(235 days)
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.
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.
Here is an analysis of the acceptance criteria and supporting study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing substantial equivalence to a predicate device rather than defining specific performance-based acceptance criteria for novel claims. The acceptance criteria are implicitly derived from the predicate device's specifications and compliance with recognized standards. Therefore, the "reported device performance" is essentially a statement of "identical" or "below" (meaning lower capacity/resolution but deemed not to affect safety/effectiveness) compared to the predicate.
| Characteristic | Acceptance Criteria (from Predicate) | Subject Device (Life Scope G5/G7) Performance | Comparison |
|---|---|---|---|
| General | Identical to CSM-1901 (K201949) | Identical to CSM-1901 (K201949) in Classification Panel, Regulation Number, Classification Name, Regulatory Class, Product Code, Patient Population, Setting, End-User, Biocompatibility, Shelf Life, Patient Contact, Single-Use. | Identical |
| Indications for Use | Monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. Monitor ECG to generate alarms when arrhythmia exists. Monitor heart rate, pulse rate, SpO2, NIBP, IBP, body temperature, BIS, CO, O2, CO2, EtCO2, respiratory rate, inspired/expired anesthetic gases. Display patient data from external devices. Generates audible/visual alarms when a measured rate falls outside preset limits. For trained medical personnel, all patient populations (adult, neonate, infant, child, adolescent). A-fib detection, ST measurement, QTc/QRSd monitoring for adult; Arrhythmia detection for child, adolescent, adult. | Identical to Predicate K201949. Patient population for each ECG analysis functionality clarified. | Identical |
| ECG | |||
| QTc/QRSd Monitoring | Yes (Spot-Check) | Yes (Spot-Check) and Continuous monitoring (Automatically started when ECG monitoring begins). | Below (Predicate had only spot-check, subject device adds continuous, but deemed not to affect safety/effectiveness) |
| Arrhythmia Recall Files | 20,000 files | 16,384 files | Below (16,384 < 20,000, deemed minor difference not affecting safety/effectiveness) |
| Respiration | Impedance, CO2, and thermistor method | Impedance and CO2 method only (no thermistor) | Below (fewer methods, but deemed not to affect safety/effectiveness) |
| Body Temp | 8 channels | 4 channels | Below (fewer channels, but deemed sufficient and not affecting safety/effectiveness) |
| Cardiac Output | 168 hours list capacity | 72 hours list capacity | Below (shorter capacity, but deemed sufficient and not affecting safety/effectiveness) |
| Display | Resolution: 1680 x 1050; Extended Display Triple: Yes | CSM-1501: 1280 x 800 (resolution), No (Extended Display Triple); CSM-1502/CSM-1701: 1366 x 768 (resolution), Yes (Extended Display Triple); CSM-1702: 1680 x 1050 (resolution), Yes (Extended Display Triple) | Below (lower resolution/fewer displays for some models due to size, but tested to IEC 60601-1 and passed, deemed not to affect safety/effectiveness) |
| Other Parameters | All other parameters (e.g., Heart rate counting, ST level, NIBP, SpO2, Pulse rate, Anesthetic agent monitoring, TOF, EEG measurements not specifically mentioned above) have identical specifications and performance to the predicate device. This includes: ECG leads, input impedance, frequency response, display sensitivity, defibrillation discharge protection, electrosurgery interface filter, pacing detection, leads off detector, filters, heart rate counting method/range/accuracy/alarm limits, ST level measuring range, QRS sync tone, arrhythmia detection method/VPC counting range/alarms/recall length/types/graphic trend, ECAPS-12 analysis, patient age for analysis, respiration rate display/alarm limits/no breath time, waveform display, connector insertion detection, apnea detection/alarm limit/methods, SpO2 probe type/input unit/displayed range/Nihon Kohden declared range/Nellcor declared range/Masimo declared range/display sensitivity/pulse sync tone/audible indication/alarm limits/pulse rate count range & accuracy, NIBP measuring range/accuracy/mode/maximum cuff inflation/rapid deflation/alarm limits, IBP measuring method/channels/range/accuracy/input sensitivity/connector insertion detection/alarm limits/pulse rate count range & accuracy/pulse sync tone, body temp measuring range/display units/accuracy/alarm limits/connector insertion detection/numeric display, CO2 method/rise time/measuring range/display values/response time/alarm limits/accuracy, O2/N2O/Anesthetic agent measuring range/displayed numerical value/connector insertion detection/alarm limits/accuracy, cardiac output measuring method/range/accuracy/catheter coefficient/alarm limits, TOF muscle movement detection/stimulation patterns/current range/pulse width, EEG alarm limits/channels/input impedance/calibration check/impedance check/CMRR/noise level/frequency response/filters/sensitivity/A-D conversion/sampling/trend parameter/MDF/TP/aEEG, sweep speed, trace movement, alarm display, extended display-dual, remote control compatible, drug calculation, car seat challenge, lung capacity calculation, recorder type/channels/annotation printing/speed. | All other parameters have identical specifications and performance to the predicate. | Identical |
