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 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, 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 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 arthythmia 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 N20, 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 and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. 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 when discomected from the core unit of the device. The input unit can be removed from one core unit and connected to another devices core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device to another device by using with or without WLAN technology. 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 (Temp), Cardiac Output (CO), TOF 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 Reys 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 personnel 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, recovery 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 The NMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. The captured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are also sent to the monitoring system to display. The AF-201P NMT Module is used to control the electrical stimulation and to measure the response. 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 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 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, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radiofrequency. 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 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 addition 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-1901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data acquisition unit is required to transmit data from the input unit to the core unit. 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.

AI/ML Overview

The provided text is a 510(k) summary for the Nihon Kohden Life Scope PT BSM-1700 Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, and Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM. It describes software modifications to enable compatibility with the Smart Cable NMT Module and Accessories, and updates to the stated Indications for Use.

The document does not contain information about an AI/algorithm-only study, a multi-reader multi-case (MRMC) comparative effectiveness study, or details on ground truth establishment for a training set. The device in question is a physiological monitor, and the software modifications are specifically related to integrating with a neuromuscular transmission (NMT) module and updating intended use statements, not for an AI/CADe (Computer-Aided Diagnosis/Detection) algorithm that would typically require such studies.

Therefore, many of the requested criteria related to AI/algorithm performance and clinical validation studies are not applicable to the information provided in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the software modifications do not change the safety, performance of the predicate devices. It refers to integration testing, not a de novo performance study with specific quantifiable acceptance criteria for a new AI algorithm.

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as intended with new software.	Confirmed operation of the device when the Smart Cable NMT software was integrated into the system. Results confirmed the device performed within specifications.
Software modifications do not raise different questions of safety and effectiveness.	Software input units modifications and labeling modification do not raise different questions of safety and effectiveness.
Compliance with relevant electrical safety and EMC standards.	Complies with ANSI AAMI ES60601-1 / IEC 60601-1 for safety and IEC 60601-1-2 for EMC.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in terms of patient data. The testing mentioned is "software unit testing, integration level testing, and system-level testing" and a "system test... based on the software requirements specification." This suggests internal product testing rather than a separate clinical test set of patient data.
Data Provenance: Not applicable, as no external clinical data test set is described. The focus is on the integration and functional testing of the software within the device system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth, in this context, would be the proper functioning and integration of the software and hardware, verified through engineering and system testing, not through expert reading of medical images or data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is typically used in clinical studies for establishing ground truth for AI algorithms, which is not the subject of this 510(k).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence." This device is not an AI-assisted diagnostic or therapeutic tool; it's a physiological monitor with updated software for compatibility.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is not an AI algorithm requiring standalone performance evaluation. The "software modification" refers to updates enabling the NMT module to work with the monitoring system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the software and system functionality: The ground truth is the predefined technical specifications and expected behavior of the device and its integrated components. This is verified through "software unit testing, integration level testing, and system-level testing."

8. The sample size for the training set:

Not applicable. There's no machine learning model or AI algorithm described that would require a "training set."

9. How the ground truth for the training set was established:

Not applicable for the same reason as above.

Summary

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December 29, 2021

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

Re: K213316

Trade/Device Name: Life Scope PT BSM-1700 Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI, MHX Dated: November 26, 2021 Received: November 29, 2021

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/cfpm/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 (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,

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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) K213316

Device Name

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

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 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

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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 N20, 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.

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 Reys 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

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.

Type of Use (Select one or both, as applicable)
	X 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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SECTION 5 510(K) SUMMARY OR 510(K) STATEMENT

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Image /page/6/Picture/1 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white abstract design on the left, followed by the text "NIHON KOHDEN" in blue. The text is in a sans-serif font and is slightly blurred.

