(30 days)
The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.
The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.
The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:
- Romeo® 2
- Romeo® 2 MIS
- Perla® Cervico-thoracic Fixation System
All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided not sterile.
The SPINEART® Navigation Instrument System instruments are not compatible with implants from other manufacturers.
The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker System.
The provided text is a 510(k) summary for a medical device (SPINEART Navigation Instrument System) seeking FDA clearance for a device modification (addition of new instruments). It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The key statement regarding testing is: "Addition of navigated instruments to SPINEART Navigation Instrument System (K183630) does not require testing." This implies that the modification is considered minor enough that the performance data from the predicate device (SPINEART Navigation Instrument System K183630) is deemed sufficient. The submission relies on the "substantial equivalence" argument, stating that the new instruments have the "same technological characteristics" and "accuracy performance" as the previously cleared predicate.
Therefore, I cannot provide the requested information from the given text because the document explicitly states that no new testing was required for this specific submission.
§ 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).