(71 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 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.
The Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.
The provided text is a 510(k) summary for the Penumbra Indigo® Aspiration System - Lightning Bolt Aspiration Tubing (K242075). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device (K223186).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the subject device meets specific clinical performance acceptance criteria in a standalone study against a predefined clinical benchmark. The studies described are primarily bench-top (non-clinical) tests to verify that the subject device performs similarly to the predicate device and functions as intended.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed, stating that the subject device met all acceptance criteria. However, it does not provide a table detailing specific quantitative acceptance criteria or corresponding device performance values for most tests. Instead, it offers general statements of compliance or similarity to the predicate device.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional/Visual Inspection | (Not explicitly stated, but implied to match design specifications and be free of defects) | Met all acceptance criteria |
| Pressurization Testing | (Not explicitly stated, but implied to withstand pressure without failure) | Met all acceptance criteria |
| Indigo Aspiration System Compatibility/Simulated Use Testing | (Not explicitly stated, but implied to function correctly with the aspiration system) | Met all acceptance criteria, performed similarly to predicate |
| Thrombus Removal Testing | (Not explicitly stated, but implied to be effective in removing thrombus) | Met all acceptance criteria, performed similarly to predicate |
| Valve Testing | (Not explicitly stated, but implied to ensure proper valve function) | Met all acceptance criteria |
| Tensile Testing | (Not explicitly stated, but implied to meet strength requirements) | Met all acceptance criteria |
| Post Destructive Testing Dimensional Inspection | (Not explicitly stated, but implied to assess structural integrity after destructive tests) | Met all acceptance criteria |
| Biocompatibility | Previously provided biocompatibility data of the predicate device (K223186) | No changes, maintained previous biocompatibility profile |
| Shelf-Life | Stability for 12 months | Met 12 months shelf-life based on accelerated aging data |
| Electrical Safety/EMC Testing | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, AIM 7351731, ISO 10079-1, and ISO 10079-4 | Complies with specified standards |
| Software Verification/Validation | Aligned with FDA's "Content of Premarket Submissions for Device Software Functions" guidance | Testing and documentation provided as recommended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly provide the sample sizes (number of units or test iterations) for each specific bench-top test. It generally references "testing performed on the subject Lightning Bolt Aspiration Tubing device."
The data provenance is non-clinical bench testing, conducted by the manufacturer, Penumbra, Inc. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence. There is no information about country of origin of the data beyond implicitly being from testing conducted by the US-based manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the non-clinical bench-top tests described, the concept of "ground truth" as established by medical experts (e.g., radiologists) is not applicable. These tests evaluate engineering and material performance against predefined specifications, often based on industry standards or internal design requirements. The "ground truth" for these tests would be the physical properties and performance of the device as measured in the lab.
4. Adjudication Method for the Test Set
Since the tests are non-clinical bench tests evaluating engineering performance, an adjudication method (like 2+1, 3+1 for clinical endpoints) is not relevant. Test results are typically objective measurements against a Pass/Fail criterion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an 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 information on the effect size of human readers improving with or without AI assistance, as this is not an AI device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone study was not done. This device is physical medical tubing, not an AI algorithm.
7. Type of Ground Truth Used
For the bench testing, the "ground truth" is based on:
- Engineering specifications and design requirements for mechanical, dimensional, and material properties.
- Industry standards (e.g., ISO for sterility, various IEC standards for electrical safety).
- Performance of the predicate device as a benchmark for comparison (e.g., "performed similarly to the predicate device").
8. Sample Size for the Training Set
Not Applicable. This is a physical medical device (tubing), not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set 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).