(179 days)
The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
The Herniatome Percutaneous Discectomy Kit is comprised of an Introducer needle and a Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device is a single-use disposable discectomy device that is designed to remove intervertebral disc nucleus pulpous material under CT and fluoroscopic guidance. Radiopaque marker bands are located on the Introducer needle and the Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device contains a battery source DC motor that causes the internal double pitch mechanism to act as a screw conveyor to retrieve and remove the excised debris through the outer cannula and into the transparent collection container.
The Herniatome Percutaneous Discectomy Device is provided in two base models, a curved or straight distal end cannula with a lateral window and each model is provided with two different gage cannulas and two different cannula lengths for utilization in the specific region of the spine.
This document describes a 510(k) premarket notification for the "Herniatome Percutaneous Discectomy Device". The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device. This is NOT a study about an AI/ML device, and therefore several of your requested categories (1, 2, 3, 4, 5, 6, 7, 8, 9) are not applicable as they relate to AI/ML device performance and testing.
Here's the relevant information that can be extracted from the provided text regarding the device and its performance testing:
Device Name: Herniatome Percutaneous Discectomy Device
Predicate Device: Stryker Instruments, Dekompressor™ Percutaneous Discectomy Probe, K032473
Intended Use: The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of explicit numeric acceptance criteria for the performance tests, nor does it report specific numerical device performance metrics. Instead, it states that the device "successfully passed all of the following performance tests."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device classified as an External Communicating Device in contact with Tissue/Bone/Dentin Communicating for a Limited Duration ( |
§ 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.