Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series

Q: Who is the manufacturer of Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

Nihon Kohden Corporation filed the 510(k) submission for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (K201949).

Q: What is the FDA product code for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

KOI. It is classified under 21 CFR 868.2775 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

TetraGraph Neuromuscular Transmission Monitor (K190795).

Q: Who can help prepare an FDA 510(k) submission like Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K201949 · Nihon Kohden Corporation · KOI · May 2, 2021 · Anesthesiology

Device Facts

Record ID	K201949
Device Name	Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
Applicant	Nihon Kohden Corporation
Product Code	KOI · Anesthesiology
Decision Date	May 2, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2775
Device Class	Class 2

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.

Device Story

Smart Cable NMT Module (AF-201P) is an accessory for Nihon Kohden bedside monitors (BSM-3000, BSM-6000, CSM-1901). System uses EMG technology to monitor neuromuscular transmission. Input: electrical stimulation pulses applied to ulnar nerve via disposable electrode array; output: EMG signals representing muscle action potential. Operation: medical personnel apply electrodes to patient hand/wrist; module delivers stimulation and captures EMG response; data transmitted to bedside monitor for display. Provides quantitative measurement of muscle relaxation to guide dosing of muscle relaxants and regional anesthetics. Benefits: objective monitoring of neuromuscular blockade to ensure patient safety during anesthesia and mechanical ventilation.

Clinical Evidence

Bench testing only. No clinical data submitted. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2, IEC 60601-2-40), biocompatibility (ISO 10993-1), mechanical strength, environmental, usability, and shelf-life testing. Electrode performance verified per ANSI/AAMI EC12:2000.

Technological Characteristics

EMG-based neuromuscular transmission monitor. Components: AF-201P module, main cable, disposable 5-electrode array (2 stimulating, 2 recording, 1 ground). Stimulation: 10-60 mA constant current, 200/300µs pulse width. Patterns: Single, TOF, PTC, TET, DBS. Connectivity: Proprietary Smart Cable interface to Nihon Kohden bedside monitors. Software: Integrated into host monitor firmware.

Indications for Use

Indicated for monitoring patient relaxation during administration of neuromuscular blockades. For use by medical personnel in clinical settings (OR, recovery room, ICU).

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

TetraGraph Neuromuscular Transmission Monitor (K190795)

Reference Devices

ToFscan (K172690)

