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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 designed to remove thrombus from large intracranial vessels by aspirating the proximal side of the thrombus using the Penumbra Reperfusion Catheter, Penumbra Separator, 3D Revascularization Device, Penumbra Aspiration Tubing, and Penumbra Aspiration Pump. The Penumbra System was most recently cleared under K162901.

The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the Aspiration Pump directly to the thrombus. The 3D Revascularization Device is used with the 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 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 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Separator is advanced and retracted through the 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 Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

The Penumbra Engine Pump and Canister

The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Penumbra System. The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stopflow filter to prevent excess fluid from entering the patient port on the lid is sized to accept the Suction Connector on the Penumbra Aspiration Tubing.

The Penumbra System is designed to remove thrombus from large intracranial vessels. The provided text outlines the acceptance criteria and the study conducted for the Penumbra Engine Pump and Canister, which are components of the Penumbra System.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The sample size for most tests for the Penumbra Engine Pump and Canister was N=5. The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated in the provided text. However, the testing was conducted by Intertek, a nationally recognized test laboratory, suggesting the testing likely adheres to international standards. The studies appear to be prospective bench-top and simulated use tests rather than clinical studies with patient data.

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

This information is not applicable as the evaluation focuses on the engineering and performance specifications of the device components (Penumbra Engine Pump and Canister) through bench-top and simulated use testing, not on clinical performance requiring expert interpretation of diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved objective engineering and performance tests with predefined acceptance criteria. There was no need for expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not done. The provided text focuses on the device's engineering performance rather than its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study was done for the Penumbra Engine Pump and Canister, as all tests listed in the table above evaluate the device's intrinsic characteristics without human intervention influencing its core function during the test.

7. Type of Ground Truth Used:

The ground truth used was based on design specifications, risk analysis, performance standards, and guidance documents for the engineering and performance characteristics of the pump and canister. For electrical safety, the ground truth was compliance with IEC 60601-1 and IEC 60601-1-2 requirements.

8. Sample Size for the Training Set:

This information is not applicable as the described studies are for verification and validation of manufactured device components and do not involve machine learning algorithms that require a "training set."

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

This information is not applicable for the same reason as point 8.

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INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4

As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

INDIGO Aspiration Tubing

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

Penumbra Aspiration Pump

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

The Indigo System (CAT RX and Separator 4) is designed to remove thrombus from the coronary and peripheral vessels by aspirating the proximal side of the thrombus. The intended users for this device are physicians who have received appropriate training in interventional techniques. The Indigo System (CAT RX and Separator 4) was most recently cleared under K163618.

The Indigo System (CAT RX and Separator 4) is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO CAT RX Aspiration Catheter is a dual lumen rapid exchange catheter that targets aspiration from the Pump directly to the thrombus, removing it via the INDIGO Aspiration Tubing and depositing it in the Pump Canister. The INDIGO Separator 4 may be used, if needed, to clear the lumen of the INDIGO CAT RX Aspiration Catheter should it become blocked with thrombus. The INDIGO CAT RX Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO CAT RX Aspiration Catheter may be provided with a rotating hemostasis valve and a peelable sheath. The INDIGO Separator 4 is provided with an introducer and torque device. The INDIGO CAT RX Aspiration Catheter and INDIGO Separator 4 are visible under fluoroscopy.

The Penumbra Engine Pump and Canister

The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Indigo System (CAT RX and Separator 4). The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stop-flow filter to prevent excess fluid from entering the pump. The patient port on the lid is sized to accept the Suction Connector on the Indigo Aspiration Tubing.

The provided text describes the acceptance criteria and study for the Penumbra Engine Pump and Canister, not the entire Indigo Aspiration System (CAT RX and Separator 4) as a complete AI-assisted device. The document primarily focuses on demonstrating the substantial equivalence of the new pump and canister to a previously cleared predicate device. Therefore, information related to AI assistance, human reader improvement with AI, or complex ground truth establishment for diagnostic performance studies is not applicable or available in this context.

