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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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