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The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance microcatheters into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MiVi 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter.

The provided text describes the MiVi 6F Guide Catheter and its substantial equivalence to predicate devices, focusing on design verification and biocompatibility testing rather than a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested data points (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI/ML models) are Not Applicable (NA) as this is a traditional medical device submission (catheter), not an AI/ML device.

Here's the information that can be extracted and a clear indication of NA for the AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: NA (Traditional device testing, not an AI/ML test set with human data). Performance tests would have involved specific test fixtures, materials, and potentially animal models for biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NA (Traditional device testing, not an AI/ML test set requiring expert consensus for ground truth). Ground truth for physical properties is based on quantifiable measurements, and for biocompatibility, it's based on standardized biological assay results.

4. Adjudication method for the test set: NA (Traditional device testing).

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: NA (Not an AI/ML device).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: NA (Not an AI/ML device).

7. The type of ground truth used:
For engineering performance tests (Push/Track, Stiffness, etc.): Defined technical specifications and measurement standards (e.g., ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1 and ISO 594-2).
For biocompatibility tests: Standardized biological assay results against established thresholds (e.g., as per EN ISO 10993-1, EN ISO 10993-7).
For packaging and sterilization: Compliance with EN ISO 11607-1 and a demonstrated SAL of 10^-6.

8. The sample size for the training set: NA (Not an AI/ML device).

9. How the ground truth for the training set was established: NA (Not an AI/ML device).

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The MiVi 6F Guide Catheter underwent a comprehensive series of design verification tests and biocompatibility tests to demonstrate its safety and effectiveness and substantial equivalence to legally marketed predicate devices.

Design Verification Testing:

• Tests Conducted: Push/Track, Stent Crossing, Tip Stiffness, Torque Response, Kink Resistance, Tensile, Luer Leakage, Coating Adhesion, Coating Uniformity, Coating Thickness, Surface Integrity, Radiopacity, System Introduction, Device Compatibility.
• Standards Followed: ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1, ISO 594-2, and FDA guidance for PTCA catheters.
• Results: All performance tests "Met established criteria."

Shelf Life and Packaging Verification:

• Tests Conducted: Shelf Life Testing (Product and Packaging) and Distribution Shipping Challenge Conditioning and Testing.
• Standards Followed: EN ISO 11607-1.
• Results: Devices met established criteria, ensuring packaging integrity and sterility maintenance.

Biocompatibility Testing:

• Category: Externally Communicating, Circulating Blood, Limited Exposure (≤24 hours) as per EN ISO 10993-1:2009.
• Tests Conducted: Cytotoxicity (ISO MEM Elution Assay), Irritation/Intracutaneous Reactivity (ISO Intracutaneous Reactivity Test), Hemolysis (ASTM Direct Contact and Extract Methods), Thrombosis (Four Hour Thromboresistance Evaluation in Dogs), Complement Activation (C3a and SC5b-9), Pyrogenicity (Limulus Amebocyte Lysate (LAL) Limit Test), Sensitization (ISO Guinea Pig Maximization Test), Systemic Toxicity (Acute Systemic Injection Test).
• Ethylene Oxide Residuals: Compliance with EN ISO 10993-7:2008 for EO and ECH residuals was confirmed. A Sterility Assurance Level (SAL) of 10^-6 was demonstrated.
• Results: All biocompatibility tests passed, concluding the device to be biocompatible for its intended use and substantially equivalent to the predicate device from a biocompatibility perspective. The thrombosis and complement activation tests specifically showed comparable or superior results to the predicate device.

Conclusion:
The "Not Applicable" for clinical performance data indicates that the extensive non-clinical testing (design verification, shelf life, packaging, and biocompatibility) was deemed sufficient by the FDA to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices, without the need for clinical studies. The collective results of these studies demonstrated that the MiVi 6F Guide Catheter meets all established acceptance criteria, supporting its market clearance.

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