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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:

• 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.

• Data provenance: For bench tests, this would be laboratory data.

• 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.

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