(66 days)
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
Merit's Impress consists of a shaft with molded hub and an overmolded segment at the proximal end of the device. The shaft is initially available in a wirebraid reinforced shaft. The distal tip is tapered for even high volume flow and dispersion of the contrast media, and flexible to minimize the potential for vessel trauma.
The provided text describes a 510(k) premarket notification for the "Merit Impress™ Radiology Catheter". This submission is to demonstrate substantial equivalence to predicate devices, not to prove the device meets specific acceptance criteria through a clinical study in the way a novel therapeutic or diagnostic device would undergo such testing.
Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission as described in the provided document.
Here's a breakdown of what can be extracted and what is not available:
Acceptance Criteria and Device Performance
The document states: "Performance testing was conducted according to protocols based on international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Impress, comparison with the predicate devices was conducted, and conformance to validated criteria was confirmed."
This indicates that internal acceptance criteria were established and met, and comparisons were made to predicate devices. However, the specific quantitative acceptance criteria and the detailed reported performance values are not provided in this summary document. The document concludes: "Performance data demonstrates that the Impress is substantially equivalent to the predicate devices."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (from International Standards/Merit Protocols) | Reported Device Performance (vs. Predicate/Criteria) |
|---|---|---|
| Functional Performance | (Not specified in the document) | Demonstrated substantial equivalence to predicates |
| Safety | (Not specified in the document) | Conformance to validated criteria confirmed |
| Effectiveness | (Not specified in the document) | Conformance to validated criteria confirmed |
| Material Compatibility | (Not specified in the document) | Comprised of similar materials to predicates |
| Design Characteristics | (Not specified in the document) | Similar method of operation and design to predicates |
Study Details (Based on available information and the nature of a 510(k) for a diagnostic catheter)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The study described is "bench testing" and "performance testing" based on international standards and Merit's in-house protocols. This implies in vitro or engineering-level testing, not clinical data involving human subjects or real-world data provenance in the way clinical studies typically refer to it.
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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. This was bench testing, not a study requiring expert ground truth for diagnostic accuracy (e.g., radiologists interpreting images).
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Adjudication method for the test set:
- Not Applicable. As above, this was bench testing.
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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:
- No. This is a diagnostic catheter used for delivering contrast media, not an AI or image-reading assistance device. Therefore, MRMC studies and AI assistance metrics are not relevant to this device's regulatory submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (catheter), not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications / Performance Standards. The "ground truth" for bench testing would be defined by pre-established engineering specifications, international standards (e.g., for flow rates, pressure resistance, material strength, biocompatibility), and performance benchmarks set against the predicate devices.
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The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set in the conventional sense.
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set in the context of AI/ML.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).