| Safety and Compliance | Compliance with relevant medical device standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61, IEC 60601-2-26, IEC 60601-2-27, IEC 60601-2-34, IEC 60601-2-49, IEC 80601-2-30, ISO 14971, IEC 62366, IEC 60601-1-6, ANSI/AAMI/EC57. | The devices comply with the applicable requirements within the listed standards for safety and EMC. Software V&V testing was conducted. No new issues of safety or effectiveness were identified. | Compliant |
2. Sample size used for the test set and the data provenance
The provided text does not explicitly state a specific sample size for a "test set" in the context of clinical performance or diagnostic accuracy. Instead, the submission relies on:
- Non-clinical bench testing: This refers to laboratory-based evaluations of the device's technical specifications and performance against engineering requirements and established standards. The text does not detail the "sample size" of this type of testing (e.g., how many units were tested, how many times).
- Electrical safety and electromagnetic compatibility (EMC) testing: Performed on the devices to comply with standards like ANSI AAMI ES60601-1 and IEC 60601-1-2. No sample size is mentioned.
- Software verification and validation (V&V): This included unit, integration, and system-level testing based on software requirements. Again, specific "sample sizes" (e.g., number of test cases, patient data used for simulated testing) are not provided in this summary.
- Comparison to a predicate device (Nihon Kohden CSM-1901, K201949): The primary evidence for substantial equivalence is based on demonstrating that the subject devices (Life Scope G5 and G7) have identical intended use, indications for use, principles of operation, and performance specifications to the predicate, with minor differences explicitly addressed and deemed not to affect safety or effectiveness. The performance of the predicate device itself would have been established through its own clearance process, which likely included clinical and non-clinical data. However, for the subject devices, no new clinical studies with patient data (and thus no specific "test set" sample size or data provenance) beyond what the predicate relied upon are detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that no explicit "test set" with ground truth established by experts is described for the subject devices, this information is not provided in the text. The submission focuses on technical equivalence and compliance with standards rather than a new clinical study requiring expert-adjudicated ground truth.
4. Adjudication method for the test set
Since no specific test set requiring expert adjudication for ground truth is described, the adjudication method information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not mentioned or described in the provided text. The submission relies on demonstrating substantial equivalence to a predicate device through technical comparison and compliance testing, not a comparative clinical study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "Multi-template software algorithm" for arrhythmia detection and "ECAPS12C" for ECG interpretation. This indicates that standalone algorithmic performance is part of the device's function. However, the document does not provide standalone performance metrics (e.g., sensitivity, specificity for arrhythmia detection or ECG interpretation) obtained from testing the algorithm in isolation. Instead, it states that "Software verification and validation testing were conducted," which would include testing of these algorithms. The performance is implicitly covered by the device's overall compliance with standards like ANSI/AAMI/EC57, which specifies testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms.
7. The type of ground truth used
For the software verification and validation, and potentially for the standards compliance (e.g., ANSI/AAMI/EC57 for ECG algorithms), the ground truth would likely be established through:
- Reference standards/simulated data: For technical specifications and algorithm testing, synthetic or pre-recorded standardized waveforms (e.g., from databases like MIT-BIH Arrhythmia Database) with known ground truth annotations are typically used.
- Predicate device performance: The "ground truth" for showing substantial equivalence is the established performance and safety profile of the predicate device itself.
The document does not explicitly state the specific type of ground truth used for any newly generated data for the subject devices, but it implicitly relies on established testing methodologies for medical devices and their components.
