(664 days)
Olympus 00216 Otis Urethrotome and 02160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults. When compared with the intended use of predicate devices, the intended use of the subject devices has not been changed.
Olympus 02161 Otis Urethrotome and 02162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children. When compared with the predicate devices, the Olympus subject devices are intended for pediatric use, while the Olympus predicate devices were cleared for Infant Use in 510(k) # K904940.
Olympus America Inc. has been marketing rigid endoscopes, hand instruments, associated accessories, and ancillary equipment for Urological Endoscopy since 1979. The Olympus Urethrotomy System includes the following products.
-
- Otis Urethrotome for Adult Use
- 00216 Otis Urethrotome, 16 cm -
- Replacement Blade for 00216 Urethrotome -02160
-
- Otis Urethrotome for Pediatric Use
- 02161 Otis Urethrotome, 10.5 cm -
- 02162 Replacement Blade for O2162 Urethrotome ・
When these subject devices are compared with the predicate devices, which were cleared in 510(k)s # K790071 and K904940, no significant changes or modifications in intended use, design, material, function, method of operation, or reprocessing that could affect the safety and efficacy of the devices have occurred.
This document describes the Olympus Otis Urethrotome System, a medical device. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
Therefore, I cannot provide the requested table or answer any of the questions about acceptance criteria, studies, sample sizes, ground truth, or expert involvement. The provided text is a 510(k) summary for a medical device submitted in 1998, focusing on describing the device, its intended use, and comparing it to predicate devices to demonstrate substantial equivalence, rather than presenting a performance study against modern acceptance criteria.
§ 876.4770 Urethrotome.
(a)
Identification. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.(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 the limitations in § 876.9.