The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered. The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.

The Life Scope® BSM-6000 Series Bedside Monitoring Systems 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 signals produced by the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart 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 and inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors and external devices which output analog voltage signal. The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, 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 and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit. The device may generate and 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. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® PT BSM-1700 Series Beside Monitor and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series has both an input and transport/standalone mode. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits or when disconnected from the core unit of the input unit can be removed from one core unit and connected to another device's core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device by using with or with or without WLAN technology. In standalone mode, the device does not require a core unit. The BSM-1700 Series can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). When the BSM-1700 Series is used in transport or standalone mode, the following can be analyzed and displayed: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS). The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.

AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems. The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.

Device Description

The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical persomel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, or intensive care unit. NMT Module is a system comprised of NMT Module. Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via Main Cable. The electrode is a single-use electrode array, and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode. TheNMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. Thecaptured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are a lso sent to the monitoring system to display. The AF-201P NMT Module is used to control the electrical stimulation and to measure theresponse. The operational setting is controlled via buttons on the module or a touch screen.

The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardial signs monitoring within a medical facility. The device is intended to produce a visualrecord of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is a lso 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 and inspired and expired a nesthetic a gents and a nesthetic gases including CO2, O2, N2O, Halothane, Isoflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920R A Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and a larms from the external devices. Supported external devices include AG-920RA Anestheic Agent Detection System, Ventilators, CO2 Monitors, BIS Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The devicemay generate anaudible and or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signa ls via radio frequency. The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® CSM-1901 Bedside Monitoring Systems which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU. HCU. NICU and an emergency room. These systems are placed near the patient and is intended to display patient's vital signs. These systems can also be connected to other external patient monitoring devices. In a ddition, these systems can communicate patient's data to a central monitoring station via network to monitor multiple patients. The input unit is common to NK parent devices that require both a core unit and input unit. NK manufactures the input units with three (3) SpO2 options. The Life Scope® CSM-1 901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data a cquisition unit is required to transmit data from the input unit to the core unit. The bedside monitoring systems require both a coreunit and an input unit interprets the electrical impulses from the patient's body and transfers this data into 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 AY Series Input unit is used with the monitoring systems platforms, when connected to the core unit of the parent device, the inputunit collects electrical impulses, and the core units calculates and displays on the core unit's screen.

The BSM-1700 Series Bedside Monitor is a multifunctional device used as an input unit, transport/standalone monitor.
· Input unit for other monitoring systems platforms, when connected to the core unit of the parent device, the input unit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
· When the patient needs to be transported, the BSM-1700 Series can be removed from the core unit, transport mode can be enabled and can be used with or without WLAN. When WLAN is enabled real time data viewing on the Nihon Kohden network or if it is disabled the BSM-1700 Series will display monitoring data and store the review data.
• When the device is removed from the coreunit it functions as a standalone or independent monitoring system.
The BSM-1700 Series has a display monitor that is disabled when connect to a core unit. Each monitor has a cobr display and is intended for one patient. When used as an inputunit with the coreunit, the system monitors a dvanced parameters. The intended populations are all patient populations under the care of health professionals. In all modes, the BSM-1700 Series uses the Smart Cable technology that is used to connect to other accessories used to collect electrical impulses. The BSM-1700 Series interprets the electrical impulses from the patient's body. When connected to a core unit, advanced calculations can be achieved. The device may generate a naudible and/or visual a larm when a measured rate falls outside preset lim its.

AI/ML Overview

Here's a breakdown of the acceptance criteria and related study information, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily a detailed clinical study report proving performance against novel acceptance criteria. In this specific case, the submission emphasizes that there are no new acceptance criteria because the device (Life Scope PT BSM-1700 Series Bedside Monitor) is being updated to include a "standalone mode," but its underlying technology and performance characteristics are unchanged from its previously cleared version (K213316). Therefore, the "study that proves the device meets the acceptance criteria" largely relies on the prior clearance and non-clinical testing for the updated mode.

1. Table of Acceptance Criteria and Reported Device Performance

Since the document explicitly states there are no new technological changes or safety/performance claims, the acceptance criteria are effectively the performance specifications of the predicate device (K213316). The reported device performance is stated to be "the same" as the predicate.

