(55 days)
Millipede 070 Aspiration Catheter
The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, 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 thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
Perfuze Aspiration Tube Set
The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).
The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.
The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.
For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
This document is a 510(k) summary for the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set. It states that the subject device is substantially equivalent to a previously cleared predicate device (K242504), also from Perfuze Ltd.
The key takeaway is that no new acceptance criteria, new studies, or performance data were generated or provided for this 510(k) submission (K250012) to prove the device meets acceptance criteria.
The reasoning presented in the document is that the subject device has identical indications for use, operating principle, and design to the predicate device. The only noted difference for the subject device (K250012) compared to the predicate device (K242504) is a different sterilization cycle for the Perfuze Aspiration Tube Set.
Therefore, the document argues that:
- Non-clinical bench testing was not required because "There are no changes to technological characteristics."
- Biocompatibility testing was not required because "The materials, formulation, and suppliers... are identical in the subject and predicate devices."
- Sterilization validation was performed only for the new sterilization cycle of the Perfuze Aspiration Tube Set to ensure it meets ISO 11135 standards, not to establish new performance criteria for the device itself.
- Shelf life and packaging testing was done to ensure the integrity of the sterile barrier with the new sterilization cycle, not to prove new performance.
- No animal or clinical studies were deemed necessary because of the substantial equivalence to the predicate device.
In summary, the document asserts substantial equivalence based on the device being functionally identical to an already cleared device, with only a change in a manufacturing process (sterilization of one component) that was validated to ensure it does not negatively impact existing performance.
Therefore, I cannot provide the requested information about acceptance criteria or specific study results for this 510(k) submission (K250012) because the document explicitly states that such studies were not performed for this submission due to perceived substantial equivalence.
The information requested, such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, and ground truth establishment, would have been part of the original K242504 submission that established the predicate device's safety and effectiveness. This current 510(k) (K250012) relies on the previous clearance rather than generating new 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).