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 devicein 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.

ECG Monitoring: The device 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.

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 device 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.

Temperature Monitoring: The device 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.

Respiration Monitoring: The device 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 device is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The device 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.

Semiautomatic Operation (AED): The device 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 as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

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.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

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.

Device Description

The ZOLL Propaq MD device is being revised with additional features and optional modules. This configuration of the device will be marketed as the ZOLL X Series. The X Series is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the X Series combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration (ZOLL X Series) adds the following features: Semi-automatic external defibrillation function (AED) Mode, CPR rate and depth monitoring, See-Thru CPR ECG filtering, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring, Oridion microMediCO2 module replaces miniMediCO2 module, Expanded Data Logging capabilities, Wide-format printer option, Wireless Data Transfer.

AI/ML Overview

This document describes a 510(k) premarket notification for the ZOLL X Series, a multi-functional medical device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the ZOLL X Series or detailing performance against them. Most performance claims are implicit in the statement of substantial equivalence to previously cleared devices.

However, the document mentions specific functional aspects and their intended performance:

Feature/Function	Acceptance Criteria (Implied/Stated)	Reported Device Performance
CPR Rate and Depth Monitoring	Encourage rescuers to perform chest compressions at AHA/ERC recommended rate of 100 cpm. Encourage minimum compression depth of 1.5 inches (3.8 cm) or 2.0 inches (5.0 cm) for adult patients.	Provides visual and audio feedback, voice and visual prompts. (Performance against specific quantitative targets is not explicitly stated in this summary, but the functionality to encourage these metrics is indicated.)
Semi-automatic External Defibrillation (AED) Mode	Correctly analyze ECG rhythm for defibrillation suitability.	Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section "ECG Analysis Algorithm Accuracy" on page A-33. (The specific accuracy numbers are not included in this summary.)
12-Lead ECG Interpretive Algorithm (Inovise Audicor)	Acquire, analyze, and report ECG data, provide interpretation for caregiver consideration. Interpretations are significant when used with caregiver overread and other patient data.	Intended for use in acquiring, analyzing, and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. (Performance metrics like sensitivity, specificity for specific conditions are not provided in this summary, but its substantial equivalence to the previously cleared Inovise Audicor K032145 implies its validated performance.)
General Device Performance	Performs as well as indicated predicate devices and meets all functional requirements and performance specifications.	"Extensive performance testing ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." (Specific data is not included in this summary.)
Safety Testing	Complies with applicable sections of recognized industry and safety standards.	"Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." (Specific standards and results are not included.)

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance for the features mentioned (CPR monitoring, AED rhythm analysis, 12-lead ECG interpretation).

The filing relies heavily on the "substantial equivalence" argument, meaning that the performance of the integrated components (like the Inovise Audicor 12-Lead ECG Interpretive Algorithm) has already been established and reviewed in their original 510(k) clearances (e.g., K032145 for Inovise Audicor). The current filing does not present new clinical study data for these components themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. For components like the 12-lead ECG interpretive algorithm, such details would have been part of its original 510(k) submission (K032145 for Inovise Audicor).

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The document emphasizes the device's functionality and substantial equivalence. For the 12-lead ECG analysis, it states, "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." This implies a human-in-the-loop approach where the device provides information for the caregiver, but it does not quantify improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For components like the AED's rhythm analysis function and the 12-lead ECG interpretive algorithm, standalone performance would have been evaluated as part of their original clearance processes. The current submission for the ZOLL X Series integrates these cleared algorithms. The 510(k) summary refers to "Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section 'ECG Analysis Algorithm Accuracy' on page A-33," suggesting that standalone algorithm performance data exists but is not included in this summary.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not explicitly stated in the 510(k) summary. For the 12-lead ECG interpretive algorithm, it is highly likely that expert consensus (e.g., multiple cardiologists' interpretations) would have been used as ground truth in its original validation studies. For AED algorithms, ground truth for rhythm detection typically comes from expert review of ECG waveforms.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding the sample size for the training set for any of the algorithms or features. This information would typically be part of the original development and validation of the individual algorithms (e.g., Inovise Audicor).

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary. Similar to the test set ground truth, the methodology for establishing ground truth for training data would have been detailed in the original submissions for the individual algorithms.

Summary of the Study Discussed in the Document:

The provided document is a 510(k) summary (K112432) for the ZOLL X Series. It is not a detailed clinical study report but rather a regulatory filing designed to demonstrate substantial equivalence to previously cleared predicate devices.

