(240 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 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 is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, nonpyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.
The INDIGO® Aspiration System is comprised of 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, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
The Penumbra, Inc. Indigo Aspiration System, specifically the Aspiration Catheter 7 and Separator 7, underwent various non-clinical tests to demonstrate its substantial equivalence to predicate devices. The following information summarizes the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biological safety in accordance with ISO 10993-1, USP standards, and FDA Good Laboratory Practices (GLP) for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (per BS EN ISO 10993-4 requirements). | Passed |
| Design Verification (Bench-top Testing) - CAT7 | ||
| Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| Simulated Use (Peripheral Access, Vessel Access Entry Performance, Delivery/Retrieval & Clot Removal) | Effectiveness of devices to remove clots and Aspiration Catheter not collapsing under vacuum when simulated in an anatomical vascular flow model with accessory devices. | Pass |
| Aspiration Catheter/7F Sheath compatibility (Friction Force) | Maximum value per specification. | Pass |
| Aspiration Catheter/0.038" Guidewire compatibility (Friction Force) | Maximum value per specification. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to and after simulated use particulate testing. | Pass |
| Particulate Testing | 75 µm and > 125 µm particles recorded for informational purposes only). | Pass |
| Hub Air Aspiration | No air leaks. | Pass |
| Catheter Pressure (Lumen Burst Pressure) | Minimum value per specification. | Pass |
| Hub / Shaft Tensile Strength | Minimum value per specification. | Pass |
| Catheter Shaft Tensile (all joints) | Minimum value per specification. | Pass |
| Elongation to Failure | Minimum value per specification. | Pass |
| Corrosion | No visible corrosion on Cathether immediately after Corrosion Testing procedure. | Pass |
| Design Verification (Bench-top Testing) - SEP7 | ||
| Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| Separator Cone Shape | Must be Diamond shape. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. | Pass |
| Particulate Testing | The maximum number of particles: 75 µm and > 125 µm particles recorded for informational purposes only). | Pass |
| Separator 7 Break Force (Cone/Wire) | Minimum value per specification. | Pass |
| Shelf Life | CAT7: 12-month shelf life (based on accelerated aging). SEP7: 36-month shelf life (leveraged from predicate device). | Met |
| Sterilization | Sterilized in accordance with BS EN ISO 11135 (Ethylene Oxide gas exposure). | Met |
| Packaging | All acceptance criteria for packaging validation. (CAT7: Packaging Validation Testing completed. SEP7: Packaging Validation Testing leveraged). | Met |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each individual test within the "Design Verification (Bench-top Testing)" section. It generally states that "units used in this Design Verification testing" were evaluated. The data provenance is not explicitly stated as country of origin, but it is implied to be from Penumbra, Inc. in Alameda, CA, USA, where the device manufacturer is located. The studies are non-clinical (bench-top and laboratory testing), not human or animal studies, so the terms "retrospective" or "prospective" are not directly applicable in the same way they would be for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The studies described are non-clinical engineering and laboratory tests (biocompatibility, mechanical performance, etc.). Ground truth in this context refers to established engineering specifications and international standards, not expert medical opinion on diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where multiple human readers are involved. The studies described here are objective, quantifiable engineering and laboratory tests with predetermined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device described (Indigo Aspiration System - Aspiration Catheter 7 and Separator 7) is a physical medical device (catheter and separator for thrombus removal), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, the device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests was based on pre-determined product specifications, engineering standards, and international regulations/guidelines. For example:
- Biocompatibility: ISO 10993-1, USP standards, FDA GLP, BS EN ISO 10993-4.
- Mechanical and Physical Properties: Specific maximum/minimum values, visual criteria (e.g., "no air leaks," "no visible corrosion," "must be Diamond shape"), and adherence to accepted test methods.
- Sterilization: BS EN ISO 11135.
- Shelf Life & Packaging: Acceptance criteria established for stability and integrity.
8. The sample size for the training set:
This information is not applicable. There is no mention of an algorithm or AI model requiring a training set. The device is a physical medical instrument.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for a physical medical 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).