(280 days)
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 Propag 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, esophageal, 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 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 for use in acquiring, analyzing and reporting physiological data via 12lead 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 Propaq M Mobile Streaming Client Application is intended for use by trained medical personnel familiar with basic monitoring, vital sign assessment, and emergency cardiac care in order to remotely view near real-time patient and device data transmitted from connected Propaq M devices. It requires a clinician at the patient's side next to the Propaq M device. The information streamed to the client application helps the remote clinician make decisions on patient care supplemental to the clinician on site with the patient. Important: The remote clinician should not use Mobile Streaming as a primary diagnostic device, but instead use the data to consult with the clinician at the patient side.
The proposed Propaq 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 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.
With the current application, we propose a revision to the Propaq M device software to introduce Mobile Streaming Client (MSC) Software Application. The proposed MSC Application is a software application used in adjunct to the Propaq M device. It is intended for use by trained medical personnel familiar with basic monitoring, vital sign assessment, and emergency cardiac care in order to remotely view patient and device data transmitted from a connected Propaq M device.
Use of MSC requires a clinician at the patient's side next to the Propaq M device. The information streamed to the client application helps a remote clinician make decisions on patient care supplemental to the decisions made by the clinician on site with the patient. The MSC Application is a software application separate from the Propaq M device and its software. The remote clinician(s) utilize the client application from a desktop computer that allows them to remotely view the streamed data in real-time from active ZOLL Propag M devices in the field. MSC is a server-based application viewed through a web browser via the MSC Website.
The provided FDA 510(k) summary for the ZOLL Propaq M device (K180482) focuses on establishing substantial equivalence to a predicate device (ZOLL Propaq XM, K121367) for various monitoring capabilities and, specifically for this submission, the introduction of a Mobile Streaming Client (MSC) software application.
Based on the provided text, the document states: "Clinical evidence was not necessary to show substantial equivalence." This means that the submission does not contain clinical studies demonstrating the device meets specific performance acceptance criteria through patient data. Instead, non-clinical evidence was primarily used to establish substantial equivalence, particularly for the software modifications related to the Mobile Streaming Client.
Therefore, many of the requested details about acceptance criteria and studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity, and ground truth for training sets) are not present in this document because a clinical study of that nature was not conducted nor deemed necessary for this 510(k) submission.
However, I can extract information related to the non-clinical evidence provided.
Description of Acceptance Criteria and Device Performance (Based on Non-Clinical Evidence)
Since a clinical study with explicit acceptance criteria for diagnostic performance is not detailed, the "acceptance criteria" here refer to the successful completion of verification and validation activities and compliance with recognized standards for the software and device safety. The device performance is described in terms of meeting these engineering and regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Study/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software V&V | Meets functional requirements and performance specifications, commensurate with a "major" level of concern for safety. | "Extensive performance testing in the form of the software verification and system level validation ensured that the Propaq M performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." |
| Safety Testing | Compliance with applicable sections of recognized industry and safety standards. | "The device was evaluated and found to be in compliance with IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-25, ISO 80601-2-61 and other applicable particular standards." |
| Electrical Safety & EMC | Proposed software-only change does not impact EMC and Electrical Safety. | "The Electromagnetic Compatibility and Electrical Safety aspect of the Propaq M device has not been impacted by the proposed change." |
| Usability Testing | Appropriate usability activities conducted, including assessment of primary operating functions, intended users, use scenarios, and corresponding use-related hazards. | "Usability evaluation was conducted to determine the appropriate usability activities for the Propaq M Mobile Streaming Client Application. As part of this process the primary operating functions, intended users and use scenarios and corresponding use related hazards were assessed." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. The document explicitly states, "Clinical evidence was not necessary to show substantial equivalence," so there isn't a "test set" in the context of clinical diagnostic performance. The testing mentioned (Software V&V, safety, usability) would involve various internal test cases and scenarios rather than a clinical patient data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. No clinical ground truth was established by experts for a test set in this submission.
4. Adjudication Method for the Test Set
- Not Applicable. No clinical test set requiring expert adjudication was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted or mentioned in this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. While the Mobile Streaming Client (MSC) is a software application, the submission does not provide specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with an AI algorithm's diagnostic capability. The MSC's function is for remote viewing of data, not independent diagnosis, and the document emphasizes: "Important: The remote clinician should not use Mobile Streaming as a primary diagnostic device, but instead use the data to consult with the clinician at the patient side."
7. The Type of Ground Truth Used
- Engineering Specifications and Regulatory Standards. For the software verification and validation, the ground truth would be the predefined functional requirements and performance specifications of the device. For safety and EMC, the ground truth is compliance with the recognized international standards (e.g., IEC 60601 series, ISO 80601 series). For usability, the ground truth would be successful completion of defined usability tasks and mitigation of identified hazards.
8. The Sample Size for the Training Set
- Not Applicable. The submission does not describe an AI/machine learning model that would require a "training set" in the conventional sense for diagnostic performance.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As no training set for an AI/ML model for diagnostic performance is mentioned, the method for establishing its ground truth is not applicable to this document.
§ 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.