Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
Device Facts
| Record ID | K213316 |
|---|---|
| Device Name | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM |
| Applicant | Nihon Kohden Corporation |
| Product Code | KOI · Anesthesiology |
| Decision Date | Dec 29, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.2775 |
| Device Class | Class 2 |
Indications for 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.
Device Story
Smart Cable NMT Module (AF-201P) uses EMG technology to monitor neuromuscular transmission; stimulates ulnar nerve via disposable electrode array; records muscle action potential. Input units (BSM-1700/AY Series) acquire physiological signals (ECG, SpO2, NIBP, IBP, CO2, Temp, CO, TOF, BIS) and transfer data to core bedside monitoring units (BSM-6000/CSM-1901). Systems display waveforms/numerics; generate audible/visual alarms for out-of-limit measurements. Used by medical personnel in hospitals (OR, ICU, recovery, emergency). Software update enables input units to recognize Smart Cable NMT Module connection. Output assists clinicians in determining muscle relaxant/anesthetic dosing. Benefits include quantitative assessment of patient relaxation levels.
Clinical Evidence
Bench testing only. Software verification and validation (unit, integration, system-level testing) performed per FDA guidance. Electrical safety and EMC testing conducted per ANSI/AAMI ES60601-1 and IEC 60601-1-2. No clinical data relied upon.
Technological Characteristics
System comprises core unit and input unit (BSM-1700/AY Series). Connectivity via cable or WLAN. Software-based signal processing for physiological parameters (ECG, SpO2, NIBP, IBP, CO2, Temp, CO, TOF, BIS). Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-40 (electromyographs).
Indications for Use
Indicated for monitoring patient relaxation during neuromuscular blockade administration. Used by medical personnel in clinical settings (OR, recovery, ICU). Compatible with Nihon Kohden bedside monitoring systems and electrodes. 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
- Life Scope BSM-6000 Series Bedside Monitors (K201949)
- Nihon Kohden CSM-1901 Bedside Monitor (K201949)
- Smart Cable NMT Module and Accessories (K201949)
Submission Summary (Full Text)
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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 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.
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 arthythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2),
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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 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
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) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| | <span> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### SECTION 5 510(K) SUMMARY OR 510(K) STATEMENT
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| 5.1 | General Provisions | Manufacturer Name: | Nihon Kohden Corporation |
|-----|--------------------|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| | | Address: | 1-31-4 Nishiochiai, Shinjuku-Ku<br>Tokyo 161-8560, Japan |
| | | Submitter Name: | Nihon Kohden America |
| | | Address: | 15353 Barranca Parkway<br>Irvine, California, USA<br>92618 |
| | | Primary Contact | Sunita Teekasingh<br>GSA2 Group LLC Consultant |
| | | Phone Number | 612-814-7999 |
| | | Email | Sunita.Teekasingh@nihonkohden.com |
| | | Secondary Contact: | Sandra Gadeyne<br>Sr. 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<br>• Life Scope® BSM-6000 Series Bedside<br>Monitors;<br>• 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 Cable<br>NMT Module<br>and Accessories<br>K201949 | Parent device Core Unit<br>software version | Input Unit Software version AY Series or<br>BSM-1700 Series |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AF-201P<br>Software<br>Version 3.0-<br>no changes to the<br>original software<br>under<br>K201949 | Life Scope®BSM-6000 Series<br>Bedside Monitoring Systems<br>(K201949) Software v08-31<br><br>Life Scope® CSM-1901<br>Bedside Monitoring Systems<br>(K201949) Software v01-32<br><br>Life Scope® BSM-3000 Series Bedside Monitors (K201949) Software v08-31 | AY Series v08-31<br>AY-631P<br>AY-633P<br>AY-651P<br>AY-653P<br>AY-671P<br>AY-673P<br><br>OR<br><br>BSM-1700 Series<br>v02-66<br>BSM-1733<br>BSM-1753<br>BSM-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 Bedside<br>Monitoring Core Units | Input Model | Configuration | |
|-----------------------------------------------------------------------------------------------------------------|-------------|-----------------|-------------------------------------------------|
| | | Multi Connector | SpO2 Probe |
| Life Scope® BSM 6000<br>Series Bedside Monitoring<br>Systems (K201949) | AY-631P | 1 | Masimo |
| | AY-633P | 3 | |
| | BSM-1733 | 3 | |
| Life Scope® CSM-1901<br>Bedside Monitoring Systems<br>(K201949) | AY-651P | 1 | Nellcor |
| | AY-653P | 3 | |
| | BSM-1753 | 3 | |
| Life Scope® G5 Series<br>Bedside Monitoring Systems<br>(K203435) | AY-671P | 1 | Nihon Kohden |
| | AY-673P | 3 | |
| | BSM-1773 | 3 | |
| Life Scope® G7 Series<br>Bedside Monitoring Systems<br>(K203435) | | | |
| Life Scope® CSM-1901 and<br>BSM-6000 Series Bedside<br>Monitoring Systems<br>(K201949)<br>Data Acquisition Unit | JA 690PA | N/A | Unit only used<br>with CSM-1901<br>and 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.<br>NMT Module is a system comprised of NMT Module, Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via<br>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<br>electrode array. The captured data from the disposable electrode is sent<br>to the monitoring system via the Smart Cable interface connector. The<br>various stimulation settings are also sent to the monitoring system to<br>display.<br>The AF-201P NMT Module is used to control the electrical stimulation<br>and to measure the response. The operational setting is controlled via<br>buttons on the module or a touch screen. | |
| Indication for Us and<br>Intended Use | The Smart Cable NMT Module and Accessories are indicated for<br>monitoring the relaxation of the patient when neuromuscular blockades<br>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<br>used as a system that requires Nihon Kohden compatible electrodes and<br>bedside monitoring systems. The Smart Cable NMT Module and<br>Accessories are intended for use by medical personnel in clinical<br>settings and are available by prescription only. | |
| Modification | There are no changes to the Smart Cable NMT Module and<br>Accessories as a result of the software update to the Life Scope® PT<br>BSM-1700 Series and or the AY Series input units. | |
| Summary of<br>Substantial<br>Equivalence | The device comparison and the results of the safety and performance<br>tests indicate that the Nihon Kohden Smart Cable NMT Module and<br>Accessories 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 Bedside<br>Monitoring Systems |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| | Trade Name: | |
| | Common Name: | Bedside Monitor, Patient Monitor,<br>Cardiac Monitor, Vital Signs Monitor and<br>Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor<br>with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| Predicate Device | | Life Scope BSM-6000 Series Bedside<br>Monitoring System |
| | Trade Name:…
