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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 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 comprised of the following devices:

• . Penumbra Reperfusion Catheter
• Penumbra Aspiration Pump .
• Penumbra Aspiration Pump/Canister Tubing .
• Penumbra Aspiration Tubing ●
• . Penumbra Separator
• Penumbra 3D Revascularization Device .

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 ID of 0.054 in. or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Penumbra System (RED 68 Reperfusion Catheter):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Design Verification Testing: The document does not specify a quantitative sample size for each individual design verification test. It states "the units" were tested.
• Biocompatibility Testing: The sample sizes for animal tests (e.g., systemic toxicity, irritation, sensitization) are not explicitly stated in this document but are implied to be sufficient for GLP compliance.
• Data Provenance: Not explicitly stated for each test, but the tests were performed by Penumbra, Inc. as part of their 510(k) submission. For biocompatibility, it states "previous biocompatibility testing on the predicate and reference devices applies to the subject device" and "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." This suggests a mix of historical data from predicate/reference devices and possibly new testing. The country of origin is not mentioned, but is likely the USA, given the FDA submission. All data appears to be retrospective in the sense that the studies were already completed for the submission.

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

There is no mention of "experts" being used to establish ground truth in the context of the design verification or biocompatibility testing described. These tests rely on predefined engineering specifications, standardized test methods (e.g., ISO standards), and laboratory procedures, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, measurable physical and biological tests against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance?

Not applicable. This device is a medical catheter and does not involve AI or human readers for diagnostic interpretation. The studies are for physical and biological performance of the device itself.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Design Verification Tests: The "ground truth" for these tests is based on engineering specifications and performance requirements defined for the device. For example, a catheter must not kink at a certain radius, or it must withstand a certain pressure.
• Biocompatibility Tests: The "ground truth" is based on established biological safety standards and criteria (e.g., ISO 10993 guidelines, USP requirements). These standards define what constitutes non-cytotoxic, non-sensitizing, non-irritating, etc.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. There is no training set mentioned or implied.

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