(63 days)
The Epiduroscope is indicated for use in the lumbar and sacral spine for observing epidural anatomy and pathology.
The KSEA Epiduroscope is a manually operated surgical devices. The KSEA Epiduroscope is a flexible fiberoptic telescope which utilize fiber-optic technology. The body contact portions of the KSEA Epiduroscope are composed of medical grade polyurethane.
This 510(k) summary does not contain information related to specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information in the format specified. The document primarily addresses:
- Device Identification: KSEA Epiduroscope
- Indication: For use in the lumbar and sacral spine for observing epidural anatomy and pathology.
- Device Description: A manually operated, flexible fiberoptic telescope utilizing fiber-optic technology, with body contact portions made of medical-grade polyurethane.
- Substantial Equivalence: Claimed based on the basic features, design, and intended uses being the same as predicate devices, with minor differences raising no new issues of safety and effectiveness.
There is no mention of performance metrics, clinical studies, test sets, ground truth establishment, or sample sizes related to proving the device's efficacy or safety against specific acceptance criteria. The FDA letter confirms the substantial equivalence determination but does not detail efficacy study results.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.