(26 days)
Indicated for atherectomy of infrainguinal arteries.
The Turbo-Tandem™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser atherectorny catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The Turbo-Tandem System is designed to directionally ablate infrainguinal concentric and eccentric lesions in vessels 5mm or greater at or above the knee. The Turbo-Tandem System is not designed to be used in total or sub-total occlusions. In the event of a total or sub-total occlusion a pilot channel is recommended. The guiding catheter portion of the Turbo-Tandem™ System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem™ System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) quidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing catheter portion of the Turbo-Tandem™ System is comprised of a handle with an incorporated flush port, proximal coupler, tail tubing, strain relief tubing, braided shaft with a hydrophilic coating, two radiopaque marker bands in the distal tip with a platform, and one radiopaque marker band at the distal end of the laser catheter.
The provided text describes a 510(k) premarket notification for the Spectranetics Turbo-Tandem™ System, a laser atherectomy catheter. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects commonly associated with clinical performance studies involving AI or expert review.
The submission focuses on establishing substantial equivalence to a predicate device, primarily through device integrity testing, rather than clinical performance evaluation against predefined criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The submission relies on substantial equivalence based on device integrity testing. | "All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements." (The specific requirements are not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance
No information is provided about a "test set" in the context of clinical performance, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned were "device integrity testing."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. The submission does not describe a study involving expert review or the establishment of ground truth for a clinical dataset. The "ground truth" seems to be implied by successful device integrity testing against internal requirements.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication by experts is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study or comparison of human readers with or without AI assistance is mentioned. This device is a physical medical device, not an AI-based diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission appears to be successful device integrity testing against internal specifications and engineering requirements, demonstrating functional and safety equivalence to the predicate device. There is no mention of clinical ground truth like pathology, outcomes data, or expert consensus related to patient outcomes for this 510(k) submission.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm.
Summary of what the document does provide:
- Device Type: Laser atherectomy catheter system.
- Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Spectranetics first generation Turbo Tandem System K091299).
- Basis for Equivalence: Device integrity testing.
- Conclusion: Device integrity tests met specified requirements, supporting substantial equivalence.
The provided document is typical for a 510(k) for a physical medical device where the primary focus is on engineering and performance testing to demonstrate equivalence rather than a clinical trial or AI performance validation.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).