Related Devices

K213316 — 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 · Nihon Kohden Corporation · Dec 29, 2021
K190795 — Tetragraph Neuromuscular Transmission Monitor · Senzime AB · Oct 18, 2019
K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) · MIPM Mammendorfer Institut für Physik und Medizin GmbH · Oct 21, 2025
K220530 — Tetragraph Neuromuscular Transmission Monitor · Senzime AB · Aug 17, 2022
K192958 — TwitchView System · Blink Device Company · Apr 2, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Nihon Kohden Corporation % Sunita Teekasingh Sr. Regulatory Affairs Consultant - GSA2 Group LLC Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618 Re: K201949 Trade/Device Name: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series Bedside Monitors, Life Scope BSM 6000 Series Bedside Monitors, and Nihon Kohden CSM-1901 Bedside Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, KOI Dated: March 30, 2021 Received: April 2, 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/cdrl/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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Todd Courtnev Assistant Director DHT1C: Division of ENT, 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K201949 ### Device Name Smart Cable NMT Module and Accessories; Life Scope BSM-3000 Series Bedside Monitors; Life Scope BSM-6000 Series Bedside Monitors; and Nihon Kohden CSM-1901 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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The Life Scope BSM-3000 Series Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or 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 (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, and inspired and expired anesthetic gases including N20. 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, rSO2 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 Life Scope BSM-6000 Series Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. {3}------------------------------------------------ The device is also intended to monitor heart rate, plood 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 N20, 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, rSO2 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 Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.375L5.75 10.875L2.75 7.875" stroke="#000000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="12" stroke="#000000" stroke-width="1.5" width="12" x="2" y="2"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {4}------------------------------------------------ #### 510(k) Summary – General Provisions 5.0 | | Manufacturer Name: | Nihon Kohden Corporation | |--------------------|---------------------|------------------------------------------------------------------| | | Address: | 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo 161-8560, Japan | | General Provisions | Submitter Name: | Nihon Kohden America | | | Address: | 15353 Barranca Parkway Irvine, California, USA 92618 | | | Contact: | Sandra Gadeyne Sr. Director of Quality and Regulatory Affairs | | | Phone Number | 949-356-3401 | | | Fax Number: | 949-580-1550 | | | Email | Sandra_Gadeyne@nihonkohden.com | | | Date of Preparation | 30Apr2021 | #### 5.1 Smart Cable NMT Module and Accessories | Subject 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 | | | Common Name: | Electrical peripheral nerve stimulator | | | Classification Name | Stimulator, Nerve, Peripheral, Electric | | | Classification: | Class II | | | Product Code: | KOI | | | Regulation Number: | 21 CFR 868.2775 | | | 510(k) Number | K201949 | | Predicate Device | Trade Name: | TetraGraph Neuromuscular Transmission Monitor | | | 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: | Senzime AB | | | 510K number: | K190795 | | Reference Device | Trade Name: | ToFscan | | | 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: | Idmed | | | 510(k): | K172690 | {5}------------------------------------------------ | Subject 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. | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The 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. | | Indications for Use and 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. | {6}------------------------------------------------ | Characteristics | Subject Device: Smart Cable NMT Module and Accessories | Predicate Device: Tetragraph Neuromuscular Transmission Monitor (K#190795) | Reference Device: ToFscan Neuromuscular Transmission Monitor (K#172690) | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology | | Classification Name | 21 CFR 868.2775 Electrical Peripheral Nerve Stimulator | 21 CFR 868.2775 Electrical Peripheral Nerve Stimulator | 21 CFR 868.2775 Electrical Peripheral Nerve Stimulator | | Regulatory Class | Class II | Class II | Class II | | Product Code | KOI | KOI | KOI | | 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 Module and Accessories are comprised of: AF-201P NMT Module with Smart Cable Disposable ElectrodesMain cableHolder (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. | The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered. | ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. The effect of neuromuscular blocking agents (NMBA) is monitored by measuring the acceleration of the muscle movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The ToFscan has a three- dimensional acceleration sensor (accelerometer) to detect and quantify a patient's thumb movement (contracting adductor pollicis). The sensor is directly integrated into the finger's splint, making it possible to obtain its optimal and reproducible positioning | | Device Description | The Smart Cable NMT Module and Accessories are comprised of: • AF-201P NMT Module with Smart Cable • Disposabl e 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 personnelin clinical settings and are available by prescription only. | The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, battery-operated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. Neuromuscular Transmission (NMT) is the transfer of an electrical impulse between a motor nerve and its associated muscle. The NMT is blocked by neuromuscular blocking agents ("NMBAs") which cause transient muscle paralysis preventing the patient from moving and breathing spontaneously. Muscle relaxation is used during general anesthesia to enable endotracheal intubation and mechanical ventilation and to provide optimal surgical conditions. Muscle relaxation may also be used in critical care during mechanical ventilation. In these circumstances, TetraGraph can be used as an objective monitor of neuromuscular transmission. