(50 days)
Cordis ENVOY, Cordis Vista Brite Tip
Cordis ENVOY, Cordis Vista Brite Tip
No
The device description and intended use describe a physical guiding catheter, and there is no mention of AI, ML, image processing, or data analysis that would indicate the use of AI/ML technology.
No
The device is a guiding catheter for introducing other interventional/diagnostic devices, not a therapeutic device performing therapy itself.
No
The device is a guiding catheter, used to introduce other devices (which can be interventional or diagnostic) into the body. This specific device itself is not described as performing diagnostic functions.
No
The device description clearly details a physical catheter with material specifications and construction, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems" and "in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body.
- Device Description: The description details the physical construction of a catheter designed for insertion into blood vessels. This aligns with the intended use of a guiding catheter.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (in a lab setting), or providing diagnostic information based on the analysis of these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vascular systems (Vista Brite Tip)
peripheral, coronary and neurovasculature (ENVOY)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis ENVOY, Cordis Vista Brite Tip
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.