(70 days)
The intended use for the Circon Lowsley™ Suprapubic Tractor is for conventional Open Perineal Prostatectomy Procedures and for Suprapubic Catheter Placement.
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I am sorry, but the provided text is a 510(k) clearance letter for the Lowsley™ Suprapubic Tractor. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The document is a regulatory approval notice, indicating that the device has been deemed substantially equivalent to a predicate device and can therefore be marketed. It does not include technical study details.
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.