(219 days)
The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
The Poseidon Microcatheter is a single lumen catheter constructed using an internal lubricious layer encapsulated by a metallic braid and lubricious outer layer. The distal tip includes a radiopaque marker band, and the distal 60 - 90 cm of the microcatheter has a hydrophilic coating.
The provided document is a 510(k) Premarket Notification for the Heraeus Poseidon Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria via a clinical study that would involve expert readers, complex adjudication, or MRMC studies.
Therefore, many of the questions asked cannot be answered directly from this type of FDA submission. The document details bench testing against general regulatory standards and comparisons to a predicate device's characteristics.
Here's a breakdown of what can and cannot be answered based on the provided text:
What can be answered:
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Acceptance Criteria and Reported Device Performance (as listed in bench tests): The document provides a table of in vitro bench tests conducted and states that "Samples passed the acceptance criteria and the device was found to be [performance outcome]." The specific numerical acceptance criteria themselves are generally not detailed in this type of summary, but the qualitative outcome is stated as "passed."
Test Acceptance Criteria (Qualitative) Reported Device Performance Cytotoxicity Non-cytotoxic Passed acceptance criteria; non-cytotoxic Sensitization No sensitization response Passed acceptance criteria; did not elicit sensitization Irritation No irritation response Passed acceptance criteria; did not elicit irritation Systemic Toxicity Non-toxic Passed acceptance criteria; non-toxic Pyrogenicity Non-pyrogenic Passed acceptance criteria; non-pyrogenic Hemolysis Non-hemolytic Passed acceptance criteria; non-hemolytic Hemocompatibility Comparable to predicate comparison article Passed acceptance criteria; comparable to predicate Thrombogenicity Non-thrombogenic Passed acceptance criteria; non-thrombogenic Corrosion Resistance No corrosive response Passed acceptance criteria; did not elicit corrosive response Dimensions Comparable to predicate Passed acceptance criteria; comparable to predicate Package Integrity Testing Comparable to predicate Passed acceptance criteria; comparable to predicate Tensile Strength Comparable to predicate Passed acceptance criteria; comparable to predicate Torque Strength Comparable to predicate Passed acceptance criteria; comparable to predicate Kink Resistance Comparable to predicate Passed acceptance criteria; comparable to predicate Radiopacity Comparable to predicate Passed acceptance criteria; comparable to predicate Flow Rate Comparable to predicate Passed acceptance criteria; comparable to predicate Burst Pressure/Freedom from Leakage Comparable to predicate Passed acceptance criteria; comparable to predicate -
Sample size used for the test set: Not explicitly stated as "sample size" in the context of cases/patients, but rather in terms of number of device units or samples tested for each bench test. These are standard in vitro tests, not human studies.
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Data provenance: For bench tests, this would be laboratory data.
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Training Set (for AI-related questions): This device is a microcatheter, not an AI/ML device. Therefore, there is no training set in the context of an algorithm.
What cannot be answered from this document:
- Number of experts used to establish ground truth: Not applicable for a physical medical device clearance based on substantial equivalence and bench testing.
- Qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/imaging device.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in this context refers to the defined acceptance criteria for physical properties and biological responses established through international standards (ISO, ASTM) and FDA guidance for medical devices, not clinical outcomes or expert consensus on medical images.
- Sample size for the training set: Not applicable (no AI/ML algorithm).
- How the ground truth for the training set was established: Not applicable (no AI/ML algorithm).
In summary: The provided 510(k) summary demonstrates the safety and effectiveness of the Heraeus Poseidon Microcatheter through a comparison to a legally marketed predicate device and extensive in vitro bench testing against established international standards. It is not an AI/ML device, and thus the questions related to clinical study design, human readers, ground truth establishment by experts, and training/test sets for algorithms are not applicable to this submission.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).