(26 days)
The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:
- · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
- · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
The Export Aspiration catheter is a dual lumen catheter for use with the GuardWire Temporary Occlusion and Aspiration System. The main (continuous) lumen of the catheter is the aspiration/infusion lumen while the smaller of the lumens is the guidewire lumen used to run over the GuardWire. The size of the wire lumen is sized so that the Export catheter may run over a 0.14-inch wire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. A 20cc aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.
This document is a 510(k) summary for the Medtronic Export Aspiration Catheter. It does not contain information about studies to prove device performance against acceptance criteria. The document states that the Export Aspiration Catheter is substantially equivalent to a legally marketed predicate device (the Export Aspiration Catheter contained in the GuardWire Temporary Occlusion and Aspiration System) because they are manufactured in the same manner, use the same processes and materials, and have the same indications for use.
Therefore, this submission does not include any performance data, acceptance criteria, or details of a study to demonstrate that the device meets specific performance metrics. It relies solely on the substantial equivalence principle to a predicate device.
To directly answer your request based on the provided text, the following information is not present:
- A table of acceptance criteria and the reported device performance: Not provided. The submission is based on substantial equivalence, not performance data.
- Sample size used for the test set and the data provenance: Not applicable, as no new performance studies were conducted or reported.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new performance studies were conducted or reported.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned as the basis for clearance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The core of this 510(k) submission is the claim of substantial equivalence, meaning that the new device is as safe and effective as a device already on the market without the need for new clinical or performance data.
§ 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).