Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System

• K Number: K203435
• Device Name: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
• Manufacturer: Nihon Kohden Corporation
• Date Cleared: 2021-07-16 ( 235 days)
• Product Code: MHX
• Regulation Number: 870.1025

Intended Use

The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

Device Description

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements. The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals. The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices. The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes: - CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display - CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes: - CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav - CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

Predicate Devices

K201949

Reference Devices

K110594, K074705, K060576, K053269

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard physiological monitoring and alarm functions without mentioning AI/ML algorithms or capabilities.

Therapeutic

No.
The device is strictly for monitoring, displaying, and recording physiological data and does not provide any treatment or therapy.

Diagnostic

Yes.
The device is intended to monitor, display, and record various physiological data, and detect arrhythmias and other conditions (e.g., A-fib, ST measurement), which involve identifying medical conditions or predispositions, fitting the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "bedside monitoring system" and requires both a "core unit" and an "input unit," which are hardware components. It also mentions electrical safety and EMC testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, the Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states that this device monitors, displays, and records physiological data directly from the patient's body. It measures parameters like ECG, blood pressure, temperature, SpO2, and respiratory gases.
• Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens outside of the body.

Therefore, the Nihon Kohden Life Scope® G5 and G7 Bedside Monitoring System falls under the category of a patient monitoring system, which is a different type of medical device than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical facility on all patient populations. including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

Product codes (comma separated list FDA assigned to the subject device)

MHX

Device Description

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
• CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
• CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

The differences between the hardware for Life Scope brands is that:

• The Life Scope® G5 comes in two sizes and is smaller than the Life Scope G7. ●
• The Life Scope® G5 has a handle and the G7 does not. ●
• The Life Scope® G5 connects directly to the input unit. ●
• The Life Scope® G7 has the Data Acquisition Unit and the G5 does not. The Data . Acquisition Unit directly connects to the input unit.

The similarities between Life Scope® G5 and Life Scope® G7 brands are that:

• Both platforms have the same software and have the same performance specification.
• Both of the platforms core unit calculates and displays the parameters of Heart Rate, NIBP, IBP, Body Temperature, Cardiac Output, and Respiratory Rate (from the impedance of the ECG electrodes) from the physiological signals (waveforms) sent from the input unit. All other parameters are calculated from an external device and the platform only displays the parameter on the monitor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

all patient populations. including adult, neonate, infant, child, and adolescent subgroups.
A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

Intended User / Care Setting

trained medical facility
medical facility

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing were conducted, and documentation are provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Software verification and validation were conducted that included software unit testing, integration level testing, and system-level testing. A system test was also performed based on the software requirements specification. Testing to compliance standards for electrical and electromagnetic safety was also performed.

Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring Systems. The devices comply with the applicable requirements within the ANSI AAMI ES60601-1 / IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. No new issues of safety or effectiveness are introduced as a result of using these devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K201949

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K110594, K074705, K060576, K053269

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Summary

0

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July 16, 2021

Nihon Kohden Corporation % Sandra Gadeyne Sr. Director, Quality and Regulatory Affairs Nihon Kohden America 15353 Barranca Pkwy Irvine. California 92618

Re: K203435

Trade/Device Name: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: June 14, 2021 Received: June 16, 2021

Dear Sandra Gadeyne:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name

Nihon Kohden Life Scope G5 Bedside Monitoring System CSM-1501and CSM-1502 Nihon Kohden Life Scope G7 Bedside Monitoring System CSM-1701and CSM-1702

Indications for Use (Describe)

The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arthythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical facility on all patient populations. including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

| Sponsor: | Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Initial Importer: | Nihon Kohden America
15353 Barranca Parkway
Irvine, CA, 92618
Sandra Gadeyne |
| Contact: | Sandra Gadeyne
Sr. Director, Quality Assurance and Regulatory Assurance
15353 Barranca Parkway
Irvine, CA, 92618
Phone: [phone]
Fax: [phone]
Email: [e-mail] |
| 510(k) Submission Type: | Traditional 510(k) |
| Date Prepared: | June 14, 2021 |

DEVICE INFORMATION:

| Proprietary Name: | Nihon Kohden Life Scope® G5 Bedside Monitoring System
and Nihon Kohden Life Scope® G7 Bedside Monitoring System |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Multiparameter Patient Monitor |
| Marketing Names: | Life Scope® G5L, Life Scope®, G5-HD, G5 All-in-one Patient
Monitor
Life Scope® G7H; Life Scope® G7 with (DAU) Data
Acquisition Module, Life Scope® G7 High Acuity Monitor |
| Classification: | Class II |
| Product Codes: | MHX |
| Regulations: | §870.1025 |
| Classification Panel: | Cardiovascular |

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PRODUCT DESCRIPTION: 11.1

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
• CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
• CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

The differences between the hardware for Life Scope brands is that:

• The Life Scope® G5 comes in two sizes and is smaller than the Life Scope G7. ●
• The Life Scope® G5 has a handle and the G7 does not. ●
• The Life Scope® G5 connects directly to the input unit. ●
• The Life Scope® G7 has the Data Acquisition Unit and the G5 does not. The Data . Acquisition Unit directly connects to the input unit.