Characteristic/Parameter (Acceptance Criteria)	Reported Device Performance (Subject Device: Life Scope BSM-1700 Series Bedside Monitor)
Intended Use/Indications for Use	Expanded to include standalone mode functionality for parameters as listed below. (Note: This is a labeling update, not a change in underlying performance for already cleared functions.)
Compatible Core Unit Options	Same as predicate (Life Scope® BSM-6000, CSM-1901, G5, G7 Series)
BSM-1700 Touchscreen Display (Input Unit)	Disabled
Measuring Parameters (Core unit + Input)	ECG, Imp Resp, NIBP, SpO2, CO2, IBP, Temp, CO, TOF, BIS
Touchscreen Display (Standalone/Transport)	Enabled
Resolution (Standalone/Transport)	640 x 480
Number of Traces (Standalone/Transport)	9, 12 (when 12 leads ECG)
Waveform Display (Standalone/Transport)	ECG, Imp Resp, NIBP, SpO2, CO2, IBP, Temp, CO, BIS
Numeric Data Display (Standalone/Transport)	Heart Rate, Pulse Rate, VPC rate, ST level, Respiration Rate, NIBP (sys/dia/mean), Temp (2), SpO2, EtCO2, FiCO2, Cardiac Output, BIS, IBP (3) (sys/dia/mean)
Alarm Display	Alarm sound, highlighted alarm display, alarm lamp
Alarm Suspend/Silence	Yes
Number of ECG Electrodes	3, 6 or 10
Defibrillation Discharge Protection	Yes
Electrosurgery Interface filter	Yes
Pacing detection	Yes
Heart Rate Counting Method	Average, instantaneous (Beat to beat)
Heart Rate Counting Range	0, 15 to 300 bpm
Heart Rate Counting Accuracy	± 2 bpm
ST Level Measuring Range	-2.5 to +2.5 mV
VPC Counting Range	0 to 99 per min
Arrhythmia Alarm	Yes
Arrhythmia Recall (Standalone Mode)	32768 items, 72 hours
Respiration Rate Display	0 to 150 bpm
SpO2 Declared Range, Accuracy (NK type)	70 to 100% (with sensor), 80 to 100% ± 2 %SpO2, 70 to 80% ± 3 %SpO2
NIBP Measuring Method	Oscillometric
NIBP Measuring Range (Adult/Pediatric)	10 - 280 mmHg
NIBP Measuring Accuracy	± 3 mmHg
IBP Measuring Range	-50 to 300 mmHg
IBP Measuring Accuracy	±1mmHg±1digit (-50 to 100 mmHg), ±1%±1 digit (100 to 300 mmHg)
Temperature Measuring Range	0 to 45°C
Temperature Accuracy	±0.1 °C (25 to 45°C), ± 0.2 °C (0 to 25°C)
CO2 Measuring Range	Depends on CO2 unit (e.g., 0 to 100mmHg for TG-900P/920P)
Cardiac Output Measuring Range	0.5 to 20 L/min
Cardiac Output Accuracy	±5%
Full Disclosure Storage (Standalone Mode)	72 hours, 5 waves
Trend Display Time (Standalone Mode)	1, 2, 4, 8, 24, 72 hours
Battery Operation Time	5 hours
General Safety	Meets IEC 60601-1:2005+Amd.1:2012, ANSI/AAMI/ES 60601-1:2005 (R2012)
EMC	Meets IEC60601-1-2:2014

Study Proving Device Meets Acceptance Criteria

The document states:

"The device performance and software have not changed from the original submission K213316." (Sections 2.4, 3.4, 4.4, 5.4)
"For this submission the BSM-1700 Bedside Monitor has been updated to include the standalone mode. There are no specification changes, technological changes or safety and Performance claims. The indications for use and labeling have been updated to include the standalone mode." (Section 6)
"The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, environmental, safety, and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device, the results confirmed that the device performed within specifications." (Section 6.3 Safety & Performance Tests)

Given this, the "study" is primarily an affirmation that the previously cleared performance for K213316 remains valid, coupled with non-clinical verification and validation testing of the additional "standalone mode" functionality to ensure it operates within the established specifications without altering the core performance characteristics.

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a clinical test set in this 510(k) summary. This type of submission relies heavily on non-clinical (bench) testing to confirm performance when significant changes are not made.
- The data provenance is implied to be from Nihon Kohden's internal testing. The submission is focused on demonstrating substantial equivalence rather than presenting a de novo clinical study with patient data. As such, the data would be laboratory-generated from testing the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided because no clinical study requiring expert ground truth establishment for a test set is detailed. The "ground truth" for non-clinical performance would be derived from established engineering and metrological standards and test procedures.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable since the submission focuses on non-clinical performance and engineering validation rather than human reader studies.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a physiological monitor, not an AI-powered diagnostic tool, and the submission does not mention AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The term "standalone" in the provided document refers to a mode of operation for the BSM-1700 device, where it functions independently without being connected to a core unit. It does not refer to a standalone performance study of an algorithm.
- However, the performance tests described in Section 6.3 were likely conducted in a "standalone" fashion for the device's functional parameters, meaning the device itself was tested to ensure its outputs (e.g., heart rate, SpO2 accuracy) met specifications. The submission highlights that "The device performance and software have not changed from the original submission K213316," implying that the standalone performance requirements were met by the previous device and confirmed for this update.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the ground truth would be based on calibrated reference standards and established measurement methodologies for physiological parameters (e.g., known electrical signals for ECG, certified NIBP simulators, calibrated temperature baths, etc.).
- No clinical ground truth (like pathology or outcomes data) is described in this submission, as it's not a clinical study.
The sample size for the training set:
- This information is not provided. Medical devices like this (physiological monitors) typically undergo engineering development, verification, and validation testing rather than a "training set" in the machine learning sense. Any underlying algorithms (e.g., for signal processing, arrhythmia detection) would have been developed and validated during earlier stages or for previous clearances.
How the ground truth for the training set was established:
- Not applicable for this type of device and submission. If any algorithms involved "training," the ground truth would have been established using rigorously collected physiological data and expert annotation/labeling, but this detail is not present in the 510(k) summary.