5.1	General Provisions	Manufacturer Name:	Nihon Kohden Corporation
		Address:	1-31-4 Nishiochiai, Shinjuku-KuTokyo 161-8560, Japan
		Submitter Name:	Nihon Kohden America
		Address:	15353 Barranca ParkwayIrvine, California, USA92618
		Primary Contact	Sunita TeekasinghGSA2 Group LLC Consultant
		Phone Number	612-814-7999
		Email	Sunita.Teekasingh@nihonkohden.com
		Secondary Contact:	Sandra GadeyneSr. Director of Quality and Regulatory Affairs
		Phone Number	949-268-7708
		Mobile Number:	949-356-3401
		Email	Sandra.Gadeyne@nihonkohden.com
		Date of Preparation	27-Dec-2021
		Submission Type	Special 510(K)
		Type of Modification	Software Modification
		Predicate	K201949 – cleared 2 May2021• Life Scope® BSM-6000 Series BedsideMonitors;• Nihon Kohden CSM-1901 Bedside Monitor

5.2 INTRODUCTION

This submission is to obtain clearance for the software modification to the input units for Life Scope® PT BSM 1700 Series and A Y Series Input Units , see Table 5-1 for the summary. The input units required an updated software package to work with the Smart Cable NMT Module and Accessories (K201949).

The software modifications on the input units does not change the safety, performance of the predicate devices.

Smart CableNMT Moduleand AccessoriesK201949	Parent device Core Unitsoftware version	Input Unit Software version AY Series orBSM-1700 Series
AF-201PSoftwareVersion 3.0-no changes to theoriginal softwareunderK201949	Life Scope®BSM-6000 SeriesBedside Monitoring Systems(K201949) Software v08-31Life Scope® CSM-1901Bedside Monitoring Systems(K201949) Software v01-32Life Scope® BSM-3000 Series Bedside Monitors (K201949) Software v08-31	AY Series v08-31AY-631PAY-633PAY-651PAY-653PAY-671PAY-673PORBSM-1700 Seriesv02-66BSM-1733BSM-1753BSM-1773

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In addition to the software changes, Nihon Kohden (NK) is updating the intended use for the Life Scope® BSM-6000 Series Bedside Monitoring Systems, and Life Scope® CSM-1901 Bedside Monitoring Systems:

A statement was added to the parent devices to clarify these systems require both a core unit and an ● input unit.
The Life Scope® PT BSM-1700 Input unit and the AY Series Input unit and accessories were added to the parent device intended use.

Compatible Parent BedsideMonitoring Core Units	Input Model	Configuration
		Multi Connector	SpO2 Probe
Life Scope® BSM 6000Series Bedside MonitoringSystems (K201949)	AY-631P	1	Masimo
	AY-633P	3
	BSM-1733	3
Life Scope® CSM-1901Bedside Monitoring Systems(K201949)	AY-651P	1	Nellcor
	AY-653P	3
	BSM-1753	3
Life Scope® G5 SeriesBedside Monitoring Systems(K203435)	AY-671P	1	Nihon Kohden
	AY-673P	3
	BSM-1773	3
Life Scope® G7 SeriesBedside Monitoring Systems(K203435)
Life Scope® CSM-1901 andBSM-6000 Series BedsideMonitoring Systems(K201949)Data Acquisition Unit	JA 690PA	N/A	Unit only usedwith CSM-1901and BSM-6000
	JA-694PA	4

Table 5-2: Parent Devices: Core Unit and Input unit configurations

5.3 SMART CABLE NMT MODULE AND ACCESSORIES
The Smart Cable NMT Module and Accessories were previously cleared under K201949, this system requires a compatible monitoring system for the NMT module to work. The input unit software has been updated to recognize the Smart Cable NMT Module connection. There have been no modifications to the Intended Use, safety or performance for Smart Cable NMT Module and Accessories as a result of the input unit software update.

