(52 days)
The suction devices, when attached to an external source of vacuum, are used for aspiration, removal, or sampling of body fluids during surgical procedures.
These devices are rigid, hollow tips or tubes, that when attached to an external source of vacuum are used for aspiration, removal, or sampling of body fluids during surgical procedures. Some suction devices are fitted with Fiber Optic bundles.
The provided text is a 510(k) premarket notification letter from the FDA to Walter Lorenz Surgical, Incorporated, regarding "Suction Instrumentation." It is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study (clinical or otherwise) that would prove the device meets such criteria.
Therefore, I cannot fulfill your request for the tables and information outlined because the source material does not provide it. The document confirms the device's regulatory classification, intended use, and substantial equivalence to existing devices but does not delve into empirical performance data or study methodologies.
§ 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.