(50 days)
Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems. ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The ENVOY and Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless 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 durometers (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.
This looks like a 510(k) premarket notification for a medical device (Cordis Guiding Catheters) and not a study describing a device that uses AI or machine learning. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML performance evaluations, are not present in the provided text.
The provided text focuses on:
- General Provisions: Common and proprietary names, predicate devices, classification, and lack of established performance standards.
- Indication For Use and Device Description: Explaining what the catheters are used for and their physical characteristics.
- Biocompatibility: Stating that tests were successfully completed.
- Summary of Substantial Equivalence: Claiming similarity to existing devices.
- Proposed Labeling: Discussing package labels, instructions for use, and intended use statements.
Conclusion:
Based on the provided document, I cannot extract the information required to populate the table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML. This document pertains to a traditional medical device submission (catheters) where performance is likely demonstrated through substantial equivalence to predicate devices and adherence to manufacturing and materials standards, rather than through complex performance metrics against a defined ground truth as would be the case for an AI algorithm.
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PREMARKET NOTIFICATION 510(k) Cordis Corporation a Johnson & Johnson Company Cordis Guiding Catheter Modifications
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions:
Common or Usual Name: Percutaneous Catheter Proprietary Name: Cordis ENVOY, Cordis Vista Brite Tip
II. Name of Predicate Devices:
AUG - 8 1996
Cordis ENVOY, and Cordis Vista Brite Tip
- Class II III. Classification
- IV. Performance Standards: Performance standards have not been established by the FDA 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 and peripheral vascular systems. ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
- Description: The ENVOY and Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless 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 durometers (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.
VIL. 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.
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PREMARKET NOTIFICATION 510(k) Cordis Corporation a Johnson & Johnson Company Cordis Guiding Catheter Modifications
Section 3 - Proposed Labeling
a) Package Labels:
Draft labeling for the ENVOY and the Vista Brite Guiding Catheters is located in Attachment I.
The Instructions For Use for the ENVOY and the Vista Brite Tip Catheters is located in Attachment I.
Sterile/Caution statement appears on the box and catheter pouch and is identical for the ENVOY and the Vista Brite Tip Guiding Catheters. It is located in Attachment I.
The labeling, IFUs and Sterile/Caution statement are identical to the predicate devices. The only possible modification is the lengths and ID (inner diameters) under the cathetr descriptions
- b) Statement of Intended Use: The intedded use is identical to the predicate catheters.
Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.
ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The indication for use can also be found on the following page pursuant to the FDA requirement, that all 510(k) submitters provide the indication for use on a separate page, in Attachment V, which clearly states, "Indications for Use".
c) Advertisements or Promotional Materials
The product advertisement/promotional materials are located in Attachment I.
§ 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).