(162 days)
Raptor Aspiration Catheter:
The Raptor Aspiration Catheter with a compatible aspiration pump and Balt 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Balt Aspiration Tubing Set:
The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered in various sizes that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The distal tip of the catheter shaft includes a markerband and the proximal end of the catheter has a luer fitting to allow for the attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The Raptor Aspiration Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Raptor Aspiration Catheters are compatible with 0.014" – 0.018" guidewires.
A peelable split Introducer Sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Raptor Aspiration Catheter into an appropriate vascular sheath. The catheter and Introducer Sheath are provided sterile, non-pyrogenic, and intended for single use only.
The Balt Aspiration Tubing Set consists of one 100" HPF proximal tubing with a suction connector on one end and male rotator on the other, one 1-way Large Bore Stopcock, and one 10" HPF distal tubing with a female luer connector on one end and a male rotator on the other.
The Balt Aspiration Tubing Set facilitates the supply of vacuum from a compatible aspiration pump to the distal tip of the Raptor Aspiration Catheter. Balt Aspiration Tubing Set is provided sterile, non-pyrogenic and it is intended for single use only.
The provided FDA 510(k) clearance letter pertains to the Raptor Aspiration Catheter and Balt Aspiration Tubing Set, medical devices used for revascularization in acute ischemic stroke patients. The document describes various performance tests conducted to demonstrate substantial equivalence to predicate devices.
However, it's crucial to note that this document does not describe the acceptance criteria and study for a software/AI device. The tests listed are for the physical catheter and tubing set. There is no mention of an algorithm, AI, or any software component that would require the specific information requested in the prompt (e.g., test set, ground truth, expert adjudication, MRMC study, standalone performance).
Therefore, I cannot provide information for points 1 through 9 of your request, as they are not applicable to the content of this FDA clearance letter. The device described is a physical medical instrument, not an AI/software-based diagnostic or assistive tool.
Key takeaway: The provided text is for a physical medical device (catheter and tubing) and does not involve AI or software-based performance. Therefore, the specific criteria requested for AI/software devices (like sample size, ground truth, expert adjudication, MRMC studies) are not present in this document.
§ 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).