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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.

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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:

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.

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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.

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 that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

The document you provided is a 510(k) premarket notification for a medical device (Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical study data often seen for novel devices that might require a PMA (Premarket Approval) or de novo classification.

Therefore, the information typically requested in your prompt (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, training set size for AI, etc.) is not present in this document because it is not a study assessing the performance of an AI/ML-driven device or an imaging diagnostic tool. Instead, this is a clearance for a physical medical catheter and tubing set.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biological performance testing, not AI/ML model validation.

Here's a breakdown based on the document, addressing what is present and explaining why other points are absent:

Device: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Regulatory Classification: Class II Percutaneous Catheter (Product Code: NRY)

Purpose of Submission: Demonstrate substantial equivalence to the SOFIA Plus Aspiration Catheter (K173200).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance tests and their conclusions, acting as the "acceptance criteria" and "reported device performance." Since this is not an AI/ML device, the criteria are physical and functional, rather than diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for kink resistance). However, for the animal study, it mentions "two comparative animal studies conducted under Good Laboratory Practices in a porcine model." The exact number of animals is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated for bench testing, but Perfuze Ltd. is based in Galway, Ireland, suggesting testing likely occurred there or at contracted labs.
  • Retrospective/Prospective: All described tests and the animal study are prospective design, as they were specifically conducted to support this premarket notification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable for this type of device. This device is a physical catheter and tube set, not a diagnostic AI/ML system. There is no "ground truth" to be established by human experts in the context of image interpretation or disease diagnosis. The "ground truth" here is the physical measurement, functional performance (e.g., flow rate), or biological response (e.g., non-cytotoxic).

4. Adjudication Method for the Test Set

• Not applicable. As there are no human expert readers establishing a diagnostic "ground truth," there is no need for an adjudication method. The test results are objective measurements or observations during laboratory testing.

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

• Not applicable. This is not an AI-assisted diagnostic device. Its function is direct mechanical aspiration. No MRMC study was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or software device. Its performance is evaluated through bench testing and animal studies as described.

7. The Type of Ground Truth Used:

• For Biocompatibility: Laboratory assays and histological/pathological evaluation (e.g., for pyrogenicity, cytotoxicity, systemic toxicity, sensitization, irritation, hemocompatibility in vitro/in vivo, and animal tissue analysis).
• For Performance Testing: Objective measurements (e.g., dimensions, flow rates, tensile strength), functional assessments (e.g., kink resistance, leakage), and simulated use observations against pre-defined engineering specifications.
• For Animal Study: Angiographic and histological evaluations of the porcine model.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. No training set for an AI/ML model is involved.

Summary regarding AI/ML related questions: The questions about experts, adjudication, MRMC studies, standalone algorithms, and training sets are relevant for submissions of Artificial Intelligence / Machine Learning (AI/ML) enabled diagnostic devices or software as a medical device (SaMD). The provided document is for a traditional, physical interventional device (catheter and tube set), and therefore, the testing described focuses on its physical, mechanical, and biological properties, as well as its functional similarity to predicate devices.

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