8. The sample size for the training set
The document does not provide information on the sample size for any training set. This is generally because the submission is for a medical device with established technological characteristics, not a novel AI/machine learning device that would typically involve a separate training phase with a distinct dataset size. The "Multi-template software algorithm" for arrhythmia detection suggests an algorithm developed or trained previously, but details of its training are not part of this 510(k) summary.
9. How the ground truth for the training set was established
As no training set is described for the subject devices in this 510(k) summary, the method of establishing its ground truth is not provided. If the algorithms were previously trained, it would have been done during their initial development, likely using expert-annotated physiological data.
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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) |
|---|
| ☑ 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 Corporation1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560 |
|---|---|
| Initial Importer: | Nihon Kohden America15353 Barranca ParkwayIrvine, CA, 92618Sandra Gadeyne |
| Contact: | Sandra GadeyneSr. Director, Quality Assurance and Regulatory Assurance15353 Barranca ParkwayIrvine, CA, 92618Phone: (949) 268-7708Fax: (949) 356-3401Email: 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 Systemand 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 PatientMonitorLife Scope® G7H; Life Scope® G7 with (DAU) DataAcquisition 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(Subject Device)Life Scope G5 Bedside Monitoring System | Life Scope G7(Subject Device)Life Scope G7 Bedside Monitoring System | CSM-1901(K#201949)PredicateCSM-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 withArrhythmia Detection | Monitor, Physiological, Patient withArrhythmia Detection | Monitor, Physiological, Patient withArrhythmia 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 forchild, adolescent, and adult patients. | detection function is intended forchild, adolescent, and adult patients. | |||
| Waveform Display | ECG, respiration curve, IBP waveform,SpO2 pulse waveform, CO2 partialpressure curve, EEG waveform,respiratory flow curve, airway pressurecurve, respiratory volume curve,EEG waveform (BIS), O2concentration curve, CO2 concentrationcurve, anesthetic agent concentrationcurve. | ECG, respiration curve, IBP waveform,SpO2 pulse waveform, CO2 partialpressure curve, EEG waveform,respiratory flow curve, airway pressurecurve, respiratory volume curve,EEG waveform (BIS), O2concentration curve, CO2 concentrationcurve, anesthetic agent concentrationcurve. | ECG, respiration curve, IBP waveform,SpO2 pulse waveform, CO2 partialpressure curve, EEG waveform,respiratory flow curve, airway pressurecurve, respiratory volume curve,EEG waveform (BIS), O2concentration curve, CO2 concentrationcurve, anesthetic agent concentrationcurve. | Same |
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| Characteristics | Numeric Data Display | Alarm Display | Alarm Suspend/SilenceFunction | 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 DischargeProtection | 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:UpperLower | 16 to 300 bpm, OFF15 to 299 bpm, OFF | 16 to 300 bpm, OFF15 to 299 bpm, OFF | 16 to 300 bpm, OFF15 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 DetectionDetection Method | Multi-template software algorithmMulti-lead analysis | Multi-template software algorithmMulti-lead analysis | Multi-template software algorithmMulti-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 RecallFiles | 16,384 files | 16,384 files | 20,000 files | Below | |
