(57 days)
No
The document describes a multi-functional vital signs monitor and defibrillator. While it performs analysis (like 12-lead ECG analysis), there is no mention of AI or ML algorithms being used for these functions or any other part of the device's operation. The analysis described appears to be based on established physiological parameters and algorithms, not learned patterns.
Yes
The device explicitly describes therapeutic functions such as manual and semi-automatic defibrillation, external transcutaneous pacing, and synchronized cardioversion, which directly treat medical conditions.
Yes
The X Series performs multiple functions that are diagnostic in nature, such as ECG Monitoring (recording ECG waveform and heart rate), SpO2 Monitoring (non-invasive monitoring of functional oxygen saturation and other parameters), Respiration Monitoring (continuous monitoring of respiration rate), CO2 Monitoring (continuous measurement of expired and inspired breath rate), Invasive Pressure Monitoring, and 12-Lead Analysis (acquiring, analyzing, and reporting ECG data with interpretation). These functions directly contribute to identifying or assessing a patient's medical condition.
No
The device description explicitly states that the X Series is a "lightweight, portable device" that combines the functions of a defibrillator, pacer, and patient monitors. This indicates the presence of hardware components beyond just software.
Based on the provided information, the X Series device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- X Series Functionality: The X Series is a multi-functional device that performs various physiological monitoring and therapeutic functions directly on the patient. These include:
- Defibrillation and pacing (therapeutic)
- ECG monitoring (physiological measurement)
- CPR monitoring (physiological measurement and feedback)
- Non-Invasive Blood Pressure monitoring (physiological measurement)
- Temperature monitoring (physiological measurement)
- SpO2, SpCO, SpMet, SpHb, SpOC, PVI, PI monitoring (physiological measurement)
- Respiration monitoring (physiological measurement)
- CO2 monitoring (physiological measurement)
- Invasive Pressure monitoring (physiological measurement)
- 12-Lead ECG Analysis (analysis of physiological data)
- Web Console (display of physiological data)
None of these functions involve testing samples in vitro (outside the body). The device directly interacts with and measures parameters from the patient's body.
Therefore, the X Series falls under the category of a patient monitoring and therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
The patient population will range from newborn (neonate) to adult.
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. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
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 tachvcardia.
- 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. The patient population will range from newborn (neonate) to adult.
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. The patient population will range from newborn (neonate) to adult.
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). 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 hospitaltype facilities, or in mobile environments.
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. The patient population will range from newborn (neonate) to adult.
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. The patient population will range from newborn (neonate) to adult.
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. Anv contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in coniunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).
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. For each patient connected to an X Series, the X Series collects patient data, consolidates the data on an embedded web page that can be requested, through an Ethernet connection, by a web browser on a PC for display.
Product codes (comma separated list FDA assigned to the subject device)
MKJ, LIX, LDD, DRT, DRO, DXN, DSK, NSX, DQA
Device Description
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 relevant license and the software code that enables the Masimo Rainbow SET Technology board to measure the additional patient monitoring parameters are purchased under an OEM contract between ZOLL and Masimo. The performance of the software code in enabling the Masimo Rainbow SET Technology board to calculate the additional patient monitoring parameters was established and subsequently cleared by the agency under K110028. As a part of the proposed change, X Series software was modified to incorporate the output signals from the Masimo board for the additional patient monitoring parameters, into the corresponding printout, logging and display elements.
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
Adult (21 years of age or older), Newborn (neonate - Birth to 1 month of age), Infant (1 month to 2 years of age), Child (2 to 12 years of age), Adolescent (12 to 21 years of age). For SpO2 monitoring specifically: adult, pediatric, and neonatal. For 12-Lead Analysis: adults (> 18 years of age).
Intended User / Care Setting
Trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. 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). Emergency care personnel. Usage may be in an ambulance or at the scene of an emergency, or during the transport of patients. In hospitals, hospital-type facilities, or in mobile 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)
N/A - Clinical evidence was not necessary to show substantial equivalence.
Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
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 X Series (K133269 and K133484)
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.
Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2015
Zoll Medical Corporation Tammay Shukla Sr. Regulatory Affairs Specialist 269 Mill Road Chelmsford, Massachusetts 01824-4105
Re: K142915 Trade/Device 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, NSX, DQA Dated: October 2, 2014 Received: October 7, 2014
Dear Tammay Shukla,
This letter corrects our substantially equivalent letter of December 03, 2014. 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. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Tammay Shukla
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 - Indications for Use
| 510(k) Number (if known): | K142915 |
|---|---|
| Device Name: | X Series |
Intended Use:
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.
| Pediatric Patient Subpopulation | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age. |
| Infant | 1 month to 2 years of age. |
| Child | 2 to 12 years of age. |
| Adolescent | 12 to 21 years of age. |
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
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.
The patient population will range from newborn (neonate) to adult.
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.
When the patient is less than 8 years of age or weighs less that 55 Ibs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
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. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
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 tachvcardia.
- · Pediatric pacing.
4
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. The patient population will range from newborn (neonate) to adult.
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. The patient population will range from newborn (neonate) to adult.
