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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 K180105.

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 may be 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 Indigo Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Indigo Aspiration Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for IST1, 0.088 in [2.24mm] for IST2, and 0.110 in [2.79mm] for IST3 and IST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices.

Here's an analysis of the acceptance criteria and supporting study for the Penumbra Indigo Aspiration System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are primarily found in Section 1.10, "Summary of Non-Clinical Data," specifically subsections 1.10.1 (Biocompatibility) and 1.10.2 (Design Verification - Bench-top Testing).

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

The document does not explicitly state the specific numerical sample sizes for each test in the tables provided for "Biocompatibility" and "Design Verification." It mentions:

• For Biocompatibility, "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)."
• For Design Verification, "All benchtop studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures."

This indicates that appropriate (but unspecified) sample sizes were used according to established scientific and regulatory guidelines.

Data provenance: The tests were non-clinical (bench-top testing, lab-based biocompatibility, shelf-life, sterilization, packaging). Therefore, there is no "country of origin of the data" in the sense of patient data, nor is it retrospective or prospective in the usual clinical study context. These are laboratory studies performed by the manufacturer, Penumbra, Inc. (Alameda, CA, USA).

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 to the provided document. The studies described are non-clinical, bench-top, and laboratory tests (biocompatibility, mechanical performance, sterility, shelf-life, packaging). These types of tests do not involve human experts establishing "ground truth" on a test set in the way a clinical study or AI algorithm evaluation would. The "ground truth" for these tests is defined by the objective measurement and adherence to established scientific and regulatory standards (e.g., ISO, AAMI standards, internal specifications).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical bench-top tests. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert review processes where there might be disagreement among reviewers, which is not relevant to chemical or mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not conducted as part of this submission. The document focuses exclusively on non-clinical (bench-top) testing to demonstrate substantial equivalence for a modified component (the 110 Aspiration Tubing) of an existing device. It does not involve human readers evaluating images or clinical outcomes, either with or without AI assistance.

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

No, a standalone performance study in the context of an algorithm or AI was not performed. This submission is for a physical medical device (aspiration system), not a software or AI diagnostic device.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility: Ground truth is established by standardized biological assays and observation against criteria defined in EN ISO 10993 guidelines.
• Design Verification (Bench-top Testing): Ground truth is established by objective measurements against predefined engineering design specifications, performance standards, and risk analyses.
• Shelf Life: Ground truth is established by measuring material degradation or performance changes over time, often using accelerated aging models and real-time stability studies, against pre-defined performance specifications.
• Sterilization: Ground truth is established by standardized microbiological and chemical tests (e.g., bioburden, sterility assurance level, EO residual levels) against criteria defined in EN ISO 11135, EN ISO 10993-7, AAMI TIR 28, and ANSI/AAMI ST72.
• Packaging: Ground truth is established by visual inspection and performance tests (e.g., seal integrity, transportation conditioning) to ensure sterility maintenance and device protection.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this submission is for a physical medical device, not an algorithm or AI.

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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