| Number of Arrhythmia RecallFiles (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 AnalysisAcquisition and Processing | Simultaneous Acquisition andProcessing for 12 LeadDevelopment with Calculations andResting ECG Analyses | Simultaneous Acquisition andProcessing for 12 LeadDevelopment with Calculations andResting ECG Analyses | Simultaneous Acquisition andProcessing for 12 LeadDevelopment with Calculations andResting 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 Acquisition12 Lead Interpretation | All ages3 Years and older | All ages3 Years and older | All ages3 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:UpperLower | 2 to 150 bpm, OFF0 to 148 bpm, OFF | 2 to 150 bpm, OFF0 to 148 bpm, OFF | 2 to 150 bpm, OFF0 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 DeclaredRange, type and Accuracy withsensor | 70 to 100% (with sensor)80 to 100% ± 2 %SpO270 to 80% ±3%SpO2 | 70 to 100% (with sensor)80 to 100% ±2%SpO270 to 80% ±3%SpO2 | 70 to 100% (with sensor)80 to 100% ± 2 %SpO270 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, MStype and Accuracy with sensor(K053269) | No motion condition70 to 100% ±2%SpO2 (adult)70 to 100% ±3%SpO2 (neonatal)motion condition70 to 100% ±3%SpO2 (adult)70 to 100% ±3%SpO2 (neonatal) | No motion condition70 to 100% ± 2 %SpO2 (adult)70 to 100% ±3%SpO2 (neonatal)motion condition70 to 100% ± 3 %SpO2 (adult)70 to 100% ±3%SpO2 (neonatal) | No motion condition70 to 100% ± 2%SpO2 (adult)70 to 100% ±3%SpO2 (neonatal)motion condition70 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 SpO2Variation | Yes | Yes | Yes | Identical | |
| SpO2 Alarm Limits:UpperLower | 51 to 100%, OFF50 to 99%, OFF | 51 to 100%, OFF50 to 99%, OFF | 51 to 100%, OFF50 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, Cuffpressure, Pulse Rate | Systolic, Diastolic, Mean, Cuffpressure, Pulse Rate | Systolic, Diastolic, Mean, Cuffpressure, 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 InflationPressure:Adult/PediatricNeonate | 300 mmHg150 mmHg | 300 mmHg150 mmHg | 300 mmHg150 mmHg | Identical | |
| Rapid Deflation If PowerFailure | Yes | Yes | Yes | Identical | |
| Alarm Limits:UpperLower | 15 to 260 mmHg, OFF10 to 255 mmHg, OFF | 15 to 260 mmHg, OFF10 to 255 mmHg, OFF | 15 to 260 mmHg, OFF10 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:UpperLower | -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:UpperLower | 0.1 to 45.0 °C, OFF0.0 to 44.9 °C, OFF | 0.1 to 45.0 °C, OFF0.0 to 44.9 °C, OFF | 0.1 to 45.0 °C, OFF0.0 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 followingsensor:TG-900P/TG-920P/TG-980P | Main Stream with the followingsensor:TG-900P/TG-920P/TG-980P | Main Stream with the followingsensor: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: < 60ms for 10 to 90%(excluding connected instruments) | TG-900P: 160ms(typical) for 10 to 90%TG-920P: 120ms(typical) for 10 to 90%TG-980P: < 60 ms for 10 to 90%(excluding connected instruments) | TG-900P: 160ms(typical) for 10 to 90%TG-920P: 120ms(typical) for 10 to 90%TG-980P: < 60 ms for 10 to 90%(excluding connected instruments) | Identical | |
| Measuring Method CO2 (2) | Main Stream, Side Stream(when GF-210RA connected) | Main Stream, Side Stream(when GF-210RA connected) | Main Stream, Side Stream(when GF-210RA connected) | Identical | |
