(204 days)
The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
The catheters included in this submission are 5 F and 6 F in diameter with a braided proximal shaft and a variety of tip configurations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cordis Infiniti Angiographic Catheters:
Summary of Device and Context:
The submission describes a modification to existing Cordis Infiniti Angiographic Catheters (5 F and 6 F diameter) for delivering radiopaque contrast medium to selected sites in the vascular system. The key aspect of this submission is that it's a modification to existing devices, and the approval is based on demonstrating substantial equivalence to previously cleared predicate devices. This implies that extensive new performance studies for efficacy might not have been required if the changes were deemed minor and within established safety and performance envelopes.
Acceptance Criteria and Device Performance:
Based on the provided document, specific quantitative acceptance criteria or detailed performance metrics are not explicitly stated or presented in a table format. This is common for 510(k) submissions focusing on substantial equivalence, especially for modifications to devices with well-established safety and performance profiles.
Instead of a table of acceptance criteria, the document focuses on demonstrating substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the modified device performs comparably to the predicate devices and maintains the same safety profile.
The document states:
- "The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially angiographic catheters."
- "All appropriate biocompatibility tests were previously performed on the materials used for the 5 F and 6 F Infiniti® Angiographic Catheters. No new tests were performed, since all materials had been successfully tested on previously concurred devices."
Therefore, a table of explicit acceptance criteria and device performance based solely on this document cannot be generated. The document indicates that the device met acceptance implicitly by demonstrating equivalence to previously approved devices.
Study Details (Based on available information):
Given the nature of a 510(k) for a device modification and the information provided, it's highly unlikely that a standalone clinical study with detailed performance metrics, ground truth establishment, or human reader effectiveness was conducted and reported within this summary. The reliance is on prior validation of the predicate devices.
1. Sample sized used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. Given the focus on substantial equivalence, any "testing" would likely involve comparing the modified design/materials to the predicate. The document mentions "All appropriate biocompatibility tests were previously performed on the materials used... No new tests were performed." This implies reliance on historical data and material testing rather than a new "test set" in the context of a clinical study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified. Ground truth establishment, in the sense of expert review for diagnostic accuracy, is not relevant to this type of submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/None specified. No clinical test set requiring adjudication is described.
4. 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:
- MRMC Study: No.
- Effect Size: Not applicable. This is not an AI/diagnostic imaging device where human reader improvement with AI assistance would be relevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical medical device (catheter), not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable in the context of a diagnostic or AI device. The "ground truth" for this catheter's performance is its ability to safely and effectively deliver contrast medium, which would be assessed through engineering testing, material compatibility, and comparison to existing predicate devices.
7. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not a machine learning or AI device that requires a training set.
8. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable.
Conclusion:
The provided document describes a 510(k) submission for a modification to an existing angiographic catheter, seeking approval based on substantial equivalence to previously cleared predicate devices. The focus is on demonstrating that the modified catheters maintain similar design, construction, indications for use, and performance characteristics, and utilize materials already proven biocompatible.
Therefore, the submission does not contain information about a traditional performance study involving a large test set, expert readers, or ground truth establishment in the way one would expect for a novel diagnostic device or AI algorithm. Instead, the "study" is the demonstration of equivalence through technical specifications, material comparisons, and reliance on the safety and effectiveness data of the predicate devices.
§ 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).