(120 days)
The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-S1 interbody fusion.
The Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior lower spine and consists of the following components: Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool
This document is a 510(k) summary for the TranS1 Trans-Sacral Spinal Access and Preparation Device, and thus does not contain information on acceptance criteria or a study proving device performance against such criteria.
The 510(k) summary states the following about the device:
- Device Name: TranS1 Trans-Sacral Spinal Access and Preparation Device (also referred to as TranS1 Trans-Sacral Spinal Access and Preparation Kit)
- Generic Name: Rigid Endoscope and Instrument Set
- Intended Use/Indications for Use: For minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L5-S1 interbody fusion.
- Technological Characteristics: Designed to gain a minimally invasive access tract to the anterior region of the lower spine and assist in the diagnosis and treatment of the area, enabling procedures such as biopsy, lumbar fusion, vertebroplasty, etc. Access up to L5 is possible.
- Predicate Devices:
- AxiaMed, Inc., Trans-Sacral Spinal Access Device
- Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit
- Argus Medical Company Laparoscopic Discectomy Instrument System
- Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter
- Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter
- Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System
- United States Surgical, Auto Suture Spinal Elevator
- Harrington Spinal Elevator
- Karlin Technology, Inc., Cobb Spinal Elevator.
The document is primarily focused on demonstrating substantial equivalence to these predicate devices for market clearance, rather than presenting a performance study with defined acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this 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.