(30 days)
The Radionics Optical Tracking System (OTS) Wireless System is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
This premarket notification describes a modification to the Radionics Optical Tracking System (OTS). The common name of this device is Intraoperative Guidance Device, and its classification name is Stereotaxic instrument. The modification involves the incorporation of battery-powered Wireless Standard Probe and DRF accessories. These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS. When coupled with the OTS workstation, the above wireless accessories function in the same way as the predicate wired versions by allowing preoperative and operative planning of cranial and spinal surgical procedures using workstation images.
The provided text is related to a 510(k) submission for a medical device modification, specifically the Radionics Optical Tracking System (OTS) Wireless System. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.
The document primarily focuses on:
- Device Identification: Radionics Optical Tracking System (OTS) Wireless System.
- Modification: Incorporation of battery-powered Wireless Standard Probe and DRF accessories.
- Substantial Equivalence Claim: The wireless accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS.
- Functionality: They function the same way as wired versions for preoperative and operative planning of cranial and spinal surgical procedures.
- Technological Characteristics: Similar to the predicate wired device, using LED-based systems and infrared signals for tracking.
- FDA Clearance: The letter from the FDA confirming clearance based on substantial equivalence.
- Indications for Use: For cranial and spinal surgical procedures where anatomical landmarks are not clearly visible or targets are close to critical structures.
Because there is no study data provided, I cannot populate the table or answer the specific questions about acceptance criteria, study design, and results. These details are typically found in the technical sections of a 510(k) submission, which are not present in the provided excerpts.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).