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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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