(29 days)
Millipede 088 Access Catheter: The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA 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.
Millipede 088 Access Catheter: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access 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 valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set: The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a 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 that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
This document describes the K242504 submission for the Perfuze Ltd. Millipede 088 Access Catheter, Millipede 070 Aspiration Catheter, and Perfuze Aspiration Tube Set. This is a 510(k) premarket notification for devices that are substantially equivalent to previously cleared predicate devices. The devices are catheters used in neurovascular procedures.
This submission focuses on a change in color additives used in the proximal shaft of the catheters and does not involve any AI/ML components. Therefore, many of the requested categories related to AI/ML performance, such as human reader improvement with AI assistance, standalone algorithm performance, training/test set sizes, expert qualifications, and ground truth establishment for AI/ML, are not applicable in this context.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test/Attribute | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO MEM Elution) | Non-cytotoxic |
| Sensitization (ISO Guinea Pig Maximization) | No sensitization response | |
| Irritation (ISO Intracutaneous Reactivity) | Met requirements | |
| Acute Systemic Toxicity (ISO Acute Systemic Injection) | Met requirements | |
| Material-Mediated Pyrogenicity | Non-pyrogenic | |
| Hemocompatibility – Complement Activation (SC5b-9) | Not a potential activator of the complement system | |
| Hemocompatibility – Partial Thromboplastin Time | Not an activator of the intrinsic coagulation pathway | |
| Hemocompatibility – ASTM Direct and Indirect (extract-based) Hemolysis | Non-hemolytic in both direct and indirect tests | |
| Hemocompatibility – Platelet and Leukocyte Count | No effect on platelet and leukocyte concentrations | |
| Performance Testing | Visual Inspection | Met established specifications (conformance to specifications) |
| Tensile Strength | Met established specifications (bonds between sections) | |
| Air Leakage | Device integrity suitable for intended use (pressurized to 300kPa) | |
| Sterilization | Sterility Assurance Level (SAL) | Validated EO process with SAL of 1x10-6 |
| Shelf Life & Packaging | Shelf Life & Packaging Configuration | Identical to predicate devices (no new testing required) |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML test set. The testing performed was for device biocompatibility and mechanical performance, not for an AI/ML algorithm. The specific number of devices tested for each biocompatibility and performance test is not detailed in this summary. The data provenance would be from laboratory testing conducted according to ISO and ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on the safety and effectiveness of a physical medical device (catheter) with a material change, not an AI/ML algorithm requiring expert-established ground truth. Expert involvement would be in the design, execution, and interpretation of the physical and chemical tests, typically by qualified laboratory personnel and engineers, rather than clinical experts establishing "ground truth" for a diagnostic reading.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human interpretation or AI/ML output requiring consensus, not for the direct physical and biological testing of a catheter.
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. This was not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This was not an AI/ML device. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. For this submission, the "ground truth" for the device's properties are established by rigorous testing against pre-defined engineering specifications and biocompatibility standards (e.g., ISO 10993-1). For example, the "ground truth" for tensile strength is whether test samples break below a specified force, and for cytotoxicity, it's whether cell viability meets a threshold.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device.
§ 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).