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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.

The INDIGO® Aspiration System is comprised of:

• 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 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.

This appears to be an FDA 510(k) summary for a medical device (Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7) and not for a software or AI/ML device requiring complex performance criteria based on imaging analysis.

Therefore, the request to describe acceptance criteria and a study proving a device meets these criteria in the context of AI/ML evaluation (e.g., expert reads, ground truth, MRMC studies) is not applicable to this document.

The document states:

• "There are no differences in the technological characteristics between the subject devices and predicate devices."
• "There are no differences in performance data between the subject and predicate devices and therefore no verification and validation studies were required."
• "The Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). A review of the technological characteristics of the subject and reference devices supported leveraging the clinical outcomes of the EXTRACT-PE clinical study for the subject devices."

This 510(k) is based on substantial equivalence to a predicate device, noting no changes in technology or performance that would necessitate new performance studies. The previous clinical study (EXTRACT-PE) mentioned relates to the reference device's clinical outcomes, not a new study on the current subject device.

Therefore, I cannot fulfill your request as it pertains to a different type of device evaluation (AI/ML software) than what is presented in this FDA 510(k) summary.

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