification/validation tests to software requirements and software risk hazards. |
| - Operating Temperatures | Testing confirmed that the proposed device is equivalent to the predicate device for safety issues such as operating temperatures. |
| - Electrical Safety and Electromagnetic Compatibility (EMC) | Device complies with relevant voluntary safety standards, specifically IEC standards 60601-1 and 60601-1-2. |
| - Biocompatibility (for diamond grit, a new direct contact material) | Cytotoxicity (ISO 10993-5): No cytotoxic potential (MEM Elution method). |
| Irritation/Intracutaneous Reactivity (ISO 10993-10, ISO 10993-12): Not reactive (Intracutaneous Reactivity in Rabbits with two extracts: 0.9% NaCl; sesame oil). | |
| Hemolysis (ISO 10993-4): No hemolytic effect (Material/surface-mediated hemolysis). | |
| Sensitization (ISO 10993-10): No sensitization (Sensitization in Guinea Pigs). | |
| Acute System Toxicity (ISO 10993-11): No evidence of AST observed (Acute System Toxicity in Mice). | |
| - Endotoxin | Met acceptance criterion ( |
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).