(201 days)
No
The summary describes a standard vital signs monitor with various physiological measurement capabilities and data display/transmission features. There is no mention of AI or ML being used for analysis, interpretation, or any other function. The 12-lead ECG analysis is a standard feature, not indicative of AI/ML without further detail.
No
The device is described as a "portable monitor designed for use by trained medical personnel who are familiar with basic monitoring and vital signs assessment," and its intended use is for "monitoring and/or recording" various physiological parameters, not for providing therapy or treatment.
Yes
The device 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, which is a diagnostic function.
No
The device description clearly states it is a "portable monitor" with a "large colorful LCD display," "USB port," and "rechargeable lithium-ion battery pack." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Propaq M system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Propaq M Function: The Propaq M system directly monitors physiological parameters from the patient's body using sensors and transducers applied externally or invasively. These parameters include ECG, blood pressure, temperature, SpO2, respiration, CO2, and invasive pressure.
- No Specimen Analysis: The device does not analyze samples taken from the patient's body in a laboratory setting.
The Propaq M is a patient monitoring device that measures vital signs directly from the patient.
N/A
Intended Use / Indications for Use
Electrocardiogram (ECG) Monitoring
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.
Non-Invasive Blood Pressure Monitoring
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.
Temperature Monitoring
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.
SpO2 Monitoring
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.
Respiration Monitoring
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.
CO2 Monitoring
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.
Invasive Pressure Monitoring
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.
TBI Dashboard
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.
12-Lead Analysis
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).
Web Console
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DRT, DXN, DSK, CCK, DQA, DPS, FLL
Device Description
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 TBI Dashboard was introduced and cleared for the ZOLL® X Series® (K141774) to be displayed on a separate mobile device that connects to the main device (ZOLL® X Series®) via Bluetooth. The new Software Version 02.34 (TBI Dashboard installed on device) was introduced to ZOLL® X Series® and submitted to the agency under P160022/S013 on August 28, 2019.
The ZOLL® Propag® M is a depopulated configuration of the ZOLL® X Series® device. The defibrillator/pacer module (circuit boards) in the Propaq® M software configuration is removed as Propaq® M is a monitoring device. The TBI Dashboard was introduced and cleared for the ZOLL® X Series® (K141774) to be displayed on a separate mobile device that connects to the main device via Bluetooth. The new Software Version 02.34 (TBI Dashboard installed on device) was introduced to ZOLL® X Series® and submitted to the agency under P160022/S013 on August 28, 2019.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborn (neonate) to adult
adult (> 18 years of age) for 12-Lead Analysis
Intended User / Care Setting
trained medical personnel
hospital, EMS, and rugged military environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation:
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 Propag® 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 Propaq® M device.
As X Series® encompasses a larger set of functionalities than the Propaq® M device, Software verification and validation testing were conducted for the ZOLL® X Series® (P160022) and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained Medical Devices". Thus, the verification and validation relevant to X Series® device is also applicable to proposed Propag® M device.
Performance testing in the form of the software verification and system level validation for the ZOLL® X Series® (P160022) 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 per the International Recognized Standards:
The device was evaluated and found to be in compliance with the standards identified in Table 1 (IEC 60601-1: 2005/A1:2012/COR 1 2014, IEC 60601-1-2: 2014, IEC 60601-1-6: 2013, IEC 60601-1-8:2006/A1:2012, IEC 60601-2-25: 2011, IEC 60601-2-27: 2011, IEC 60601-2-34: 2011, IEC 60601-2-49: 2011, IEC 62304: 2006 AMD 1: 2015, IEC 62366-1:2015 COR 1 2016, ISO 80601-2-30: 2009, ISO 80601-2-55: 2011/AC: 2012, ISO 80601-2-56: 2009, ISO 80601-2-61: 2011, EN ISO 10993-1: 2009 AC: 2010, EN ISO 15223-1: 2016 COR 2017, BS EN 1041: 2008+A1:2013, EN ISO 14971: 2012). Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards. No new safety testing was conducted with the introduction of the changes proposed in this application.
Electrical Safety and electromagnetic compatibility (EMC):
At this time ZOLL® proposes to revise the Propaq® M device software to introduce TBI Dashboard and 12-Lead re-transmission. As the proposed modification involves a software-only change, the Electromagnetic Compatibility and Electrical Safety aspect of the Propag® M device has not been impacted by the proposed change.
Usability Testing:
Summative usability evaluations were performed for the ZOLL® X Series® to validate the usability of the new Software revision 02.34 user interface. All identified use-related hazards have been found to be mitigated to acceptable levels.
