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The Propaq M system is indicated to monitor and/or record 3-, 5-, or 12-lead electrocardiogram (ECG) waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. ECG monitoring is indicated for patients from newborn (neonate) to adult, with and without heart dysfunction.

The Propaq M system is indicated for use to make non-invasive measurements of arterial pressure and to alarm if either parameter is outside of the limits set by the user. The non-invasive blood pressure is indicated for patients from newborn (neonate) to adult.

The Propaq M system is indicated for use to make continuous temperature measurements of rectal, or surface temperatures, and to alarm if the temperature is outside of the user. The temperature monitoring feature is indicated for use in patients from newborn (neonate) to adult.

The Propaq M system is indicated for use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI) via the pulse Co-oximeter and accessories. The pulse Co-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

The Propaq M system is indicated for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The respiration monitoring feature is indicated for use on patients from newborn (neonate) to adult.

The Propaq M system is indicated for use in continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The CO2 monitoring feature is indicated for use on patients from newborn (neonate) to adult.

The Propaq M system is indicated for use to display and make continuous invasive pressure measurements via a compatible pressure transducer. The invasive pressure is indicated for use on patients from newborn (neonate) to adult.

The Propaq M system is indicated to provide graphical trend data for SpO2, Systolic BP (SBP) and EtCO2 as well as ventilation assistance relevant to the management of a TBI patient.

The Propaq M system is indicated for use in acquiring, and reporting physiological data via 12-lead ECG Analysis, and to provide interpretation of the data for consideration by caregivers. The 12-lead ECG Analysis feature is indicated for use on adults (> 18 years of age).

The Propaq M system is indicated for the remote display of physiological data displayed on connected Propaq M systems via the Web Console feature, including electrocardiogram (ECG), non-invasive blood pressure (NIBP), temperature, and heart rate.

The proposed ZOLL® Propag® M is a portable monitor designed for use by trained medical personnel who are familiar with basic monitoring and vital signs assessment. In the currently cleared configuration, the ZOLL® Propaq® M provides monitoring capabilities for ECG, Pulse CO-Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), End Tidal CO2, Temperature, and Respiration. The device is powered by an auxiliary power supply or an easily replaced battery pack that is quickly recharged in the device when it is connected to the auxiliary power supply. The product is designed for use in hospital. EMS, and rugged military environments. The unit has a large colorful LCD display of numerics and waveform data that provides easy visibility from across the room and at any angle. ECG, plethysmograph, and respiration waveform traces can be displayed simultaneously, providing easy access to all patient monitoring data at once. The display screen is configurable to allow the best visual layout according to monitoring needs. The Propaq® M has a patient data review and collection system that allows the user to view, store, and transfer patient data. The Propaq® M unit contains a USB port, which the user can use to transfer data to a PC and, optionally, a printer, which can be used to print patient data. The Propaq® M unit can send data through a wireless connections. The unit can send 12lead report snapshots (including trend data) or disclosure logs to a recipient via a ZOLL® server. In addition, full disclosure cases, which also contain trend data, can be automatically retrieved from the Propaq® M unit using ZOLL® RescueNet® or ePCR software. Propaq® M models use an easily replaced rechargeable lithium-ion battery pack (the SurePower II Battery Pack). A new, fully charged battery pack typically delivers more than 8 hours of ECG monitoring. Use of other functions (such as higher screen brightness or shorter NIBP intervals) reduces this time. A clinical dashboard for monitoring patients with suspected traumatic brain injury (TBI) has been added as part of Software Version 02.34 of the proposed Propaq® M device. The TBI Dashboard was initially cleared for ZOLL® X Series® (K141774) to be displayed on a separate mobile device that connects to the main device (ZOLL® X Series®) via Bluetooth. The proposed feature is to display the TBI Dashboard directly on the Propag® M device via Software 02.34. The TBI Dashboard presents the user with graphical trend plots of 3 different parameters - (1) 15 minutes of systolic blood pressure (SBP), (2) 3 minutes of oxygen saturation of arterial hemoglobin (SpO2), and (3) 3 minutes of carbon dioxide concentration of the expired breath (EtCO2). The proposed ZOLL® Propaq® M device already provides this information in tabular format and in the live parameter boxes. The TBI Dashboard groups the information on one screen in a graphical format. The trend graphs display supervisor-configurable limits to allow the user to monitor patient parameters based on their local protocols. These protocol limits only appear in Adult mode. There is also a ventilation panel available on the TBI Dashboard to assist the user with manual ventilations. The TBI Dashboard allows the user to modify the target ventilation rate, the scale of each graphical trend, and to turn the ventilation timer and prompt on or off. Software Version 02.34 introduces automatic retries of failed 12-Lead report transmissions. While legacy Software of the Propaq® M attempts transmission of the 12-Lead report only once, the new proposed Software Version 02.34 attempts re-transmission up to five times if the initial attempt fails. This feature is a non-clinical enhancement since it affects only an external communication feature of the device with no impact to the acquiring, analyzing, or reporting process of ECG data. The Propaq® M device is an alternate configuration of the ZOLL® X Series® device that depopulates the defibrillator/pacer module circuitry. Removal of this circuitry also removes CPR Monitoring capability from the device as the sensor that enables the CPR feature resides in the defibrillation electrodes. Physical changes to the proposed Propaq® M device are limited to removing the defibrillator and pacer modules, removing the defibrillator and pacer controls from the front keypad, and changing the color scheme of the device. The remaining features and functions of the proposed Propaq® M device are identical to the existing ZOLL® X Series® model. In order to simulate the functioning of the Propag® M device, a regression testing was conducted on the X Series device by disabling the defibrillator/pacer module, which ensures the effective functioning of the proposed Propag® M device.

