Search Results

Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 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 ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).

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 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 Power Infuser® is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood. The device is not intended to support the delivery of any pharmaceutical or other medications.

The ZOLL Power Infuser (reviewed and cleared with K090736) is a miniature battery-operated infusion pump designed for rapid intravenous fluid delivery in the field, in pre-hospital transport, or in the hospital. The device supports two types of Power Infuser Cartridges, both of which are sterile and intended for single use: - · When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products. - · When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. whole blood and packed red blood cells. The device, along with the cartridges, is not intended to support the delivery of any pharmaceutical or other medications. Power infuser works on the principle of the shuttle pump mechanism wherein the tubing in the cartridges is squeezed (but not fully occluded) to allow the free flow of the fluid in the forward direction. As a part of the current application we are proposing a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing (S-40-HL Manufactured by Saint Gobain) has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing (ND 100-40, manufactured by Saint Gobain). The proposed material change is restricted to the Crystalloid/Colloid Cartridge and Blood Cartridge only. No changes has been made to the Power Infuser Pump as a result of the proposed change. The indications for use of the device, as described in the current application, has not changed as a result of the proposed modification. No new accessories have been added, as part of the current submission, due to the proposed change. All the accessories offered with the ZOLL Power Infuser have been reviewed and cleared with the K090736.

Ventilation Each model of the ZOLL 731 Series of Ventilators is in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an " label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers Pulse Oximetry (SpO2) The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

The ZOLL 731 Series Ventilators family (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc. and reviewed and cleared under K111473) consists of AEV, EMV+ and Eagle II models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (> 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV)/ Positive Pressure Ventilation (PPV). As part of the current submission we are proposing to revise the device software to accomplish the following: - Introduce Bilevel Mode Functionality - Expanded Leak Compensation Functionality - Introduce Start Menu Functionality - . Expanded Parameter Ranges - . Introduce Plateau Pressure (Pplat) Functionality - . Introduce Automatic Tubing Compensation Functionality - Change Oxygen Supply Pressure Alarm Logic - Introduce Inverse I:E Ratio Functionality ● No hardware changes were made to the 731 Series Ventilators for the proposed software change.

The ZOLL® Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

The ZOLL Model 330 Multifunction Aspirator is a product based on the currently marketed Model 326/326M Aspirator (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc., reviewed and cleared under K951423). Similar to the currently marketed 326 Aspirator, the ZOLL 330 Aspirator is a small, durable, full-featured portable aspirator designed to operate in the hospital, prehospital, field hospital, mass casualty and during ground or air transport settings. Like the predicate 326 Aspirator, the proposed 330 Aspirator is an electrically powered suction pump intended to remove debris from a patient's airway or respiratory system, secretions, blood, yomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials during surgery. Both the devices can also be used to perform programmable intermittent gastrointestinal and abdominal wound drainage. Both Aspirators can be operated from an AC or DC external power source, or from an internal rechargeable battery system, and supports both aspiration modes: Continuous and Intermittent. The Continuous mode in the proposed 330 Aspirator is sub-divided into four procedure types: Surgical, Pharyngeal, Tracheal, and CASS (Continuous Aspiration of Subglottic Secretions). Each procedure has a pre-set pressure range under which the device can be operated. Additionally with the proposed device we have introduced the following functionality: - . Start Menu Functionality: Start Menu functionality is developed that allows the user to select from a series of preconfigured options that are appropriate for different patient groups: adult, pediatric, the last device settings and a custom start configuration established by the user or their organization. - SMART FLOW Functionality: The feature detects a drop in the measured vacuum level when the ● therapy is not being applied and in response allows the aspirator to reduce the applied vacuum thereby allowing quieter operation of the device in the continuous mode. - . ALARMS: The 330 Aspirator offers a suite of visual alarm indicators by illuminating red, yellow and green LED lights, and audible alarm indicators, to alert the user about issues relating to external power or battery, environmental conditions that could affect device performance, and device selfcheck failures.

