(228 days)
The CMS-5000 is a bioimpedance spectroscopy device for use on adult human patients utilizing impedance ratios that are displayed as a B-DEX ratio as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The CMS-5000 is an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution and is not intended to be a sole determinant.
The CMS-5000 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.
The provided text is a 510(k) summary for the Cerebrotech CMS-5000 device. It states that no clinical testing was required due to the device's substantial equivalence to predicate devices, and therefore, it does not contain the detailed information about acceptance criteria and the study that proves the device meets those criteria, as requested in the prompt. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Impedimed L-Dex U400) through comparison of technological characteristics and non-clinical performance (bench tests, human head phantoms, mathematical models).
Therefore, I cannot provide the requested information from the given text.
§ 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.