(109 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.
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 ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180939.
The INDIGO® Aspiration System is comprised of the several devices:
- · INDIGO Aspiration Catheter
- Penumbra Aspiration Pump
- INDIGO Pump/Canister Tubing
- 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.
Lightning Aspiration Tubing: The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration.
This document is a 510(k) Pre-market Notification for a medical device (Indigo Aspiration System - Lightning Aspiration Tubing) and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a comparative effectiveness study with human readers assisting AI or an AI standalone system. The concepts of AI assistance, multi-reader multi-case studies, and specific performance metrics like sensitivity/specificity for AI are not applicable here.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing conducted to ensure the new device functions as intended and is equivalent to the predicate device. The prompt's request for information largely aligns with the type of evaluation performed for an AI-powered diagnostic device, which is not what this document describes.
Therefore, providing a direct answer to all points of the prompt as though the document describes an AI diagnostic or assistive device study would be factually incorrect and misleading.
However, I can extract the relevant information regarding the engineering/performance acceptance criteria and the supporting studies from the provided document as it pertains to the device's substantial equivalence.
Here's how the information can be broken down based on the document's content, focusing on what is present:
Device: Indigo Aspiration System - Lightning Aspiration Tubing
Regulatory Class: Class II
Product Code: QEW (Embolectomy Catheter)
Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K180939, 110 Aspiration Tubing, modified).
1. Table of Acceptance Criteria and Reported Device Performance
The document details various non-clinical tests performed to demonstrate the device meets its design specifications and is substantially equivalent to the predicate. These are more akin to engineering and material acceptance criteria rather than diagnostic performance metrics.
| Acceptance Criteria (Attribute/Specification) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility: | |
| In Vitro Cytotoxicity (ISO Elution Test) - Non-Toxic | Pass - Non-Toxic |
| Sensitization (ISO Maximization Test) - Non-Sensitizing | Pass - Non-Sensitizing |
| Irritation (ISO Intracutaneous Reactivity) - Non-Irritant | Pass - Non-Irritant |
| Design Verification (Bench-Top Testing): | |
| Dimensional/Visual Inspection (Units meet all product specifications) | Pass |
| Simulated Use (Units meet specifications) | Pass |
| Tensile Strength (Minimum value per specification) | Pass |
| Indigo Aspiration System Compatibility (Must meet specification) | Pass |
| Lightning Aspiration Tubing Valve Sense Testing (Must meet specification) | Pass |
| Shelf Life: | |
| Support a 12-month shelf life (based on accelerated aging) | Shelf life supported |
| Sterilization: | |
| Ethylene Oxide (EO) gas exposure in accordance with BS EN ISO 11135 | Device provided sterile |
| Packaging: | |
| Packaging Validation Testing - Met all acceptance criteria | Met all acceptance criteria |
| Software Verification and Validation: | |
| Complies with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Minor Level of Concern) | Complies |
| Electrical Safety/EMC Testing: | |
| Complies with IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, and IEC/EN 62366-1 | Complies |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI study. The "test sets" for each specific engineering/performance test (e.g., biocompatibility, tensile strength, simulated use) would vary, but the document does not provide the exact sample sizes for each. It generally states that "units" or "the subject device" were tested.
- Data Provenance: The tests are non-clinical (bench-top, laboratory testing) and focused on device performance, not clinical patient data. The provenance is internal to Penumbra, Inc. (Alameda, CA, USA). The document does not specify if any retrospective or prospective patient data was used, as it explicitly states "Clinical Testing was not required".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this 510(k) submission. "Ground truth" in the context of AI diagnostic performance is typically established by medical experts (e.g., radiologists, pathologists). Here, the "ground truth" for each test is its defined engineering specification or a generally accepted laboratory standard (e.g., ISO guidelines for biocompatibility). The experts would be engineers, chemists, and quality control professionals, but their number and specific qualifications are not detailed in this regulatory summary.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements among human readers or between human readers and AI outputs in diagnostic studies. For engineering tests, results are typically binary (pass/fail) based on objective measurements against pre-defined 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
Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers. It's a medical device (aspiration tubing) used in a non-AI surgical/interventional procedure. Therefore, no MRMC study with human readers and AI assistance was conducted or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the various non-clinical tests were:
- Pre-defined engineering specifications (e.g., dimensional requirements, tensile strength minimums).
- International and national standards (e.g., ISO 10993-1 for biocompatibility, IEC/EN 60601 series for electrical safety).
- Results from previously cleared predicate devices for comparison.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set exists 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).