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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) 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 comprised of the following devices:

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

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature 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. [1.37 mm] 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 Aspiration Pump Canister. 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 System (Reperfusion Catheter RED 43) is a medical device used for the revascularization of patients with acute ischemic stroke. The device's acceptance criteria and performance were evaluated through a series of design verification tests, as detailed in the FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the design verification. It only indicates that "the subject device met all established requirements."
The data provenance is from benchtop testing, which is a prospective method of evaluation performed in a controlled laboratory setting. There is no mention of country of origin for the data as it's not a clinical study.

3. Number of Experts and their Qualifications for Ground Truth:
This information is not provided in the document as the device's performance was evaluated through benchtop testing, not through expert-reviewed clinical data. Therefore, the concept of "experts establishing ground truth" in the context of clinical outcomes or imaging interpretations does not apply here.

4. Adjudication Method for the Test Set:
The concept of an adjudication method (like 2+1, 3+1) is typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Since the testing involved design verification and benchtop methods, such an adjudication method was not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers' improvement with AI assistance.

6. Standalone Performance:
The performance described is essentially standalone (algorithm only without human-in-the-loop performance), as it pertains to the physical and functional characteristics of the device itself as evaluated through bench testing. There is no "human-in-the-loop" component in the described verification tests.

7. Type of Ground Truth Used:
The ground truth used was based on ** predefined product specifications and established test methods** (e.g., ISO standards, internal design requirements) for each performance criterion. This is a form of technical and engineering ground truth rather than clinical, pathological, or outcomes data.

8. Sample Size for the Training Set:
A "training set" is typically associated with machine learning or AI models. Since this submission focuses on the physical device's performance through bench testing and explicitly states no animal or clinical studies were conducted, there is no mention or relevance of a training set in this context.

9. How the Ground Truth for the Training Set Was Established:
As there was no training set for an AI model, the concept of establishing ground truth for a training set is not applicable to this submission.

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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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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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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.

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.

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the 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 is a 510(k) Summary for the Penumbra System (Reperfusion Catheter RED 62). It asserts substantial equivalence to predicate devices based on bench testing. The information provided is characteristic of a Class II medical device submission, which generally focuses on non-clinical performance data unless clinical data is deemed necessary to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (catheter) and not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device performance, such as ground truth establishment with experts, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

Here's an analysis of the provided document regarding acceptance criteria and study proof:

1. A table of acceptance criteria and the reported device performance:

The document provides a table of "Design Verification Tests" and their conclusions. The "Acceptance Criteria" themselves are not explicitly detailed in numerical or categorical form within this table, but the "Conclusion" column consistently states "Acceptance Criteria Met," implying that internal, predefined criteria were satisfied.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify the exact sample size (number of units tested) for each of the design verification and biocompatibility tests. It broadly states "the units" were tested. This is common for bench testing summaries where detailed test reports would contain specific sample sizes.
• Data Provenance: The data is from "Design Verification Testing" and "Biocompatibility" studies, which are typically performed in a laboratory setting by the manufacturer (Penumbra, Inc., Alameda, CA, USA). The studies are retrospective from the perspective of this 510(k) submission, meaning they were completed prior to the submission. The document does not specify the country of origin of where the testing itself was performed, but it references ISO standards and FDA GLP, implying internationally recognized practices. This is not clinical data from patients.

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 question is Not Applicable to this submission. This is a submission for a physical medical device (catheter) based on bench testing (performance and biocompatibility), not an AI/ML device that requires human expert review for establishing ground truth on image or patient data.

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

This question is Not Applicable. As stated above, this is bench testing of a physical device. There is no "ground truth" to be adjudicated by multiple readers or experts in the context of diagnostic agreement. The "acceptance criteria met" indicates that the device met pre-defined engineering and safety specifications.

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:

This question is Not Applicable. This is not an AI/ML device, and no MRMC study was conducted or required. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

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

This question is Not Applicable. This is a physical medical device, not an algorithm.

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

This question is Not Applicable for the type of device and studies presented. The "ground truth" for this device is its adherence to engineering specifications, material properties, and biological safety standards, verified through objective bench tests (e.g., measurements for dimensions, leak tests, tensile strength tests, chemical analysis for biocompatibility). There is no "expert consensus" on imaging or clinical outcomes data required to validate the device's fundamental performance.

8. The sample size for the training set:

This question is Not Applicable. This is not an AI/ML device, so there is no training set mentioned or used.

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

This question is Not Applicable. As there is no training set (being a physical medical device and not an AI/ML device), no ground truth was established for it.

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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.

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.

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

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

The Penumbra System Reperfusion Catheter Penumbra JET 7 with Xtra Flex technology (JET 7 Xtra Flex) is a component to the currently available Penumbra System. The JET 7 Xtra Flex delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The Penumbra System Penumbra JET 7MAX is an additional configuration to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the JET 7 Xtra Flex and is removed prior to aspiration.