The 12-Lead transmission retry enhancement does not change the user interface or the user interaction with the device. The process of capturing a 12-Lead, selecting the 12-Lead to send, selecting the transmission destination and sending the file will remain the same. If the transmission fails due to a connection issue, the device will attempt to automatically re-try the transmission up to 5 times. After 5 retries the user would revert to the previous method of manually transmitting the user would need to manually transmit the case file upon each transmission failure. Therefore, usability testing is not required for the 12-Lead transmission feature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
ZOLL® Propaq® M, K180482, ZOLL® X Series®, K141774
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.
Not Found
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).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 9, 2021
ZOLL Medical Corporation Elizabeth McMeniman Director, Regulatory Affairs 269 Mill Road Chelmsford, Massachusetts 01824
Re: K202375/S002
Trade/Device Name: ZOLL Propaq M Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II Product Code: MWI, DRT, DXN, DSK, CCK, DQA, DPS, FLL Dated: August 19, 2020 Received: August 20, 2020
Dear Elizabeth McMeniman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name ZOLL® Propaq® M
Indications for Use (Describe)
Electrocardiogram (ECG) Monitoring
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.
Non-Invasive Blood Pressure Monitoring
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.
Temperature Monitoring
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.
SpO2 Monitoring
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name ZOLL® Propaq® M
Indications for Use (Describe)
Respiration Monitoring
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.
CO2 Monitoring
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.
Invasive Pressure Monitoring
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.
TBI Dashboard
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K202375
Device Name ZOLL® Propaq® M
Indications for Use (Describe)
12-Lead Analysis
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).
Web Console
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.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
ZOLL®
269 Mill Road Chelmsford, Massachusetts 01824-4105
978.421.9655 (main) 978.421.0025 (fax) www.zoll.com
An Asahi Kasei Group Company
510(k) Summary
Sponsor Information:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824
Contact Person: Elizabeth McMeniman Director, Regulatory Affairs Phone: (978) 569-6862 Fax: (978) 421-0010 Email: emcmeniman@zoll.com
Date of Summary: September 1, 2020
Device Name and Classification:
Device Name: ZOLL® Propaq® M Common Name: Portable Patient Monitor Regulatory Class: Class II Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (21 CFR 870.2300)
Product Code: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) (MWI) Cardiac Monitors - including Cardiotachometer and Rate Alarms (DRT) Noninvasive Blood Pressure Measurement System (DXN) Blood Pressure Computer (DSK) Carbon Dioxide Gas Analyzer (CCK) Oximeter (DQA) Electrocardiograph (DPS) Clinical electronic thermometer (FLL)
6
Predicate Devices:
Trade Name: ZOLL® Propaq® M Regulation Number: 21 CFR 870.2300 Regulatory Class: Class II Product Code: MWI, DRT, DXN, DSK, CCK, DQA, DPS, FLL Identification Predicate Device: ZOLL® Propaq® M, K180482
Trade Name: ZOLL® X Series® Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LIX, LDD, DRT, DRO, DXN, DSK, CCK, DQA Identification Predicate Device: ZOLL® X Series®, K141774 (K141774 introduced the TBI Dashboard)
Device Description
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
7
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.
The Indications for use section in the Propaq® M Operator's Guide was updated to include the following statement for introducing of the TBI Dashboard:
TBI Dashboard
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 lower half of Figure 1, identified by the red box, depicts the TBI Dashboard on the host device's screen and includes the SBP (teal), SpO2 (yellow), and EtCO2 (purple) trend graphs.
Image /page/7/Figure/6 description: The image shows a medical monitor displaying various vital signs and readings. The heart rate is 80 bpm, NIBP is 117/80 mmHg, EtCO2 is 30 mmHg, SpO2 is 97%, and the temperature is 72.3 *F. There is also a TBI section showing trends for SBP, EtCO2, and SpO2 over time.
Figure 1: TBI Dashboard displayed on front panel user interface
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
8
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 TBI Dashboard was introduced and cleared for the ZOLL® X Series® (K141774) to be displayed on a separate mobile device that connects to the main device (ZOLL® X Series®) via Bluetooth. The new Software Version 02.34 (TBI Dashboard installed on device) was introduced to ZOLL® X Series® and submitted to the agency under P160022/S013 on August 28, 2019.
The ZOLL® Propag® M is a depopulated configuration of the ZOLL® X Series® device. The defibrillator/pacer module (circuit boards) in the Propaq® M software configuration is removed as Propaq® M is a monitoring device. The TBI Dashboard was introduced and cleared for the ZOLL® X Series® (K141774) to be displayed on a separate mobile device that connects to the main device via Bluetooth. The new Software Version 02.34 (TBI Dashboard installed on device) was introduced to ZOLL® X Series® and submitted to the agency under P160022/S013 on August 28, 2019.
Indications for Use
Electrocardiogram (ECG) Monitoring
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.
Non-Invasive Blood Pressure Monitoring
The Propaq® M system is indicated 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. The non-invasive blood pressure monitoring feature is indicated for patients from newborn (neonate) to adult.
