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The INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The 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 Aspiration System is comprised of several devices: - INDIGO CAT RX Aspiration Catheter . - INDIGO Separator 4 ● - . INDIGO Aspiration Tubing - . INDIGO Pump Canister/Tubing - . Penumbra Aspiration Pump The INDIGO Aspiration System 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 provided text is a 510(k) summary for the Penumbra INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4). It is a submission to the FDA for market clearance, asserting substantial equivalence to a previously cleared predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/ML perspective. The device in question is a medical aspiration system, not an AI/ML diagnostic or therapeutic device.

The "Performance Data - Non-Clinical" and "Performance Data - Clinical" sections explicitly state:

• "The subject and predicate Indigo System (CAT RX Aspiration Catheter and Separator 4) devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." (Section 1.10)
• "No clinical study was conducted as previously performed bench and animal testing was determined sufficient for verification and validation purposes for substantial equivalence determination." (Section 1.16)

The submission leverages prior testing and clearance of an identical predicate device. Therefore, there are no new studies or acceptance criteria specifically for this 510(k) submission to describe. The original predicate device (K180412 and reference K163618) would have had its own performance data and acceptance criteria, but those are not detailed in this document.

Therefore, it is not possible to answer the requested questions based on the provided text. The text does not describe an AI/ML device, nor does it present new performance data or acceptance criteria for a study demonstrating adherence to such criteria. The entire premise of the 510(k) is that the device is identical to a predicate and thus no new performance testing is required for this submission.

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