This FDA 510(k) summary does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The document explicitly states:

• "There are no differences in technological characteristics between the subject device and predicate device." (Section 1.6)
• "There are no differences in technological characteristics between the subject and predicate devices and therefore no verification and validation studies were required." (Section 1.7)

This means the submission is based on the substantial equivalence principle, asserting that the new device (Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)) is largely identical to previously cleared predicate devices, and therefore does not require new performance data to demonstrate safety and effectiveness. The changes made were solely labeling changes for clarity.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting new performance data against acceptance criteria.

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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 JET 7 with MAX Delivery Device, known as Penumbra JET 7MAX, is an additional configuration being added to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the Penumbra JET 7 Reperfusion Catheter and is removed prior to aspiration. The Reperfusion Catheter Penumbra JET 7 delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.

The provided text describes the 510(k) submission for the Penumbra System® JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX). The submission primarily relies on non-clinical data (biocompatibility and bench-top testing) and reference to previous animal testing of a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document clearly outlines acceptance criteria and results for Biocompatibility Testing and Design Verification (Bench-Top Testing).

Biocompatibility Testing (for MAX Delivery Device only, as Reperfusion Catheter was previously tested):

Design Verification - Bench-Top Testing:

2. Sample size used for the test set and the data provenance

• Test set sample size: Not explicitly stated for each test, but implied to be sufficient for the "Pass" results, particularly for biocompatibility (e.g., "no single animal," "2 or more animals" in acceptance criteria implies a small animal sample). For bench testing, it refers to "the units used in this Design Verification testing." No human subjects were involved in the testing for this specific submission.
• Data Provenance: The data is non-clinical (biocompatibility and bench testing), conducted by the manufacturer, Penumbra, Inc. The biocompatibility studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The animal testing for the predicate device (Penumbra JET 7) was performed using a "porcine model" (K173761). The document does not specify the country of origin for the data other than the manufacturer being based in Alameda, California, USA. The studies are prospective in the sense of being planned tests to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on objective physical and chemical testing (biocompatibility, bench testing) and animal study results rather than expert interpretation of patient data to establish ground truth for the device's performance. The ground truth for these tests is based on pre-defined scientific and engineering specifications and established biological responses.

4. Adjudication method for the test set

Not applicable. As the testing involves objective measurement of physical and biological properties against set specifications, expert adjudication (like in clinical trial image reading) is not required.

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 device is a mechanical medical device (catheter system), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance for human readers are not relevant.

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

Not applicable. This is not an AI/algorithm-based device. Its performance is evaluated through physical, mechanical, and biological testing.

7. The type of ground truth used

The ground truth for this submission is based on:

• Pre-defined quantitative specifications: For bench-top testing (e.g., minimum bond strength, maximum friction force, particulate counts, dimensional measurements).
• Biological response criteria: For biocompatibility testing, based on ISO standards (e.g., cytotoxicity grade, irritation difference, systemic toxicity signs, pyrogenicity temperature rise, hemolytic index, statistical similarity to predicate for clotting times and complement activation).
• Physiological/anatomical models: For simulated use in bench testing and animal models for previous evaluations of the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device approval based on non-clinical performance data and substantial equivalence to a predicate, not an AI/ML model trained on a dataset.

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

Not applicable, as there is no training set for an AI/ML model in this submission.

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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 Reperfusion Catheter JET 7 (modified) is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 (modified) delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.

The provided document is a 510(k) Premarket Notification for the Penumbra System® (Reperfusion Catheter JETTM 7). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in a clinical or comparative effectiveness setting (especially for AI where human-in-the-loop performance is assessed) cannot be fully provided based on the given text.

The document does include acceptance criteria for biocompatibility testing and bench-top testing and reports whether the device passed these criteria. However, these are engineering and materials performance criteria, not clinical performance criteria with a test set of patient data, ground truth established by experts, or MRMC studies typically seen for AI-based diagnostic devices.

Here's what can be extracted and what cannot:

Information that CAN be extracted and presented:

• Table of acceptance criteria and reported device performance (for non-clinical tests): This is available for biocompatibility and bench-top testing.
• Sample size for non-clinical testing: This is generally implied by "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)" for biocompatibility and for bench tests by "These evaluations confirm that the units used in this Design Verification testing meet all product specifications." but specific numbers are not given for each test.
• Data provenance for non-clinical testing: Performed internally by Penumbra, Inc. labs or contracted labs following GLP.
• Ground truth type for non-clinical testing: Based on established industry standards and regulatory guidelines (e.g., EN ISO 10993-1, specific assay results, physical measurements).

