(51 days)
The Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The overying tobace, as were of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.
The provided text is a 510(k) summary for the Endius® Atavi System, which is an endoscopic spinal access system. It describes the device, its indications for use, and states its substantial equivalence to previously cleared devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that often relies on comparison of design, materials, and intended use, rather than extensive performance studies with acceptance criteria in the same way a de novo or PMA application might require.
Therefore, I cannot provide the requested information based on the input text. The sections of your request (1-9) would typically be found in detailed verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) filing.
§ 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.