5

The similarities between Life Scope® G5 and Life Scope® G7 brands are that:

• . Both platforms have the same software and have the same performance specification.
• . Both of the platforms core unit calculates and displays the parameters of Heart Rate, NIBP, IBP, Body Temperature, Cardiac Output, and Respiratory Rate (from the impedance of the ECG electrodes) from the physiological signals (waveforms) sent from the input unit. All other parameters are calculated from an external device and the platform only displays the parameter on the monitor.

11.1.1 Principles of Operation

The Life Scope® G5 and Life Scope® G7 Bedside Monitoring Systems are intended to monitor, record, and display (local and remotely) physiological data including electrocardiogram (ECG), blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), Carbon Dioxide (CO2), End Tidal Carbon Dioxide (EtCO2), Respiratory Rate (RR), BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2, Halothane, Isoflurane, Enflurance, Sevoflurance, and Desflurane. These features are currently available in the legally marketed Nihon Kohden predicate devices.

11.1.2 Indications for Use/Intended Use:

The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

6

11.1.3 Predicate Device

Table 1 - 1 lists the basic information about the CSM-1901 (G9) Bedside Monitoring System including 510(k) number, device trade name, 510(k) holder, and clearance date.

Table11-1. Table of CSM-1901 (G9) Bedside Monitoring System Information

510(k)	Product	510(k) Holder	Clearance Date
K201949	CSM-1901	Nihon Kohden Corporation	May 02, 2021

11.1.4 Comparison to Predicate Device

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring Systems are substantially equivalent to the Nihon Kohden CSM-1901 Bedside Monitor (K201949). The subject devices have the same intended use, indications for use, principles of operation, and performance specifications as the predicate device, see Table 11-2, for the comparison of the subject devices to the predicate devices.

The similarities between the two (2) subject devices- Life Scope G5 and Life Scope G7 to the predicate devices:

• All the platforms have a similar performance specification. ●
• All the core units of the platform calculate and display the parameters of Heart Rate, NIBP, IBP, Body Temperature, Cardiac Output, and Respiratory Rate (from the impedance of the ECG electrodes) from the physiological signals (waveforms) sent from the input unit. All other parameters are calculated from an external device and the platform only displays the parameter on the monitor.
• All the platforms use the same common accessories and interfaces with the same external devices.

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11.2 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICAT

DEVICE:

Table 11-2 is a detailed compariso

Table 11-2. Comparison of the Life Scope G5 and the Life Scope G7 and to predicate device Life Scope G9
Characteristics	Life Scope G5
(Subject Device)
Life Scope G5 Bedside Monitoring System	Life Scope G7
(Subject Device)
Life Scope G7 Bedside Monitoring System	CSM-1901
(K#201949)
Predicate
CSM-1901 Bedside Monitor	Comparison
Trade Name				N/A
Common Name	G5	G7	G9	N/A
Classification Panel	Cardiovascular	Cardiovascular	Cardiovascular	Identical
Regulation Number	870.1025	870.1025	870.1025	Identical
Classification Name	Monitor, Physiological, Patient with
Arrhythmia Detection	Monitor, Physiological, Patient with
Arrhythmia Detection	Monitor, Physiological, Patient with
Arrhythmia Detection	Identical
Regulatory Class	Class II	Class II	Class II	Identical
Product Code	MHX	MHX	MHX	Identical
Patient Population	Neonate, children, and adults	Neonate, children, and adults	Neonate, children, and adults	Identical
Setting	Clinical	Clinical	Clinical	Identical
End-User	Health Care Professionals	Health Care Professionals	Health Care Professionals	Identical
Biocompatibility	N/A	N/A	N/A	Identical
Shelf Life	N/A	N/A	N/A	Identical
Patient Contact	No	No	No	Identical
Single-use	No	No	No	Identical
Characteristics	Life Scope G5
(Subject Device)	Life Scope G7
(Subject Device)	CSM-1901
(K#201949)
Predicate	Comparison
Indications for Intended Use	No	No	No	Identical
Indications for Use/Intended Usewavef	The Nihon Kohden Life Scope G5 bedside monitors are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.	The Nihon Kohden Life Scope G7 bedside monitors are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.	The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.
Below & Section 5.3-8
	The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.	The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.	The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
	The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.	The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.	The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
	A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia	A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia
Characteristics	Life Scope G5
(Subject Device)	Life Scope G7
(Subject Device)	CSM-1901
(K#201949)
Predicate	Comparison
	detection function is intended for
child, adolescent, and adult patients.	detection function is intended for
child, adolescent, and adult patients.
Waveform Display	ECG, respiration curve, IBP waveform,
SpO2 pulse waveform, CO2 partial
pressure curve, EEG waveform,
respiratory flow curve, airway pressure
curve, respiratory volume curve,
EEG waveform (BIS), O2
concentration curve, CO2 concentration
curve, anesthetic agent concentration
curve.	ECG, respiration curve, IBP waveform,
SpO2 pulse waveform, CO2 partial
pressure curve, EEG waveform,
respiratory flow curve, airway pressure
curve, respiratory volume curve,
EEG waveform (BIS), O2
concentration curve, CO2 concentration
curve, anesthetic agent concentration
curve.	ECG, respiration curve, IBP waveform,
SpO2 pulse waveform, CO2 partial
pressure curve, EEG waveform,
respiratory flow curve, airway pressure
curve, respiratory volume curve,
EEG waveform (BIS), O2
concentration curve, CO2 concentration
curve, anesthetic agent concentration
curve.	Same

