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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:

1. 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 (

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