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The Penumbra System / Penumbra System MAX are 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.

The Penumbra System 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. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

The subject Penumbra System 110 Aspiration Tubing Assembly connects the Pump Canister to the Reperfusion Catheters, providing a means for introducing vacuum during procedures, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458]. Furthermore, the 110 Aspiration Tubing has a flow valve that allows the physician to start and stop the flow of aspiration, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458]. The Penumbra System 110 Aspiration Tubing has a slightly larger inner diameter of 0.110in compared to the predicate to accommodate larger clot burdens, this is the only difference to the predicate MAX Aspiration Tubing [K133317 and K142458]. The Penumbra System 110 Aspiration Tubing is compatible with all Penumbra System Reperfusion Catheters and Separators included in K133317 and K142458. The device is provided sterile, non-pyrogenic, and intended for single use only, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458].

This document is a 510(k) premarket notification for the Penumbra System 110 Aspiration Tubing, a medical device used for revascularization in acute ischemic stroke patients. The provided text describes the acceptance criteria and study results for this device, which focuses on non-clinical testing for biocompatibility and bench-top performance.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state the sample size (number of units) for each specific test in the "Bench-top Testing" section. It notes "units used in this Design Verification testing," implying multiple units were tested, but the exact count isn't given. For biocompatibility, it refers to "a series of previously successfully performed studies on the predicate device," which doesn't specify the sample size for the current device's testing.
• Data Provenance: The document does not specify the country of origin for the data. The biocompatibility tests were "conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)," which suggests a controlled experimental setting, likely within the US given the FDA submission. The studies were retrospective in the sense that the biocompatibility data was "derived from a series of previously successfully performed studies on the predicate device." The bench-top testing appears to be newly performed for the subject device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This is a submission for a physical medical device (aspiration tubing), not an AI algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" for the performance tests would be the measured physical and mechanical properties of the device against predefined engineering specifications.

4. Adjudication Method for the Test Set:

Not applicable. As this involves physical device testing against specifications, there is no need for expert adjudication in the manner of diagnostic AI performance evaluation. The results are objective measurements against set criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is a submission for a physical medical device. MRMC studies are relevant for evaluating the performance of diagnostic imaging aids or AI tools where human readers interpret cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

For biocompatibility, the ground truth was established by internationally recognized standards (EN ISO 10993-1, 10993-5, 10993-10) and their specific acceptance criteria for cytotoxicity, sensitization, and irritation.

For bench-top testing, the ground truth was established by documented engineering specifications and direct physical measurements (e.g., specific force in lbf, vacuum pressure, visual inspection for defects).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI algorithm.

In summary, this document details the non-clinical testing for the Penumbra System 110 Aspiration Tubing. The device demonstrated substantial equivalence to predicate devices through successful completion of biocompatibility and bench-top performance tests, meeting all specified acceptance criteria. The evaluation did not involve AI, human readers, or expert ground truth in the context of diagnostic performance.

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