Summary

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July 21, 2022

Nihon Kohden Corporation % Sunita Teekasingh Principal Regulatory Consultant - GSA2 Group LLC Nihon Koden America, Inc 15353 Barranca Parkway Irvine, California 92618

Re: K220976

Trade/Device Name: Life Scope PT BSM-1700 Series Bedside Monitor Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI Dated: June 14, 2022 Received: June 16, 2022

Dear Sunita Teekasingh:

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-reportingcombination-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 medical devices and radiation-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,

for Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220976

Device Name

Smart Cable NMT Module and Accessories; Life Scope® BSM-6000 Series Bedside Monitoring Systems; Life Scope® CSM-1901 Bedside Monitoring Systems; AY Series And Life Scope® BSM-1700 Series PT Bedside Monitor

Indications for Use (Describe)

The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.

The Smart Cable NMT Module and Accessories are comprised of:

AF-201P NMT Module with Smart Cable Disposable Electrodes Main cable Holder (optional)

The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.

Life Scope® BSM-6000 Series Bedside Monitoring Systems:

The device is also intended to monitor heart 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 and inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors and external devices which output analog voltage signal.

The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

Life Scope® CSM-1901 Bedside Monitoring Systems:

The device is also intended to monitor heart 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 monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.

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The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Life Scope® PT BSM-1700 Series and Accessories:

The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

AY Series and Accessories:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

1 GENERAL PROVISIONS

ADMINISTRATIVE INFORMATION
Sponsor	Nihon Kohden Corporation1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560
Initial Importer	Nihon Kohden America15353 Barranca ParkwayIrvine, CA
Primary Contact/OfficialCorrespondent	Sunita Teekasingh RN, BSN, CCRN, MScGSA2 Group LLCMobile: 612-814-7999Email: Sunita_Teekasingh@nihonkohden.com
Secondary Contact/CompanyRepresentative	Sandra Gadeyne, MBA, ASQ-CQASr. Director, Quality Assurance and Regulatory Affairs15353 Barranca ParkwayIrvine, CAOffice Phone: 949-268-7708Mobile Phone: 949-356-3401Email: Sandra_Gadeyne@nihonkohden.com
SUBMISSION INFORMATION
Submission Type	Specia1510(k)
Product Names	Life Scope® PT BSM-1700 Series Bedside Monitor and AccessoriesLife Scope® BSM-6000 Series Bedside Monitoring SystemsLife Scope® G5 Series Bedside Monitoring SystemsLife Scope® G7 Series Bedside Monitoring SystemsLife Scope® CSM-1901 Bedside Monitoring SystemsAY Series and Accessories, Data Acquisition UnitSmart Cable™ NMT Module and Accessories
Common Names	Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs MonitorStimulator, Nerve, Peripheral, Electric
Classification	Class II
Predicate 510(k)	K213316
Product Code	KOI
Primary Product CodeKOI Products	KOI:Smart Cable™ NMT Module and Accessories
Secondary Product CodeMHX Products	MHX:Life Scope® BSM-6000 Series Bedside Monitoring SystemsLife Scope® G5 Series Bedside Monitoring SystemsLife Scope® G7 Series Bedside Monitoring SystemsLife Scope® CSM-1901 Bedside Monitoring SystemsAY Series and Accessories, Data Acquisition UnitLife Scope® PT BSM-1700 Series and Accessories
Submission Basis	Labeling Modification to Nihon Kohden's legally authorized device: Life Scope® PT BSM-1700 Series Bedside Monitor
Submission Date	1 June 2022

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2 KOI: SMART CABLE NMT MODULE AND ACCESSORIES

The Smart Cable NMT Module and Accessories were previously cleared under K213316. This system requires a compatible monitoring system for the MMT Module to work. There has been no modification to the Smart Cable NMT Module's intended Use, safety or performance to as a result of the inclusion of standalone for the BSM-1700 Series la beling update.

