(124 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 the 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 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 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.
This document describes the Indigo® Aspiration System - Lightning Bolt Aspiration Tubing (K223186). However, it does not describe a study that proves the device meets specific acceptance criteria in the context of image analysis, AI performance, or clinical effectiveness as one might expect for an AI/ML medical device. Instead, this document presents a 510(k) summary for a medical device (aspiration tubing) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench-top) testing.
Therefore, many of the requested elements regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment (which are standard for AI/ML device evaluations) are not applicable to the information provided in this document.
However, I can extract the relevant information on the non-clinical testing performed and the general acceptance of satisfactory performance.
Here's the breakdown based on the provided text, indicating where information is present and where it is not applicable:
1. Table of acceptance criteria and the reported device performance:
The document broadly states that the device met acceptance criteria, but it does not specify quantitative acceptance criteria for each test or provide detailed performance measurements.
| Test Performed | Reported Device Performance |
|---|---|
| Biocompatibility | Lightning Bolt Aspiration Tubing shown to be biocompatible. |
| Dimensional/Visual Inspection | Met all acceptance criteria. |
| Pressurization Testing | Met all acceptance criteria. |
| Indigo Aspiration System Compatibility/Simulated Use Testing (Thrombus Removal Testing) | Performed similarly to the predicate devices. Met all acceptance criteria. |
| Valve Testing | Met all acceptance criteria. |
| Tensile Testing | Met all acceptance criteria. |
| Post Destructive Testing Dimensional Inspection | Met all acceptance criteria. |
| Electrical Safety/EMC Testing | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, AIM 7351731, and ISO 10079-1. |
| Software Verification & Validation | Testing and documentation provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical (bench-top).
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 as the document describes non-clinical engineering and biocompatibility testing, not evaluation by human experts, or clinical studies for AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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 as this is not an AI/ML device for diagnostic imaging or similar applications that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an aspiration tubing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by engineering specifications, accepted ISO/IEC standards, and observation of physical performance (e.g., successful thrombus removal in a simulated environment, material integrity). It is not based on expert consensus, pathology, or outcomes data in the traditional sense for medical imaging or AI/ML evaluations.
8. The sample size for the training set
This information is not applicable; there is no AI/ML component with a training set described in this document.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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).