(603 days)
Intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.
The AURORA is a single lumen radiopaque catheter with a proximal Luer fitting. The AURORA is pakaged sterile and is intended for single use only.
The provided documentation for the AURORA™ Guide Catheter (K972065) is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through extensive clinical studies, especially for Class II devices like guide catheters.
Therefore, the information required to populate the fields in your request, such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training and test sets, is not typically found in a 510(k) submission for a device like this.
Here's why and what can be extracted from the document:
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Focus of 510(k) for this device: The 510(k) process for a Class II device like a guide catheter primarily relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This usually involves bench testing and material biocompatibility rather than large-scale clinical trials or detailed performance metrics against specific acceptance thresholds in human subjects.
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"Acceptance Criteria" and "Device Performance": In this context, "acceptance criteria" most likely refer to the performance specifications developed by the manufacturer for their own product, which are then verified through bench testing. These are not typically made public in detail within a 510(k) summary, as the FDA reviewer examines the full submission for conformance.
Let's break down what is available and explain why other information is missing:
Summary of Available Information (and reasons for missing info):
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Table of Acceptance Criteria and Reported Device Performance: This specific table is not present.
- Explanation: For a 510(k) of a guide catheter, the "acceptance criteria" are internal product specifications (e.g., burst pressure, torque response, flow rate requirements). The document mentions "Product testing was conducted to evaluate conformance to product specification. Testing included flow rate, torque, static pressure, bond strength and demensional equivalence." However, the specific values for these specifications (the acceptance criteria) and the results (reported device performance) are not detailed in this publicly available summary. The FDA generally reviews these detailed bench test reports internally.
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Sample size used for the test set and the data provenance: Not explicitly stated for specific tests.
- Explanation: The testing mentioned ("flow rate, torque, static pressure, bond strength and demensional equivalence") would have involved a certain number of devices tested. This sample size would be part of the manufacturer's internal test protocols and reports submitted to the FDA, but not typically summarized in the public 510(k) summary. Data provenance would be from internal lab testing at Neurovena.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not stated.
- Explanation: "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where interpretive accuracy is key. For a mechanical device like a guide catheter, "ground truth" is established by engineering measurements (e.g., a pressure gauge measures static pressure, a flow meter measures flow rate) against established engineering standards or internal specifications, not by human experts interpreting clinical data.
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Adjudication method for the test set: Not applicable/not stated.
- Explanation: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing ground truth for subjective assessments, primarily in clinical studies of diagnostic or AI-assisted devices. This is not relevant for the bench testing of a guide catheter.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- Explanation: An MRMC study is a clinical study design used to evaluate the performance of diagnostic devices or AI algorithms, often comparing human reader performance with and without AI assistance. This is not applicable to a guide catheter, which is an interventional tool, not a diagnostic one. The 510(k) focuses on substantial equivalence via bench testing and material biocompatibility, not clinical comparative effectiveness in this manner.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
- Explanation: "Standalone performance" refers to the performance of an algorithm without human intervention, again primarily relevant for AI/diagnostic devices. This is not applicable to a mechanical guide catheter.
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The type of ground truth used: Engineering measurements against product specifications.
- Explanation: As discussed in point 3, the "ground truth" for a guide catheter's performance would be derived from objective physical measurements (e.g., actual flow rates, actual torque response, actual bond strength) validated against predefined engineering specifications and industry standards.
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The sample size for the training set: Not applicable.
- Explanation: "Training set" refers to data used to train machine learning models. This is not relevant for a mechanical medical device like a guide catheter, which does not involve AI or algorithms requiring training.
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How the ground truth for the training set was established: Not applicable.
- Explanation: See point 8.
Conclusion:
The provided K972065 document for the AURORA™ Guide Catheter describes a 510(k) submission, confirming the device's substantial equivalence to a predicate device based primarily on bench testing and material biocompatibility. It does not include the detailed clinical study data, expert consensus, or performance metrics against specific acceptance criteria that would be found for a diagnostic device or an AI-enabled product. The "testing" mentioned refers to internal product verification against specifications, the details of which are not public in this summary.
§ 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).