2.1 Device Description

The AF-201P NMT Module is used to control the electrical stimulation and to measure theresponse. The operational setting is controlled via buttons on the module or a touch screen.

2.2 Indications for Use/Intended Use

The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.

The Smart Cable NMT Module and Accessories are comprised of :

AF-201P NMT Module with Smart Cable •
Disposable Electrodes
Main cable .
Holder (optional) .

2.3 Equivalent device

There ha ve been no modifications the Smart Cable NMT Module and Accessories in this submission and this device is the equivalent to the device presented under K213316.

2.4 Performance Results

The device performance and software have not changed from the original submission K213316.

2.5 Summary

Based on the intended use, product, performance and software information provided in this notification, the subject devicehas been shown to be substantially equivalent to the currently marketed predicate devices.

3 MHX:BSM-6000 Series

There are no changes to the Life Scope® BSM-6000 from K2 133 16.

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3.1 Device Description:

pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired a nesthetic a gents and a nesthetic gases including CO2, O2, N2O, Halothane, Isoflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920R A Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and a larms from the external devices. Supported external devices include AG-920RA Anestheic Agent Detection System, Ventilators, CO2 Monitors, BIS Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The devicemay generate anaudible and or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signa ls via radio frequency. The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

Compatible Parent Bedside Monitoring Configurations
Core Unit	Input Model	Multi-Connector	Spo2 Probe
Life Scope® BSM-6000Series BedsideMonitoring Systems	AY-631P	1	Masimo
	AY-633P	3
	BSM-1733	3
	AY-651P	1	Nellcor
	AY-653P	3
	BSM-1753	3
	AY-661P	1
	AY-663P	3
	BSM-1763	3	Nihon Kohden
	AY-671P	1
	AY-673P	3
	BSM-1773	3
DataAcquisitionUnit	JA 690PA	N/A	N/A
	JA-694PA	4	N/A

Table 1: Compatible Input Unit and Core Units

3.2 Indications For Use/Intended Use

The device is also intended to monitor heart 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 and inspired and expired a nesthetic a gents and a nesthetic gases including N2O , Halothane, I soflurane, En flurane and Desflurane.

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K220976 Nihon Kohden BSM-1700 Series- Special 510(k)

Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detectionsystem, Anesthesia machine, Ventilators, CCO monitors, CCO/SvO2 Monitors, EEG monitoring device, tc PO2/tcPCO2 monitors, rSO2 monitors and external devices which output analog voltage signal. The device will be a vailable for use by medical personnel on patients within a medical facility on all pa tient populations.

The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

3.3 Equivalent device

There ha ve been no modifications the Life Scope® BSM-6000 Series in this submission and this device is the equivalent to the device presented under K213316.

3.4 Performance Results

The device performance and software have not changed from the original submission K213316.

3.5 Summary

Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

3.6 Summary

Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

MHX: LIFE SCOPE® CSM-1901 BEDSIDE MONITORING SYSTEMS ব

There have been no modifications to the Life Scope® CSM-1901 as a result of the standalone mode on the BSM-1700 Series. The technological, Safety and Performance is the same o the previous submission K213316.

4.1 Device Description

The input unit is common to NK parent devices that require both a core unit and input unit. NK manufactures the input units with three (3) SpO2 options. The Life Scope® CSM-1 901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data a cquisition unit is required to transmit data from the input unit to the core unit.

The bedside monitoring systems require both a coreunit and an input unit interprets the electrical impulses from the patient's body and transfers this data into 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.

Table 2:Compatible Input Unit and Core Units

Compatible Parent Bedside Monitoring Configurations
Core Unit	Input Model	Multi-Connector	SpO2 Probe
	AY-631P	1	Masimo

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Life Scope® CSM-1901	AY-633P	3
Bedside Monitoring	BSM-1733	3
Systems	AY-651P	1	Nellcor
	AY-653P	3
	BSM-1753	3
	AY-661P	1	Nihon Kohden
	AY-663P	3
	BSM-1763	3
	AY-671P	1
	AY-673P	3
	BSM-1773	3
	Data Acquisition Unit	Multi-Connector	SpO2 Probe
	JA 690PA	N/A	N/A
	JA-694PA	4	N/A

4.2 Indications for Use/Intended Use

The device is a lso 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 a nesthetic a gents and a nesthetic gases including N2O, halothane, isoflurane, en flurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, CCO/SvO2 monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a mea sured rate falls outside preset lim its.

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

The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

4.3 Equivalent device

There have been no modifications the Life Scope® CSM-1901 and Accessories in this submission and this device is the equivalent to the device presented under K213316.

4.4 Performance Results

The device performance and software have not changed from the original submission K2 133 16.

