(28 days)
The APRO 55 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended 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.
The Alembic Aspiration Tubing is intended to connect the APRO 55 Swift Catheter to the aspiration pump.
The APRO 55 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove thrombus from the vasculature using aspiration. It targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature, guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation, and a radiopaque marker is at the distal end for fluoroscopic visualization. It is used with an aspiration pump connected via the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The catheter is available in lengths of 125 cm and 137 cm and is supplied with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 55 Swift Catheter to the aspiration pump and features a flow control valve with an ON/OFF switch. It is available in a single size.
This FDA 510(k) clearance letter details a device called the "APRO 55 Swift Catheter and Alembic Aspiration Tubing." However, this document does not describe a study that uses a test set, ground truth established by experts, or any of the elements typically found in a study demonstrating AI/ML device performance.
Instead, the submission for the APRO 55 Swift Catheter and Alembic Aspiration Tubing focuses on demonstrating substantial equivalence to a predicate device (K232971 APRO 55 Catheter and Alembic Aspiration Tubing) based on non-clinical performance data and a comparison of technological characteristics.
The core of this 510(k) is that the only difference between the subject device (APRO 55 Swift Catheter) and its predicate (APRO 55 Catheter) is the packaging configuration. The "Swift" designation appears to indicate a change in how the catheter is packaged (coiled in a dispenser tube) rather than a fundamental change in the device itself or its functionality.
Therefore, the requested information about acceptance criteria, test set, ground truth, expert consensus, MRMC studies, or standalone algorithm performance for this specific device cannot be extracted from the provided text because such studies were not conducted or deemed necessary for this particular submission.
The document explicitly states:
- "Performance bench testing was not conducted as sterility and shelf-life testing was sufficient for verification and validation of the change in packaging configuration."
- "An animal study was deemed not necessary to support the substantial equivalence of the subject device."
- "Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary."
In summary, the provided document does not contain the information required to answer your prompt, as it relates to a physical medical device (catheter) whose clearance was based on demonstrating equivalence through non-clinical bench testing for packaging changes, not on the performance of a diagnostic AI/ML algorithm.
§ 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).