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| Characteristics | Numeric Data Display | Alarm Display | Alarm Suspend/Silence
Function | ECG | Comparison |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------|
| Life Scope G5
(Subject Device) | Heart rate, VPC rate (per minute), ST level, respiration rate, NIBP (Sys, Dia, MAP), IBP (Sys, Dia, Mean), SpO2, pulse rate, temperature, cardiac output (CO), cardiac index (CI), injectate temperature (Ti), blood temperature (Tb), O2 concentration (O2),
end tidal CO2 partial pressure (ETCO2), BIS, inspired/expired N2O concentration, inspired/expired CO2 partial pressure, inspired/expired CO2 concentration, inspired/expired O2 concentration, inspired/expired anesthetic agent concentration (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane), minimum alveolar concentration (MAC), peak airway pressure (Ppeak), positive end expiratory pressure (PEEP), mean airway pressure (Pmean), minute volume (MV), inspiratory tidal volume (TVi), expiratory tidal volume (TVe), compliance (C), airway resistance (R), inspiratory airway resistance (Ri), expiratory airway resistance (Re), inspiration expiration ratio (I:E),
90 or 95% spectral edge frequency (SEF), median frequency (MDF), peak power frequency (PPF), total power (TP), power of frequency (Abs δ, Abs θ, Abs α, Abs β, Abs γ), power ratio of frequency (% δ,) | Alarm sound, highlighted alarm display, alarm lamp | Yes | | Same |
| Life Scope G7
(Subject Device) | Heart rate, VPC rate (per minute), ST level, respiration rate, NIBP (Sys, Dia, MAP), IBP (Sys, Dia, Mean), SpO2, pulse rate, temperature, cardiac output (CO), cardiac index (CI), injectate temperature (Ti), blood temperature (Tb), O2 concentration (O2),
end tidal CO2 partial pressure (ETCO2), BIS, inspired/expired N2O concentration, inspired/expired CO2 partial pressure, inspired/expired CO2 concentration, inspired/expired O2 concentration, inspired/expired anesthetic agent concentration (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane), minimum alveolar concentration (MAC), peak airway pressure (Ppeak), positive end expiratory pressure (PEEP), mean airway pressure (Pmean), minute volume (MV), inspiratory tidal volume (TVi), expiratory tidal volume (TVe), compliance (C), airway resistance (R), inspiratory airway resistance (Ri), expiratory airway resistance (Re), inspiration expiration ratio (I:E),
90 or 95% spectral edge frequency (SEF), median frequency (MDF), peak power frequency (PPF), total power (TP), power of frequency (Abs δ, Abs θ, Abs α, Abs β, Abs γ), power ratio of frequency (% δ,) | Alarm sound, highlighted alarm display, alarm lamp | Yes | | Same |
| CSM-1901
(K#201949)
Predicate | Heart rate, VPC rate (per minute), ST level, respiration rate, NIBP (Sys, Dia, MAP), IBP (Sys, Dia, Mean), SpO2, pulse rate, temperature, cardiac output (CO), cardiac index (CI), injectate temperature (Ti), blood temperature (Tb), O2 concentration (O2),
end tidal CO2 partial pressure (ETCO2), BIS, inspired/expired N2O concentration, inspired/expired CO2 partial pressure, inspired/expired CO2 concentration, inspired/expired O2 concentration, inspired/expired anesthetic agent concentration (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane), minimum alveolar concentration (MAC), peak airway pressure (Ppeak), positive end expiratory pressure (PEEP), mean airway pressure (Pmean), minute volume (MV), inspiratory tidal volume (TVi), expiratory tidal volume (TVe), compliance (C), airway resistance (R), inspiratory airway resistance (Ri), expiratory airway resistance (Re), inspiration expiration ratio (I:E),
90 or 95% spectral edge frequency (SEF), median frequency (MDF), peak power frequency (PPF), total power (TP), power of frequency (Abs δ, Abs θ, Abs α, Abs β, Abs γ), power ratio of frequency (% δ,) | Alarm sound, highlighted alarm display, alarm lamp | Yes | | Same |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949) Predicate | Comparison | |
| Number of ECG Electrodes | 3, 6 or 10 | 3, 6 or 10 | 3, 6 or 10 | Identical | |
| ECG Leads | I, II, III, aVR, aVL, aVF, V1 to V6 | I, II, III, aVR, aVL, aVF, V1 to V6 | I, II, III, aVR, aVL, aVF, V1 to V6 | Identical | |
| Input Impedance | 5 M ohm | 5 M ohm | 5 M ohm | Identical | |
