(22 days)
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No
The summary describes a standard angiographic catheter and makes no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No.
The device is intended for the delivery of contrast medium for diagnostic imaging, not for treating a disease or condition.
No
Explanation: The device is an angiographic catheter intended for the delivery of contrast medium for imaging, not for diagnosing disease itself. It facilitates a diagnostic procedure (angiography) but is not a diagnostic device.
No
The device description clearly indicates a physical catheter, which is a hardware component, not a software-only device.
Based on the provided information, the Cordis 4F Infiniti Angiographic Catheters are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for the delivery of radiopaque contrast medium to selected sites in the vascular system." This describes a device used within the body for a diagnostic procedure (angiography), not a test performed outside the body on biological samples.
- Device Description: The description of a catheter with a braided shaft and radiopaque tip is consistent with a device used for accessing and navigating the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cordis 4F Infiniti Angiographic Catheters are used in vivo (within the living body) as part of a diagnostic imaging procedure.
N/A
Intended Use / Indications for Use
The Cordis 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Product codes
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Device Description
The catheter is 4F in diameter with a braided proximal shaft and radiopaque tip.
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
vascular system
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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
PREMARKET NOTIFICATION 510(k) Cordis Corporation 4F Infiniti Angiographic Catheter
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions I.
Diagnostic Intravascular Catheter and Percutaneous Catheter Common or Usual Name:
Cordis 4F Infiniti™ Angiographic Catheter Proprietary Name:
Name of Predicate Devices II.
Cordis Corporation 4F Nylex Angiographic Catheter (K930479)
Cordis Corporation Paragon Angiographic Catheter (K921310/A)
Classification III.
Class II
Performance Standards IV.
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description V.
The Cordis 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system. The catheter is 4F in diameter with a braided proximal shaft and radiopaque tip.
VI. Biocompatibility
All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Corporation Infiniti Angiographic Catheters.
Summary of Substantial Equivalence VII.
The Cordis 4F Infiniti Angiographic Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available angiographic catheters.