(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.
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 Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.
The INDIGO Aspiration System is comprised of several devices: INDIGO Aspiration Catheter, INDIGO SeparatorTM, INDIGO Aspiration Tubing, INDIGO Pump/Canister Tubing, Penumbra Aspiration Pump. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used in parallel with the INDIGO Separator and an aspiration source to separate the embolus or thrombus and aspirate it from the occluded vessel. The INDIGO Separator is deployed from the INDIGO Aspiration Catheter. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion. This facilitates aspiration and debulking of the thrombus and reduces or eliminates the endovascular clot burden. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The devices are visible under fluoroscopy.
The provided text describes the INDIGO™ Aspiration System and its components (INDIGO Aspiration Catheters, Separators, Tubing, and Penumbra Pump MAX). The acceptance criteria outlined and the study performance reported are primarily for the Separator 8 component of the system.
Here's the breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Attribute | Specification | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Dimensional/Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Effectively, 100% compliance with inspection criteria | 100% Pass |
| Simulated Use (Peripheral Access, Vessel Access Entry Performance & Clot Removal) | Effectiveness of devices to remove clots and Aspiration Catheter does not collapse under vacuum when delivered through a tortuous anatomical model. | Effectively, 100% effectiveness/no collapse | 100% Pass |
| Separator Shape (for Subject Separator 8) | Must be diamond shaped | 100% Must meet Specification | 100% Pass |
| Advanced Separator 8 and Wire Joint Break Force | $\ge$ 0.67 lb | 100% Must meet Specification | 100% Pass |
| Core Wire PTFE Coating Integrity (after simulated use) | Coating has not delaminated, peeled, or flaked | 100% Must meet Specification | 100% Pass |
| Particulate Testing with Heparinized Saline (Separator) | Maximum number of particles: |
- $\ge$ 10 μm will be $\le$ 6000 particles
- $\ge$ 25 μm will be $\le$ 600 particles.
- $\ge$ 75 μm & $\ge$ 125 μm will be recorded. | 100% Must meet Specification | 10μm: 100% Pass
25μm: 100% Pass
Data recorded for informational purposes only (for $\ge$ 75 μm & $\ge$ 125 μm) |
Study Details for Testing Subject Separator 8:
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for individual acceptance criteria tests. It generally refers to "units used in this Design Verification testing" for dimensional/visual inspection and "devices used for mechanical testing."
- Data Provenance: The studies are described as "bench-top testing" and were selected in accordance with EN ISO 10993-1 guidelines and conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. This indicates in-vitro testing rather than human or animal studies, and the data originates from internal verification testing. No country of origin is explicitly stated beyond the company's location (Alameda, CA, USA). It is retrospective in the sense that the testing was performed, and results compiled for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The testing described is primarily mechanical and physical in nature, with "clinically acceptable product" being a criterion for visual inspection, implying expert judgment, but no details on who made these judgments or their qualifications are given.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. The assessment appears to be based on direct measurement or observation against predetermined specifications, not multi-reader adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for a physical medical device (aspiration system/catheter components), not an AI/software device that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. The device is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and mechanical tests, the "ground truth" is defined by pre-determined specifications and international standards (e.g., ISO 10555-1) and internal design requirements. For example, for "Separator Shape," the ground truth is "diamond shaped." For "Break Force," the ground truth is "$\ge$ 0.67 lb." For "Simulated Use," it is the device's demonstrated ability to remove clots and not collapse.
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The sample size for the training set:
- This concept is not applicable here. This is a physical medical device. There is no training set in the context of an algorithm or AI.
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How the ground truth for the training set was established:
- This question 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).