Information that CANNOT be extracted from the provided text:

• Sample sized used for the test set (clinical data): No specific clinical test set data is provided. The document states "No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes."
• Data provenance (e.g., country of origin of the data, retrospective or prospective) for clinical data: Not applicable, as no new clinical study was conducted.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical study was conducted involving expert ground truth for patient data. Physician evaluation was done for bench testing, but details on the number and qualifications of physicians are not given, nor is it a blind adjudication process.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, but a physical medical device (catheter).
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical data: Not applicable.
• The sample size for the training set (for AI): Not applicable.
• How the ground truth for the training set was established (for AI): Not applicable.

Acceptance Criteria and Device Performance (Non-Clinical Data from provided text):

The device is a medical catheter, and the performance criteria discussed are related to its physical properties, material safety, and mechanical function, not an AI's diagnostic performance.

1. Table of acceptance criteria and the reported device performance (for Biocompatibility and Bench-Top Testing):

Biocompatibility Test Results

Design Verification - Bench Top Testing

2. Sample sized used for the test set and the data provenance:

• Biocompatibility: "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." Specific sample sizes for each test are not detailed but are implied by GLP standards. Data provenance is implied to be laboratory testing within the US (due to FDA submission) or by a GLP-compliant lab.
• Bench-Top Testing: No specific sample sizes mentioned for each attribute, but the results indicate performance of "the units used in this Design Verification testing." Data provenance is laboratory testing.
• Clinical/AI study: No clinical study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Biocompatibility/Bench-Top Testing: For "Physician Evaluation" in bench testing, "Multiple Physician performance evaluation" was conducted. The specific number or qualifications are not provided beyond "Physician." This is not establishing "ground truth" in the sense of clinical disease states.
• Clinical/AI study: Not applicable.

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

• Not applicable as no clinical test set for diagnosis/AI performance was used.

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 is not an AI-assisted diagnostic device.

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

• Not applicable. This is a physical medical device.

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

• Biocompatibility: Ground truth is based on established, quantitative laboratory standards and biological responses as defined by ISO and USP guidelines.
• Bench-Top Testing: Ground truth is based on engineering specifications, physical measurements, and functional performance in simulated environments.
• Clinical/AI study: Not applicable.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

In summary, the provided document details the non-clinical (biocompatibility and bench) testing and acceptance criteria for a physical medical device (catheter) to demonstrate substantial equivalence, rather than a clinical study for an AI-based diagnostic device.

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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 3D Revascularization Device is designed to revascularize patients experiencing acute ischemic stroke as a component of the Penumbra System. The Penumbra System's fundamental mechanism of action is aspiration removes clot by drawing it into the Penumbra Reperfusion Catheter. The 3D Revascularization Device is designed to assist the Reperfusion Catheter with thrombus removal if needed. Intended users for this device are physicians who have received appropriate training in interventional neuro-endovascular techniques and treatment of acute ischemic stroke. The device is provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the Penumbra System (3D Revascularization Device) and its substantial equivalence to a predicate device (Penumbra 3D Revascularization Device, K162901). The submission relies on non-clinical data for verification and validation, explicitly stating that "No clinical study was conducted."

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the 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 specify a distinct "test set" sample size in the clinical sense, as no clinical study was conducted for this specific submission. The evaluations were primarily bench-top testing and previously completed animal studies. The document does not specify sample sizes for individual bench tests beyond stating "units used in this Design Verification testing." The provenance of the data for bench testing is not explicitly stated beyond being conducted by Penumbra, Inc.

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)

For the "Physician Evaluation" in bench-top testing, the document mentions "Multiple Physician performance evaluation." However, it does not specify the exact number of physicians or their specific qualifications (e.g., years of experience, specialty).

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

The document does not describe an adjudication method for the physician evaluations; it merely states that the evaluations were part of the 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

No MRMC study was performed, as stated: "No clinical study was conducted." The device does not appear to be an AI-assisted diagnostic tool, but rather a mechanical revascularization device.

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

This question is not applicable to the device described. The Penumbra System (3D Revascularization Device) is a physical medical device for revascularization, not a standalone algorithm.

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

For the bench-top testing, the "ground truth" was established by predetermined acceptance criteria and product specifications for physical and mechanical properties. For the simulated use and physician evaluations, the ground truth was based on the effectiveness of the devices to remove clots in anatomical models and physician perception of deliverability and clot removal compared to a baseline.

For the animal study portion, the ground truth for vessel response was derived from existing GLP test results from rabbit vessel response studies on the predicate device.

8. The sample size for the training set

No "training set" in the context of an algorithm or AI is mentioned in the document, as no clinical study was conducted for this submission, and the device is a mechanical one. The previous animal studies used for the predicate device were not described as a "training set" in this context.

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

Not applicable, as no training set (in the AI/algorithm sense) was used or described. The document relies on equivalence to a predicate device and extensive non-clinical bench testing and prior animal studies.

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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

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