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.

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).

AI/ML Overview

The provided text describes ZOLL X Series device and its substantial equivalence to predicate devices, particularly concerning new monitoring parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the ZOLL X Series (K142915) is an update to an existing device (K133269 and K133484) to include additional monitoring parameters: Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI), and Perfusion Index (PI). These parameters are enabled by the Masimo Rainbow SET Technology board, which was already installed in the device, through new software and licenses.

The key acceptance criterion is demonstrating substantial equivalence to the predicate device, the Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028), for these new monitoring parameters. The reported performance is that the ZOLL X Series, utilizing the same Masimo Rainbow SET Technology, has the same performance specifications as the predicate device for SpHB, SpOC, PVI, and PI.

Acceptance Criteria (for new monitoring parameters)	Reported Device Performance (for SpHB, SpOC, PVI, PI)
Substantial equivalence to Masimo Radical 7 Pulse CO-Oximeter (K110028) in performance specifications.	X Series and predicate Masimo Radical 7 Pulse CO-Oximeter (K110028) utilize the same Masimo Rainbow SET Technology and therefore have the same performance specifications.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" for the new parameters in the context of a prospective clinical study directly for K142915. Instead, it relies on the performance of the Masimo Rainbow SET Technology, which was already established in the predicate device (K110028).

Sample Size for Test Set: Not applicable/not explicitly stated for K142915. The evaluation for the new parameters leverages the performance data from the predicate device (Masimo K110028).
Data Provenance: The performance of the Masimo Rainbow SET Technology board and its software for these parameters was "established and subsequently cleared by the agency under K110028." This implies the original data for K110028 would have included clinical or performance data for these specific parameters. The provenance of that original data (country, retrospective/prospective) is not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The substantial equivalence argument for the new monitoring parameters within K142915 hinges on the fact that the underlying technology and software for these parameters were already cleared under K110028 (Masimo Radical 7 Pulse CO-Oximeter). There is no mention of a new expert panel or ground truth establishment specifically for the K142915 submission regarding these parameters.

4. Adjudication method for the test set

Not applicable. As noted above, the submission relies on previously cleared technology and software.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical monitoring and defibrillation system, not an AI-assisted diagnostic imaging or interpretation tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance of the algorithm (Masimo Rainbow SET Technology software) for the additional parameters (SpHB, SpOC, PVI, PI) was established as part of the clearance for the predicate device, Masimo Radical 7 Pulse CO-Oximeter (K110028). The current submission states that the ZOLL X Series incorporates this same "relevant license and the software code" whose "performance of which was established under K110028." This implies a standalone evaluation of the algorithm's performance for these parameters occurred within K110028.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for the original Masimo K110028 clearance related to SpHB, SpOC, PVI, and PI. For physiological monitoring parameters like these, ground truth typically involves a reference standard measurement method (e.g., laboratory blood analysis for hemoglobin, or invasive continuous measurement for pressure/perfusion indices).

8. The sample size for the training set

The document does not provide information about a "training set" for the software in K142915. The evaluation relies on the already established performance of the Masimo Rainbow SET Technology from K110028. If machine learning was involved in the development of the Masimo algorithm, such information would have been part of the K110028 submission, but it's not referenced here for K142915.

9. How the ground truth for the training set was established

Not applicable, as no training set information is provided in this document for the K142915 submission.

Summary

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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

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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

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Section 4 - Indications for Use

510(k) Number (if known):	K142915
Device Name:	X Series

Intended Use:

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)

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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.

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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).

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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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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)
-------------------	--------------------------------------------------------------------------------------------------

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Description:

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:

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.

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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.

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)

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.

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ECG Monitoring

CPR Monitoring

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

Temperature Monitoring

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

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

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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.

Regulation Number and Section

§ 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.