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The MegaVac Mechanical Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• The non-surgical removal of thrombi from synthetic grafts.
• Use in temporary blood vessel/graft occlusion.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft
• Catheter placement over a guidewire

The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.

The provided document is a 510(k) Summary for the MegaVac Mechanical Thrombectomy System. This regulatory submission primarily focuses on establishing substantial equivalence to predicate devices based on design, function, materials, sterilization, and in vitro testing. It does not contain information about clinical studies (comparative effectiveness or standalone), sample sizes for test or training sets for AI devices, expert qualifications for ground truth establishment, or adjudication methods, as these are typically associated with performance evaluations of AI/ML-based devices or clinical trials rather than a 510(k) submission for a traditional medical device demonstrating substantial equivalence through bench testing.

Therefore, many of the requested details related to AI device performance evaluation are not present in this document.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements." However, specific numerical acceptance criteria for each test are not provided. The table below lists the tests performed and the general statement about meeting acceptance criteria.

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INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4

As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

INDIGO Aspiration Tubing

As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX 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 Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vessels by aspirating the proximal side of the thrombus using the Aspiration Catheter, Separator, and Aspiration Tubing. The Penumbra Aspiration System components were originally cleared under K161506.

The Penumbra Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and the Pump Canister/Tubing. The Aspiration Catheter is provided with a rotating hemostasis valve and an introducer sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy.

The CAT RX Aspiration Catheter is a dual lumen, rapid exchange, intravascular catheter. It is designed and composed of materials common to interventional devices. The distal lumen is PTFE lined and the shaft is reinforced with both nitinol round wire and a flexible laser cut stainless steel hypotube. The shaft has variable stiffness with progressively softer polymer extrusion materials moving distally along its length. The distal portion of the shaft is hydrophilically coated for lubricity. The distal tip has a radiopaque platinum/iridium markerband.

The CAT RX Aspiration Catheter is available in effective lengths ranging from 120cm to 160cm and is provided sterile for single use. The CAT RX Aspiration Catheter is packaged in a kit with the Aspiration Tubing. The kit also contains a rotating hemostasis valve (RHV) and introducer sheath.

The Aspiration Tubing connects the Penumbra Aspiration Pump to the CAT RX Aspiration Catheter within the sterile field. The Aspiration Tubing has a flow valve which connects directly to the CAT RX Aspiration Catheter hub or RHV and allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is provided sterile, and is available either individually packaged or in a kit with the CAT RX Aspiration Catheter.

The provided text describes the safety and performance testing for the Penumbra INDIGO Aspiration System, specifically focusing on the CAT RX Aspiration Catheter and Aspiration Tubing, in comparison to a predicate device. It details non-clinical data, including biocompatibility and bench-top testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Biocompatibility test results:

• In Vitro Cytotoxicity: Non-Toxic
• Sensitization: Non-Sensitizing
• Acute Intracutaneous Reactivity (Irritation): Non-Irritant
• Acute Systemic Toxicity: Non-Toxic
• Rabbit Pyrogen Study: No evidence of material-mediated pyrogenicity
• In Vitro Hemolysis: Non-Hemolytic
• In Vitro Coagulation (PT, PTT): No Statistical Difference from control / Non-Thrombogenic
• Complement Activation: No greater biological response than corresponding control
• Dog Thrombogenicity: Non-Thrombogenic

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Bench-top Testing:
  • Shaft Kink Resistance: 30
  • Markerband Visibility: 30
  • Particulate Testing: 10
  • Hub/Air Aspiration: 30
  • Static Burst Pressure: 30
  • Friction: 30
  • Bond Strengths (Markerband/Distal Guidewire, Distal Shaft/Guidewire section 1, Distal Shaft/Guidewire section 2, Midjoint/Proximal Guidewire, Hub/Shaft): 30 for Distal Shaft/Guidewire section 2, sample size not explicitly stated for others but assumed to be similar given similar rows.
  • Elongation to failure: 30
  • Torsion: 30
  • Corrosion: 30
  • Compatibility with RHV for Aspiration Tubing: 30 (as part of Simulated Use)
• Data Provenance: The studies are non-clinical, bench-top, and biocompatibility studies. The document does not specify the country of origin for the data, but it is submitted to the U.S. FDA. The nature of the studies implies they are prospective tests conducted to evaluate the device's performance characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This document describes non-clinical, bench-top, and biocompatibility testing. It does not involve human expert interpretation of images or clinical outcomes that would require "ground truth" established by experts in the context of, for example, an AI/radiology study. The "ground truth" for these tests is based on objective, measurable physical properties and standardized testing methods (e.g., ISO standards, ASTM methods, USP tests).

4. Adjudication Method for the Test Set:

• This is not applicable as the studies described are non-clinical bench-top tests and biocompatibility evaluations, not reader studies or clinical trials requiring adjudication of human observations. The results are quantitative measurements or qualitative observations against predefined criteria.

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:

• No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of a medical device (catheter and tubing) based on its physical, mechanical, and biological properties, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, this is a physical medical device (catheter system), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The performance is the direct mechanical and biological behavior of the device itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the non-clinical tests is established by:
  • Defined physical and mechanical specifications: For example, a target burst pressure, a maximum friction force, or a minimum bond strength.
  • Standardized assay results: For biocompatibility, results like "Non-Toxic," "Non-Sensitizing," "Non-Hemolytic" are determined by specific laboratory assays and their established cut-offs/controls.
  • Visual observation against criteria: For example, "No kinking," "Markerband is fluoroscopically visible," "No visible catheter corrosion."

8. The Sample Size for the Training Set:

• This document describes testing performed to demonstrate substantial equivalence for a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm. The "training" in this context refers to the manufacturing and design iterations that lead to the final device components.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there is no "training set" for an algorithm. The device's design and manufacturing are based on engineering principles, material science, and regulatory requirements, culminating in the performance demonstrated by the testing described.

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