Here's an analysis of the provided information, focusing on the Penumbra Engine Pump and Canister:

1. Table of acceptance criteria and the reported device performance:

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

   • Sample Size: The sample sizes for the various tests were either N=1 or N=5, as indicated in the table above.
   • Data Provenance: The document does not explicitly state the country of origin. The studies were non-clinical bench-top and electrical safety/EMC testing, which are typically conducted in a controlled laboratory environment. The testing was performed by Intertek, a nationally recognized test laboratory. The nature of these tests (evaluating device components and performance, not patient data) means the retrospective or prospective classification of patient data is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the studies described are non-clinical engineering and performance tests for a medical device's electromechanical components (pump and canister), not a clinical study involving diagnostic interpretation or human experts establishing ground truth for patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where multiple readers evaluate cases and a consensus or tie-breaker mechanism is needed. The tests performed here are engineering verification tests with defined specifications and pass/fail criteria, not subjective interpretations requiring expert adjudication.

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, an MRMC comparative effectiveness study was not done. This document describes the clearance of an aspiration pump and canister, which are electromechanical components of a medical device system, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   No, a standalone algorithm-only performance study was not done. This device is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth for these non-clinical tests was based on pre-defined design specifications, risk analysis, performance standards (e.g., IEC 60601-1, IEC 60601-1-2, EN ISO 10079-1), and guidance documents. For example, electrical safety tests were assessed against the requirements of IEC 60601-1, and dimensional inspections were assessed against product specifications.

8. The sample size for the training set:
   This information is not applicable. This submission details the clearance of a medical device (pump and canister) based on engineering verification, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   This information is not applicable for the same reason as point 8. There is no training set for an AI model discussed in this document.

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INDIGO Aspiration Catheters and Separators

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.

INDIGO Aspiration Tubing

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

Penumbra Aspiration Pump

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

The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K161523.

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

The Penumbra Engine Pump and Canister

The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Indigo System. The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stop-flow filter to prevent excess fluid from entering the pump. The patient port on the lid is sized to accept the Suction Connector on the Indigo Aspiration Tubing.

The provided document describes the Indigo Aspiration System - Penumbra Engine Pump and Canister. It is a 510(k) premarket notification for a medical device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K161523 cleared on July 1, 2016, also called Indigo Aspiration System, and a reference device K122756 Penumbra Pump MAX).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table for the "Design Verification (Bench-top Testing and Electrical Safety/EMC Testing)" of the Penumbra Engine Pump and Canister.

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

The sample size for the test set is indicated in the "Sample Size" column of the table above:

• For "Pump - Electrical Safety": N=1
• For all other tests related to the Pump and Canister: N=5

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the tests are described as "Bench-top testing" and "Electrical safety and EMC testing," performed by "Intertek, a nationally recognized test laboratory." This implies laboratory-based testing rather than clinical data from human subjects.

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

This information is not provided in the document. The tests described are engineering and performance verification tests for a mechanical/electrical device, not diagnostic or interpretive tasks where human experts would establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective engineering performance measures, not subjective interpretations requiring adjudication. The "100% Pass" acceptance criteria suggest direct measurement against specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not done. This device is a pump and canister, which are components of an aspiration system, not a diagnostic imaging device or an AI algorithm intended to assist human readers. The clinical performance of the entire Indigo Aspiration System (catheters and separators) for removing emboli and thrombi is separate from the performance of the vacuum pump itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone study was done, but it refers to the standalone performance of the device (pump and canister) itself, not an algorithm. The tests listed in the table demonstrate the performance of the Penumbra Engine Pump and Canister without human intervention for the specific parameters being tested (e.g., electrical safety, dimensional inspection, performance specs, 500-hour use). This is a technical performance assessment, not an AI algorithm assessment.

7. Type of Ground Truth Used:

For the tests described, the "ground truth" is based on engineering specifications, performance standards (e.g., IEC 60601-1, EN ISO 10079-1), and product design specifications. These are objective, measurable criteria, not expert consensus, pathology, or outcomes data typically associated with diagnostic or therapeutic device efficacy.

8. Sample Size for the Training Set:

This information is not applicable. The device is an electromechanical pump and canister, not an artificial intelligence or machine learning device that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Riptide™ Aspiration 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

• Arc™ Catheter .
• Riptide™ Aspiration Tubing .
• Riptide™ Aspiration Pump ●
• Riptide™ Collection Canister with Intermediate Tubing .

The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Riptide™ Aspiration System to its predicate device, the Penumbra System® and Penumbra Pump MAX™.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists numerous tests conducted on various components of the Riptide™ Aspiration System, with an explicit statement that the device met the acceptance criteria for each. The specific acceptance criteria values are generally not quantified in the "Results" column, but rather stated qualitatively (e.g., "met the acceptance criteria").