| Frequency Response | 3.2 Time Constant = 0.05 to 150Hz | 3.2 Time Constant = 0.05 to 150Hz | 3.2 Time Constant = 0.05 to 150Hz | Identical | |
| Display Sensitivity | x1/8, x1/4, x1/2, x1, x2, x4, Auto | x1/8, x1/4, x1/2, x1, x2, x4, Auto | x1/8, x1/4, x1/2, x1, x2, x4, Auto | Identical | |
| Defibrillation Discharge
Protection | Yes | Yes | Yes | Identical | |
| Electrosurgery Interface filter | Yes | Yes | Yes | Identical | |
| Pacing detection | Yes | Yes | Yes | Identical | |
| Leads OFF Detector | Yes | Yes | Yes | Identical | |
| Filters | Diag, Mon, ST, Max + AC | Diag, Mon, ST, Max + AC | Diag, Mon, ST, Max + AC | Identical | |
| Heart Rate Counting Method | Average, instantaneous (beat to beat) | Average, instantaneous (beat to beat) | Average, instantaneous (beat to beat) | Identical | |
| Heart Rate Counting Range | 0, 15 to 300 bpm | 0, 15 to 300 bpm | 0, 15 to 300 bpm | Identical | |
| Counting Accuracy | ± 2 bpm | ± 2 bpm | ± 2 bpm | Identical | |
| Alarm Limits:
Upper
Lower | 16 to 300 bpm, OFF
15 to 299 bpm, OFF | 16 to 300 bpm, OFF
15 to 299 bpm, OFF | 16 to 300 bpm, OFF
15 to 299 bpm, OFF | Identical | |
| ST Level Measuring Range
(adults only) | -2.5 to +2.5 mV | -2.5 to +2.5 mV | -2.5 to +2.5 mV | Identical | |
| QTc/QRSd Monitoring
(adult only) | Yes | Yes | No | Below | |
| QRS Sync Tone | Yes | Yes | Yes | Identical | |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949)
Predicate | Comparison | |
| Arrhythmia Detection
Detection Method | Multi-template software algorithm
Multi-lead analysis | Multi-template software algorithm
Multi-lead analysis | Multi-template software algorithm
Multi-lead analysis | Identical | |
| VPC Counting Range | 0 to 99 per min | 0 to 99 per min | 0 to 99 per min | Identical | |
| Arrhythmia Alarms | Yes | Yes | Yes | Identical | |
| Arrhythmia Recall | Yes | Yes | Yes | Identical | |
| Number of Arrhythmia Recall
Files | 16,384 files | 16,384 files | 20,000 files | Below | |
| Number of Arrhythmia Recall
Files (hrs) | 168 hrs | 168 hrs | 168 hrs | Identical | |
| Length of Recall Files | 12 seconds | 12 seconds | 12 seconds | Identical | |
| Arrhythmia Graphic Trend | Yes | Yes | Yes | Identical | |
| Number of Arrhythmia types | 25 | 25 | 25 | Identical | |
| Arrhythmia Graphic Trend | Yes | Yes | Yes | Identical | |
| ECAPS- 12 Lead Analysis
Acquisition and Processing | Simultaneous Acquisition and
Processing for 12 Lead
Development with Calculations and
Resting ECG Analyses | Simultaneous Acquisition and
Processing for 12 Lead
Development with Calculations and
Resting ECG Analyses | Simultaneous Acquisition and
Processing for 12 Lead
Development with Calculations and
Resting ECG Analysis | Identical | |
| ECG Interpretation Program | ECAPS12C | ECAPS12C | ECAPS12C | Identical | |
| 12 lead ST Analysis | Yes | Yes | Yes | Identical | |
| QTc/QRSd Measurement | Yes | Yes | Yes | Identical | |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949) Predicate | Comparison | |
| Patient Age:
12 Lead Acquisition
12 Lead Interpretation | All ages
3 Years and older | All ages
3 Years and older | All ages
3 Years and older | Identical | |
| Respiration | | | | | |
| Method | Impedance, CO2 | Impedance, CO2 | Impedance, thermistor, CO2 | Below | |
| Respiration Rate Display | 0 to 150 bpm | 0 to 150 bpm | 0 to 150 bpm | Identical | |
| Respiration Rate Alarm Limits:
Upper
Lower | 2 to 150 bpm, OFF
0 to 148 bpm, OFF | 2 to 150 bpm, OFF
0 to 148 bpm, OFF | 2 to 150 bpm, OFF
0 to 148 bpm, OFF | Identical | |
| No breath time Limit | 5 to 40 seconds, OFF | 5 to 40 seconds, OFF | 5 to 40 seconds, OFF | Identical | |
| Waveform Display | Yes | Yes | Yes | Identical | |
| Connector Insertion Detection | Yes | Yes | Yes | Identical | |
| Apnea Detection | Yes | Yes | Yes | Identical | |
| Apnea Alarm Limit: | 5 to 40s, OFF | 5 to 40s, OFF | 5 to 40s, OFF | Identical | |
| Apnea methods | Impedance from ECG and Resp waveform, CO2 waveform | Impedance from ECG and Resp waveform, CO2 waveform | Impedance from ECG and Resp waveform, CO2 waveform | Identical | |
| Oxygen Saturation - SpO2 | | | | | |
| Probe Type | Nihon Kohden (NK), Nellcor (NL) or Masimo (MS) | Nihon Kohden (NK), Nellcor (NL) or Masimo (MS) | Nihon Kohden (NK), Nellcor (NL) or Masimo (MS) | Identical | |
| Input Unit | AY Series and BSM-1700 Series | AY Series and BSM-1700 Series | AY Series and BSM-1700 Series | Identical | |
