(47 days)
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these Class II products cleared for use in an MR environment. Various sizes and shapes of patient positioning devices are offered in order to install on a specific system which the device is used on and/or the body region to be positioned. Devices are sold non-sterile and may be re-used for multiple patient or single patient use if set-up for a single patient.
This document describes the 510(k) submission for CIVCO MR & Radiological Patient Positioning Devices, which seeks to clear existing Class II patient positioning devices for use in an MR environment. The submission focuses on demonstrating substantial equivalence to previously cleared devices.
Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative, objective manner (e.g., a specific numerical threshold for performance metrics). Instead, it relies on demonstrating substantial equivalence to predicate devices by showing that the proposed device has equivalent intended uses, manufacturing, quality systems, device body contacting category, and safety parameters. The "reported device performance" is essentially the claim of "Same" or "Equivalent" to the predicate for these parameters, with specific testing conducted for MR compatibility and biocompatibility.
Parameter Acceptance Criteria (Implied) Reported Device Performance Intended Use / Indications for Use Must be equivalent to predicate device for safety & effectiveness. CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures. (Expanded from predicate's "radiological and other procedures" to include MR, but still for support and positioning). Manufacturing Must be the same or demonstrably equivalent. Same (Machined, injection molded, formed, assembled, painted). Quality Systems Must be the same or demonstrably equivalent. Same (FDA/QSR cGMP 21CFR Part 820. ISO 9001 / ISO 13485). Device Body Contact Category Must be the same or demonstrably equivalent. Same (Surface devices, intact skin; limited contact duration (
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.