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Cybersecurity
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Proactive software security patch
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A device manufacturer finds a security vulnerability as part of an ongoing security evaluation of their device. The manufacturer modifies the software solely to remove this vulnerability. The manufacturer's analysis determined that the change does not have any other impact on the software or the device.
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The change solely addresses cybersecurity vulnerabilities and has no impact on the device or safety.
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Document as part of Change Management Process - No New 510(k)
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Changes inline with recently cleared Predicate
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Error during a maintenance procedure
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A manufacturer makes a software modification to fix an automated scheduled daily maintenance procedure. The defect concerned the cleaning solution bottle size parameter used in a maintenance procedure. The defect impacted the system's ability to detect fluid on the bottle septum and caused intermittent fluid detection errors during the maintenance procedure. The user may need to repeat the procedure 2-3 times to complete the procedure without error. A software change is made to update the size parameter as was originally documented in the software specifications.
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The change is to correct the software error of changing the bottle size parameter back to the specified bottle size to bring the system back to specification.
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Document as part of Change Management Process - No New 510(k)
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Changes introducing new risk or modifying existing risk
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Adding a new programming mode to a cardiac monitor
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The device is an implantable, automatically activated monitoring system that records subcutaneous electrocardiograms designed to record the arrhythmias in a patient. The manufacturer has made a software modification to add an alternative programming mode to change the way the device interacts with the programmer. This new programming mode provided different capabilities for data programming, interrogating, and managing the device data and function. The mode introduces new technology that impacts the safety profile of the device as a result of the energy transfer that occurs during programming.
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This feature brings new risks due to the new programming mode, which could cause harm through energy transfer to the patient.
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Document as part of Change Management Process - New 510(k) Required
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Removing a diagnostic parameter
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An electroencephalogram (EEG) diagnostic monitor was cleared with Spectral Edge Frequency (SEF) and Peak Power (PP). SEF and PP are used by neurologists as quantitative parameters along with the raw EEG trace and other clinical metrics to arrive at a clinical decision. The device's intended use is to monitor brain electrical activity through electrodes placed on the surface of the head. A modification is made to remove PP from the displayed quantitative parameters based on a marketing conducted survey that indicated customers did not use PP in their clinical decisions.
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Removal of PP does not add a new risk or modify any of the existing risks for the device.
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Document as part of Change Management Process - No New 510(k)
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Changes introducing new risk control measure or modifying existing risk control measure
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Adding user interface alerts and controls
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An IVD analyzer manufacturer makes software modifications to replace existing modes of controls for handling samples having invalid characters in specimen IDs (specimen identification mis-association) received from Laboratory Information Systems or middleware vendors. Existing manual modes of control were adequate but required operator interaction to evaluate whether a result record for a sample had an invalid specimen ID. The new modes of control include additional automation through a design improvement that will not generate results for a sample having an invalid specimen ID. Instead, the system software will: (1) generate a warning message to the operator that an invalid specimen ID was detected; (2) not generate or report results for a sample having an invalid specimen ID; and (3) create a system log entry.
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This software change automates a risk control for identifying invalid characters, replacing a manual process. If invalid characters aren't properly identified, patient lab results could be lost or replaced with incorrect ones, potentially affecting treatment decisions and causing harm.
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Document as part of Change Management Process - New 510(k) Required
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Infusion pump alarm
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A general-purpose infusion pump has one alarm to alert the user when an occlusion has been detected. The software change modifies the existing alarm to provide two alarms related to occlusion: occlusion downstream and occlusion upstream. These alarms provide specific information to help resolve the occlusion.
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The change updates the existing alarm for occlusion, an important safety measure to help prevent harm by managing specific occlusion events effectively.
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Document as part of Change Management Process - New 510(k) Required
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Changes in line with clinical functionality and performance specifications
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Modify device algorithms
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A manufacturer makes a software modification to enhance an arrhythmia detection algorithm. The device is intended to provide detection alarms for life-threatening arrhythmias in an intensive care unit (ICU) environment. The change impacts sensitivity and specificity and therefore the detection of arrhythmias, which are critical to the clinical performance of the device.
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The modification has a direct impact on the diagnostic performance of the device in which the performance of the arrhythmia detection was changed.
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Document as part of Change Management Process - New 510(k) Required
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Steriliser user interface change
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A sterilizer display provides vital information on the temperature, the pressure, and the remaining cycle time. Software changes are made to increase the font size of these parameters on the display due to customer feedback (not related to any adverse events). The items are all in the same location and the appearance is unchanged aside from the larger font size.
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The information was previously displayed and the change has no significant effect on the functionality or the performance of the device.
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Document as part of Change Management Process - No New 510(k)
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