(87 days)
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No
The description focuses on the physical construction and materials of a guiding catheter, with no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: The device is described as a "guiding catheter" intended for the "intravascular introduction of interventional/diagnostic devices." Its function is to facilitate the delivery of other devices, not to provide a therapeutic effect itself.
No
The device is a guiding catheter used for introducing other devices, not for diagnosis itself. While it mentions "diagnostic devices," it clarifies that it introduces them, rather than being one.
No
The device description clearly describes a physical catheter with material components (nylon, stainless braid wire, pellethane) and a lumen, 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 the "intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems." This describes a device used within the body to facilitate other procedures, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This aligns with an in-vivo (within the living organism) medical device, not an in-vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on testing samples outside the body.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This guiding catheter 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.
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 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
coronary and 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
Reference Device(s)
Not Found
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
00-00007
PREMARKET NOTIFICATION 510(k) Cordis Corporation
Cordis Guiding Catheter
OCT 17 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
- I. General Provisions:
K962830
Common or Usual Name: Percutaneous Catheter Proprietary Name: Cordis Vista Brite Tip®
-
IL Name of Predicate Devices:
Cordis Vista Brite Tip -
III. Classification Class II
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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
- Indications: Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and 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 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, materials, indication for use and performance characteristics to other commercially available guiding catheters.