Table 1: Acceptance Criteria and Reported Device Performance (Summary)

Study Information:

The provided document describes non-clinical bench testing and non-clinical animal testing. It explicitly states "Not Applicable" for clinical performance data. Therefore, questions related to human reader studies, ground truth establishment for a test set of clinical images, and training set details are not directly addressed in this document.

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

• Test Set Sample Size:
  • Bench Testing: The document does not specify the exact sample sizes (number of units tested) for each individual bench test. The nature of these tests often involves a batch of devices or components.
  • Animal Testing: The document mentions "a porcine model" but does not specify the number of animals used for the animal testing.
• Data Provenance:
  • Bench Testing: Conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, as part of their R&D and regulatory submission process. Location not specified, but the company is based in Irvine, California, USA.
  • Animal Testing: Conducted "in a porcine model." Location not specified.
  • Retrospective/Prospective: These are non-clinical studies (bench and animal), so the terms retrospective/prospective in the context of human data acquisition do not directly apply. They are inherently prospective in the sense that the tests were designed and executed to evaluate this specific device for its regulatory submission.

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)

• Not Applicable. The studies described are non-clinical (bench and animal). There is no mention of human expert-established ground truth for a test set of clinical images or data. The "ground truth" for these tests comes from objective measurements against defined standards (e.g., ISO, ASTM, USP standards, or internal specifications) and observations in animal models.

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

• Not Applicable. As no human expert evaluation of clinical data for ground truth establishment is described, adjudication methods are not relevant to this submission.

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. The document explicitly states "Performance Data - Clinical: Not Applicable." This means no human reader studies (MRMC or otherwise) were conducted or submitted as part of this 510(k). The device is not an AI-powered system that assists human readers.

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

• No. This device is a medical instrument (aspiration system for stroke), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

• Bench Testing: Ground truth is established by objective measurements against pre-defined engineering specifications, international standards (ISO, ASTM, USP), and validated test methods. For example, "The Arc™ Catheter met the acceptance criteria for EO Residual" means the measured residual levels were below the established safe limits per ISO 10993-7.
• Animal Testing: Ground truth is established through direct observation and measurement in a controlled porcine model, in accordance with "21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies". The goal was to evaluate "safety, efficacy, and usability" and compare it to the predicate device.

8. The sample size for the training set

• Not Applicable. No AI/machine learning component is described for this device, so there is no concept of a "training set" in the context of algorithm development.

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

• Not Applicable. As there is no training set for an AI algorithm mentioned, this question is not relevant.

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Penumbra Aspiration Catheters and Separators: As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing: As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Aspiration 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 Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology. The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using an Aspiration Catheter with an I.D. of 0.054 in or larger. The Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy. The Penumbra Pump MAX is the aspiration source for the Penumbra Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions. The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

The provided document is a 510(k) premarket notification for the Penumbra Aspiration System. It details the device's indications for use, its classification, and a comparison to predicate and reference devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical (benchtop) and animal study data, largely leveraging existing data from previously cleared similar devices.

Crucially, this document does NOT contain information about specific "acceptance criteria" or "device performance" in terms of clinical outcomes, nor does it describe a study involving human subjects or experts for establishing ground truth for AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified sub-points (table of acceptance criteria/performance, sample size, experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details) because this information is not present in the provided text.

The document discusses:

• Leveraged Non-Clinical Data (Section 1.10): This section lists benchtop tests (Friction, Visual & Dimensional, Pouch Seal Strength, Flow Rate, Tensile, Elongation, Bond Strength, Hub Air Aspiration, Torsion, Burst, Simulated Use, Particulate, Flexibility, Packaging, Corrosion). It states that "all established requirements and acceptance criteria were met," but it does not specify what those acceptance criteria were in measurable terms (e.g., "flow rate X L/min," "tensile strength Y N"). It also does not define "device performance" in the way requested (e.g., diagnostic accuracy, sensitivity, specificity).
• Leveraged Animal Studies (Section 1.11): This section summarizes findings from design validation in GLP animal testing, noting "No vessel injury," "No abnormal gross or histology findings," and "no significant vascular response." This is performance data in an animal model, but not clinical performance in humans, nor does it relate to acceptance criteria for an AI/algorithm-driven device.

