(28 days)
The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.
The Visor System is an adjunct to standard methodologies for clinical evaluation.
The Visor System is a bioimpedance spectroscopy device used to monitor patients who have conditions that predispose them to fluid volume changes. The device uses Volumetric Integral Phase-Shift Spectroscopy (VIPS) technology. Changes in the volume of fluids in the human skull can be detected by monitoring changes in electrical properties. VIPS technology measures the frequency response of the phase angle shift between an emitter antenna and a detector antenna, when placed on opposite sides of the head. The device is intended to be used as an aid to clinical assessment in conjunction with current standards of care.
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Cerebrotech Visor System, detailing its substantial equivalence to a predicate device (CMS-5000) based on modifications to its physical dimensions, user interface software platform, and power source.
The document discusses:
- Indications for Use: To measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment, as an adjunct to standard methodologies.
- Technological Characteristics: Multi-frequency Bioimpedance Spectroscopy using low-power radio frequency current.
- Comparison to Predicate: The Visor System is essentially the CMS-5000 with a smaller profile due to a change from a MacBook laptop to an Android tablet for the user interface, and a removable rechargeable battery.
It explicitly states, "The Visor System is the same device as the predicate with some modifications. It provides adjunct information about tissue fluid differences derived from bioimpedance ratios and does not replace standard diagnostic techniques, which may include physical examination, medical imaging, and professional judgment. The systems are therefore substantially equivalent."
This means the submission focuses on demonstrating that the modified device (Visor System) is as safe and effective as the previously cleared predicate device (CMS-5000), rather than providing new performance criteria and a study to meet those criteria. The verification of the CerebroScan software in the Android Tablet is mentioned as being provided in the 510(k) submission, but the details of this verification, including specific acceptance criteria, sample size, or study design, are not included in this summary.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.