The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Device Description

The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced 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 catheters are designed with nylons of different durometer (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is Pellethane® with a radiopaque filler, this is the softest material in the catheter.

AI/ML Overview

This 510(k) premarket notification for the Cordis Guiding Catheter (K965211) does not contain the information requested in your prompt. The document is from 1997 and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert involvement, or specific ground truth methodologies.

Here's why the information cannot be extracted:

Type of Device: The Cordis Guiding Catheter is a physical medical device (catheter) used for vascular access, not a software algorithm or AI-powered diagnostic tool. The concepts of "acceptance criteria" and "study" in your prompt primarily relate to the performance of such algorithms, often involving metrics like sensitivity, specificity, AUC, etc., derived from analyzing a dataset.
Regulatory Context (1997 510(k)): In 1997, 510(k) submissions for physical devices like catheters focused heavily on demonstrating substantial equivalence to already legally marketed predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The core of such a submission usually involves:
- Comparison of design, materials, and manufacturing processes.
- Bench testing (mechanical strength, material properties, biocompatibility).
- Sometimes limited animal or human use data if there are significant technological differences or new intended uses, but it's not the primary focus for demonstrating equivalence.
Missing Information:
- Acceptance Criteria & Device Performance Table: Not applicable/provided in this context. Performance is typically demonstrated through bench testing (e.g., tensile strength, burst pressure) and comparison to predicates, not metrics like sensitivity found in diagnostic AI.
- Sample Size (Test Set) & Data Provenance: Not applicable for this type of device and submission.
- Number/Qualifications of Experts for Ground Truth: Not relevant for a physical catheter's equivalence claim.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable.
- Standalone Performance Study: The document doesn't detail a specific performance study in the way you're asking. It mentions "All appropriate biocompatibility tests for the guiding catheters were successfully completed" but doesn't provide the raw data, acceptance criteria, or methodology for these tests.
- Type of Ground Truth: Not applicable in the context of diagnostic accuracy.
- Training Set Sample Size/Ground Truth: Not applicable, as this is not an algorithm based on machine learning.

In summary, the provided 510(k) document is for a physical medical device and therefore does not contain the information typically associated with the performance evaluation of diagnostic algorithms or AI-powered devices as outlined in your prompt.

Summary

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PREMARKET NOTIFICATION 510(k) Cordis Corporation

K965211

Cordis Guiding Catheter

MAR 1 1 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

I. General Provisions:

Common or Usual Name: Percutaneous Catheter Proprietary Name: Cordis Vista Brite Tip®

Name of Predicate Devices: IL

Cordis Vista Brite Tip Cordis Endovascular Systems, ENVOY Guiding Catheters

Class II III. Classification
Performance Standards: Performance standards have not been established by the FDA IV. under section 514 of the Food, Drug and Cosmetic Act.

V. Indication For Use and Device Description

Vista Brite Tip: The guiding catheter is intended for use for intravascular Indications: introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Description: The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced 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 catheters are designed with nylons of different durometer (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is Pellethane® with a radiopaque filler, this is the softest material in the catheter.

VL Biocompatibility:

All appropriate biocompatibility tests for the guiding catheters were successfully completed.

VII. Summary of Substantial Equivalence:

The Cordis Guiding Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters.

Regulation Number and Section

§ 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).