(87 days)
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No
The summary describes a standard infusion catheter and explicitly states that it is similar to other commercially available devices, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics associated with AI/ML models.
No
The device is used for the infusion of diagnostic and embolic agents into the vasculature, which are medical interventions but the device itself is a delivery mechanism, not a therapeutic agent.
No
The device is used to infuse diagnostic agents, but it is an infusion catheter, not a diagnostic device itself.
No
The device description explicitly states it is a "catheter," which is a physical hardware device, not software.
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 "infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures." This describes a device used within the body for delivering substances, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description focuses on the physical characteristics and performance of a catheter, which is a medical device used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for infusion, not an IVD.
N/A
Intended Use / Indications for Use
CES Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures.
Product codes
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Device Description
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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
peripheral, coronary and neurovasculatures
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
MAR 21 1997
如何
PREMARKET NOTIFICATION 510(k) Cordis Endovascular Systems, Inc. CES Infusion Catheters Modification
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions:
Diagnostic, Intravascular Catheter Common or Usual Name:
CES Infusion Catheters Proprietary Name:
Name of Predicate Devices ய
| 1. | Trade Name:
Manufacturer: | TRANSIT® Infusion Catheter
Cordis Endovascular Systems, Inc. |
|----|------------------------------|---------------------------------------------------------------------|
| 2. | Trade Name:
Manufacturer: | RapidTRANSIT® Infusion Catheter
Cordis Endovascular Systems, Inc |
| 3. | Trade Name:
Manufacturer: | Tracker Infusion Catheters
Target Therapeutics |
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.
Intended Use and Device Description V.
CES Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures.
Biocompatibility VL
All appropriate biocompatibility tests were successfully performed on the CES Infusion Catheters.
VIL Summary of Substantial Equivalence
The CES Infusion Catheters are similar in its basic design, construction, indication for use and performance characteristics to other commercially available infusion catheters.