(86 days)
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No
The summary describes a standard angiographic catheter and does not mention any AI/ML terms, image processing, or data sets related to training or testing AI/ML models.
No
The device is described as an angiographic catheter intended for the delivery of radiopaque contrast medium, which is a diagnostic function rather than a therapeutic one.
No
The device is intended for the delivery of contrast medium for angiographic procedures, which is a method of introducing a substance to visualize the vasculature, but it does not diagnose a condition itself. It is an accessory for a diagnostic procedure.
No
The device description clearly states it is a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the delivery of radiopaque contrast medium to selected sites in the vasculature." This describes a device used within the body for imaging purposes, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description of a "single lumen catheter with a radiopaque tip" further supports its use as an interventional or diagnostic tool within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Cordis 4F Nylex Angiographic Catheter is a medical device used for angiography, not an IVD.
N/A
Intended Use / Indications for Use
The Cordis 4F Nylex Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The catheter is a 4F diameter single lumen catheter with a 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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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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 Corporation 4F Nylex Angiographic Catheter, Cordis Corporation 4F Infiniti Angiographic Catheter
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.
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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).
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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 Nylex Angiographic Catheter Modification
0-000015
K9622759
OCT 1 0 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
1 . . .
Diagnostic Intravascular Catheter and Percutaneous Catheter Common or Usual Name:
Cordis 4F Nylex™ Angiographic Catheter Proprietary Name:
II. Name of Predicate Devices
Cordis Corporation 4F Nylex Angiographic Catheter
Cordis Corporation 4F Infiniti Angiographic Catheter
III. Classification
Class II
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis 4F Nylex Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature. The catheter is a 4F diameter single lumen catheter with a radiopaque tip.
VI. Biocompatibility
All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Corporation 4F Nylex Angiographic Catheters per ISO 10993-1.
VII. Summary of Substantial Equivalence
The Cordis 4F Nylex Angiographic Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available angiographic catheters.