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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 arterial and venous systems, and for the treatment of pulmonary embolism.

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 is comprised of several devices:

• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing
• INDIGO Separator

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical 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 INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra 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. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister.

The Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.

The provided text is a 510(k) summary for the Penumbra Indigo® Aspiration System - Lightning Bolt Aspiration Tubing (K242075). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device (K223186).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the subject device meets specific clinical performance acceptance criteria in a standalone study against a predefined clinical benchmark. The studies described are primarily bench-top (non-clinical) tests to verify that the subject device performs similarly to the predicate device and functions as intended.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed, stating that the subject device met all acceptance criteria. However, it does not provide a table detailing specific quantitative acceptance criteria or corresponding device performance values for most tests. Instead, it offers general statements of compliance or similarity to the predicate device.

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

The document does not explicitly provide the sample sizes (number of units or test iterations) for each specific bench-top test. It generally references "testing performed on the subject Lightning Bolt Aspiration Tubing device."

The data provenance is non-clinical bench testing, conducted by the manufacturer, Penumbra, Inc. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence. There is no information about country of origin of the data beyond implicitly being from testing conducted by the US-based manufacturer.

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

For the non-clinical bench-top tests described, the concept of "ground truth" as established by medical experts (e.g., radiologists) is not applicable. These tests evaluate engineering and material performance against predefined specifications, often based on industry standards or internal design requirements. The "ground truth" for these tests would be the physical properties and performance of the device as measured in the lab.

4. Adjudication Method for the Test Set

Since the tests are non-clinical bench tests evaluating engineering performance, an adjudication method (like 2+1, 3+1 for clinical endpoints) is not relevant. Test results are typically objective measurements against a Pass/Fail criterion.

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

No, an 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 information on the effect size of human readers improving with or without AI assistance, as this is not an AI device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This device is physical medical tubing, not an AI algorithm.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" is based on:

• Engineering specifications and design requirements for mechanical, dimensional, and material properties.
• Industry standards (e.g., ISO for sterility, various IEC standards for electrical safety).
• Performance of the predicate device as a benchmark for comparison (e.g., "performed similarly to the predicate device").

8. Sample Size for the Training Set

Not Applicable. This is a physical medical device (tubing), not a machine learning algorithm. Therefore, there is no "training set."

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

Not Applicable. There is no training set for this device.

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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 arterial and venous systems, and for the treatment of pulmonary embolism.

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 the Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of the several devices:

• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing
• INDIGO Separator

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical 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 INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra 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. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The provided text is a compilation of FDA documents related to the 510(k) clearance for the Penumbra, Inc. Indigo® Aspiration System – Lightning® Flash. It describes the device, its indications for use, and a comparison to predicate devices, along with summaries of non-clinical data (biocompatibility and bench-top testing).

Based on the information provided, here's an analysis regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative manner as one might expect for an AI/ML device. Instead, it describes general compliance and qualitative outcomes for various tests.

The reported performance is described in a narrative format, indicating that tests "met all acceptance criteria" and "performed similarly to the predicate devices."

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

The document does not provide details on the specific sample sizes used for each non-clinical (bench-top) test or biocompatibility test. It mentions "testing was conducted" and "tests were performed" without quantifying the number of units or replicates involved.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as the studies described are non-clinical bench-top tests and biocompatibility assessments, not clinical studies involving patient data.

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. The device is an embolectomy catheter system, which is a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert interpretation to establish ground truth for a test set. The "ground truth" for its performance is established through measurable physical and biological parameters in laboratory settings (e.g., tensile strength, aspiration efficacy in simulated models, biocompatibility of materials).

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

This information is not applicable for the reasons stated in point 3. The studies are technical verification and validation, not studies requiring adjudication of image interpretations or clinical outcomes by multiple experts.

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 type of study is relevant for AI/ML-driven diagnostic tools, not for a mechanical medical device like an aspiration system. The document explicitly states: "No clinical study was conducted as bench and previously performed animal 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:

No. This concept is not applicable as the Indigo® Aspiration System – Lightning® Flash is a mechanical medical device, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on well-established engineering standards, material science principles, and biological safety assessments. This includes:

• Quantitative measurements from bench-top tests (e.g., dimensions, tensile strength, vacuum pressure).
• Adherence to recognized standards (e.g., ISO, ASTM for materials and performance, IEC for electrical safety).
• Biocompatibility testing results (e.g., lack of cytotoxicity, sensitization).
• Functional performance in simulated use models (e.g., removal of simulated thrombi).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that undergoes a "training set" for model development. The development process involves engineering design, prototyping, and testing of physical units.

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

Not applicable, as there is no "training set" in the context of this mechanical medical device.

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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 arterial and venous systems, and for the treatment of pulmonary embolism.

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 is comprised of the several devices:

• · INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• · INDIGO Aspiration Pump Canister
• · INDIGO Aspiration Tubing
• · INDIGO Separator™

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical 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 INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra 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. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

Lightning Aspiration Tubing: The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.

This document is a 510(k) premarket notification for the Penumbra, Inc. Indigo® Aspiration System - Lightning™ Aspiration Tubing (K210323). It claims substantial equivalence to a predicate device (K193244).

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the subject device "met all specifications and testing requirements under the previously established test methods" for the predicate device. However, it does not provide a specific table of quantitative acceptance criteria or detailed reported device performance values. Instead, it makes general statements about meeting requirements.

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

The document mentions "Bench-top performance (design verification)" and "Electrical Safety and Suction Equipment Testing." However, it does not specify the sample sizes used for these tests. The data provenance is also not explicitly stated in terms of country of origin or whether it's retrospective/prospective, but the nature of the testing (bench-top, electrical safety) implies internal laboratory testing, which is typically prospective for verification.

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

This information is not applicable and not provided. The testing described relates to the physical and electrical properties of medical device components, not diagnostic accuracy or clinical outcomes that would require expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As with point 3, adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for bench-top or electrical safety testing of device components.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, and the subject device (Lightning Aspiration Tubing) is a physical component, not an AI or imaging diagnostic tool.

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

No, a standalone algorithm performance study was not done. This is not an AI-powered device. The testing described focuses on the physical and electrical performance of the aspiration tubing.

7. The Type of Ground Truth Used:

For the bench-top performance and electrical safety testing, the "ground truth" would be the established engineering specifications and regulatory standards (e.g., IEC 60601 series). The device's performance was compared against these predefined requirements.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable and not provided. As mentioned, there is no training set for this type of device.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence of a medical device component (aspiration tubing) through bench-top and electrical safety testing. The criteria for acceptance are compliance with established engineering specifications and regulatory standards. The document asserts that these criteria were met but does not provide the granular data or specific acceptance thresholds that would be found in a detailed test report. It is not an AI-enabled device, and therefore many of the requested data points (like expert ground truth, MRMC studies, training sets) are not relevant to this submission.

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