(444 days)
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:
- · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
- MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
- MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
- · Neuronetics Inc .: NeuroStar coil
The visor2 system must be operated by a trained physician and must not be used during surgical operations.
The visor2 system is a 3D navigation system, supporting external/surface positioning of labeling identified commercially available Transcranial Magnetic Stimulation (TMS) coils based on the anatomical and functional areas for which use of the coil has been FDA cleared and as identified in cleared labeling for the coil. The visor2 system optionally records and processes electrophysiological signals to guide the user in the TMS coil placement. The visor2 system is compatible with TMS stimulators identified in the labeling that meet IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC standards, a compatible optical tracking system, and further compatible accessories. Optionally, a compatible amplifier identified in the labeling may be applied for measuring electrophysiological signals. The visor2 system must be operated by a trained physician, and must not be used during surgical operations.
The visor2 system consists of a cart, an All-in-One medical computer with touch interface, a mounting plate for an optional amplifier applied for EMG recording and a Tracking camera with mounting arm. There are two fundamental visor2 system variants: single or dual display. the second configuration is available with an additional touch display added next to the All-in-One computer. Both variants are identical with regard to hardware features.
The acceptance criteria for the visor2 system and the study results are detailed in the provided text. The device is a 3D navigation system that aids in the positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on MRI measurements or scalp landmarks, with optional EMG recording.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The provided text combines the acceptance criteria (defined as "Main PASS criteria:" or implicitly as "Pass" alongside the test method and results) and the reported device performance within the "Bench testing demonstrated that the performance parameters of the visor2 system meets pre-specified requirements and are substantially equivalent to those of the predicate device" section.
| Test / Feature | Acceptance Criteria (Main PASS criteria / Result) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Pass (IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 +A1:2012) | Passed |
| Electromagnetic Compatibility | Pass (IEC 60601-1-2 Edition 4.0 2014-02) | Passed |
| Compliance with Special Controls | Pass (Review and document compliance with Class II Special Controls guidance document: Repetitive Transcranial Magnetic Stimulation Systems, issued July 26, 2011) | Passed |
| System performance to specifications | Pass (Hardware, software and system evaluations) | Passed |
| Biocompatibility evaluation | Pass (The Pointer Tool patient contact materials are identical to the StimGuide TMS coil location/navigation feature in K183376) | Passed |
| Software verification, validation | Pass (Compliance with FDA Guidance document: Guidance for the Content of Premarket Submissions for Software Content in Medical Devices, May 11, 2005; including intentional and unintentional cybersecurity risks and mitigations applied) | Passed |
| Commercial TMS Coil compatibility | Pass | The compatible commercially compatible TMS coils are demonstrated to be able to be calibrated and properly applied within the location accuracy defined by the visor2 system. |
| Overall accuracy of TMS coil position relative to the head (absolute value) | N/A (Worst case upper limit of the position mismatch in positioning the coil relative to the head) | Pass, Range |
§ 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).