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Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) 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.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is intended for the removal of thrombus from the neuro vasculature using continuous aspiration. Intended users for this device are physicians who have received appropriate training in interventional neuroradiology and the treatment of acute ischemic stroke.

The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in or largerfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

The Penumbra Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Penumbra Reperfusion Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for PST1, 0.088 in [2.24mm] for PST2, and 0.110 in [2.79mm] for PST3 and PST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices. The Modified 110 Aspiration Tubing (PST4) is the subject device for this submission (K182522).

The provided text describes the acceptance criteria and the study for the Penumbra System (Modified 110 Aspiration Tubing), regulated under K182522.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state specific sample sizes for each test within the "Bench-top Testing" summary. However, it indicates that "All bench-top studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures." The data provenance is not specified, but the context implies it is generated internally by Penumbra, Inc. (Alameda, CA, USA) as part of their design verification process. The studies are non-clinical (bench-top and laboratory tests).

For Biocompatibility, the studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The studies described are non-clinical, involving laboratory and bench-top testing, and thus do not involve human expert interpretation for establishing ground truth in the way a medical imaging study might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. The studies described are non-clinical, involving objective measurements and established laboratory procedures, which do not typically involve human adjudication for ground truth.

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

A multi-reader, multi-case comparative effectiveness study was not done. The submission focuses on the modified aspiration tubing and its physical and mechanical properties, not on diagnostic performance or AI assistance.

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

A standalone performance study of an algorithm was not done. The device is a physical medical device (aspiration tubing), not a software or AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical studies:

• Biocompatibility: Ground truth was established by adherence to recognized standards (EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-10) and specific acceptance criteria determined by these standards and GLP.
• Bench-top Testing: Ground truth was based on pre-defined design specifications, risk analysis, and performance standards.
• Shelf Life & Sterilization: Ground truth was established by adherence to recognized standards (ASTM D4169, EN ISO 11135, EN ISO 10993-7, AAMI TIR 28, ANSI/AAMI ST72) and specific acceptance criteria.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set for a machine learning model, no ground truth needed to be established for it.

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