(168 days)
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No
The summary describes a standard thermodilution catheter and does not mention any AI or ML components or capabilities.
No.
The device is used to obtain diagnostic measurements (right heart pressure and cardiac output), not to treat a condition.
Yes
The intended use explicitly states that the device is used to obtain right heart pressure readings and cardiac output, which are diagnostic measurements used to assess cardiac function.
No
The device description explicitly states it is a "Flow Directed Thermodilution / Infusion Balloon Catheter," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain right heart pressure readings and cardiac output from within the body. This is an in vivo measurement, not an in vitro (outside the body) diagnostic test.
- Device Description: A flow-directed thermodilution/infusion balloon catheter is a device used for direct measurement within the cardiovascular system.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is a hallmark of IVD devices.
Therefore, this device falls under the category of a medical device used for physiological monitoring and measurement within the patient's body.
N/A
Intended Use / Indications for Use
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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
right heart
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
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)
Engineering tests of the design indicate the effectiveness and safety of these devices present an acceptable level of safety when properly used by a trained physician.
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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§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
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Summary of Safety and Effectiveness
FEB - 3 1997
Flow Directed Thermodilution / Infusion Balloon Catheter Ref : By J-Lloyd Medical, Inc.
The effectiveness of the J-Lloyd catheter is equivalent to the Nova Medical Specialties, Inc. design, in that they both perform their designed functions, which is to provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output. Test indicate that the materials used in both catheters exceed the strength required. The bond joints will withstand tensile pressures in excess of that required for safety and effectiveness. Tests for other design characteristics such as balloon burst strength, and injection rate showed little of significance. As with any invasive procedure, there are certain inherent hazards. These hazards have been identified in the instruction sheet under the titles of Precautions and Warnings. it is important that the physicians be aware of the basic principles involved prior to using these devices in their varied application.
Engineering tests of the design indicate the effectiveness and safety of these devices present an acceptable level of safety when properly used by a trained physician.