(29 days)
Millipede70 Aspiration Catheter
The Millipede70 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 Millipede70 Aspiration Catheter to a compatible aspiration pump.
The Millipede70 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 Millipede70 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 connector connects to the hub of a Millipede70 Aspiration Catheter. The suction connector 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 Millipede70 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.
The provided FDA 510(k) clearance letter and summary for the Perfuze Ltd. Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set do not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers with and without AI assistance.
This submission focuses on demonstrating substantial equivalence of a physical medical device (catheter and aspiration tube set) to a previously cleared predicate device. The primary change is a minor modification to the outer diameter of the distal end of the catheter.
Therefore, many of the requested criteria regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models are not applicable to this specific 510(k) submission.
However, I can still extract information about the acceptance criteria and the study that proves the physical device meets these criteria based on the provided document.
Acceptance Criteria and Device Performance for the Physical Device
The acceptance criteria for this physical device are primarily demonstrated through performance testing (bench testing), confirming its mechanical properties and functionality meet defined specifications and are comparable to the predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test Method (Acceptance Criteria) | Reported Device Performance (Conclusion) |
|---|---|
| Dimensional Verification: Conformance to specifications (specifically the outer diameter of the distal end) | The device met established specifications. (Outer diameter increased from 0.0835" to 0.0837"). |
| Simulated Use Testing: Deliverability and compatibility with accessory devices in a neurovascular model | The device performs as intended under simulated use conditions. |
| Visual Inspection: Device surface characteristics assessed after simulated use testing for freedom from defects | The device surface characteristics are suitable for its intended use. |
| Hydrophilic Coating Integrity: Evaluated after multiple insertion and withdrawal cycles | The hydrophilic coating integrity is suitable for its intended use. |
| Kink Resistance: Specimen segments formed into a defined bend diameter to evaluate kink resistance | The device met established specifications. |
| Tip Stiffness: Bending stiffness of the tip measured to confirm conformance to specification | The device met established specifications. |
| Torque Strength: Test specimens rotated with distal end constrained to evaluate integrity post-rotation | The device met established specifications. |
| Biocompatibility: Materials, formulation, and suppliers identical to predicate. | No biocompatibility testing required. |
| Sterilization: EO process with 1x10-6 sterility assurance level, identical to predicate. | No new sterilization testing required; method is identical and validated. |
| Shelf Life and Packaging: Identical to predicate. | No shelf-life testing or packaging validation required. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes (N-values) for each bench test (e.g., how many catheters were subjected to kink resistance or torque strength testing). It broadly states "test specimen segments" or "test specimens."
- Data Provenance: The studies are bench (laboratory) tests conducted by the manufacturer, Perfuze Ltd., in Ireland. They are inherently prospective in the sense that they are designed and executed specifically for this regulatory submission. Country of origin of the data would be Ireland (where Perfuze Ltd. is based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML device where expert consensus would establish ground truth for image interpretation or diagnosis. The "ground truth" for this physical device's performance is established by engineering specifications and physical measurements, and its functionality evaluated against predefined criteria in simulated environments.
4. Adjudication method for the test set:
- Not Applicable. As this is not a study involving human-in-the-loop assessment or expert review of clinical cases. Bench testing results are typically evaluated against pre-defined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this is a physical medical device (catheter) and not an AI/ML diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not a standalone algorithm.
7. The type of ground truth used:
- For the physical device, the "ground truth" is defined by engineering specifications, performance standards, and functional demonstration in controlled laboratory environments (e.g., neurovascular models). The goal is to demonstrate that the device performs according to its design, is safe, and is substantially equivalent to a previously cleared device.
8. The sample size for the training set:
- Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set. The device's design and manufacturing are based on established engineering principles and material science, verified through the bench testing described.
Summary of the Device and Study:
The Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set are physical devices indicated for the revascularization of patients with acute ischemic stroke. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (Millipede 070 Aspiration Catheter; K250012) due to a minor change in the distal outer diameter (from 0.0835" to 0.0837").
The study to prove the device meets acceptance criteria was non-clinical bench (laboratory) testing. This testing confirmed that the slightly modified device still met all relevant engineering specifications for dimensions, simulated use performance, coating integrity, kink resistance, tip stiffness, and torque strength. No new biocompatibility, sterilization, shelf-life, animal, or clinical studies were deemed necessary because the materials, fundamental design, indications for use, and operating principle remained the same as the predicate device. The change was determined not to raise different questions of safety or effectiveness.
§ 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).