(117 days)
The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.
The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.
The provided 510(k) summary describes a medical device, the HYPERTRANSIT™ Infusion Catheter, and its substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a standalone study with specific performance metrics.
Instead, the document details comparative and performance testing to demonstrate safety and effectiveness and substantial equivalence to existing devices already on the market. It does not present acceptance criteria with target performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML medical device.
Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or available in this document.
However, I can extract information related to the types of testing conducted and the basis for substantial equivalence.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: This section is adapted as the document focuses on equivalence and performance testing rather than acceptance criteria for an AI/driven device's diagnostic performance. The "Acceptance Criteria" here are implicitly meeting performance benchmarks comparable to predicate devices and acceptable safety profiles. "Reported Device Performance" refers to the successful completion of these tests as implied by the FDA's clearance.
| Acceptance Criteria (Implied for Device Performance & Safety) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| Comparative Testing: | |
| Linear Stiffness within acceptable range and comparable to predicates | Testing conducted (e.g., comparable to MASSTRANSIT®, Renegade HI-FLO, PROWLER® SELECT™) |
| Flow Rate Testing demonstrating adequate flow and comparability to predicates | Testing conducted (e.g., comparable to MASSTRANSIT®, Renegade HI-FLO, PROWLER® SELECT™) |
| Shape Retention meeting design specifications and comparable to predicates | Testing conducted |
| Acute Animal Studies demonstrate safety in-vivo and comparable to predicates | Testing conducted |
| Embolic Particle (PVA) Functional Compatibility Testing | Testing conducted |
| Pushable Coil Functional Compatibility Testing | Testing conducted |
| Performance Testing (Safety & Effectiveness): | |
| Dimensional Inspection meets specifications | Testing conducted |
| Joint Pull Test meets strength requirements | Testing conducted |
| Static Burst Test meets pressure resistance requirements | Testing conducted |
| Dynamic Burst Test meets pressure resistance requirements over time | Testing conducted |
| Particulate Testing meets cleanliness standards | Testing conducted |
| Coating Integrity maintained during use | Testing conducted |
| Flow Rate Testing demonstrates intended flow characteristics | Testing conducted |
| Acute Animal Studies demonstrate in-vivo safety | Testing conducted |
| Biocompatibility Testing meets regulatory standards for patient contact | Testing conducted |
| Overall Substantial Equivalence: | Determined to be substantially equivalent to predicate devices (MASSTRANSIT®, PROWLER® SELECT™, Renegade HI-FLO Microcatheter) for basic design, intended use, sterilization, and performance. |
Not Applicable / Not Provided Information for AI/ML Device Study:
The following information is not present in the given document because the device (HYPERTRANSIT™ Infusion Catheter) is a physical medical device, not an AI/ML software or algorithm requiring diagnostic performance metrics.
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes testing for a physical catheter, not an AI/ML algorithm that uses a test set of data. The "test set" would refer to the catheters themselves undergoing various physical and functional tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of AI/ML, refers to a label or diagnosis established by experts for a dataset. For a physical device, testing involves measuring physical properties or observing performance in simulated/animal environments, not expert labeling of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI/ML ground truth. This is not relevant for testing a physical instrument.
5. 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
- Not Applicable. MRMC studies are specific to AI/ML devices that aim to assist human readers in tasks like image interpretation. This device is a catheter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to the performance of an AI algorithm in isolation. The HYPERTRANSIT™ Infusion Catheter is a physical device used by clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the physical device, "ground truth" is established by engineering specifications, validated test methods (e.g., for flow rate, burst pressure), and clinical/biological observations in animal studies.
8. The sample size for the training set
- Not Applicable. Training sets are used for machine learning. This document describes the development and testing of a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it is irrelevant in this context.
§ 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).