(230 days)
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the peripheral and coronary vasculature. The Twin-Pass catheter consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has a working length of 135cm and have white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a platinum-iridium marker band located 1mm from the distal tip and a second platinum-iridium marker band located 11mm from the distal tip, identifying the distal end of the OTW lumen.
The provided text is a 510(k) summary for the Twin-Pass Dual Access Catheter. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a report of a clinical study or performance evaluation with human subjects that would typically involve acceptance criteria for AI/ML devices or specific clinical endpoints.
Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and human reader performance for an AI/ML device is not applicable to this document.
The document describes device performance verification tests to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy/effectiveness trials for an AI/ML diagnostic or prognostic tool.
Here's a breakdown of the available information:
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1. A table of acceptance criteria and the reported device performance: This information is not presented in a table with specific quantitative acceptance criteria and reported performance values. Instead, the document lists various verification tests performed and states that "The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness." The specific numerical acceptance criteria and corresponding numerical results are not detailed in this summary.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided. The "test set" in this context refers to physical device samples for engineering and biocompatibility testing, not patient data.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would relate to the validation of a diagnostic or prognostic capability, which is not the purpose of this device's submission. The tests are engineering and biocompatibility evaluations.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for clinical endpoint assessment by multiple experts, which is not described here.
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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: Not applicable. This device is a catheter, not an AI-powered diagnostic tool.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device's performance is based on established engineering standards (e.g., ISO 10555-1, ISO 594) and biocompatibility testing.
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8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
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9. How the ground truth for the training set was established: Not applicable.
Summary of Device Performance Verification (as provided in the document):
The device performance was verified through the following tests, and the results "met the specified acceptance criteria":
- Deliverability:
- Track Force
- Kink Resistance
- Guide Catheter Compatibility
- Guidewire Movement
- Hydrophilic Coating Evaluation:
- Particulate
- Coating Lubricity/Durability
- Drops of Fluid
- Tensile Strength:
- Shaft
- Tip
- Hub
- Torque Robustness
- Hub Markings
- ISO 10555-1 Verification:
- Working Length
- Crossing Profile
- Radiopacity
- Aspiration
- Liquid Leak
- Static Pressure
- Dynamic Pressure
- Surface Defects
- ISO 594 Hub Verification:
- Luer Gage
- Air Leakage During Aspiration
- Liquid Leakage Under Pressure
- Separation Force of Luer Fitting
- Unscrewing Torque
- Ease of Luer Fitting Assembly
- Resistance to Overriding
- Stress Cracking
Biocompatibility Tests (in accordance with ISO 10993-1):
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation
- Thrombogenicity
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).