| Displayed Range | 0 to 100% | 0 to 100% | 0 to 100% | Identical | |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949)
Predicate | Comparison | |
| Nihon Kohden Declared
Range, type and Accuracy with
sensor | 70 to 100% (with sensor)
80 to 100% ± 2 %SpO2
70 to 80% ±3%SpO2 | 70 to 100% (with sensor)
80 to 100% ±2%SpO2
70 to 80% ±3%SpO2 | 70 to 100% (with sensor)
80 to 100% ± 2 %SpO2
70 to 80% ±3%SpO2 | Identical | |
| Nellcor Declared Range,
type and Accuracy with sensor
(K060576) | 70 to 100%
70 to 100% ± 2 %SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal) | 70 to 100%
70 to 100% ± 2 %SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal) | 70 to 100%
70 to 100% ± 2 %SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal) | Identical | |
| Masimo Declared Range, MS
type and Accuracy with sensor
(K053269) | No motion condition
70 to 100% ±2%SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal)
motion condition
70 to 100% ±3%SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal) | No motion condition
70 to 100% ± 2 %SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal)
motion condition
70 to 100% ± 3 %SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal) | No motion condition
70 to 100% ± 2%SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal)
motion condition
70 to 100% ±3%SpO2 (adult)
70 to 100% ±3%SpO2 (neonatal) | Identical | |
| Display Sensitivity | x1/8, x1/4, x1/2, x1, x2, x4, x8, Auto | x1/8, x1/4, x1/2, x1, x2, x4, x8, Auto | x1/8, x1/4, x1/2, x1, x2, x4, x8, Auto | Identical | |
| Pulse Sync Tone | Yes | Yes | Yes | Identical | |
| Audible Indication to SpO2
Variation | Yes | Yes | Yes | Identical | |
| SpO2 Alarm Limits:
Upper
Lower | 51 to 100%, OFF
50 to 99%, OFF | 51 to 100%, OFF
50 to 99%, OFF | 51 to 100%, OFF
50 to 99%, OFF | Identical | |
| Pulse Rate Count Range: | 0, 30 to 300 bpm (NK)
0, 20 to 300 bpm (NL)
0, 25 to 240 bpm (MS) | 0, 30 to 300 bpm (NK)
0, 20-300 bpm (NL)
0, 25-240 bpm (MS) | 0,30-300 bpm (NK)
0, 20-300 bpm (NL)
0,25-240 bpm (MS) | Identical | |
| Pulse Rate Counting Accuracy | ±3% ±1 beat/min (NK)
±3 beat/min (NL)
±3 beat/min No motion (MS)
±5 beat/min Motion (MS) | ±3% ±1 beat/min (NK)
±3 beat/min (NL)
±3 beat/min No motion (MS)
±5 beat/min Motion (MS) | ±3% ±1 beat/min (NK)
±3 beat/min (NL)
±3 beat/min No motion (MS)
±5 beat/min Motion (MS) | Identical | |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949)
Predicate | Comparison | |
| Pressure Data Display | Systolic, Diastolic, Mean, Cuff
pressure, Pulse Rate | Systolic, Diastolic, Mean, Cuff
pressure, Pulse Rate | Systolic, Diastolic, Mean, Cuff
pressure, Pulse Rate | Identical | |
| Measuring Range,
Adult/Pediatric | 0 to 300 mmHg | 0 to 300 mmHg | 0 to 300 mmHg | Identical | |
| Measuring Range,
Neonates | 0 to 150 mmHg | 0 to 150 mmHg | 0 to 150 mmHg | Identical | |
| Measuring Accuracy | $±3 mmHg (0 mmHg ≤ NIBP ≤ 300mmHg)$ | $±3 mmHg (0 mmHg ≤ NIBP ≤ 300mmHg)$ | $±3 mmHg (0 mmHg ≤ NIBP ≤ 300mmHg)$ | Identical | |
| Measurement Mode | Manual, STAT, Periodic, SIM | Manual, STAT, Periodic, SIM | Manual, STAT, Periodic, SIM | Identical | |
| Maximum Cuff Inflation
Pressure:
Adult/Pediatric
Neonate | 300 mmHg
150 mmHg | 300 mmHg
150 mmHg | 300 mmHg
150 mmHg | Identical | |
| Rapid Deflation If Power
Failure | Yes | Yes | Yes | Identical | |
| Alarm Limits:
Upper
Lower | 15 to 260 mmHg, OFF
10 to 255 mmHg, OFF | 15 to 260 mmHg, OFF
10 to 255 mmHg, OFF | 15 to 260 mmHg, OFF
10 to 255 mmHg, OFF | Identical | |
| Invasive Pressure (IBP) | | | | | |
| Measuring Method | Pressure transducer | Pressure transducer | Pressure transducer | Identical | |
| Number of Channels | 8 | 8 | 8 | Identical | |
| Measuring Range | -50 to 300 mmHg | -50 to 300 mmHg | -50 to 300 mmHg | Identical | |
| Measuring Accuracy | $±1mmHg, ±1digit (-50 to 100 mmHg)±1%, ±1digit (100 to 300 mmHg)$ | $±1mmHg, ±1digit (-50 to 100 mmHg)±1%, ±1digit (100 to 300 mmHg)$ | $±1mmHg, ±1digit (-50 to 100 mmHg)±1%, ±1digit (100 to 300 mmHg)$ | Identical | |
| Input Sensitivity | 50 µV/V/10mmHg | 50 µV/V/10mmHg | 50 µV/V/10mmHg | Identical | |
| Connector Insertion Detection | Yes | Yes | Yes | Identical | |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949)
Predicate | Comparison | |
| Alarm Limits:
Upper