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Subject Device	Trade Name:	Smart Cable NMT Module and Accessories
	Common Name:	Electrical peripheral nerve stimulator
	Classification Name	Stimulator, Nerve, Peripheral, Electric
	Classification:	Class II
	Product Code:	KOI
	Regulation Number:	21 CFR 868.2775
Predicate Device	Trade Name:	Smart Cable NMT Module and Accessories
	Marketing Names:	NMT Smart Cable TOF Pod; Smart Cable NMT Pod, with EMG Support; NMT Pod TOF Pod; TOF Smart Pod; NMT Smart Pod, NMT Module, AF-201P, Smart Cable NeuroMuscular Transmission Pod, NMT Pod and Train of Four Pod, Disposable electrodes, EMG electrodes, NMT electrodes
	Classification Name:	Electrical peripheral nerve stimulator
	Premarket Notification	Stimulator, Nerve, Peripheral, Electric
	Product Code:	KOI
	Device Classification:	Class II
	Regulation Number:	21 CFR 868.2775
	Manufacturer:	Nihon Kohden
	510K number:	K201949
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 personnel 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, recovery 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 viaMain Cable. The electrode is a single-use electrode array and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode The NMT module can transmit an electrical
	stimulation pulse to the patient and can receive EMG signals via theelectrode array. The captured data from the disposable electrode is sentto the monitoring system via the Smart Cable interface connector. Thevarious stimulation settings are also sent to the monitoring system todisplay.The AF-201P NMT Module is used to control the electrical stimulationand to measure the response. The operational setting is controlled viabuttons on the module or a touch screen.
Indication for Us andIntended Use	The Smart Cable NMT Module and Accessories are indicated formonitoring the relaxation of the patient when neuromuscular blockadesare 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 beused as a system that requires Nihon Kohden compatible electrodes andbedside monitoring systems. The Smart Cable NMT Module andAccessories are intended for use by medical personnel in clinicalsettings and are available by prescription only.
Modification	There are no changes to the Smart Cable NMT Module andAccessories as a result of the software update to the Life Scope® PTBSM-1700 Series and or the AY Series input units.
Summary ofSubstantialEquivalence	The device comparison and the results of the safety and performancetests indicate that the Nihon Kohden Smart Cable NMT Module andAccessories is substantially equivalent to the predicate devices.

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LIFE SCOPE® BSM-6000 SERIES BEDSIDE MONITORING SYSTEM 5.4
The intended Use for BSM-6000 was updated to include the statement "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® BSM-6000 Series Bedside Monitoring System, the input unit software has been updated to recognize the connection to the Smart Cable NMT Module and Accessories. There are no changes to the specifications or performance from the predicate device under K201949.

The Intended Use further clarifies the addition of Life Scope® BSM-1700 Series and the AY Series Input Units to BSM-6000 Intended Use is substantially equivalent to the predicate K201949.

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Subject Device		Life Scope BSM-6000 Series BedsideMonitoring Systems
	Trade Name:
	Common Name:	Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitor andAnesthesia Monitor
	Classification Name	Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms
	Classification:	Class II
	Product Code:	MHX
	Regulation Number:	21 CFR 870.1025
Predicate Device		Life Scope BSM-6000 Series BedsideMonitoring System
	Trade Name:
	Common Name:	Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitor andAnesthesia Monitor
	Classification Name	Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms
	Classification:	Class II
	Product Code:	MHX
	Regulation Number:	21 CFR 870.1025
	Manufacturer	Nihon Kohden
	510(K):	K201949
Device Description	The Life Scope BSM-6000 Series Bedside Monitoring Systems areintended to monitor, display and record physiological data to providecardiac and vital signs monitoring within a medical facility. The device isintended to produce a visual record of the electrical signals produced by theheart and monitor the electrocardiogram to generate visible and/or audiblealarms when an arrhythmia exists. The device is also intended to monitorheart rate, pulse rate, blood oxygen saturation (SpO2), non- invasive bloodpressure (NIBP), invasive blood pressure (IBP), body temperature, CardiacOutput (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratoryrate, BIS and inspired and expired anesthetic agents and gases includingCO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane andDesflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface toexternal equipment to display numerical and waveform data and alarmsfrom the external devices. Supported external devices include AG-920RAAnesthetic Agent Detection System, Ventilators, CO2 Monitors, TOFMonitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBPMonitors. The device may generate an audible and/or visual alarm when ameasured rate falls outside preset limits. This device may also be used tocondition and transmit physiological signals via radiofrequency.The system requires a BSM 6000 core unit with a compatible input unit:AY Series or Life Scope® PT BSM-1700 Series.

