(245 days)
The NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with the NuVasive Spinal Arthroscope, but may be used with other arthroscopes having a minimum working length of 400 mm, an outer sheath diameter of 5.0 mm, and which are indicated for use in the spine.
The subject System consists of a rigid instrument guide frame adjustable in multiple dimensions and planes, a series of expanding tip cannulae which can be introduced with precision to the operative site through the guide frame, and related manual arthroscopic instruments. Under radiographic guidance, the System assists the physician in gaining controlled, percutaneous access to the spine and adjacent tissues and structures, via uniportal or biportal approach.
This document, a 510(k) summary for the NuVasive Guided Spinal Arthroscopy System, does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.
Here's why and what information is provided:
- No Acceptance Criteria and Reported Performance Table: The document does not define specific acceptance criteria (e.g., accuracy, precision metrics) for the device's performance, nor does it present a table outlining these criteria and corresponding device performance data.
- No Study Information: The document explicitly states "Summary of Non-Clinical Tests (Not applicable)" and "Summary of Clinical Tests (Not applicable_". This indicates that no non-clinical or clinical studies involving performance measurements were submitted or deemed necessary for this 510(k) clearance.
What the document does provide is a declaration of substantial equivalence to predicate devices, focusing on:
- Device Description: The system consists of a rigid instrument guide frame, expanding tip cannulae, and manual arthroscopic instruments. It assists in gaining controlled, percutaneous access to the spine and adjacent tissues under radiographic guidance.
- Intended Use: To assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, using real-time or near real-time radiographic visualization. It's designed for use with NuVasive Spinal Arthroscope or other compatible arthroscopes.
- Predicate Devices: Several predicate devices are listed, including endoscopes, micro-endo instruments, percutaneous discectomy systems, stereotactic frames, and biopsy systems.
- Comparison to Predicate Devices: The submission argues substantial equivalence based on:
- Similar indications for use.
- Same or equivalent materials.
- Substantially equivalent design features (e.g., adjustable frame, expanding cannula tip, selection of instrument/cannula diameters).
- Equivalent functions (establishing a port of entry for arthroscopic instrumentation).
- Similar packaging and labeling.
Therefore, I cannot provide the requested table and study details because they are not present in the provided text. The 510(k) clearance for this device was based on substantial equivalence to existing legally marketed devices, rather than a new performance study against specific acceptance criteria.
§ 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.