The "study" presented here is a collection of performance and safety testing aimed at showing that the newly configured ZOLL X Series, incorporating additional features and modules, functions as intended and is as safe and effective as its predicates.

According to the document:

Type of Study: The document describes "Extensive performance testing" and "Safety testing" to ensure the device performs as well as predicate devices and meets its specifications. It is a design verification and validation effort rather than a comparative clinical effectiveness trial.
Purpose: To demonstrate that the ZOLL X Series' new features (e.g., AED mode, CPR monitoring, See-Thru CPR, Inovise Audicor 12-Lead ECG Interpretive Algorithm, Masimo Rainbow MX3, Oridion microMediCO2) are substantially equivalent to previously cleared devices or modules.
Key Finding: The conclusion states, "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."

In essence, this 510(k) summary indicates that the ZOLL X Series meets its acceptance criteria by demonstrating that its integrated components and overall system performance are equivalent to those of devices already cleared by the FDA, relying heavily on the pre-existing validation of those predicate devices and modules.

Summary

{0}------------------------------------------------

K112432 pg 1 of 6

MAR 2 1 2012

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A

510(k) Summary:

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655

Contact Person:

Chuck Kolifrath (978) 421-9786

Date Summary Prepared:

August 18, 2011

Device:

ZOLL X Series

Classification: Class III

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)

{1}------------------------------------------------

K112432 pg 20f6

Description:

Additionally, the proposed configuration (ZOLL X Series) adds the following features:

Semi-automatic external defibrillation function (AED) Mode .
CPR rate and depth monitoring .
See-Thru CPR ECG filtering
Inovise Audicor 12-Lead ECG Interpretive Algorithm .
ECG Life Threatening Alarms
Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring .
. Oridion microMediCO2 module replaces miniMediCO2 module
Expanded Data Logging capabilities .
Wide-format printer option .
. Wireless Data Transfer

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 device. The device 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 devicewill 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 device 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.

{2}------------------------------------------------

When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedispadz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.

The following indications for use are identical to the previous configuration of the Propaq MD (reviewed and cleared by the FDA under application K100654):

Manual Defibrillation

Use of the devicein 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.

ECG Monitoring

The device 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.

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

{3}------------------------------------------------

The device 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.

K112432

4086

Temperature Monitoring

The device 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.

Respiration Monitoring

The device 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 device 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 device 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.

The following indications for use represent additional features being added in the proposed X Series configuration:

Semiautomatic Operation (AED)

The device 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.

{4}------------------------------------------------

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 as indicated by:

· Unconsciousness.
· Absence of breathing.
· Absence of pulse.

Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section"ECG Analysis Algorithm Accuracy" on page A-33.

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.

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.

SpO2 Monitoring

The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

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).

Substantial Equivalence:

{5}------------------------------------------------

K112432 PS 60f6

The ZOLL X Series is substantially equivalent to the features and functions of the predicate units: ZOLL Propaq MD (K102468), ZOLL E Series (K072923, K110168, K070455), Inovise Audicor 12-lead Interpretive algorithm (K032145), Masimo Rainbow MX3 module (K100428) and Oridion microMediCO2 module (K094012) reviewed and cleared by the FDA.

Comparison of Technological Characteristics

The ZOLL X Series utilizes the same features and functions as the indicated predicate devices: ZOLL Propaq MD (K102468), ZOLL E Series (K072923, K110168, K070455), Inovise Audicor 12-lead Interpretive algorithm (K032145), Masimo Rainbow MX3 module (K100428) and Oridion microMediCO2 module (K094012) reviewed and cleared by the FDA.

Performance Testing:

Extensive performance testing 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.

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.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 1 2012

ZOLL Medical Corporation c/o Mr. Charles W. Kolifrath Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824

Re: K112432

Trade/Device Name: ZOLL X Series Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ, LDD, LIX, DRT, DRO, DXN, DSK, CCK, and DQA Dated: February 3, 2012 Received: February 6, 2012

Dear Mr. Kolifrath:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{7}------------------------------------------------

Page 2 - Mr. Charles W. Kolifrath

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 forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fo C

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

K112432
pg 1 of 4

SECTION 4 - Indications for Use

510(k) Number (if known):

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 pedirpadz® 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 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 X (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)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K112432

Page 1 of 4

{9}------------------------------------------------

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.

Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section "ECG Analysis Algorithm Accuracy" on page A-33.

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

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:

{10}------------------------------------------------

· 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 and the Rainbow series of sensors, is intended for use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). 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 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 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.

{11}------------------------------------------------

K112432
pg 4 of 4

12-Lead Analysis

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.