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	Table 5-3: Compatible Input Unit and Core units
	Compatible Parent Bedside Monitoring Configurations
	CoreUnits	InputModel	MultiConnector	SpO2 Probe
	Life Scope®BSM-6000Series BedsideMonitoringSystems	AY-631P	1	Masimo
		AY-633P	3
		BSM-1733	3
		AY-651P	1	Nellcor
		AY-653P	3
		BSM-1753	3
		AY-671P	1	Nihon Kohden
		AY-673P	3
		BSM-1773	3
	Life Scope®BSM-6000Series	JA 690PA	N/A	Unit only used withBSM-6000
		JA-694PA	4
	DataAcquisitionUnit
	The input units are common to NK parent devices that require both a coreunit and an input unit. NK manufactures the input units with three (3)SpO2 options. The Life Scope® BSM-6000 Series (K201949) have aninterchangeable input units that contains the MULTI socket ports. Forlarger monitoring systems is data acquisition unit is required to transmitdata from the input unit to the core unit.
	The input unit interprets the electrical impulses from the patient's body andtransfers this data into the core unit. The core unit calculates the electricalimpulses. Each monitor has a color display and is intended for one patient.The intended populations are all patient populations under the care of healthprofessionals.
Proposed Indicationsfor Use and IntendedUse	The Life Scope® BSM-6000 Series Bedside Monitoring System is intendedto monitor, display, and record physiological data to provide cardiac andvital signs monitoring within a medical facility. The device is intended toproduce a visual record of the electrical signals produced by the heart andmonitor the electrocardiogram to generate visible and/or audible alarmswhen an arrhythmia exists.
	The device is also intended to monitor heart rate, pulse rate, blood oxygensaturation (SpO2), non- invasive blood pressure (NIBP), invasive bloodpressure (IBP), body temperature, BIS, cardiac output (CO), oxygenconcentration (FiO2), carbon dioxide concentration (CO2), EtCO2,respiratory rate and inspired and expired anesthetic agents and anestheticgases including N2O, Halothane, Isoflurane, Enflurane, Sevoflurane andDesflurane.
	The device may generate an audible and/or visual alarm when a measuredrate falls outside preset limits. The device may also be used to condition and

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	transmit physiological signals via radio frequency. The device can interfaceto external equipment to display numerical and waveform data and alarmsfrom the external devices. Supported external devices include CO2monitors, BIS monitors, Anesthetic agents/gases detection system,Anesthesia machine, Ventilators, CCO monitors, TOF monitors,CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors,rSO2 monitors and external devices which output analog voltage signal.The device will be available for use by medical personnel on patients withina 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.
Intended Use: LifeScope® PT BSM-1700Series and AccessoriesUpdated from thePredicate device	The Life Scope® PT BSM-1700 Series and Accessories are intendedacquire and transfer electrical impulses from the patient to the main unit ofthe device. The BSM-1700 Series input unit monitors physiological dataand may generate an audible and/or visual alarm when a measured rate fallsoutside preset limits when disconnected from the core unit of the device.The input unit can be removed from one core unit and connected to anotherdevices core unit. The Life Scope® PT BSM-1700 Series can be used intransport mode where data is transferred from one device to another deviceby using with or without WLAN technology. The input unit can acquire thefollowing parameter signals: Electrocardiogram (ECG), Impedancerespiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterialoxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasiveblood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF andBispectral 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 inputunit using connection cables. The keys on the DAU allow operation of thebedside monitor remotely. The DAU is only compatible with the LifeScope® PT BSM-1700 Series and the AY Series Input Units.
Intended Use: AYSeries and AccessoriesUpdated from thePredicate Device	AY Series and Accessories are intended to acquire and transfer electricalimpulses from the patient to the core unit of the device. The input unit canacquire 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 addsadditional MULTI sockets to an AY Series input unit and can only be usedwith compatible monitoring systems.
	The Data Acquisition Unit (DAU) is an optional accessory. The DAU isused to communicate between the compatible parent core unit and the inputunit using connection cables. The keys on the DAU allow operation of thebedside monitor remotely. The DAU is only compatible with the LifeScope® PT BSM-1700 Series and the AY Series Input Units.
Modification	The input units software has been updated to work with the Smart CableNMT Module and Accessories. The indication for use was updated toinclude a description of the input units and accessories.
TechnologicalCharacteristics	The indications for use/intended use statement have been updated to includethe description of the input units and core units. There are no hardwarechanges compared to the predicate devices. There has been softwareupdates to the input units to integrate with the Smart Cable NMT Moduleand accessories.
Safety & PerformanceTests	The Life Scope® BSM-6000 Series Bedside Monitoring Systemsincorporated all software changes in the integration testing. The testingconfirmed the operation of the device when the Smart Cable NMT softwarewas integrated into the system. The results confirmed that the deviceperformed within specifications. No clinical tests have been submitted,referenced or relied on in this premarket notification submission for adetermination of substantial equivalence.
Summary ofSubstantialEquivalence	The Life Scope® BSM-6000 Series Bedside Monitoring Systems areequivalent to the Life Scope BSM-6000 Series (K201949). The indicationsfor use have been updated to include a description of the core unit and theinput units, the software verification and validation confirmed performanceand technological equivalency.

