(74 days)
Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters
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No
The summary describes a physical medical device (guiding catheter) with no mention of software, algorithms, or any terms related to AI/ML.
No.
The device is a guiding catheter intended for the introduction of other devices, not for direct therapeutic treatment itself.
No
The device is a guiding catheter used for the introduction of other devices, not for diagnosing conditions itself.
No
The device description clearly describes a physical catheter with material components (nylon, stainless steel braid wire, Pellethane®) and a specific physical structure, 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 the device is for "intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems." This describes a device used within the body for delivering other devices, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for navigation within blood vessels. This aligns with an in-vivo (within the body) medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions by examining samples outside the body.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This guiding catheter's function is purely mechanical and procedural within the vascular system.
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 or peripheral vascular systems.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
coronary or peripheral vascular systems
Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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.