(36 days)
The Bochringer MRI Suction Regulators are designed to provide accurate control of wall suction for use in suction therapy procedures in an MRI environment.
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This document is an FDA 510(k) clearance letter for the Boehringer MRI Suction Regulator, stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain any information regarding acceptance criteria, device performance, statistical studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and compliance.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.