Lower | -48 to 300 mmHg, OFF
-50 to 298 mmHg, OFF | -48 to 300 mmHg, OFF
-50 to 298 mmHg, OFF | -48 to 300 mmHg, OFF
-50 to 298 mmHg, OFF | Identical | |
| Pulse Rate Count Range: | 0, 30 to 300 bpm | 0, 30 to 300 bpm | 0, 30 to 300 bpm | Identical | |
| Pulse Rate Counting Accuracy | $\pm$ 2 bpm | $\pm$ 2 bpm | $\pm$ 2 bpm | Identical | |
| Pulse Sync Tone | Yes | Yes | Yes | Identical | |
| Body Temp | | | | | |
| Number of channels | 4 ch | 4 ch | 8 ch | Below | |
| Measuring Range | 0 to 45 °C | 0 to 45 °C | 0 to 45 °C | Identical | |
| Display Units | °C or °F | °C or °F | °C or °F | Identical | |
| Accuracy | $\pm$ 0.1 °C (25 to 45 °C)
$\pm$ 0.2 °C (0 to 25 °C) | $\pm$ 0.1 °C (25 to 45 °C)
$\pm$ 0.2 °C (0 to 25 °C) | $\pm$ 0.1 °C (25 to 45 °C)
$\pm$ 0.2 °C (0 to 25 °C) | Identical | |
| Alarm Limits:
Upper
Lower | 0.1 to 45.0 °C, OFF
0.0 to 44.9 °C, OFF | 0.1 to 45.0 °C, OFF
0.0 to 44.9 °C, OFF | 0.1 to 45.0 °C, OFF
0.0 to 44.9 °C, OFF | Identical | |
| Connector Insertion Detection | Yes | Yes | Yes | Identical | |
| Numeric Display | Yes | Yes | Yes | Identical | |
| Carbon Dioxide (CO2) Gas Monitoring | | | | | |
| Measuring Method CO2 (1) | Main Stream with the following
sensor:
TG-900P/TG-920P/TG-980P | Main Stream with the following
sensor:
TG-900P/TG-920P/TG-980P | Main Stream with the following
sensor:
TG-900P/TG-920P/TG-980P | Identical | |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949)
Predicate | Comparison | |
| Rise Time | TG-900P: 160ms(typical) for 10 to 90%
TG-920P: 120ms(typical) for 10 to 90%
TG-980P: 10 kΩ within ± 20 % | >10 kΩ within ± 20 % | >10 kΩ within ± 20 % | Identical |
| Common-Mode Rejection
Ratio (CMRR) | 110 dB or more (in isolation mode)
60 dB or more (in balance mode) | 110 dB or more (in isolation mode)
60 dB or more (in balance mode) | 110 dB or more (in isolation mode)
60 dB or more (in balance mode) | Identical |
| Noise Level | 26dB | Rejection ratio: >26dB | Rejection ratio: >26dB | Identical |
| Sensitivity | OFF, 1 to 200 uV/mm
(14 steps) | OFF, 1 to 200 uV/mm
(14 steps) | OFF, 1 to 200 uV/mm
(14 steps) | Identical |
| A-D Conversion | 16 bits | 16 bits | 16 bits | Identical |
| Sampling | All channels 200 Hz
(A-D Conversion: 4 kHz) | All channels 200 Hz
(A-D Conversion: 4 kHz) | All channels 200 Hz
(A-D Conversion: 4 kHz) | Identical |
| Trend parameter | DSA aEEG | DSA aEEG | DSA aEEG | Identical |
| MDF (Median Frequency) | Yes | Yes | Yes | Identical |
| TP (Total Power Value) | Yes | Yes | Yes | Identical |
| aEEG | Yes | Yes | Yes | Identical |
| Display | | | | |
| Resolution | CSM-1501: 1280 x 800
CSM-1502: 1366 x 768 | CSM-1701: 1366 x 768
CSM-1702: 1680 x 1050 | 1680 x 1050 | Below |
| Sweep Speed | 1.56, 6.25, 12.5, 25, 50 mm/s | 1.56, 6.25, 12.5, 25, 50 mm/s | 1.56, 6.25, 12.5, 25, 50 mm/s | Identical |
| Trace Movement | Moving or fixed | Moving or fixed | Moving or fixed | Identical |
| Alarm Display | Alarm sound, highlighted alarm
display, alarm lamp | Alarm sound, highlighted alarm
display, alarm lamp | Alarm sound, highlighted alarm
display, alarm lamp | Identical |
| Extended Display - Dual | Yes | Yes | Yes | Identical |
| Characteristics | Life Scope G5
(Subject Device) | Life Scope G7
(Subject Device) | CSM-1901
(K#201949)
Predicate | Comparison |
| Extended Display Triple
Display | CSM-1501: No
CSM-1502: Yes | Yes | Yes | Below |
| Remote Control Compatible | Yes | Yes | Yes | Identical |
| Calculations | | | | |
| Drug Calculation | Yes | Yes | Yes | Identical |
| Car Seat Challenge | Yes | Yes | Yes | Identical |
| Lung Capacity Calculation | Yes | Yes | Yes | Identical |
| Recorder | | | | |
| Type | Thermal Array | Thermal Array | Thermal Array | Identical |
| Number of Channels | 3 | 3 | 3 | Identical |
| Annotation printing | Patient Name, bed ID, date, recording
type, sensitivity, paper speed,
parameter data, ECG lead, arrhythmia
classification, QRS classification | Patient Name, bed ID, date, recording
type, sensitivity, paper speed,
parameter data, ECG lead, arrhythmia
classification, QRS classification | Patient Name, bed ID, date, recording
type, sensitivity, paper speed,
parameter data, ECG lead, arrhythmia
classification, QRS classification | Identical |
| Recorder Speed | 12.5, 25, 50 mm/sec | 12.5, 25, 50 mm/sec | 12.5, 25, 50 mm/sec | Identical |

