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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:

• 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 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 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.

This FDA 510(k) Premarket Notification is for the Indigo Aspiration System - Aspiration Catheter 12 and Separator 12. The document states that the subject device is identical to the predicate device (K192981) and leverages clinical data from a reference device (K192833). Therefore, the information below focuses on the clinical study (EXTRACT-PE) mentioned as supporting the substantial equivalence for the subject device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the subject device. Instead, it states that the EXTRACT-PE trial (for the reference device K192833) "demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met."

• Acceptance Criteria (Implied from the statement): Meeting primary efficacy and safety endpoints for acute Pulmonary Embolism (PE) treatment, demonstrating substantial equivalence to existing treatments. Specific numerical acceptance criteria are not provided in this document.
• Reported Device Performance: Achieved substantially equivalent safety and effectiveness outcomes for acute PE, and met primary efficacy and safety endpoints.

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

The document refers to the EXTRACT-PE clinical study for the reference device (K192833). However, it does not provide the specific sample size used for this trial nor the data provenance (country of origin, retrospective/prospective) within this 510(k) summary. Further documentation would be needed to extract this detail.

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 given document. The summary only mentions "primary efficacy and safety endpoints were met," implying clinical assessment, but not the specifics of ground truth establishment by experts.

4. Adjudication Method for the Test Set:

This information is not provided in the given document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device described is an aspiration system (a medical device used for removing emboli and thrombi), not an AI-based diagnostic or imaging device that would involve human readers interpreting output with or without AI assistance.

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

This is not applicable. The device is a physical medical device, not an algorithm. Performance is assessed through its use in a clinical setting by medical professionals.

7. The Type of Ground Truth Used:

For the EXTRACT-PE study, the ground truth would have been established through clinical outcomes data related to the efficacy (e.g., successful removal of thrombi, resolution of PE symptoms, improvements in relevant physiological parameters) and safety (e.g., adverse events, complications) of the device in treating acute PE.

8. The Sample Size for the Training Set:

This information is not provided in the given document. As it is a non-AI medical device, the concept of a "training set" in the context of machine learning does not directly apply. The clinical study for the reference device would have involved a patient cohort, but the specific number is not stated.

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

As above, the concept of a "training set" is not directly applicable. For the clinical study that demonstrated the device's performance, the "ground truth" (clinical outcomes, safety events, etc.) would have been established through standard clinical trial methodologies, including objective measurements, physician assessments, and follow-up data collection on patients enrolled in the trial.

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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 is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing 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 techniques.

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 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.

The provided text describes the submission of a 510(k) premarket notification for the "Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12." This specific document is a summary of non-clinical data and does not contain information about a study based on the performance of an AI/ML powered medical device.

Therefore, I cannot answer questions 1 through 9. The information provided in the document focuses on the physical and material properties of a medical device (a catheter and separator for aspiration), its biocompatibility, shelf life, sterilization, and packaging, rather than the performance of an AI/ML algorithm.

The "Acceptance Criteria" table in this document refers to engineering specifications (e.g., maximum friction force, minimum burst pressure, particle limits) for the physical device, not performance metrics for an AI/ML model.

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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 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 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.

The provided text describes the 510(k) summary for the Penumbra Indigo Aspiration System. The core of this submission is to demonstrate substantial equivalence to a predicate device, with an expanded indication for the treatment of pulmonary embolism.

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

1. Table of Acceptance Criteria and Reported Device Performance

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