The ZOLL Propaq M device received 510(k) clearance (K202375) and is a portable patient monitor indicated for various physiological monitoring functions including ECG, SpO2, Non-Invasive Blood Pressure, Invasive Blood Pressure, End Tidal CO2, Temperature, Respiration, 12-Lead Analysis, and a new TBI Dashboard feature. The submission focuses on the substantial equivalence of the modified Propaq M (with Software Version 02.34 incorporating the TBI Dashboard and 12-Lead re-transmission) to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter for K202375 does not explicitly list acceptance criteria in a quantitative table format for the device's overall performance. Instead, the clearance is based on the device meeting various recognized standards and demonstrating substantial equivalence to predicate devices through technical comparisons and verification/validation testing. The key additions covered by this submission are the TBI Dashboard and 12-Lead transmission retry enhancement.

Since specific numerical acceptance criteria for the TBI Dashboard and 12-Lead re-transmission were not provided as such in the given document, the table will reflect the types of performance assessments conducted and the outcome in terms of meeting requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a distinct "test set" in the context of diagnostic accuracy or a clinical trial for the TBI Dashboard or 12-Lead re-transmission. Instead, the testing appears to be primarily non-clinical for these specific software enhancements.

• TBI Dashboard & 12-Lead Re-transmission: The evaluation revolved around software verification and validation (V&V) through regression testing on the X Series device (which encompasses the Propaq M's functionalities with defibrillator/pacer module disabled) and usability testing. The sample sizes for these V&V activities are not explicitly detailed in the provided text.
• Data Provenance: The document does not specify country of origin for any data related to these specific updates. The testing described (software V&V, safety, EMC, usability) are typically internal company processes. The submission refers to prior clearances for the predicate devices (K180482, K141774, P160022/S013), suggesting the data originates from previous testing submissions for those devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The TBI Dashboard update primarily involves displaying existing physiological data in a new graphical format and providing ventilation assistance. The 12-Lead re-transmission is a technical enhancement. Ground truth for these features would typically be established through engineering specifications, software requirements, and expert review within the development process, rather than a clinical "ground truth" derived from patient data by independent medical experts for performance validation.

4. Adjudication Method for the Test Set

This information is not provided as the submission focuses on non-clinical testing for software updates and substantial equivalence, not a clinical study requiring adjudication of expert interpretations against ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in the provided text for the TBI Dashboard or 12-Lead re-transmission features. The submission states, "Clinical evidence was not necessary to show substantial equivalence." The improvements are primarily in data presentation and system reliability, not diagnostic accuracy requiring human reader comparison.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm of the TBI Dashboard or 12-Lead re-transmission, separate from the human-in-the-loop, was not explicitly detailed. The TBI Dashboard is a display feature and ventilation assistance tool presenting existing physiological data. The 12-Lead re-transmission is a software function to improve data transfer reliability. Their performance is assessed through software verification and validation, as well as usability testing, which inherently involves human interaction with the device.

7. Type of Ground Truth Used

For the software updates (TBI Dashboard and 12-Lead re-transmission), the "ground truth" implicitly used is:

• Engineering Specifications and Software Requirements: The device's performance is validated against its pre-defined functional and performance specifications.
• Existing Physiological Data Streams: The TBI Dashboard utilizes existing, cleared physiological monitoring parameters (SpO2, SBP, EtCO2) from the Propaq M. The "ground truth" for these underlying parameters would have been established in previous clearances. The TBI Dashboard's "truth" is the faithful and accurate graphical representation of these established data streams.

8. Sample Size for the Training Set

The document does not mention a training set sample size because the TBI Dashboard and 12-Lead re-transmission are not described as machine learning or AI models that require a distinct "training set" in the conventional sense. They are software features that process and display data based on predefined rules and algorithms.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for these specific features (TBI Dashboard and 12-Lead re-transmission), this question is not applicable.

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