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Next Generation Aspiration Catheter:

The Next Generation Aspiration Catheter with a compatible aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment.

Balt Aspiration Tubing Set:

The Balt Aspiration Tubing Set is intended to connect the Next Generation Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The Next Generation Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite catheter that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The Next Generation Aspiration Catheter is comprised of a hollow cylindrical tube which incorporates a standard luer fitting to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The wall of the tube is constructed using a combination of metal coils and medical grade polymers. The distal portion of the Next Generation Aspiration Catheter has a hydrophilic coating which provides a lubricious surface during use to aid in tracking through the vasculature. The catheter includes a radiopaque marker providing the user with visual confirmation of the distal tip location under fluoroscopy. The Next Generation Aspiration Catheter is offered in various working lengths and nominal inner diameters and outer diameters.

An introducer sheath is provided in the package to support and facilitate the insertion of the Next Generation Aspiration Catheter's distal tip into an appropriate vascular sheath.

The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.

The Balt Aspiration Tubing Set is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Next Generation Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Balt Aspiration Tubing Set is made of common medical grade polymers, is provided sterile, and is intended for single use only.

The Next Generation Aspiration Catheter and Balt Aspiration Tubing Set are intended to be used with:

• Guidewires
• Guide Sheaths
• Aspiration Pump

The provided text is a 510(k) Summary for a new medical device, the "Next Generation Aspiration Catheter" and "Balt Aspiration Tubing Set." It details the device description, indications for use, comparison to a predicate device, and various performance tests conducted.

However, the question asks about acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI software. The provided document does not describe an AI/software device or related performance studies. Instead, it outlines the regulatory submission for a physical medical device (catheter and tubing set) and its non-clinical (biocompatibility, bench, and animal) testing for substantial equivalence to a predicate device.

Therefore, I cannot extract the information requested regarding acceptance criteria and studies proving an AI device meets them from this document. The document simply doesn't contain that type of information.

To answer your question based only on the provided text, the answer is that the document does not contain information about an AI device, its acceptance criteria, or studies proving it meets those criteria.

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