Life Scope PT BSM-1700 Series Bedside Monitor

K220976 · Nihon Kohden Corporation · KOI · Jul 21, 2022 · Anesthesiology

Device Facts

• Record ID: K220976
• Device Name: Life Scope PT BSM-1700 Series Bedside Monitor
• Applicant: Nihon Kohden Corporation
• Product Code: KOI · Anesthesiology
• Decision Date: Jul 21, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: Pediatric

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) 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 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. Life Scope® CSM-1901 Bedside Monitoring Systems: 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, 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. 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 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: 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 Story

Life Scope PT BSM-1700 Series is a multifunctional bedside monitor functioning as an input unit for larger monitoring systems or as a standalone/transport monitor. It acquires physiological signals including ECG, Imp Resp, NIBP, SpO2, CO2, IBP, Temp, Cardiac Output, TOF, and BIS. In input mode, it transmits data to a core unit for calculation and display. In standalone/transport mode, it processes and displays data locally, with or without WLAN connectivity. It uses Smart Cable technology for accessory connection. The device provides visual/audible alarms for out-of-limit measurements. Medical personnel use the device to monitor vital signs and neuromuscular blockade levels to guide anesthesia and clinical decision-making. It supports remote operation via an optional Data Acquisition Unit (DAU).

Clinical Evidence

Bench testing only. Electromagnetic, environmental, safety, and performance testing verified device operation. Software validation confirmed functions perform within specifications.

Technological Characteristics

Multifunctional bedside monitor; input unit and transport/standalone modes. Parameters: ECG, Imp Resp, NIBP, SpO2, CO2, IBP, Temp, CO, TOF, BIS. Connectivity: Ethernet, WLAN. Power: 100-240V, Li-ion battery (5-hour operation). Standards: IEC 60601-1, IEC 60601-1-2. Software: ECAPS12C for ECG interpretation. Dimensions: 147x194x94 mm. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for monitoring patient relaxation during neuromuscular blockade administration. Intended for all patient populations (adult, neonate, infant, child, adolescent) in clinical settings (OR, ICU, recovery, general wards, emergency) by trained medical personnel. Prescription only.

Regulatory Classification

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.

Predicate Devices

• BSM-1700 Series Bedside Monitoring System (K213316)

Reference Devices

• Life Scope G5 Series Bedside Monitoring System (K203435)
• Life Scope G7 Series Bedside Monitoring System (K203435)

Submission Summary (Full Text)

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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 [phone] 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 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.

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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.

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Life Scope® CSM-1901 Bedside Monitoring Systems:

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, 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 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:

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.

Type of Use (Select one or both, as applicable)

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|--------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) Summary

#### 1 GENERAL PROVISIONS

| ADMINISTRATIVE INFORMATION | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Nihon Kohden Corporation<br>1-31-4 Nishiochiai, Shinjuku-Ku<br>Tokyo, Japan 161-8560 |
| Initial Importer | Nihon Kohden America<br>15353 Barranca Parkway<br>Irvine, CA |
| Primary Contact/Official<br>Correspondent | Sunita Teekasingh RN, BSN, CCRN, MSc<br>GSA2 Group LLC<br>Mobile: [phone]<br>Email: [e-mail] |
| Secondary Contact/Company<br>Representative | Sandra Gadeyne, MBA, ASQ-CQA<br>Sr. Director, Quality Assurance and Regulatory Affairs<br>15353 Barranca Parkway<br>Irvine, CA<br>Office Phone: [phone]<br>Mobile Phone: [phone]<br>Email: [e-mail] |
| SUBMISSION INFORMATION | |
| Submission Type | Specia1510(k) |
| Product Names | Life Scope® PT BSM-1700 Series Bedside Monitor and Accessories<br>Life Scope® BSM-6000 Series Bedside Monitoring Systems<br>Life Scope® G5 Series Bedside Monitoring Systems<br>Life Scope® G7 Series Bedside Monitoring Systems<br>Life Scope® CSM-1901 Bedside Monitoring Systems<br>AY Series and Accessories, Data Acquisition Unit<br>Smart Cable™ NMT Module and Accessories |
| Common Names | Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor<br>Stimulator, Nerve, Peripheral, Electric |
| Classification | Class II |
| Predicate 510(k) | K213316 |
| Product Code | KOI |
| Primary Product Code<br>KOI Products | KOI:<br>Smart Cable™ NMT Module and Accessories |
| Secondary Product Code<br>MHX Products | MHX:<br>Life Scope® BSM-6000 Series Bedside Monitoring Systems<br>Life Scope® G5 Series Bedside Monitoring Systems<br>Life Scope® G7 Series Bedside Monitoring Systems<br>Life Scope® CSM-1901 Bedside Monitoring Systems<br>AY Series and Accessories, Data Acquisition Unit<br>Life 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 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.

