(27 days)
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
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I am sorry, but the provided text only contains an FDA notification letter regarding a 510(k) premarket notification for a medical device called "Gibbons' Sterile Trocar Kit".
This document does not contain any information about:
- Acceptance criteria or reported device performance. The letter merely states the device is substantially equivalent to a predicate device.
- Study details: No mention of sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.
§ 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.