(267 days)
Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Stereotaxic Guiding Surgical Devices, NaoTrac S is a robotized platform for the guidance of neurosurgical instruments compatible with the diameter of instrument adaptor provided by Brain Navi Biotechnology Co., Ltd.
Stereotaxic Guiding Surgical Devices, NaoTrac S is composed of a compact robotic arm and display screen mounted on a wheeled trolley. Different types of instruments may be attached to the end of the arm and changed according to the requirements of the procedure to be completed.
The display screen permits to ensure the communication between NaoTrac S and its user by indicating the realizable actions as well as by proposing various commands. NaoTrac S is an aid for locating anatomical structures in either open or percutaneous procedures.
The provided FDA 510(k) Clearance Letter for the Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) includes details on acceptance criteria and supporting studies.
Here's an analysis of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (NaoTrac S) |
|---|---|
| Positional Error (Euclidean distance) |
§ 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).