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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 thrombolytic drug therapy or who failed thrombolytic drug 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 thrombolytic drug therapy or who failed thrombolytic drug 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 3D Revascularization Device
• Penumbra Aspiration Pump
• . Penumbra Aspiration Pump Canister/Tubing
• Penumbra Aspiration Tubing
• Penumbra Separator .

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The Reperfusion Catheter delivers aspiration from the pump directly to the site of occlusion to remove the clot. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. Alternatively, a Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. 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 Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. The Penumbra Reperfusion Catheter is connected to the Penumbra Aspiration Pump using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel, rotating hemostasis valve (RHV), peelable sheath, and optionally, SENDit Technology (cleared under K191946). The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

The provided text describes specific acceptance criteria and performance data for the Penumbra System (Reperfusion Catheter RED 72). However, it notes that no animal or clinical studies were conducted for this particular device submission (K242104). The evidence for meeting acceptance criteria comes solely from bench and biocompatibility testing. Therefore, information regarding sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, which are typically associated with clinical or AI/algorithm performance studies, are not applicable or available in this document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The document states that "No animal or clinical study was conducted as bench and biocompatibility testing were determined sufficient for verification and validation purposes." The tests listed are primarily bench (in-vitro) tests on manufactured units or material samples. The specific number of units or samples tested for each bench test is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these engineering and biocompatibility tests is based on established scientific principles, industry standards, and specified material properties, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set: Not applicable. Adjudication methods are typically employed in clinical studies or studies involving human assessment of data, which were not performed in this case.

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 MRMC study was performed as this device is a physical medical device (catheter system) and not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
* Bench Testing: Engineering specifications, material properties, and functionality performance standards.
* Biocompatibility Testing: Established biological safety standards (ISO 10993 series, USP standards, 21 CFR Part 58 GLP).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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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.

This document describes the acceptance criteria and study proving the performance of the Penumbra System® (Reperfusion Catheter RED™ 72). It is a 510(k) summary, indicating that the device is being cleared based on substantial equivalence to a legally marketed predicate device, rather than requiring a full premarket approval (PMA) with extensive clinical trials.

It's important to note that because this is a 510(k) submission based on substantial equivalence to an existing device (the Penumbra System (Reperfusion Catheter JET 7)), the studies primarily focus on engineering and biocompatibility performance data against established requirements, rather than clinical efficacy studies often seen with novel AI devices. There are no AI/ML components described in this document, thus the requested information regarding MRMC studies, standalone AI performance, human expert ground truth for imaging, and training/test set sample sizes for AI models are not applicable.

Here's the breakdown of the acceptance criteria and study details provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a series of design verification tests and biocompatibility tests. The acceptance criteria for each test are stated, and the conclusion is consistently that the "Acceptance Criteria Met" or "Pass."

Design Verification Testing:

Biocompatibility Testing (Based on predicate/reference devices):

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

The document does not specify the exact sample sizes (number of units) used for each design verification bench test, as is typical for 510(k) summaries of mechanical devices. However, it indicates that units were tested. The data provenance would be from internal testing conducted by Penumbra, Inc. (the manufacturer). This is a retrospective evaluation of the device's physical and functional properties. There is no indication of country of origin for specific test data beyond the manufacturer being in Alameda, California, USA.

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

Not applicable. This submission is for a mechanical medical device (catheter system), not an AI/ML device that requires human expert annotation for ground truth in image analysis. The "ground truth" for this device's performance is established by objective physical and chemical testing against engineering specifications and international standards (e.g., ISO, USP).

4. Adjudication Method for the Test Set

Not applicable. As there are no human expert readings or interpretations involved in the performance data presented (it's benchmark and material testing), there is no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a mechanical catheter system for stroke intervention, not an AI/ML diagnostic tool. Therefore, no such study was performed or required.

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

No. This refers to the standalone performance of an AI algorithm. Since this is a mechanical device, this concept is not applicable. The standalone "performance" refers to the device meeting its physical and functional specifications during bench testing.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance evaluation comes from engineering specifications, international standards (e.g., ISO 10993 series), and validated test methods. This includes:

• Pre-defined dimensional and visual product specifications.
• Measured physical properties (friction, tensile strength, pressure, elongation, torque, burst pressure).
• Chemical and biological properties (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) determined through laboratory assays adhering to GLP (Good Laboratory Practices) and ISO standards.
• Functionality in simulated clinical use benchtop models.

8. The Sample Size for the Training Set

Not applicable. This refers to a training set for an AI model. This device is a mechanical medical device, not an AI/ML product.

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

Not applicable. As there is no AI training set, there is no ground truth establishment for it. The "ground truth" for the device's design and manufacturing is based on established engineering principles, materials science, and medical device regulations.

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