Temperature Monitoring
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 limits set by the user. The temperature monitoring feature is indicated for use in patients from newborn (neonate) to adult.
SpO2 Monitoring
The Propaq® M system is indicated for use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz), 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 and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.
Respiration Monitoring
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
9
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.
CO2 Monitoring
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.
TBI Dashboard
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.
Invasive Pressure Monitoring
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.
12-Lead Analysis
The Propaq® M system is indicated for use in acquiring 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).
Web Console
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.
Comparison of Technological Characteristics:
The principles of operation are identical between the predicate ZOLL® Propaq® M (K180482) and subject device ZOLL® Propaq® M. The subject device is an easy-to-use portable monitor that has the following monitoring capabilities: ECG, CO-Oximeter, Non-invasive Blood Pressure, IBP, CO2 SpO2 Temperature, and Respiration. The technological difference between the ZOLL® Propaq® M subject device and the predicate device ZOLL® Propag® M (K180482) is the introduction of Software 02.34/ TBI Dashboard. Therefore, the ZOLL® X Series® (K141774) will be referenced as a predicate for the TBI Dashboard.
Substantial Equivalence - Non-Clinical Evidence:
The following performance data were provided in support of substantial equivalence determination:
Software Verification and Validation
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 Propag® 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
10
was conducted on the X Series device by disabling the defibrillator/pacer module, which ensures the effective functioning of the proposed Propaq® M device.
As X Series® encompasses a larger set of functionalities than the Propaq® M device, Software verification and validation testing were conducted for the ZOLL® X Series® (P160022) and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained Medical Devices". Thus, the verification and validation relevant to X Series® device is also applicable to proposed Propag® M device.
Performance testing in the form of the software verification and system level validation for the ZOLL® X Series® (P160022) 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 per the International Recognized Standards
The device was evaluated and found to be in compliance with the standards identified in Table 1.
| Table 1: Propaq® M Standards | |
|---|---|
| FDA Consensus # | Standard Designation |
| 19-4 | IEC 60601-1: 2005/A1:2012/COR 1 2014 |
| 19-8 | IEC 60601-1-2: 2014 |
| 5-89 | IEC 60601-1-6: 2013 |
| 5-76 | IEC 60601-1-8:2006/A1:2012 |
| 3-105 | IEC 60601-2-25: 2011 |
| 3-126 | IEC 60601-2-27: 2011 |
| 3-115 | IEC 60601-2-34: 2011 |
| N/A | IEC 60601-2-49: 2011 |
| 13-79 | IEC 62304: 2006 AMD 1: 2015 |
| 5-114 | IEC 62366-1:2015 COR 1 2016 |
| 3-152 | ISO 80601-2-30: 2009 |
| N/A | ISO 80601-2-55: 2011/AC: 2012 |
| N/A | ISO 80601-2-56: 2009 |
| N/A | ISO 80601-2-61: 2011 |
| 2-220 | EN ISO 10993-1: 2009 AC: 2010 |
| 5-117 | EN ISO 15223-1: 2016 COR 2017 |
| N/A | BS EN 1041: 2008+A1:2013 |
| 5-40 | EN ISO 14971: 2012 |
Table 1: Propaq® M Standards
Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards. No new safety testing was conducted with the introduction of the changes proposed in this application.
Electrical Safety and electromagnetic compatibility (EMC)
At this time ZOLL® proposes to revise the Propaq® M device software to introduce TBI Dashboard and 12-Lead re-transmission. As the proposed modification involves a software-only change, the Electromagnetic Compatibility and Electrical Safety aspect of the Propag® M device has not been impacted by the proposed change.
11
Usability Testing
Summative usability evaluations were performed for the ZOLL® X Series® to validate the usability of the new Software revision 02.34 user interface. All identified use-related hazards have been found to be mitigated to acceptable levels.
The 12-Lead transmission retry enhancement does not change the user interface or the user interaction with the device. The process of capturing a 12-Lead, selecting the 12-Lead to send, selecting the transmission destination and sending the file will remain the same. If the transmission fails due to a connection issue, the device will attempt to automatically re-try the transmission up to 5 times. After 5 retries the user would revert to the previous method of manually transmitting the user would need to manually transmit the case file upon each transmission failure. Therefore, usability testing is not required for the 12-Lead transmission feature.
Substantial Equivalence - Clinical Evidence:
Clinical evidence was not necessary to show substantial equivalence. However, relevant clinical literature is provided in Section 20. Performance Testing - Clinical.
Conclusion:
The information provided in this 510(k) demonstrates that the proposed Propaq® M is substantially equivalent to its predicate ZOLL® Propaq® (K180482) and ZOLL® X Series® (K141774) for TBI Dashboard for the new introduced Software Release 02.34.