(94 days)
The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.
The Turbo-Tandem® System (Laser Guide Catheter with Laser Atherectomy Catheter) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectorny catheter. Specifically, the guiding catheter portion of the Turbo-Tandem® System includes an angled biasing tip 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 incorporated laser catheter of Turbo-Tandem® System is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) guidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter has a radiopaque marker bands at the distal tip. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing.
The guiding catheter portion of the Turbo-Tandem® System is comprised of a handle with an incorporated flush port, a braided shaft with hydrophilic coating, and a biasing tip with two radiopaque marker bands. The handle features a six-position locking mechanism to position the laser catheter on the ramp of the biasing tip.
The Turbo-Tandem® System is provided sterile and is intended to be single-use.
The provided text describes the 510(k) summary for the Spectranetics 8Fr Turbo-Tandem® System, which is a percutaneous guide catheter with a laser atherectomy catheter. The submission seeks to demonstrate substantial equivalence to a predicate device, the Spectranetics 7Fr Turbo-Tandem® System.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Specified Requirements) | Reported Device Performance |
|---|---|
| Dimensional test | Met the specified requirements. |
| In vitro tip position functional test | Met the specified requirements. |
| In vitro performance test | Met the specified requirements. |
| Laser ablation performance test | Met the specified requirements. |
| Physical test | Met the specified requirements. |
| Accelerated age test | Met the specified requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that Spectranetics performed "device integrity testing." However, it does not specify any sample sizes for these tests (e.g., number of devices tested for dimensional, functional, or performance tests).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. Given that the tests are described as "in vitro" and "device integrity testing," it implies laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for the test set. The tests performed are engineering and performance-based tests on the device itself, not assessments requiring clinical expert interpretation.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the "tests" described are for device integrity and performance, not for clinical outcomes or diagnostic accuracy requiring human expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The study described focuses on demonstrating substantial equivalence of the 8Fr device to the 7Fr predicate device through device integrity and performance tests, not through human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
This device is a physical medical device (a catheter system), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. Type of Ground Truth Used:
The "ground truth" for the device integrity tests would be the engineering specifications and performance parameters defined by Spectranetics for the device. The tests determine if the device's physical and functional characteristics meet these predefined specifications. It is not clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set:
The document does not mention a "training set" as this is a physical medical device and not a machine learning model. The study described involves testing the physical device against predefined engineering requirements to demonstrate substantial equivalence to a predicate device.
9. How Ground Truth for the Training Set Was Established:
As there is no "training set" for an AI or machine learning model, this question is not applicable. The "ground truth" for the device's expected performance in the integrity tests would be established by the device's design specifications and manufacturing standards.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).