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LIFE SCOPE® CSM-1901 BEDSIDE MONITORING SYSTEM ર્સ્ટ

The intended Use for CSM-1901 was updated to include the statement, "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® CSM-1901 Bedside Monitoring System, the input unit software has been updated to recognize the connection to the Smart Cable NMT Module and Accessories. There are no changes to the specifications or performance from the predicate device under K201949.

The Intended Use further clarifies the addition of Life Scope® BSM-1700 Series and the AY Series Input unit and Accessories to CSM-1901 Intended Use. The Life Scope® CSM-1901 Bedside Monitoring System, Intended Use is substantially equivalent to the predicate K201949.

Subject Device	Trade Name:	Life Scope CSM-1901 BedsideMonitoring Systems
	Common Name:	Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitorand Anesthesia Monitor
	Classification Name	Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms
	Classification:	Class II
	Product Code:	MHX
	Regulation Number:	21 CFR 870.1025
Predicate Devices	Trade Name	Nihon Kohden CSM-1901 Bedside
		Monitor
	Common Name:	Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitorand Anesthesia Monitor

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	Classification Name			Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms
	Classification:		Class II
	Product Code:	MHX
	Regulation Number:		21 CFR 870.1025
	510(K):		K201949
Device Description	The Life Scope® CSM-1901 Bedside Monitoring Systems are systemswhich continuously monitors physiological information of a patient and isused in an operation room, a recovery room, general wards, ICU, CCU,HCU, NICU and an emergency room. These systems are placed near thepatient and is intended to display patient's vital signs. These systems canalso be connected to other external patient monitoring devices. In additionthese systems can communicate patient's data to a central monitoringstation via network to monitor multiple patients.
Table 5-4: Compatible Input Unit and Core units
Compatible Parent Bedside Monitoring Configurations
	CoreUnits	InputModel	MultiConnector	SpO2 Probe
	Life Scope®CSM-1901(K201949)	AY-631P	1	Masimo
		AY-633P	3
		BSM-1733	3
		AY-651P	1	Nellcor
		AY-653P	3
		BSM-1753	3
		AY-671P	1	Nihon Kohden
		AY-673P	3
		BSM-1773	3
	DataAcquisitionUnit LifeScope® CSM-1901(K201949)	JA 690PAJA-694PA	N/A	Unit only used withCSM-1901 DataAcquisition


	The input unit is common to NK parent devices that require both a coreunit and input unit. NK manufactures the input units with three (3) SpO2options. The Life Scope® CSM-1901 Bedside Monitoring Systems haveinterchangeable input units that contains the MULTI socket ports. Forlarger monitoring systems is data acquisition unit is required to transmitdata from the input unit to the core unit.
	The bedside monitoring systems require both a core unit and an input unitThe input unit interprets the electrical impulses from the patient's body

