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 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).

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.

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.

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.

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 X Series Defibrillator/Monitor cleared under 510k application K112432 is a light weight, 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 monitor (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). X Series software has been revised to support the OneStep Pediatric CPR Electrode. This electrode was previously cleared for use with the ZOLL R Series (K120907). As in the R Series, the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" from the Indications For Use for CPR Monitoring currently cleared for the X Series (K112432).

AI/ML Overview

The ZOLL X Series Defibrillator/Monitor (K133269) received 510(k) clearance based on its substantial equivalence to predicate devices (ZOLL X Series K112432 and ZOLL R Series K120907). The modification primarily involved a software revision to support the OneStep Pediatric CPR Electrode for pediatric CPR monitoring. The submission did not include a traditional study with acceptance criteria and reported device performance metrics in the typical sense of a diagnostic or predictive AI algorithm.

Instead, the acceptance criteria are implicitly tied to demonstrating that the modified device performs as well as the predicate devices and meets its functional and performance specifications, especially concerning the new pediatric CPR monitoring feature.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a modification to an existing device, the "acceptance criteria" are not presented as specific performance metrics and thresholds (e.g., sensitivity, specificity) but rather as compliance with existing safety and performance standards, and comparison to predicate devices. The document explicitly states: "Extensive performance testing in 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."

Therefore, a table of specific quantitative acceptance criteria and reported device performance values cannot be constructed from the provided text in the way one would for a diagnostic AI. The acceptance criteria essentially were:

Feature/Function	Acceptance Criteria	Reported Device Performance
Overall Device Performance and Safety	The device performs as well as the indicated predicate devices (ZOLL X Series K112432 and ZOLL R Series K120907) and meets all its functional requirements and performance specifications. The device complies with applicable sections of recognized industry and safety standards.	"Extensive performance testing in 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." (Direct quote from the document, page 5) This statement serves as the reported performance, indicating successful fulfillment of the criteria.
CPR Monitoring Function (Pediatric Patients)	The revised software enables the X Series device to provide CPR monitoring for Pediatric patients using the OneStep Pediatric CPR Electrode, as previously cleared for the ZOLL R Series (K120907). The contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" is removed from the Indications For Use. The device should provide CPR timing and numeric display of actual rate and depth of chest compressions for pediatric patients, equivalent to the R Series.	"Support for the CPR monitoring feature of the OneStep Pediatric CPR Electrode is added through a software revision. As in the R Series (K120907), the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication 'The CPR monitoring function is not intended for use on patients under 8 years of age'..." (page 1) "As in the R Series (K120907), the electrode will enable the X Series device to provide pediatric CPR monitoring information specifically, the CPR timer and the numeric display of the actual rate and depth of chest compression." (page 5)
Substantial Equivalence to Predicate Devices	The device's features and functions are substantially equivalent to the predicate devices.	"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." (Page 5)

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

The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the modified pediatric CPR monitoring algorithm. Instead, the assessment relies on software verification and system-level validation. This implies engineering tests rather than a cohort of patient data.

Sample Size for Test Set: Not applicable/not specified as clinical test data in the provided document.
Data Provenance: Not applicable, as no clinical test data for the specific modification is detailed. The assessment was based on engineering and validation testing.

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

Not applicable. The submission is based on engineering verification, system-level validation, and comparison to predicate devices. There is no mention of a test set requiring expert-established ground truth in the context of diagnostic performance for the new feature or the overall device.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

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

No MRMC comparative effectiveness study was mentioned. The device provides CPR monitoring feedback; it is not described as an AI system assisting human readers in interpreting clinical data.

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

The device's CPR monitoring function provides automated feedback (rate and depth) but operates with a human rescuer in the loop. The document doesn't describe a "standalone algorithm" performance study in the absence of human interaction. The functions described are inherent to the device and its sensors, providing real-time data to the user.

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

For the pediatric CPR monitoring feature, the "ground truth" would implicitly be the physical measurements of chest compression rate and depth, compared against the AHA/ERC recommended targets (e.g., 100 compressions per minute, 1.5-2.0 inches depth). This "truth" is established by physical measurement standards rather than expert clinical consensus or pathology. The document, however, does not detail the specific methodology for verifying the accuracy of these measurements. It states that "performance testing" and "software verification and system level validation" were performed.

8. The Sample Size for the Training Set

Not applicable. The document describes a software revision for a medical device. There is no mention of a "training set" for a machine learning or AI algorithm in the context of this 510(k) submission.

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

Not applicable, as no training set for a machine learning or AI algorithm is mentioned.

Summary

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ZOLL

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:

Date Summary Prepared:

Classification:

Device Name

Product Code

Tanmay Shukla 978-421-9171

December 23, 2013

Class III

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)

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K133269

Predicate Devices

ZOLL X Series (K112432) ZOLL R Series (K120907)

Description:

X Series software has been revised to support the OneStep Pediatric CPR Electrode. This electrode was previously cleared for use with the ZOLL R Series (K120907). As in the R Series, the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" from the Indications For Use for CPR Monitoring currently cleared for the X Series (K112432).

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.

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.

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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.

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K133269

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.

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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 conditions, and for patients who are well or poorly perfused, in 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

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K133269

consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).

Substantial Equivalence - Non-Clinical Evidence:

Features and functions cleared with the predicate device ZOLL X Series (K112432) have remained unchanged in the proposed version of the device. Support for the CPR monitoring feature of the OneStep Pediatric CPR Electrode is added through a software revision. As in the R Series (K120907), the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. 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

Features and functions cleared with the predicate ZOLL X Series (K112432) have remained unchanged in the proposed version of the device. Support for the CPR monitoring feature of the OneStep Pediatric CPR Electrode is added through a software revision. As in the R Series (K120907), the electrode will enable the X Series device to provide pediatric CPR monitoring information specifically, the CPR timer and the numeric display of the actual rate and depth of chest compression.

Performance Testing:

Extensive performance testing in 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.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with outstretched wings.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-0002

May 22, 2014

Zoll Medical Corporation, World Wide Headquarters Tanmay Shukla 269 Mill Road Chelmsford, MA 01824-4105 US

Re: K133269

Trade/Device Name: Zoll X Series Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillators (Non-Wearable) Regulatory Class: Class III Product Code: MKJ Dated: April 22, 2014 Received: April 23, 2014

Dear Mr. Tanmay Shukla,

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.

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

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Page 2 - Tanmay Shukla

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/7/Picture/7 description: The image shows a logo with the letters FDA. The letters are stylized and have a handwritten font overlaying them. There are lines crossing through the letters, making them difficult to read.

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): K133269 Device Name: X Series AED

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.

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 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)

Image /page/8/Picture/16 description: The image shows a logo with the letters FDA in a stylized font. The logo also includes the word "Date" and the date "2014.05.22 09:30:50 -04'00'". There is also a signature on the left side of the logo.

Page 1 of 3

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The unit can also be used for synchronized cardioversion of certain atrial or ventricular armythmias. 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 Ibs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.

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.

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Non-Invasive Blood Pressure Monitoring

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

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

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.