The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Do not use the unit's AED function on patients under 8 years of age. Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed). The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation. The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age. This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradvcardia might be expected, Suppression of tachycardia. This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The ZOLL E Series® Defibrillator, reviewed and cleared by FDA under premarket notification K111594, is designed for all emergent care situations and provides multiparameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, noninvasive blood pressure measurement and data printing and recording in a single instrument. The previously cleared Shock Conversion Estimator (SCE), initially reviewed and cleared by the agency under K072923, utilizes Shock Predictive (SPI) as a parameter in the shock advisory algorithm. Shock Predictive Index number is also called "Amplitude Spectral Area (AmSA) value" of the ECG Waveform, developed by the Weil Institute of Critical Care Medicine. In the previously cleared version of the E-Series, when the E Series device is configured to enable the Shock Conversion Estimator (SCE) function, the software compares the calculated Shock Predictive Index (AmSA) against a userconfigurable threshold during shock advisory rhythm analysis. If the rhythm is shockable and the computed index is greater-than or equal-to the pre-configured threshold, the shock advisory algorithm will then issue a "Shock Advised" prompt to the user. If the Shock Predictive Index (AmSA) is less-than the threshold, the shock advisory algorithm will then issue a "Continue CPR" prompt to the user. With the current application, we are proposing a software revision that will enable the E Series device to display the calculated Shock Predictive Index (AmSA) when used in manual mode with CPR defibrillation electrodes. After the trained rescuer has confirmed the ECG rhythm by manually analyzing the characteristics of the ECG waveform, the rescuer may utilize the displayed Shock Predictive Index (AmSA) value to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (SCE), reviewed and cleared by the agency under K072923.

The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series 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 X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series 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. Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate. Semiautomatic Operation (AED): X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. ECG Monitoring: The X Series 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. CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia; Pediatric pacing. Non-Invasive Blood Pressure Monitoring: The X Series 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. Temperature Monitoring: The X Series 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. SpO2 Monitoring: The X Series pulse CO-oximeter with Masimo Rainbow SET technology is intended for use for continuous noninvasive monitoring 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). Respiration Monitoring: The X Series 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. CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate. Invasive Pressure Monitoring: The X Series 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. 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. Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate.

The X Series (reviewed and cleared under K133269 and K133484) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring). The currently marketed ZOLL X Series device (K133269 and K133484) uses the Masimo Rainbow SET technology to offer the SpO2, SpCO and SpMet functionality. With the current application, we are proposing to revise the X Series software to optionally support additional monitoring parameters - Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI), offered by the Masimo Rainbow SET Technology board that is installed in the currently marketed X Series device (K133269 and K133484).

The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series, The X Series 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 X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series 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.

The predicate X Series is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring). With the current application, we are proposing to revise the X Series communication processor software to create a web page with a graphical trend format and countdown timer for ventilations that consolidates the existing SBP (systolic blood pressure from the NIBP monitoring), SpO2, EtCO2 data and the timer on the display of the X Series. The access to this web page will be marketed as the Traumatic Brain Injury (TBI) Dashboard. This TBI Dashboard assists the operator who is ventilating a patient to follow recommendations in the TBI guidelines. Through an encrypted and password protected communications protocol, a suitable separate device with touchscreen, web browser capability and Bluetooth communications can display the TBI Dashboard. As described above, the proposed software change impacts only the communication aspects of the X Series device. Therapeutic and monitoring capabilities of the X Series device as cleared under K133269 have remained unchanged and are not impacted by the proposed change. The X Series therapeutic and monitoring functionality is entirely controlled by access directly through the X Series device, itself, and not through the TBI Dashboard. TBI Dashboard is intended to supplement and not replace any part of the device monitoring.

Defibrillator Function: The E Series ALS products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series ALS products must be prescribed for use by a physician or medical advisor of an emergency response team. Intended Use — Manual Operation: Use of the E Series ALS products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series ALS unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. Intended Use - CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age. Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradvcardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia. Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended. Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The predicate ZOLL E Series External Defibrillator/Monitor reviewed and cleared by the FDA (K111594 and K092598) is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. It combines the function of a manual defibrillator, noninvasive transcutaneous pacer. ECG monitor, pulse oximeter, end tidal CO2 monitor. 12-Lead EGG monitor, non-invasive blood pressure monitor and CPR performance monitor along with data printing and recording capabilities. Functions are offered as options, and functions can be configured during manufacturing to meet the needs of a particular application. Through a manufacturing configuration option that is already available in the device's software and currently offered for distribution (reviewed and cleared by FDA under K111594), the ECG rhythm analysis (advisory) option can be disabled during the manufacturing of the device. This creates a manual-only/ non-AED configuration of the device which is marketed as E Series ALS and intended to be used by ACLS qualified personnel. On the hardware side, the front panel that is offered with this configuration does not include the analyze button that is used to initiate ECG rhythm analysis.