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		one patient. The intended populations are all patient populations under the
		care of health professionals.
Proposed Indicationsfor Use and IntendedUse-	The Life Scope® CSM-1901 Bedside Monitoring Systems are intended tomonitor, display and record physiological data to provide cardiac and vitalsigns monitoring within a medical facility. The device is intended toproduce a visual record of the electrical signal produced by the heart andmonitor the electrocardiogram to generate visible and/or audible alarmswhen an arrhythmia exists. The device is also intended to monitor heartrate, pulse rate, blood oxygen saturation (SpO2), non-invasive bloodpressure (NIBP), invasive blood pressure (IBP), body temperature, BIS,cardiac output (CO), oxygen concentration (FiO2), carbon dioxideconcentration (CO2), EtCO2, respiratory rate, inspired and expiredanesthetic agents and anesthetic gases including N2O, halothane,isoflurane, enflurane, sevoflurane and desflurane. The device also displayspatient data from external devices such as ventilators, TOF monitors,CCO/SvO2 monitors, and EEG measuring unit. The device may generateand audible and/or visual alarm when a measured rate falls outside presetlimits.
	The device will be available for use by trained medical personnel within amedical 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.
Intended Use: LifeScope® PT BSM-1700Series and AccessoriesUPDATED from thepredicate	The Life Scope® PT BSM-1700 Series and Accessories are intendedacquire and transfer electrical impulses from the patient to the main unit ofthe device. The BSM-1700 Series input unit monitors physiological dataand may generate an audible and/or visual alarm when a measured ratefalls outside preset limits when disconnected from the core unit of thedevice. The input unit can be removed from one core unit and connected toanother devices core unit. The Life Scope® PT BSM-1700 Series can beused in transport mode where data is transferred from one device toanother device by using with or without WLAN technology. The input unitcan 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).
	The Data Acquisition Unit (DAU) is an optional accessory. The DAU isused to communicate between the compatible parent core unit and theinput unit using connection cables. The keys on the DAU allow operationof the bedside monitor remotely. The DAU is only compatible with theLife Scope® PT BSM-1700 Series and the AY Series Input Units.
Intended Use: AYSeries and AccessoriesUPDATED from thepredicate	AY Series and Accessories are intended to acquire and transfer electricalimpulses from the patient to the core unit of the device. The input unit canacquire the following parameter signals: Electrocardiogram (ECG).
	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 addsadditional MULTI sockets to an AY Series input unit and can only be usedwith compatible monitoring systems.The Data Acquisition Unit (DAU) is an optional accessory. The DAU isused to communicate between the compatible parent core unit and the inputunit using connection cables. The keys on the DAU allow operation of thebedside monitor remotely. The DAU is only compatible with the LifeScope® PT BSM-1700 Series and the AY Series Input Units.
Modification	The input unit software has been updated to works with the Smart CableNMT Module and Accessories. The indication for use was updated toinclude a description of the input units and accessories.
TechnologicalCharacteristics	The indications for use/intended use statement have been updated toinclude the description of the input units and core units. There are nohardware changes compared to the predicate devices. There has beensoftware update to the input units to integrate with the Smart Cable NMTModule and accessories.
Safety & PerformanceTests	The Life Scope® CSM-1901 Bedside Monitoring Systems incorporated allsoftware changes in the integration testing. The testing confirmed theoperation of the device when the Smart Cable NMT software wasintegrated into the system. The results confirmed that the device performedwithin specifications. No clinical tests have been submitted, referenced orrelied on in this premarket notification submission for a determination ofsubstantial equivalence.
Summary ofSubstantialEquivalence	The Life Scope® CSM-1901 Bedside Monitoring Systems are equivalent tothe Nihon Kohden CSM-1901 Bedside Monitor. The indications for usehave been updated to include a description of the core unit and the inputunits, the software verification and validation confirmed performance andtechnological equivalent.

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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 systemlevel 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. 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.

ર્ડદર્

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No.	Standard
1.	EN/ISO 14971:2012 Medical Devices - Application of Risk Management toMedical Devices
2.	IEC 60601-1: 2005+Amd.1:2012 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance.
3.	ANSI/AAMI/ES 60601-1:2005 (R2012) with amendmentsMedical electrical equipment - Part 1: General requirements for basic safety andessential performance (IEC 60601-1:2005, MOD)(Consolidated Text) (includes ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012)
4.	IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests
5.	IEC 60601-2-40:2016 Medical electrical equipment - Part 2-40: Particularrequirements for the basic safety and essential performance of electromyographs andevoked response equipment.
6.	IEC60601-1-6: 2010+Amd.1:2013 Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance - Collateral standard:Usability.
7.	ISO10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process
8.	IEC62366:2007+Amd. 1 2014 Amendment 1 - Medical devices - Application ofusability engineering to medical devices
9.	IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION - Medical devicesoftware – Software life cycle processes

The software input units modifications and labeling modification do not raise different questions of safety and effectiveness when compared to the predicate devices perform as intended, and have the same performance characteristics and are substantially equivalent to the predicate devices under K201949.

5.7

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).