(217 days)
Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters
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No
The description focuses solely on the physical construction and materials of a guiding catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a guiding catheter intended for the introduction of other devices, not for therapeutic intervention itself.
No
The device is described as a "guiding catheter" intended for "intravascular introduction of interventional/diagnostic devices." While it facilitates the use of diagnostic devices, the catheter itself is an access tool, not a device that directly performs diagnosis (e.g., by taking measurements or creating images).
No
The device description clearly details a physical catheter with material properties, reinforcement, and a radiopaque tip, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a "guiding catheter" intended for "intravascular introduction of interventional/diagnostic devices into the coronary, peripheral and neurovasculature." This means it's a tool used inside the body to help guide other devices.
- Lack of Specimen Testing: There is no mention of this device being used to test or analyze any biological specimens. Its function is purely mechanical and procedural, facilitating access within the vascular system.
Therefore, based on the provided information, this guiding catheter is a medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The guiding catheter is intended for use for intravascular Indications: introduction of interventional/diagnostic devices into the coronary, peripheral and neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Vista Brite Tip Guiding Catheters are single lumen catheters which Description: 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, peripheral and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K6346a
Cordis Guiding Catheter
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions:
Common or Usual Name: Percutaneous Catheter Proprietary Name: Cordis Vista Brite Tip®
II. Name of Predicate Devices:
Cordis Vista Brite Tip Cordis Endovascular Systems, ENVOY Guiding Catheters
- III. Classification Class II
- Performance Standards: Performance standards have not been established by the FDA IV. under section 514 of the Food, Drug and Cosmetic Act.
Indication For Use and Device Description V.
- Vista Brite Tip: The guiding catheter is intended for use for intravascular Indications: introduction of interventional/diagnostic devices into the coronary, peripheral and neurovasculature.
- The Vista Brite Tip Guiding Catheters are single lumen catheters which Description: 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.
Biocompatibility: VI.
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.
MAY - 7 1997