#### 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) .

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 a vailable by prescription only.

#### 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:

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.

| Compatible Parent Bedside Monitoring Configurations | | | |
|--------------------------------------------------------------|-------------|---------------------|--------------|
| Core Unit | Input Model | Multi-<br>Connector | Spo2 Probe |
| Life Scope® BSM-6000<br>Series Bedside<br>Monitoring 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 | |
| Data<br>Acquisition<br>Unit | 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 Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, andrecord 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 genera te visible and/or audible alarms when an arrhythmia ex ists.

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.

The device may generate an audible and/or visual a larm when a measured rate falls outside preset limits. The device may a lso be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and wa veform data and a larms from theexternal devices.

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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 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.

## 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 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 and/or audible alarms when an arrhythmia ex ists.

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

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.

#### 5 MHX: AY SERIES AND ACCESSORIES

#### 5.1 Device Description

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.

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#### 5.2 Indications for Use/Intended Use

AY Series and Accessories are intended to a cquire and transfer electrical impulses from the patient to the core unit of the device. The inputunit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (ImpResp), 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 a dds 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 and the AY Series Input Units.

#### 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

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.

#### 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 6000<br>Series Bedside Monitoring<br>Systems (K213316) | BSM-1733 | 3 | Masimo |
| Life Scope® CSM-1901<br>Series Bedside Monitoring<br>Systems (K213316) | BSM-1753 | 3 | Nellcor |
| Life Scope® G5 Series<br>Bedside Monitoring Systems<br>(K203435) | BSM-1763<br>BSM-1773 | 3 | Nihon Kohden |
| Life Scope® G7 Series<br>Bedside Monitoring Systems<br>(K203435) | | | |
| Data Acquisition Unit Life<br>Scope® CSM-1901 Bedside<br>Monitoring Systems<br>(K213316) | JA 690PA<br>JA-694PA | N/A | Unit only used with<br>CSM-1901 and BSM-<br>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).

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.

