(30 days)
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No
The summary describes a device for displaying and monitoring pressure during cardiopulmonary bypass, with no mention of AI, ML, image processing, or data analysis that would typically involve such technologies. The predicate device is also from 1985, predating widespread AI/ML use in medical devices.
No
The device is used for displaying and monitoring pressures, which supports a medical procedure (cardiopulmonary bypass surgery) but does not directly treat a disease or condition. Its function is diagnostic/monitoring, not therapeutic.
No
The devices are described as displaying and monitoring pressures, which are measurements of physiological parameters but not interpretations leading to a diagnosis. They are tools for use during surgery to observe real-time data, not to diagnose a condition.
No
The 510(k) summary describes a "Pressure Display Box" and a "Disposable Pressure Display Set," which are explicitly hardware components used in cardiopulmonary bypass surgery. The summary does not mention any software component or its function.
Based on the provided information, neither the Pressure Display Box nor the DLP® Disposable Pressure Display Set are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use of these devices is to display and monitor pressures during cardiopulmonary bypass surgery, which is a procedure performed on the patient's body. They are not used to analyze blood, tissue, or other bodily fluids outside of the body.
- The intended use clearly describes monitoring pressures within the circulatory system during surgery. This is a direct measurement of physiological parameters within the patient, not an analysis of a sample.
Therefore, these devices fall under the category of medical devices used for monitoring during a surgical procedure, not IVDs.
N/A
Intended Use / Indications for Use
Pressure Display Box Indications for Use:
This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.
DLP® Disposable Pressure Display Set Indications for Use:
This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
Product codes (comma separated list FDA assigned to the subject device)
DXS
Device Description
No modifications have been made to the Devices as a result of this change. This submission is a result of a change to the labeling. The devices operating principle and technological characteristics are remaining the same.
As described in this submission, minor modifications since the original submission have been made to the Devices Directions for Use and the device packaging labels for the convenience of the user.
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.
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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§ 870.4310 Cardiopulmonary bypass coronary pressure gauge.
(a)
Identification. A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.(b)
Classification. Class II (performance standards).
0