(45 days)
The Propaq XM is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, and the use of the Propaq XM. The Propaq XM is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq XM will be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq XM unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
ECG Monitoring: The Propaq XM is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
Non-Invasive Blood Pressure Monitoring: The Propaq XM is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.
Temperature Monitoring: The Propaq XM is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. The patient population will range from newborn (neonate) to adult.
SpO2 Monitoring: The Propaq XM pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Respiration Monitoring: The Propaq XM is intended 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 patient population will range from newborn (neonate) to adult.
CO2 Monitoring: The Propaq XM is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The patient population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring: The Propaq XM is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.
12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).
The ZOLL X Series was cleared by the agency under 510(k) application K112432 as a multi-parameter monitor / defibrillator / external transcutaneous pacer with the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures, CO2. temperature, data recording and printing. The device is designed for use by trained medical personnel in both out-of-hospital and in-hospital applications. The proposed device (Propag XM) is a monitor-only version of the cleared device. The Propag XM is a configuration of the X Series device that depopulates the defibrillator/pacer and printer modules. All remaining features and functions of the two devices are identical and they share the same software code base.
The provided 510(k) summary for the ZOLL Propaq XM indicates that the device is a modified version of a previously cleared device (X Series, K112432). As such, the performance testing for the Propaq XM focuses on demonstrating substantial equivalence to the predicate device rather than establishing new acceptance criteria or conducting extensive effectiveness studies.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document states that "Extensive performance testing ensures that Propaq XM performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards." However, no specific quantitative acceptance criteria or detailed reported device performance metrics are provided in the document. The key acceptance criterion appears to be "performs as well as the indicated predicate device."
| Parameter/Feature | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Overall Performance | Performs as well as the predicate device (ZOLL X Series, K112432) regarding its functional requirements and performance specifications for all monitoring capabilities (ECG, NIBP, Temperature, SpO2, Respiration, CO2, Invasive Pressure, 12-Lead Analysis). | Demonstrated through "extensive performance testing" that the Propaq XM utilizes the "same features and functions" as the predicate and "performs as well as" the predicate. No specific quantitative performance metrics are provided. |
| Safety | Complies with applicable sections of recognized industry and safety standards. | Demonstrated through "safety testing" which "assures the device complies with applicable sections of recognized industry and safety standards." No specific standards or results are detailed. |
Study Details
Given the nature of a substantial equivalence submission for a modified device, the "study" described is primarily focused on performance testing to demonstrate equivalence, rather than a clinical trial to establish new performance metrics.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document broadly refers to "extensive performance testing."
- Data Provenance: Not specified. It's likely that the testing involved a combination of bench testing and potentially some internal evaluation against the predicate device, but no details on patient data (country, retrospective/prospective) are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a substantial equivalence claim based on hardware/software de-population, the "ground truth" would generally be the established performance of the predicate device and relevant industry standards. There is no mention of expert consensus for ground truth on a test set in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None specified. The submission does not detail an adjudication process for a test set as would be found in a clinical study.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a physiological monitor, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "performance testing" described is essentially standalone testing of the device's functions against the predicate and standards. The device itself is a standalone monitor. However, the 12-lead ECG analysis component explicitly states: "The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data." This indicates that while the analysis is standalone, the interpretation requires human oversight.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence claim appears to be the established performance and specifications of the predicate device (ZOLL X Series, K112432) and compliance with recognized industry and safety standards. There is no mention of pathology, outcomes data, or expert consensus in the context of establishing ground truth for new performance claims.
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The sample size for the training set:
- Not applicable/Not specified. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/machine learning device.
In summary, the 510(k) for the ZOLL Propaq XM relies on demonstrating substantial equivalence to an existing cleared device (ZOLL X Series, K112432). The "study" consists of performance testing to ensure the modified device (Propaq XM) functions identically to the predicate device for all its monitoring capabilities and meets safety standards. Specific quantitative acceptance criteria, sample sizes, and detailed performance metrics are not publicly disclosed in this summary, as is common for substantial equivalence submissions that leverage a predicate's prior clearance.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.