In summary, the provided text describes the regulatory clearance process for a medical device (an aspiration system) based on substantial equivalence to existing devices, supported by benchtop testing and animal studies. It does not contain the kind of information typically found in a study proving an AI/algorithm-driven device meets specific clinical acceptance criteria, which would involve human data, expert review, and metrics like accuracy, sensitivity, or specificity.

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Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
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 Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. 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 [1.37mm] 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 Penumbra Pump MAX 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 Penumbra Pump MAX, 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 Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.

The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the KIT configuration, as that's where new testing was performed:

1. Table of Acceptance Criteria and Reported Device Performance (KIT Configuration)

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

The document does not explicitly state the numerical sample size for the "Design Verification testing" for the KIT configuration. It only mentions "units used in this Design Verification testing" for Visual Inspection, and implicitly for Simulated Use, Catheter Coating, and Gross Leak tests as they all report 100% Pass.

• Sample Size: Not explicitly stated as a number, but all tested units passed.
• Data Provenance: The tests are described as "additional testing performed for the KIT configuration packaging," suggesting these are prospective, benchtop tests conducted by Penumbra, Inc. The country of origin for the data generation would logically be the USA, given the company's location.

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

There is no mention of experts or clinicians being used to establish a ground truth for these non-clinical tests. The tests are focused on physical and mechanical properties and simulated use in anatomical models.

4. Adjudication Method for the Test Set

Not applicable, as these are non-clinical, objective tests and not based on expert review or consensus.

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 document describes a medical device (Penumbra System and Penumbra Pump MAX) for treating acute ischemic stroke, not an AI-based diagnostic or treatment guidance system that would involve human readers or AI assistance.

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

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:
* Defined specifications and performance expectations: For Visual Inspection, Catheter Coating, and Gross Leak, the "ground truth" is adherence to predefined quality and integrity standards.
* Simulated physiological conditions and objective performance: For Simulated Use, the "ground truth" is the effective removal of clots and prevention of catheter collapse in an anatomical model that mimics neurovasculature.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable.

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INDIGO Aspiration Catheters and Separators: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.

INDIGO Aspiration Tubing: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.

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

The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial and venous systems. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for the Aspiration Catheters with Aspiration Tubing is available. Intended users for this device are physicians who have received appropriate training in interventional radiology.

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The use of the INDIGO Separator may not be necessary when using an INDIGO Aspiration Catheter with an I.D. of 0.054in [1.37mm] or larger. The INDIGO Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The INDIGO Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

The Penumbra Pump MAX is the aspiration source for the INDIGO Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHz. The pump is available in both 110Vac and 230Vac versions.

The front face of the Penumbra Pump MAX has a display panel with a vacuum gauge, suction regulating valve, and power switch. The Penumbra Pump MAX connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System).

It's important to note that this document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of all validation studies. Therefore, some information requested might not be explicitly present or might be referenced by prior clearances.

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 for the "Visual Inspection," "Catheter Coating," and "Gross Leak" tests. For the "Simulated Use" test, it states that "Devices were delivered through the tortuous anatomical model..." but doesn't provide a specific number of devices or trials.

Data Provenance: The studies described in Section 1.11 Non-Clinical Data – KIT Configuration are benchtop or laboratory studies, not directly involving human or animal data for this specific submission. The original provenance for the predicate device and leveraged data (as mentioned in Sections 1.10 and 1.12) would be from previous submissions (K142870, K121917, K122756), which are not detailed in this document.

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

The described tests (Packaging Validation) are physical and mechanical property assessments. These typically do not involve human expert adjudication for ground truth, but rather engineering or quality control personnel assessing against defined specifications. Therefore, information about experts and their qualifications (like radiologists) is not applicable to these specific tests.

4. Adjudication Method for the Test Set

Not applicable for these types of engineering/benchtop tests. The results are binary (Pass/Fail) based on objective measurements against specifications.

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

No. The document describes a 510(k) submission primarily based on demonstrating substantial equivalence to a predicate device through non-clinical (benchtop) testing and leveraging data from prior clearances. It does not include an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a mechanical system, not an AI diagnostic tool.

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

No. This device is a mechanical aspiration system, not an algorithm.

7. The Type of Ground Truth Used

For the Packaging Validation tests, the "ground truth" is defined by the technical specifications and performance criteria established for the device's physical and mechanical properties. This is typically determined through engineering design documents and quality control standards.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a mechanical device.

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