4.5 Summary

5 MHX: AY SERIES AND ACCESSORIES

5.1 Device Description

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5.2 Indications for Use/Intended Use

5.3 Equivalent device

There ha ve been no modifications the AY Series and Accessories in this submission and this device is the equivalent to the device presented under K213316.

5.4 Performance Results

The device performance and software have not changed from the original submission K213316.

ર .5 Summarv

6 MHX:BSM-1700 SERIES BEDSIDE MONITOR

Forthis submission the BSM-1700 Bedside Monitor la s been updated to include the standalone mode. There are no specification changes, technological changes or sa fety and Performance claims. The indications for use and labeling have been updated to include the standalone mode

6.1 Device Description

The BSM-1700 Series Bedside Monitor is a multifunctional device used as an input unit, transport/standalone monitor.

· Input unit for other monitoring systems platforms, when connected to the core unit of the parent device, the input unit collects electrical impulses, and the core units calculates and displays on the core unit's screen.

· When the patient needs to be transported, the BSM-1700 Series can be removed from the core unit, transport mode can be enabled and can be used with or without WLAN. When WLAN is enabled real time data viewing on the Nihon Kohden network or if it is disabled the BSM-1700 Series will display monitoring data and store the review data.

• When the device is removed from the coreunit it functions as a standalone or independent monitoring system.

The BSM-1700 Series has a display monitor that is disabled when connect to a core unit. Each monitor has a cobr display and is intended for one patient. When used as an inputunit with the coreunit, the system monitors a dvanced parameters. The intended populations are all patient populations under the care of health professionals.

In all modes, the BSM-1700 Series uses the Smart Cable technology that is used to connect to other accessories used to collect electrical impulses. The BSM-1700 Series interprets the electrical impulses from the patient's body. When connected to a core unit, advanced calculations can be achieved. The device may generate a naudible and/or visual a larm when a measured rate falls outside preset lim its

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When the inputunit is connected to a core unit calculates and displays the electrical impulses.

BSM-1700 Series with Core Units
Core Units	Input Model	Configuration
		Multi-Connector	SpO2 Probe
Life Scope® BSM 6000Series Bedside MonitoringSystems (K213316)	BSM-1733	3	Masimo
Life Scope® CSM-1901Series Bedside MonitoringSystems (K213316)	BSM-1753	3	Nellcor
Life Scope® G5 SeriesBedside Monitoring Systems(K203435)	BSM-1763BSM-1773	3	Nihon Kohden
Life Scope® G7 SeriesBedside Monitoring Systems(K203435)
Data Acquisition Unit LifeScope® CSM-1901 BedsideMonitoring Systems(K213316)	JA 690PAJA-694PA	N/A	Unit only used withCSM-1901 and BSM-6000
		4

Table 3 BSM-1700 Serieswith Compatible Core Units

As an input unit, the device can interface with external accessories to display numerical and wa veform data and a la rms from the external a ccessories. The Core unit supports external devices including CO2 monitors, BIS monitors. Anesthetic agents/gases detection system. Anesthesia machine. Ventilators. CCO monitors. TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors andexternal devices which output analog voltage signal.

When used as an inputunit, the device can be removed from the core unit, and transport mode can be enabled. The device in transport mode can be used with or without WLAN is enabled, real time data can be seen on the Nihon Kohden network monitors. When WLAN is disabled, the BSM-1700 Series will display the monitoring data and store the review data. When used in a transport/standalone mode, the device can store the review data while transferring the patient. The review data can be transmitted via a direct network connection when the device is connected to a host monitor. When used in transport/standalone mode, the following can be analyzed and displayed: Electrocardiogram(ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP). Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS).

