(90 days)
The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.
Not Found
This document is a 510(k) premarket notification letter from the FDA to Fortune Medical Instrument Corp. for a Suprapubic Catheter. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Critical information for describing acceptance criteria and a study demonstrating device performance is absent from this document. Section {0} is the FDA's acceptance letter, and Section {2} is the Indications for Use statement for the device. Neither of these sections
contain information about:
- Acceptance criteria
- Reported device performance
- Details of any study (sample size, data provenance, ground truth, adjudication, MRMC, standalone performance, training set details).
This document primarily serves as regulatory clearance, not a performance study report. Therefore, I cannot provide the requested information based solely on the provided text.
§ 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.