| Measuring Range, CO2 | TG-900P/TG-920P: 0 to 100mmHgTG-980P: 0 to 150mmHg | TG-900P/TG-920P: 0 to 100mmHgTG-980P: 0 to 150mmHg | TG-900P/TG-920P: 0 to 100mmHgTG-980P: 0 to 150mmHg | Identical | |
| Display Values | EtCO2, CO2, Resp. rate Inspired CO2 | EtCO2, CO2, Resp. rate Inspired CO2 | EtCO2, CO2, Resp. rate Inspired CO2 | Identical | |
| Response Time | Depends on CO2 unit160msec (TG-900P)120msec (TG-920P/970P)<60msec (TG-980P) | Depends on CO2 unit160msec (TG-900P)120msec (TG-920P/970P)<60msec (TG-980P) | Depends on CO2 unit160msec (TG-900P)120msec (TG-920P/970P)<60msec (TG-980P) | Identical | |
| Alarm Limits- CO2:UpperLower | 2 to 99 mmHg, OFF1 to 98 mmHg, OFF | 2 to 99 mmHg, OFF1 to 98 mmHg, OFF | 2 to 99 mmHg, OFF1 to 98 mmHg, OFF | Identical | |
| Accuracy CO2 | TG-900P/TG-920P±3 mmHg (0≤ CO2 ≤10mmHg)±4 mmHg (10 <CO2 ≤40mmHg)± 10% reading (40 <CO2 ≤100mmHg)(At 1 atmospheric pressure, airinspiration, no condensation)TG-980P±2mmHg (0≤ CO2 ≤40mmHg)±5% reading (40 <CO2≤70mmHg)± 7% reading (70<CO2 ≤100mmHg)± 10% reading (100 <CO2 ≤150mmHg) | TG-900P/TG-920P±3 mmHg (0≤ CO2 ≤10mmHg)+4 mmHg (10 <CO2 ≤40mmHg)± 10% reading (40 <CO2 ≤ 100mmHg)(At 1 atmospheric pressure, airinspiration, no condensation)TG-980P±2mmHg (0≤ CO2 ≤ 40mmHg)±5% reading (40 <CO2≤70mmHg)± 7% reading (70<CO2 ≤100mmHg)± 10% reading (100 <CO2 ≤150mmHg) | TG-900P/TG-920P±3 mmHg (0≤ CO2 ≤10mmHg)+4 mmHg (10< CO2 ≤40mmHg)± 10% reading (40 <CO2 ≤100mmHg)(At 1 atmospheric pressure, airinspiration, no condensation)TG-980P±2mmHg (0≤ CO2 ≤40mmHg)± 5% reading (40 <CO2 ≤70mmHg)± 7% reading (70 <CO2 ≤100mmHg)± 10% reading (100 < CO2 ≤150mmHg) | Identical |
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Nihon Kohden
Traditional S10(k) – Life Soope® G5 Bedside Monitoring and
Life Scope® G7 Bedside Monitoring System
K203435 510(k) Summary
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Identical
Oscillometric
Oscillometric
Oscillometric
Non- Invasive Blood Pressure (NIBL
Measuring Method
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| Characteristics | Life Scope G5(Subject Device) | Life Scope G7(Subject Device) | CSM-1901(K#201949)Predicate | Comparison |
|---|---|---|---|---|
| Anesthetic agent | $\pm$ (0.2 vol% + 15% rel.) | $\pm$ (0.2 vol% + 15% rel.) | $\pm$ (0.2 vol% + 15% rel.) | Identical |
| Alarm Limits-Anesthetic agent(ISO-I/E, ENF-I/E):UpperLower | 0.1 to 7.0 %, OFF0.0 to 6.9 %, OFF | 0.1 to 7.0 %, OFF0.0 to 6.9 %, OFF | 0.1 to 7.0 %, OFF0.0 to 6.9 %, OFF | Identical |
| Alarm Limits-Anesthetic agent:UpperLower | 0.1 to 8.5 %, OFF0.0 to 8.4 %, OFF | 0.1 to 8.5 %, OFF0.0 to 8.4 %, OFF | 0.1 to 8.5 %, OFF0.0 to 8.4 %, OFF | Identical |
| Alarm Limits-Anesthetic agent:UpperLower | 0.1 to 20.0 %, OFF0.0 to 19.9 %, OFF | 0.1 to 20.0 %, OFF0.0 to 19.9 %, OFF | 0.1 to 20.0 %, OFF0.0 to 19.9 %, OFF | Identical |
| Cardiac Output | ||||
| Measuring Method | Thermodilution | Thermodilution | Thermodilution | Identical |
| Measuring Range:Cardiac OutputInjection Temp | 0.5 to 20 L/min0 to 27 °C15 to 45 °C | 0.5 to 20 L/min0 to 27 °C15 to 45 °C | 0.5 to 20 L/min0 to 27 °C15 to 45 °C | Identical |
| Accuracy:Cardiac OutputInjection Temp | $\pm$ 5 %$\pm$ 0.2 °C$\pm$ 0.2 °C (15 to 45°C)$\pm$ 0.1 °C (25 to 45°C) | $\pm$ 5 %$\pm$ 0.2 °C$\pm$ 0.2 °C (15 to 45°C)$\pm$ 0.1 °C (25 to 45°C) | $\pm$ 5 %$\pm$ 0.2 °C$\pm$ 0.2 °C (15 to 45°C)$\pm$ 0.1 °C (25 to 45°C) | Identical |
| Catheter Coefficient | Auto or Manual | Auto or Manual | Auto or Manual | Identical |
| Alarm Limits - Blood Temp:UpperLower | 15.1 to 45.0°C15.0 to 44.9°C | 15.1 to 45.0°C15.0 to 44.9°C | 15.1 to 45.0°C15.0 to 44.9°C | Identical |