Table 4: Predicate Device Comparison

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	Subject Device: Life Scope BSM-1700Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring SystemK213316-
		Input Unit and Transport Mode
Intended Use/Indications for Use	The Life Scope® PT BSM-1700 SeriesBedside Monitor and Accessories areintended acquire and transfer electricalimpulses from the patient to the main unit ofthe device. The BSM-1700 Series has bothan input and transport/standalone mode. TheBSM-1700 Series input unit monitorsphysiological data and may generate anaudible and/or visual alarm when ameasured rate falls outside preset limits orwhen disconnected from the core unit of thedevice. The input unit can be removed fromone core unit and connected to anotherdevice's core unit. The Life Scope® PTBSM-1700 Series can be used in transportmode where data is transferred from onedevice to another device by using with orwithout WLAN technology. In standalonemode, the device does not require a coreunit. The BSM-1700 Series can acquire thefollowing parameter signals:Electrocardiogram (ECG), Impedancerespiration (Imp Resp), Non-invasive bloodpressure (NIBP), Arterial oxygen saturation(SpO2), Carbon dioxide concentration(CO2), Invasive blood pressure (IBP),Temperature (Temp), Cardiac Output (CO),TOF and Bispectral Index (BIS). When theBSM-1700 Series is used in transport orstandalone mode, the following can beanalyzed and displayed: Electrocardiogram(ECG), Impedance respiration (Imp Resp),Non-invasive blood pressure (NIBP),Arterial oxygen saturation (SpO2), Carbondioxide concentration (CO2). Invasive bloodpressure (IBP), Temperature (Temp),Cardiac Output (CO), and Bispectral Index(BIS).The Data Acquisition Unit (DAU) is anoptional accessory. The DAU is used tocommunicate between the compatible parentcore unit and the input unit using connectioncables. The keys on the DAU allowoperation of the bedside monitor remotely.The DAU is only compatible with the LifeScope® PT BSM-1700 Series and the AYSeries Input Units.	The Life Scope® PT BSM-1700Series and Accessories are intendedacquire and transfer electricalimpulses from the patient to the mainunit of the device. The BSM-1700Series input unit monitorsphysiological data and may generatean audible and/or visual alarm whena measured rate falls outside presetlimits when disconnected from thecore unit of the device. The input unitcan be removed from one core unitand connected to another devicescore unit. The Life Scope® PT BSM-1700 Series can be used in transportmode where data is transferred fromone device to another device by usingwith or without WLAN technology.The input unit can acquire thefollowing parameter signals:Electrocardiogram (ECG),Impedance respiration (Imp Resp),Non-invasive blood pressure (NIBP),Arterial oxygen saturation (SpO2),Carbon dioxide concentration (CO2),Invasive blood pressure (IBP),Temperature (Temp), Cardiac Output(CO), TOF and Bispectral Index(BIS).The Data Acquisition Unit (DAU) isan optional accessory. The DAU isused to communicate between thecompatible parent core unit and theinput unit using connection cables.The keys on the DAU allowoperation of the bedside monitorremotely. The DAU is onlycompatible with the Life Scope® PTBSM-1700 Series and the AY SeriesInput Units.
	Subject Device: Life Scope BSM-1700Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring SystemK213316-Input Unit and Transport Mode
Compatible Core UnitOptions: requires InputUnit	Life Scope® BSM-6000 Bedside MonitoringSystems; Life Scope® CSM-1901 BedsideMonitoring Systems; Life Scope® G5 SeriesBedside Monitoring System, Life Scope® G7Series Bedside Monitoring System.	Same
BSM-1700 TouchscreenDisplay	Disabled	Same
Measuring Parameters asa Bedside MonitoringSystem(Core unit + Input Unit)	Electrocardiogram (ECG), Impedancerespiration (Imp Resp), Non-invasive bloodpressure (NIBP), Arterial oxygen saturation(SpO2), Carbon dioxide concentration(CO2), Invasive blood pressure (IBP),Temperature (Temp), Cardiac Output (CO),TOF and Bispectral Index (BIS).	Same
Touchscreen Display	Default to Core unit Monitor	Same
Resolution	Default to Core unit Monitor Resolution	Same
	System Configuration - Transport mode/Standalone Mode only
BSM-1700 TouchscreenDisplay	Enabled	Same
BSM-1700 Resolution	640 x 480	Same
Number Of Traces in	9	Same
transport/standalone	12 (when 12 leads ECG is displayed)
Waveform Display	Electrocardiogram (ECG),Impedance respiration (Imp Resp),Non-invasiveblood pressure (NIBP),Arterial oxygen saturation (SpO2),Carbon dioxide concentration (CO2),Invasiveblood pressure (IBP),Temperature (Temp), Cardiac Output (CO),and Bispectral Index (BIS).	Same
	Functions - Transport mode/Standalone Modeonly
Trace Movement	Fixed	Same
Numeric Data Display	Heart Rate, Pulse Rate, VPC rate, ST level(12 leads), Respiration Rate, NIBP(sys/dia/mean), Temperature (2), SpO2,EtCO2, FiCO2, Cardiac output,BIS, IBP (3) (sys/dia/mean)	Same
Alarm Display	Alarm sound, highlighted alarm display,alarm lamp	Same
Alarm Suspend/ SilenceFunction	Yes	Same
	ECG- All Modes
Number Of ECGElectrodes	3, 6 or 10	Same
Defibrillation DischargeProtection	Yes	Same
		Subject Device: Life Scope BSM-1700Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring SystemK213316-
			Input Unit and Transport Mode
	Electrosurgery Interfacefilter	Yes	Same
	Pacing detection	Yes	Same
	Heart Rate CountingMethod	Average, instantaneous(Beat to beat)	Same
	Heart Rate CountingRange	0, 15 to 300 bpm	Same
	Counting Accuracy	$\pm$ 2 bpm	Same
	Alarm Limits:UpperLower	16 to 300 bpm, OFF15 to 299 bpm, OFF	Same
	ST Level MeasuringRange	-2.5 to +2.5 mV	Same
	QRS Sync Tone	Yes	Same
	Detection Method	Multi-template software algorithm multi-lead analysis	Same
	VPC Counting Range	0 to 99 per min	Same
	Arrhythmia Alarm	Yes	Same
	Arrhythmia Recall	Yes	Same
	Number of ArrhythmiaRecall files as input unit	Defaults to core unit	Defaults to core unit
	Number Of ArrhythmiaRecall Files intransport/standalonemode	32768 items, 72hours (Standalone Mode)8192 items, 24hours (Transport Mode)	8192 items, 24hours (TransportMode)
		Respirations- All modes
	Respiration	Yes	Same
	Respiration RateDisplay	0 to 150 bpm	Same
	Alarm Limits:UpperLower	2 to 150 bpm, OFF0 to 148 bpm, OFF	Same
	No breath time Limit	5 to 40 seconds, OFF	Same
	Waveform Display	Yes	Same
	Connector InsertionDetection	Yes	Same
Apnea Detection		Yes	Same
		SpO2 - All modes
	Probe Type	Nihon Kohden, Nellcor (NL) or Masimo(MS)	Same
	Displayed Range,	0 to 100%	Same
NK	Declared Range,NKtype and Accuracywith sensor	70 to 100% (with sensor)80 to 100% $\pm$ 2 %SpO270 to 80% $\pm$ 3 %SpO2	Same
		Subject Device: Life Scope BSM-1700 Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring System K213316-Input Unit and Transport Mode