Table 4: Predicate Device Comparison

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| | Subject Device: Life Scope BSM-1700<br>Series Bedside Monitor<br>Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series<br>Bedside Monitoring System<br>K213316- | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | | Input Unit and Transport Mode | |
| Intended Use/<br>Indications for Use | The Life Scope® PT BSM-1700 Series<br>Bedside Monitor and Accessories are<br>intended acquire and transfer electrical<br>impulses from the patient to the main unit of<br>the device. The BSM-1700 Series has both<br>an input and transport/standalone mode. The<br>BSM-1700 Series input unit monitors<br>physiological data and may generate an<br>audible and/or visual alarm when a<br>measured rate falls outside preset limits or<br>when disconnected from the core unit of the<br>device. The input unit can be removed from<br>one core unit and connected to another<br>device's core unit. The Life Scope® PT<br>BSM-1700 Series can be used in transport<br>mode where data is transferred from one<br>device to another device by using with or<br>without WLAN technology. In standalone<br>mode, the device does not require a core<br>unit. The BSM-1700 Series can acquire the<br>following parameter signals:<br>Electrocardiogram (ECG), Impedance<br>respiration (Imp Resp), Non-invasive blood<br>pressure (NIBP), Arterial oxygen saturation<br>(SpO2), Carbon dioxide concentration<br>(CO2), Invasive blood pressure (IBP),<br>Temperature (Temp), Cardiac Output (CO),<br>TOF and Bispectral Index (BIS). When the<br>BSM-1700 Series is used in transport or<br>standalone mode, the following can be<br>analyzed and displayed: Electrocardiogram<br>(ECG), Impedance respiration (Imp Resp),<br>Non-invasive blood pressure (NIBP),<br>Arterial oxygen saturation (SpO2), Carbon<br>dioxide concentration (CO2). Invasive blood<br>pressure (IBP), Temperature (Temp),<br>Cardiac Output (CO), and Bispectral Index<br>(BIS).<br>The Data Acquisition Unit (DAU) is an<br>optional accessory. The DAU is used to<br>communicate between the compatible parent<br>core unit and the input unit using connection<br>cables. The keys on the DAU allow<br>operation of the bedside monitor remotely.<br>The DAU is only compatible with the Life<br>Scope® PT BSM-1700 Series and the AY<br>Series Input Units. | The Life Scope® PT BSM-1700<br>Series and Accessories are intended<br>acquire and transfer electrical<br>impulses from the patient to the main<br>unit of the device. The BSM-1700<br>Series input unit monitors<br>physiological data and may generate<br>an audible and/or visual alarm when<br>a measured rate falls outside preset<br>limits when disconnected from the<br>core unit of the device. The input unit<br>can be removed from one core unit<br>and connected to another devices<br>core unit. The Life Scope® PT BSM-<br>1700 Series can be used in transport<br>mode where data is transferred from<br>one device to another device by using<br>with or without WLAN technology.<br>The input unit can acquire the<br>following parameter signals:<br>Electrocardiogram (ECG),<br>Impedance respiration (Imp Resp),<br>Non-invasive blood pressure (NIBP),<br>Arterial oxygen saturation (SpO2),<br>Carbon dioxide concentration (CO2),<br>Invasive blood pressure (IBP),<br>Temperature (Temp), Cardiac Output<br>(CO), TOF and Bispectral Index<br>(BIS).<br>The Data Acquisition Unit (DAU) is<br>an optional accessory. The DAU is<br>used to communicate between the<br>compatible parent core unit and the<br>input unit using connection cables.<br>The keys on the DAU allow<br>operation of the bedside monitor<br>remotely. The DAU is only<br>compatible with the Life Scope® PT<br>BSM-1700 Series and the AY Series<br>Input Units. | |
| | Subject Device: Life Scope BSM-1700<br>Series Bedside Monitor<br>Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series<br>Bedside Monitoring System<br>K213316-<br>Input Unit and Transport Mode | |
| Compatible Core Unit<br>Options: requires Input<br>Unit | Life Scope® BSM-6000 Bedside Monitoring<br>Systems; Life Scope® CSM-1901 Bedside<br>Monitoring Systems; Life Scope® G5 Series<br>Bedside Monitoring System, Life Scope® G7<br>Series Bedside Monitoring System. | Same | |
| BSM-1700 Touchscreen<br>Display | Disabled | Same | |
| Measuring Parameters as<br>a Bedside Monitoring<br>System<br>(Core unit + Input Unit) | Electrocardiogram (ECG), Impedance<br>respiration (Imp Resp), Non-invasive blood<br>pressure (NIBP), Arterial oxygen saturation<br>(SpO2), Carbon dioxide concentration<br>(CO2), Invasive blood pressure (IBP),<br>Temperature (Temp), Cardiac Output (CO),<br>TOF and Bispectral Index (BIS). | Same | |
| Touchscreen Display | Default to Core unit Monitor | Same | |
| Resolution | Default to Core unit Monitor Resolution | Same | |
|…