(65 days)
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Y ankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs
This is a 510(k) summary for a Suction Connecting Tubing device. It describes the device, its intended use, and identifies a predicate device. However, this document does NOT contain information regarding acceptance criteria, performance studies, or any of the detailed data points you've requested about AI/algorithm performance.
The provided text focuses on the regulatory aspects of introducing a physical medical device (suction tubing), not on the validation of an AI or algorithmic medical device. Therefore, I cannot generate the requested table and information based on this input.
To answer your request, I would need a 510(k) summary (or similar regulatory submission document) for a device that involves an algorithm, AI, or software component whose performance is being evaluated and compared to acceptance criteria.
§ 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.