(91 days)
Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/ CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.
The Subject Device is intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.
In a spinal context, Automatic Registration serves as accessory to the Spine & Trauma navigation system.
The Matrices are reusable devices delivered in non-sterile condition. The devices makes the Correlation ("Registration") of Intraoperative acquired patient data to the surgical environment possible by determining its position in relation to the patient and the navigated instruments.
The document describes K203679, a premarket notification for the "Automatic Registration" device by Brainlab AG. The device is a surgical device for image-guided surgery intended to be used in combination with compatible Brainlab navigation systems, providing image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.
Here's an analysis of the acceptance criteria and study data provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance |
|---|---|
| Mean navigation accuracy: |
§ 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).