(63 days)
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary, peripheral, and neufosvasculature.
The Cordis Vista Brite Tip Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless steel braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different stiffness to provide gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter.
This document is a 510(k) summary for the Cordis Vista Brite Tip Guiding Catheter. It establishes substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the manner of a clinical trial for a new therapeutic device.
Therefore, many of the requested sections regarding acceptance criteria and a study proving their fulfillment, especially those involving expert reviews, ground truth, and statistical analyses (like MRMC studies) are not applicable or extractable from this type of regulatory submission. The document focuses on performance characteristics and biocompatibility to demonstrate equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific, quantifiable acceptance criteria (e.g., specific thresholds for success, safety endpoints) with corresponding device performance results from a dedicated study. Instead, it relies on demonstrating substantial equivalence to a previously approved predicate device.
The performance characteristics mentioned are general design features and biocompatibility.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Similar Design | The Cordis Vista Brite Tip Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless steel braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different stiffness to provide gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter. Similar in design, construction... to other commercially available Cordis guiding catheters. |
| Similar Construction | (See "Similar Design" above) |
| Biocompatibility | All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Vista Brite Tip Catheter. |
| Intended Use | The Cordis Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary, peripheral, and neurovasculature. Similar in... indication for use... to other commercially available Cordis guiding catheters. |
| Performance Characteristics | (Implicitly similar to predicate device) Similar in... performance characteristics to other commercially available Cordis guiding catheters. Performance standards have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic Act for this device type. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission demonstrating substantial equivalence, not a clinical study involving a test set of data or patient samples. The review is based on device design, materials, and comparison to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set was established by external experts in the context of this submission. The FDA reviews the provided information to determine substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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. This device is a guiding catheter, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (guiding catheter), not an algorithm or software requiring standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There was no "ground truth" in the context of a clinical study or diagnostic performance evaluation. The "truth" in this submission is that the device is demonstrably equivalent in design, materials, indications, and performance to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device where a training set would be used.
9. How the ground truth for the training set was established
Not applicable. There was no training set.
§ 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).