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). 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 hospitaltype facilities, or in mobile environments.
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. The patient population will range from newborn (neonate) to adult.
CO2 Monitorina
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. The patient population will range from newborn (neonate) to adult.
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. Anv contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in coniunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).
5
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. For each patient connected to an X Series, the X Series collects patient data, consolidates the data on an embedded web page that can be requested, through an Ethernet connection, by a web browser on a PC for display.
6
Image /page/6/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The letters are outlined with a rough, textured edge, giving them a slightly distressed appearance. To the right of the second "L" is a circled "R", indicating a registered trademark.
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.
978-421-9655 978-421-0025 Main Fax
510(k) Summary:
| Applicant's Name and Address: | ZOLL Medical Corporation |
|---|---|
| 269 Mill Road | |
| Chelmsford, MA 01824 |
Application Correspondent:
Tanmay Shukla 978-421-9171
October 6, 2014
Class III
Date Summary Prepared:
Classification:
Device Name
Product Code
ZOLL X Series
Automated External Defibrillators (MKJ) Cardiopulmonary Resuscitation Aid (LIX) Low-Energy – Defibrillators (LDD) Cardiac Monitors - including Cardiotachometer and Rate Alarms (DRT) External Transcutaneous Cardiac Non-Invasive Pacemaker (DRO) Noninvasive Blood Pressure Measurement System (DXN) Blood Pressure Computer (DSK) Carbon Dioxide Gas Analyzer (CCK) Oximeter (DQA)
| Predicate Devices | ZOLL X Series (K133269 and K133484) Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028) |
|---|---|
| ------------------- | -------------------------------------------------------------------------------------------------- |
7
Description:
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 relevant license and the software code that enables the Masimo Rainbow SET Technology board to measure the additional patient monitoring parameters are purchased under an OEM contract between ZOLL and Masimo. The performance of the software code in enabling the Masimo Rainbow SET Technology board to calculate the additional patient monitoring parameters was established and subsequently cleared by the agency under K110028. As a part of the proposed change, X Series software was modified to incorporate the output signals from the Masimo board for the additional patient monitoring parameters, into the corresponding printout, logging and display elements.
Indications for Use:
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.
| Pediatric Patient Subpopulation | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age. |
| Infant | 1 month to 2 years of age. |
| Child | 2 to 12 years of age. |
| Adolescent | 12 to 21 years of age. |
8
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.). use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
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.
The patient population will range from newborn (neonate) to adult.
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.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
9
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. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
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. The patient population will range from newborn (neonate) to adult.
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. The patient population will range from newborn (neonate) to adult.
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). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no
10
motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Respiration Monitoring
The 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. The patient population will range from newborn (neonate) to adult.
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 and breath rate. The patient population will range from newborn (neonate) to adult.
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. The patient population will range from newborn (neonate) to adult.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).
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. For each patient connected to an X Series, the X Series collects patient data, consolidates the data on an embedded web page that can be requested, through an Ethernet connection, by a web browser on a PC for display.
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Substantial Equivalence - Non-Clinical Evidence:
Features and functions cleared with the ZOLL X Series (K133269 and K133484) device has remained unchanged in the proposed version of the device. The currently marketed ZOLL X Series (K133269 and K133484) is installed with the same Masimo Rainbow SET Technology board, as the one used in Masimo Rainbow SET Radical 7 Pulse COoximeter (K110028), along with the appropriate license and software codes to support SpO2. SpCO and SpMet functionality. As a part of the OEM purchase contract between ZOLL and Masimo, ZOLL has agreed to purchase the additional license and software code (reviewed and cleared with K110028) to enable the installed Masimo Rainbow SET Technology board to optionally support the additional patient parameter monitoring capabilities - Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI). As a part of the proposed change, X Series software was modified to incorporate the output signals from the Masimo board for the additional patient monitoring parameters, into the corresponding printout, logging and display elements. Safety, efficacy and substantial equivalence was shown through software verification and system level validation.
Substantial Equivalence - Clinical Evidence:
N/A - Clinical evidence was not necessary to show substantial equivalence
Comparison of Technological Characteristics
Ability of the X Series device to optionally support additional monitoring parameters -Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI), through a software revision, is substantially equivalent to the Masimo Radical 7 Pulse CO-Oximeter (K110028). The X Series and the predicate Masimo Radical 7 Pulse CO-Oximeter (K110028) utilizes Masimo Rainbow SET Technology, Hence, the predicate Masimo Radical 7 Pulse CO-oximeter and the X Series device have the same performance specifications for the additional patient monitoring parameters.
Performance Testing:
The relevant license and the software code (reviewed and cleared by agency under K 110028) that enables the Masimo Rainbow SET Technology board, installed in the currently marketed X Series device, to measure the additional patient monitoring parameters are purchased under an OEM contract between ZOLL and Masimo. The performance of the which was established under K 110028. As a part of the proposed change, X Series software was modified to incorporate the output signals from the Masimo board for the additional patient monitoring parameters, into the corresponding printout, logging and display elements.
Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
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Conclusion
The information provided in this 510(k) demonstrates that the ZOLL X Series' features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness.
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