(29 days)
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 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, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
This document describes a 510(k) premarket notification for the Indigo® Aspiration System - Lightning® Flash, which is an embolectomy catheter used for removing fresh, soft emboli and thrombi.
Here's an analysis of the provided text with respect to acceptance criteria and the study:
1. Tabulation of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate." and "The subject Indigo Aspiration System – Lightning Flash Aspiration Tubing met all established requirements." However, the exact quantitative acceptance criteria are not explicitly listed in the provided text. The performance is reported as meeting "all established requirements."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional/Visual Inspection | Met all established requirements |
| Performance/Simulated Use Testing | Met all established requirements |
| Tensile Testing | Met all established requirements |
| Indigo Aspiration System Compatibility | Met all established requirements |
| Valve Sense Testing | Met all established requirements |
| Vacuum Testing | Met all established requirements |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance, implied to meet requirements. |
| Biocompatibility | No changes from predicate, previously cleared. |
| Shelf-Life (36 months) | Met based on accelerated aging data. |
| Packaging | No changes from predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no test set of human/animal data in the traditional sense, and thus no data provenance for such studies.
The testing was "bench-top" and would involve physical devices. The number of devices tested is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
As no animal or clinical study was conducted, there are no experts used to establish ground truth for a test set in the context of clinical outcomes. The "ground truth" for bench testing would be predefined engineering specifications, which are established by the device manufacturer's design and engineering teams. The qualifications of these individuals are not stated.
4. Adjudication Method for the Test Set:
Not applicable, as there was no test set involving human/animal data requiring adjudication. Bench testing typically relies on pass/fail criteria against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was NOT done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
This device does not appear to be an AI/software-driven diagnostic device requiring standalone algorithm performance evaluation. The "additional software features" mentioned would likely be related to control or operational aspects of the device, not image analysis or diagnostic capabilities. Therefore, a standalone performance evaluation of an algorithm in this context is not applicable/not reported.
7. Type of Ground Truth Used:
For the bench-top testing, the ground truth was engineering specifications and established requirements (e.g., dimensional tolerances, tensile strength values, vacuum levels, system compatibility).
8. Sample Size for the Training Set:
This is not applicable as the document does not describe the development or training of any AI or machine learning models. The device is a physical medical device (embolectomy catheter system).
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set mentioned or implied for this device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).