| Characteristics | Life Scope G5(Subject Device) | Life Scope G7(Subject Device) | CSM-1901(K#201949) Predicate | Comparison |
| List Capacity | 72 hours | 72 hours | 168 hours | Below |
| Train of Four (TOF) | ||||
| Muscle Movement detection | Electromyography (EMG) | Electromyography (EMG) | Electromyography (EMG) | Identical |
| Stimulation Patterns | Single stimulation,TOF (Train Of Four),PTC (Post Tetanic Count),TET (tetanic stimulation),DBS (Double Burst Stimulation | Single stimulation,TOF (Train Of Four),PTC (Post Tetanic Count),TET (tetanic stimulation),DBS (Double Burst Stimulation | Single stimulation,TOF (Train Of Four),PTC (Post Tetanic Count),TET (tetanic stimulation),DBS (Double Burst Stimulation | Identical |
| Stimulation Current Range | 10-60 mA | 10-60 mA | 10-60 mA | Identical |
| Stimulation Pulse width | Square wave, constant current:200µs or 300μς | Square wave, constant current:200µs or 300μς | Square wave, constant current:200µs or 300μς | Identical |
| EEG | ||||
| Alarm Limits - SEF:UpperLower | 1.0 to 60.0 Hz, OFF0.5 to 59.5 Hz, OFF | 1.0 to 60.0 Hz, OFF0.5 to 59.5 Hz, OFF | 1.0 to 60.0 Hz, OFF0.5 to 59.5 Hz, OFF | Identical |
| Alarm Limits - TP:UpperLower | 0.02 to 9.99 nW, OFF0.01 to 9.98 nW, OFF | 0.02 to 9.99 nW, OFF0.01 to 9.98 nW, OFF | 0.02 to 9.99 nW, OFF0.01 to 9.98 nW, OFF | Identical |
| Number of Channels | 8 | 8 | 8 | Identical |
| Input Impedance | 15 ΜΩ at 10 Hz | 15 ΜΩ at 10 Hz | 15 ΜΩ at 10 Hz | Identical |
| Calibration Check | Step square 50 uV | Step square 50 uV | Step square 50 uV | Identical |
| Impedance Check | >10 kΩ within ± 20 % | >10 kΩ within ± 20 % | >10 kΩ within ± 20 % | Identical |
| Common-Mode RejectionRatio (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 | < 3 uV p-p(0.53 to 30 Hz) | < 3 uV p-p(0.53 to 30 Hz) | < 3 uV p-p(0.53 to 30 Hz) | Identical |
| Characteristics | Life Scope G5(Subject Device) | Life Scope G7(Subject Device) | CSM-1901(K#201949) Predicate | Comparison |
| Frequency Response | 0.08 to 70 Hz | 0.08 to 70 Hz | 0.08 to 70 Hz | Identical |
| High-pass Filter (Low-cut) | 0.08 to 5.3 Hz | 0.08 to 5.3 Hz | 0.08 to 5.3 Hz | Identical |
| Low-pass Filter (High-cut) | 15 to 70 Hz | 15 to 70 Hz | 15 to 70 Hz | Identical |
| AC Filter | Rejection ratio: >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 800CSM-1502: 1366 x 768 | CSM-1701: 1366 x 768CSM-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 alarmdisplay, alarm lamp | Alarm sound, highlighted alarmdisplay, alarm lamp | Alarm sound, highlighted alarmdisplay, 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 TripleDisplay | CSM-1501: NoCSM-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, recordingtype, sensitivity, paper speed,parameter data, ECG lead, arrhythmiaclassification, QRS classification | Patient Name, bed ID, date, recordingtype, sensitivity, paper speed,parameter data, ECG lead, arrhythmiaclassification, QRS classification | Patient Name, bed ID, date, recordingtype, sensitivity, paper speed,parameter data, ECG lead, arrhythmiaclassification, 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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 usabilityengineering to medical devices |
| 14 | IEC 60601-1-6: 2010+A1: 2013 Medical electrical equipment - Part 1-6: Generalrequirements for safety - collateral standard: Usability |
| 15 | ANSI/AAMI/EC57:2012 Testing and reporting performance results of cardiacrhythm 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.
§ 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.