N	Displayed Range,Declared Range,NL type andAccuracy withsensor	1 to 100%70 to 100%70 to 100% ± 2 digits(adult)70 to 100% ±3 digits (neonatal)	Same
M	Displayed Range,Declared Range,MS type andAccuracy withsensor	1 to 100%no motion conditions70 to 100% ± 2 digits(adult)70 to 100% ±3 digits(neonatal) motioncondition70 to 100% ±3 digits(adult)70 to 100%±3 digits(neonatal)	Same
	Pulse Rate Count	Yes	Same
	Pulse Sync Tone	Yes	Same
	Audible Indication toSpO2 Variation	Yes	Same
	SpO2 Alarm Limits:UpperLower	51 - 100%, OFF50 - 99%, OFF	Same
	Pulse Rate Count Range:	0, 30-300 bpm (NK)0, 20-300 bpm (NL)0, 25-240 bpm (MS)	Same
		NiBP-All modes
	Measuring Method	Oscillometeric	Same
	Pressure Data Display	Systolic, Diastolic, Mean, Cuff pressure	Same
	Measuring Range,Adult/ Pediatric	10 - 280 mmHg	Same
	Measuring Range,Neonates	10 - 140 mmHg	Same
	NIBP MeasuringAccuracy	± 3 mmHg	Same
	Alarm Limits: Adult/PediatricUpperLower	15 - 260 mmHg, OFF10 - 255 mmHg, OFF	Same
	Alarm Limits: NeonateUpperLower	15 - 140 mmHg, OFF10 - 135 mmHg, OFF	Same
		IBP
	Measuring Method	Pressure transducer	Same
	Number Of Channels	Up to 3	Same
	Measuring Range	-50 to 300 mmHg	Same
	Measuring Accuracy	±1mmHg±1digit (-50 to 100 mmHg)±1%±1 digit (100 to 300 mmHg)	Same
	Connector InsertionDetection	Yes	Same
	Subject Device: Life Scope BSM-1700Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring SystemK213316-Input Unit and Transport Mode
		Same
Alarm Limits:		Same
Upper	-48 - 300 mmHg, OFF	Same
Lower	-50 - 298 mmHg, OFF	Same
Pulse Svnc Tone	Yes	Same
Pulse Rate Count Range:	0, 30 - 300 bpm	Same
	Temperature -All modes
Number of channels	Up to 2	Same
Measuring Range	0 to 45°C	Same
Display Units	°C or °F	Same
Accuracy	±0.1 °C (25 to 45°C)± 0.2 °C (0 to 25°C)	Same
Connector InsertionDetection	Yes	Same
Numeric Display	Yes	Same
Alarm Limits:		Same
Upper	0.1 to 45°C, OFF	Same
Lower	0 to 44.9ºC, OFF	Same
	Carbon Dioxide-All modes
Measuring Method	Mainstream	Same
Response Time	Depends on CO2 unit160msec (TG-900P)120msec (TG-920P/970P)< 60msec(TG-980P)	Same
Measuring Range, CO2	Depends on CO2 unit0 to 100mmHg(TG-900P/920P)0 to 150mmHg(TG-970P/980P)	Same
Displayed Values	EtCO2, CO2, Resp. rate	Same
Measuring Range,Respiration	Depends on CO2 unit3 to 150 counts/min (TG-900P/920P)0 to 150 counts/min (TG-970P/980P)	Same
Accuracy	Depends on CO2 unit<TG-900P/920P>± 3 mmHg(0 to10mmHg),± 4 mmHg(10 to 40mmHg),± 10% reading (40 to 100mmHg)<TG-970P/980P>±2 mmHg(0 to 40mmHg),± 5% reading(40 to 70mmHg),± 7% reading(70 to 100mmHg),± 10% reading (100 to 150mmHg)	Same
Alarm Limits, CO2:		Same
Upper	2 to 99mmHg, OFF	Same
Lower	1 to 98 mmHg, OFF	Same
Apnea Alarm Limits	5 to 40 seconds, OFF	Same
	Cardiac Output- All modes
Measuring Method	Thermodilution	Same
Measuring Range:Cardiac Output	0.5 to 20 L/min	Same
	Subject Device: Life Scope BSM-1700Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring SystemK213316-
		Input Unit and Transport Mode
Injection Temp.Blood Temp.	0 to 27 °C15 to 45 °C
