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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Primary Efficacy Endpoint: Lower limit of the 95% confidence interval (CI) of the change in RV/LV ratio from baseline to 48 hours for acute PE patients (assessed by CTA) must be > 0.20 (indicating reduction in right ventricular dilation).	Absolute reduction in RV/LV ratio of 0.42 ± 0.25 (95% CI 0.37, 0.46). The lower limit of the 95% CI (0.37) is > 0.20. (26.9% reduction, p<0.0001)
Primary Safety Endpoint: 48-hour rate of major adverse events (composite of device-related death, major bleeding, and device-related SAEs including clinical deterioration, pulmonary vascular injury, and cardiac injury) should not be equal to 40%.	The 48-hour rate of major adverse events was 1.7% (95% CI 0.0%, 4.0%), p<0.0001. This is significantly lower than 40%.

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

Sample Size:
- ITT (Intent-To-Treat) analysis population: 119 subjects
- mITT (Modified ITT) population (primary for efficacy): 110 subjects (excluded subjects who received adjunctive treatments or thrombolytics intra-procedure through 48 hours post-procedure).
- Safety endpoints: Evaluated based on the ITT population (119 subjects).
Data Provenance: The Penumbra EXTRACT-PE trial was a prospective, multicenter, single-arm trial conducted at 22 centers in the U.S.

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

The document states: "An independent imaging core lab and a clinical events committee (CEC) reviewed safety endpoints data." It does not specify the exact number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience"). However, the involvement of an "independent imaging core lab" implies that imaging specialists (e.g., radiologists) were involved in assessing the imaging data for the RV/LV ratio, and a "clinical events committee" suggests physicians or clinical experts were involved in assessing safety events.

4. Adjudication Method for the Test Set

The document mentions an "independent imaging core lab" and a "clinical events committee (CEC)" reviewed endpoints data. This implies a form of expert review and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

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

No, an MRMC comparative effectiveness study was not done. The EXTRACT-PE trial was a single-arm trial, evaluating the device's performance without direct comparison to human readers or another treatment arm within the study design (though it established substantial equivalence to a predicate device based on its performance). Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here, as this device itself is a mechanical aspiration system, not an AI-assisted diagnostic tool.

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

Yes, in a sense. The "device performance" in this context refers to the Indigo Aspiration System as a standalone therapeutic device. The clinical trial evaluated the device's ability to achieve specific physiological outcomes (RV/LV ratio reduction) and safety outcomes when used by clinicians. Since it's a therapeutic device for mechanical thrombectomy, its performance is its standalone performance in treating patients. There isn't an "algorithm" being evaluated in the AI sense; rather, the mechanical system's efficacy is being assessed.

7. Type of Ground Truth Used

The ground truth for efficacy (reduction in RV/LV ratio) was established by CTA (Computed Tomography Angiography) images assessed by an independent imaging core laboratory.
The ground truth for safety (major adverse events) was established by clinical evaluation and review by a clinical events committee (CEC). This would incorporate clinical diagnoses, patient outcomes, and potentially imaging findings.

8. Sample Size for the Training Set

Not applicable / Not explicitly stated for this submission. The Indigo Aspiration System is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and functionality are based on engineering principles and prior validated devices. The clinical study (EXTRACT-PE) served as a validation study for the expanded indication.

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

Not applicable. As explained above, this device does not involve an AI/ML algorithm that requires a "training set" with established ground truth. The development and validation of this mechanical device rely on engineering design, bench testing, animal studies, and then human clinical trials to demonstrate safety and efficacy. The prior versions of the device (predicate and reference devices) would have undergone similar developmental and validation processes.

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