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The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

The Merit Embolectomy Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100 cm, and 110 cm proximal of the distal tip.

This document describes the premarket notification (510(k)) for the Merit Embolectomy Catheter (K100569). It primarily focuses on demonstrating substantial equivalence to a predicate device through safety and performance testing. However, it does NOT contain the specific information required to complete the table and answer the study-related questions.

Here's why and what can be extracted:

What's missing for your request?
The provided text is a 510(k) summary and FDA clearance letter. It outlines the device, its intended use, lists the tests performed, and states that acceptance criteria were met. However, it does not provide:

• The specific acceptance criteria values.
• The reported device performance values against those criteria.
• Details about any clinical studies (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that would typically be associated with performance claims for AI-driven devices. Embolectomy catheters are physical devices, and their evaluation typically involves bench testing, animal models, and sometimes human clinical trials, but not in the format of AI performance metrics.

Extracted Information (based on the provided text):

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that a "battery of tests was performed... and were shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device," but it does not list these criteria or the test results.

2. Sample size used for the test set and the data provenance
Not applicable/provided for this type of device. The testing described is primarily bench-top (physical and mechanical properties) and biocompatibility, not data-driven performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided for this type of device. Ground truth as typically understood for AI/diagnostic devices is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/provided for this type of device.

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. This is a physical medical device (embolectomy catheter), not an AI/software device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this type of device. The "ground truth" for this device would relate to its physical performance (e.g., successful clot removal in a model, material integrity, biocompatibility), which is assessed through the listed tests.

8. The sample size for the training set
Not applicable/provided for this type of device. There is no "training set" as this is not an AI/machine learning product.

9. How the ground truth for the training set was established
Not applicable/provided for this type of device.

Summary of Device and Testing (from the document):

• Device Name: Merit Embolectomy Catheter
• Intended Use: Removal of fresh, soft emboli and thrombi from vessels of the arterial system (not for cerebral vasculature).
• Regulatory Class: Class II
• Product Code: OEZ (initially DXE, updated to OEZ in 2021)
• Predicate Device: Pronto V3 Extraction Catheter, Model 5003 (K063371)
• Tests Performed: A comprehensive battery of tests was performed based on ISO standards and FDA requirements, covering:
  • Surface Condition
  • Force at Break
  • Freedom from Leakage (Pressure & Aspiration)
  • Dimensional Verification (OD, lengths, marks, tip angle)
  • Radio-detectability
  • Visual Inspection
  • Aspiration
  • Flow
  • Lubricious Coating Effectiveness (Lubricity and Durability, Accelerated Aging)
  • Coating Integrity (Dye Test)
  • Lubricious Coating Length
  • Guide Wire Compatibility
  • Stiffness (Proximal, Mid, Distal Section)
  • Kink Test (Proximal, Mid, Distal Section)
  • Marker Band Retention
  • Rapid Exchange Lumen Attachment
  • Simulated Use Testing:
    • Tortuous Path (Tracking, Guide Wire, Crossing a deployed stent, Soft emboli aspiration)
  • Biocompatibility Tests:
    • Cytotoxicity
    • Sensitization
    • Irritation
    • Acute Systemic Toxicity
    • Pyrogenicity
    • Genotoxicity
    • Hemocompatibility
  • Packaging Performance:
    • Bubble emission
    • Dye penetration
    • Seal peel tensile strength
    • Burst strength
    • Visual inspection (before and after accelerated aging and simulated shipping)

The document concludes that the device "meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device" based on these tests.

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