Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
Device Facts
| Record ID | K203435 |
|---|---|
| Device Name | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System |
| Applicant | Nihon Kohden Corporation |
| Product Code | MHX · Cardiovascular |
| Decision Date | Jul 16, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 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.
Device Story
LCD touchscreen bedside monitoring system; monitors physiological data including ECG, SpO2, NIBP, IBP, temperature, CO, CO2, respiratory rate, and anesthetic gases. Input unit interprets patient electrical impulses; core unit processes data; displays waveforms and numeric values. Used in clinical settings (e.g., OR, ICU) by trained medical personnel. Provides audible/visual alarms for out-of-limit measurements; supports network communication with central monitors. Assists clinicians in patient assessment and decision-making by providing real-time vital sign monitoring and arrhythmia detection.
Clinical Evidence
Bench testing only. Includes software verification and validation, electrical safety (ANSI/AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per standards including ISO 80601-2-55 (gas monitors), ISO 80601-2-56 (thermometers), ISO 80601-2-61 (pulse oximeters), and ANSI/AAMI/EC57 (cardiac rhythm/ST-segment algorithms).
Technological Characteristics
LCD touchscreen bedside monitor; core unit and input unit architecture. Parameters: ECG (3, 6, 10 electrodes), NIBP (oscillometric), IBP, SpO2, CO2 (main/side stream), temperature, BIS, TOF, anesthetic gases. Connectivity: Networked to central monitors. Software: Multi-template arrhythmia algorithm, ECAPS12C interpretation program. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55/56/61, IEC 60601-2-26/27/34/49, IEC 80601-2-30.
Indications for Use
Indicated for cardiac and vital signs monitoring in medical facilities for all patient populations (neonate, infant, child, adolescent, adult). A-fib detection, ST measurement, and QTc/QRSd monitoring indicated for adults only. Arrhythmia detection indicated for child, adolescent, and adult patients.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- CSM-1901 (G9) Bedside Monitoring System (K201949)
Reference Devices
Submission Summary (Full Text)
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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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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# 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) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary
| Sponsor: | Nihon Kohden Corporation<br>1-31-4 Nishiochiai, Shinjuku-Ku<br>Tokyo, Japan 161-8560 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Initial Importer: | Nihon Kohden America<br>15353 Barranca Parkway<br>Irvine, CA, 92618<br>Sandra Gadeyne |
| Contact: | Sandra Gadeyne<br>Sr. Director, Quality Assurance and Regulatory Assurance<br>15353 Barranca Parkway<br>Irvine, CA, 92618<br>Phone: (949) 268-7708<br>Fax: (949) 356-3401<br>Email: Sandra_Gadeyne@nihonkohden.com |
| 510(k) Submission Type: | Traditional 510(k) |
| Date Prepared: | June 14, 2021 |
### DEVICE INFORMATION:
| Proprietary Name: | Nihon Kohden Life Scope® G5 Bedside Monitoring System<br>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<br>Monitor<br>Life Scope® G7H; Life Scope® G7 with (DAU) Data<br>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.
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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.
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### 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<br>(Subject Device)<br>Life Scope G5 Bedside Monitoring System | Life Scope G7<br>(Subject Device)<br>Life Scope G7 Bedside Monitoring System | CSM-1901<br>(K#201949)<br>Predicate<br>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<br>Arrhythmia Detection | Monitor, Physiological, Patient with<br>Arrhythmia Detection | Monitor, Physiological, Patient with<br>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<br>(Subject Device) | Life Scope G7<br>(Subject Device) | CSM-1901<br>(K#201949)<br>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.<br>Below & Section 5.3-8 | |
| | The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.…