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TECHNOLOGICAL CHARACTERISTICS COMPARISON 11.3

The Nihon Kohden Bedside Monitors are substantially equivalent to the predicate. The Life Scope® G5 and Life Scope® G7 Bedside Monitoring System share the same Intended Use as the Nihon Kohden CSM-1901 Bedside Monitor. There are slight technological differences described below. Differences between the devices are minor and mainly due to the smaller size of the subject device and do not raise different questions of safety or efficacy.

• 1. O2/FiO2: The subject devices and the predicate CSM-1901 both monitor oxygen concentration (O2) using the same multi-gas unit, GF-210R, which was previously cleared in K110594. The predicate CSM-1901 has an additional option, sensor JO-900P (K074705), that measures the fraction or percentage of oxygen (FiO22). But this difference does not affect the O2 monitoring of the subject device. Thus, this is not considered a technological change.
• 2. QTc/QRSd monitoring: The subject devices and the predicate device have the same ECG interpretation program, ECAPS 12C, and both the subject and the predicate can measure QTc/QRSd (Spot-Check). But the subject device also supports Continuous monitoring of QTc/QRSd. In Continuous monitoring, the QT interval and ORS duration measuring is started automatically when ECG monitoring is started, while the Spot-Check of the QT interval and QRS duration measuring is started manually. This technological difference does not affect the safety and effectiveness of the subject device compared to the predicate.
• 3. Arrhythmia Recall Files: Arrhythmia recall files are created automatically when arrhythmias occur. The subject devices have less storage capacity (16.384 files) than the CSM-1901 (20,000 files): The subject devices and the predicate, CSM-1901, both save arrhythmia recall files for review on the device. The predicate CSM-1901 can store more files than the subject devices. This difference is minor, and this storage difference does not affect the safety and effectiveness of the subject device compared to the predicate.
• 4. Respiration: The subject devices measure respiration using only the impedance and CO2 method while the CSM-1901 uses the impedance, CO2, and thermistor method. The subject devices and the predicate CSM-1901 both measure respiration using the ECG impedance and CO2 method. The predicate CSM-1901 has another option, the thermistor method, but this does not affect the respiration monitoring of the subject device. Thus, this difference is not considered a technological change.
• 5. Body Temp Number of Channels: The subject devices have a smaller number of channels (4 channels) than the CSM-1901 (8 channels). The predicate CSM-1901 has more channels since the CSM-1901 is meant as a high-end model. The number of body temp measurement channels in the subject devices and the predicate CSM-1901 are both sufficient for monitoring a patient for its intended