Accuracy:Cardiac OutputInjection Temp.Blood Temp.	±5%± 0.2 °C± 0.2% (15 to 25 °C)± 0.1% (25 to 45 °C)	Same
Catheter Coefficient	Auto or Manual	Same
Injection TemperatureMeasurement Method	Temperature probe or inline sensor	Same
Alarm Limits, BloodTemp:UpperLower	15.1 to 45.0 °C, OFF15.0 to 44.9 °C, OFF	Same
	Network Connection
Central StationCommunications	Yes (Standard)	Same
Communication Method	EthernetWLAN	Same
	Others
ECG Output	Yes	Same
IBP Output	Yes	Same
Connector forTransmitter	No	Same
External DisplayConnector	No	Same
Serial Data Interface	No	Same
Touchscreen	Yes	Same
Alarm Indicator Lamp	Yes	Same
Dedicated FunctionKeys	Yes	Same
Full Disclosure Storage	72hours, 5 waves (Standalone Mode)24hours, 5 waves (Transport Mode)	24hours, 5 waves (Transport Mode)
Trend Display Time	1, 2, 4, 8, 24, 72* hours(72 hours: Standalone Mode)	1, 2, 4, 8, 24 hours
Vital Sign List Interval	1, 5, 10, 15, 30, 60 minuteNIBP list (Triggered by NIBPmeasurement)	Same
List Capacity	72hours (Standalone Mode)24hours (Transport Mode)	24hours (Transport Mode)
Recorder Type	Network printer	Same
Battery Type	Li-ion (Option)	Same
Number of batteries	1	Same
Battery Operation Time	5 hours	Same
Charge time	4.5 hours Typical	Same
Acquisition andProcessing	Simultaneous Acquisition and Processingfor 12 Lead Development with Calculationsand Resting ECG Analyses	Same
	Subject Device: Life Scope BSM-1700Series Bedside MonitorInput Unit and Transport/Standalone Mode	Predicate Device: BSM 1700 SeriesBedside Monitoring SystemK213316-Input Unit and Transport Mode
ECG InterpretationProgram	ECAPS12C	Same
12 lead ST Analysis	Yes	Same
Patient Age:12 Lead Acquisition12 Lead Interpretation	ALL ages3 Years and older	Same
Line Voltage	100 to 240V	Same
Power Consumption	80VA	Same
Operating Temperature	10 to 40 deg C	Same
Operating RelativeHumidity	30 to 85% RH	Same
Operating AtmosphericPressure	70 to 106 kPa	Same
Dimensions, mm (W, H,D)	147 x 194 x 94(without the wireless LAN station)147 x 210 x 94(with the wireless LAN station)	Same
Weight, kg (withoutoptions)	1.4 (without the battery and options)1.57 (with the battery pack)	Same
General Safety	IEC 60601-1:2005+Amd.1:2012ANSI/AAMI/ES 60601-1:2005 (R2012)	Same
EMC	IEC60601-1-2:2014	Same

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Technological Characteristics 6.2

There are no technological changes to the predicate devices. Both the predicate and the subject device measure the same functions.

6.3 Safety & Performance Tests

The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, en vironmental, sa fety, and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device, the results confirmed that the device performed within specifications.

6.4 Summary of Substantial Equivalence

The Life Scope BSM 1700 Series Bedside Monitor is equivalent to the Life Scope BSM-1700 Series and Accessories. The indications for Use ha ve been updated to include the standalone mode.

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).