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use. This technological difference does not affect the safety and effectiveness of the subject devices compared to the predicate.

• 6. Cardiac Output List Capacity: The subject devices have a smaller list capacity (72 hours) than the CSM-1901 (168 hours). The subject devices and the predicate CSM-1901 both save the cardiac output list for review on the device. The predicate CSM-1901 has a larger list capacity since the CSM- 1901 is meant as a high-end model. The cardiac output list capacity in the subject devices and the predicate CSM-1901 are both sufficient for checking the data for its intended use. This technological difference does not affect the safety and effectiveness of the subject devices compared to the predicate.
• 7. Display: The resolution is less than the predicate. The CSM-1901 has a resolution of 1680 x 1050. The CSM-1501 has a resolution of 1280 x 800. The CSM-1502 and CSM-1701 have a resolution of 1366 x 768 and the CSM-1702 has a resolution of 1680 x 1050. Although this is a difference, it is due to the size of the monitors. CSM-1501 has a smaller number of displays (up to 2) than CSM-1901 (up to 3) since CSM-1501 is meant as a low-end model. All the systems were tested to IEC 60601-1 and passed.
• 8. Indication for Use/Intended Use: The subject devices have the same intended use/Indication for use as the predicate device. The difference is that the patient population of each ECG analysis functionality of the subject devices has been clarified.

PERFORMANCE DATA 11.4

The Life Scope® G5 and the Life Scope® G7 Bedside Monitoring Systems share the same software. Software verification and validation testing were conducted, and documentation are provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Software verification and validation were conducted that included software unit testing, integration level testing, and system-level testing. A system test was also performed based on the software requirements specification. Testing to compliance standards for electrical and electromagnetic safety was also performed.

Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring Systems. The devices comply with the applicable requirements within the ANSI AAMI ES60601-1 / IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. No new issues of safety or effectiveness are introduced as a result of using these devices.

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No.	Standard
01	AAMI/ANSI ES 60601-1:2005/(R)2012 & A1: 2012, C1:2009/(R)2012 & A2:2010/(R)2012 (IEC 60601-1:2005 + A1:2012): Medical Electrical Equipment - Part 1: General Requirements for Basic Safety & Essential Performance
02	IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety & Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements & Tests
03	IEC 60601-1-8:2006 & A1:2012 Medical electrical equipment – Part 1-8: General requirements for basic safety & essential performance - collateral standard: General requirements, tests & guidance for alarm systems in medical electrical equipment & medical electrical systems
04	ISO 80601-2-55:2018 Medical Electrical Equipment - Part 2-55: Particular Requirements for the Basic Safety & Essential Performance of Respiratory Gas Monitors
05	ISO 80601-2-56:2017+Am1:2018 Medical Electrical Equipment - Part 2-56: Particular Requirements for the Basic Safety & Essential Performance of Clinical Thermometers for Body Temperature Measurement
06	ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for the basic safety & essential performance of pulse oximeter equipment
07	IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
08	IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety & essential performance of electrocardiographic monitoring equipment
09	IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety & essential performance of invasive blood pressure monitoring equipment
10	IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety & essential performance of multifunction patient monitoring equipment
11	IEC 80601-2-30:2018 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety & essential performance of automated non-invasive sphygmomanometers
12	ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices
No.	Standard
13	IEC 62366:2007 + Amendment 1:2014 - Medical devices -- Application of usability
engineering to medical devices
14	IEC 60601-1-6: 2010+A1: 2013 Medical electrical equipment - Part 1-6: General
requirements for safety - collateral standard: Usability
15	ANSI/AAMI/EC57:2012 Testing and reporting performance results of cardiac
rhythm and ST-segment measurement algorithms

Table 11-3. Standards Used for Compliance Testing

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11.5 CONCLUSION

The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility testing, and software verification and validation, demonstrate that the Nihon Kohden Life Scope®G5 and Life Scope®G7 Bedside Monitoring Systems do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the Nihon Kohden Life Scope® G9 predicate device.