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph supplements the use of clinical information/data obtained from other monitors, such | The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the acceleration of the muscle movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The ToFscan has a three-dimensional acceleration sensor (accelerometer) to detect and qualify a patient's thumb movement (contracting adductor pollicis). The sensor is directly integrated into the finger's splint, making it possible to obtain it's optimal and reproducible positioning. | {7}------------------------------------------------ {8}------------------------------------------------ | | saturation (SpO2), end- tidal carbon dioxide (ETCO2), as well as clinical assessment, to determine the adequacy of | | |--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | ventilation. The level of neuromuscular block is | | | | routinely measured by stimulating a peripheral nerve, usually in the forearm and by evaluating | | | | the muscle response typically in the thumb or little finger. The TetraGraph controls the | | | | level of electrical stimulation applied to the nerve and monitors the muscle response by the | | | | use of Electromyography (EMG) detected by electrodes on the muscle. | | | | TetraGraph consists of the followingmain components | | | | TetraGraph Monitor The TetraGraph Monitor is used to control the electrical stimulation and to measure the EMG- response. The Monitor is controlled via a | | | | touch screen and a power button. The Senzime AB Traditional 510(k) Premarket Submission TetraGraph Page 005- | | | | 3TetraGraph Monitor is connected to the electrode via a cable (the TetraCord Cable). The battery in the TetraGraph Monitor is | | | | charged via a communication port connected to a USB- supply adapter. | | | | TetraSens Electrode The TetraSens Electrode is a single-use electrode array. Each array includes | | | | two stimulating electrodes (applied along the ulnar nerve at the wrist) and two recording electrodes | | | | (applied on the hand). The TetraGraph Monitor can transmit stimulation pulses to the patient and can | | | | receive EMG signals via the electrode array. The electrodes are neither supplied sterile nor intended to be sterilized by | | {9}------------------------------------------------ | Electrode for Stimulation | Single-use electrode array (5 electrodes on an | Single-use electrode array (4 electrodes on an array) | Uses 3D Accelerometer Sensor to measure thumb movement instead of | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electrode Connection | Reusable Cable | Reusable Cable | Reusable Cable | | movement detection technology | (EMG) | | | | Muscle | Electromyography | from the Tetragraph kit. Rechargeable lithium- polymer battery A re-chargeable lithium- polymer battery is included in the TetraGraph, and also available as spare part. The rechargeable battery is charged using the USB power supply adapter. USB power supply adapter and USB cable The rechargeable battery is charged using the USB power supply adapter. The adapter is configured for local power outlets and connects to the TetraGraph using a USB cable. Data can also be transferred to a PC via the USB-port by using the USB-cable. Electromyography (EMG) | Acceleromyography | | | | TetraGraph Pole Clamp kit A Pole clamp kit is available for mounting the TetraGraph on a pole stand. The kit includes a mounting device and an attachment to the Tetragraph. The Pole clamp kitis supplied separately | | | | | TetraCord Cable The TetraCord Cable is connected to the TetraGraph Monitor via a portand is connected to the TetraSens Electrode via the cable connector at the other end of the TetraCord Cable. The TetraCord Cable is supplied in together with the TetraGraph monitor as part of the kit and can also be sold separately as a spare part. | | | | | the user. The TetraSens Electrodes are sold separately from the TetraGraph monitor and are available in boxes of 20 pcs. | | | | array) | | electrode | | Electrode applied part | Total of 5: Two stimulating electrodes are applied along the ulnar nerve at the wrist and two recording electrodes are applied on the hand. One grounding electrode applied on the hand | Total of 4: Two stimulating electrodes are applied along the ulnar nerve at the wrist and two recording electrodes are applied on the hand. | Not Applicable (Uses D Accelerometer Sensor to measure thumb movement instead of the electrode) | | Stimulation Patterns | Single stimulation, TOF (Train Of Four), PTC (Post Tetanic Count), TET (tetanic stimulation), DBS (Double Burst Stimulation) | Single Twitch (ST), Train-of-Four (TOF), Post-tetanic Count (PTC) | TOF (Train Of Four) - PTC (Post Tetanic Count) - ATP (Automated TOF PTC) - DBS (Double Burst) (3,3) (3,2) - ST (Single Twitch) 0.1 Hz and 1 Hz - TET (Tetanus) 50 Hz | | Stimulating Current Range | 10-60 mA | 10-60 mA | 0-60 mA | | Stimulation Pulse Width | Square wave, constant current: 200µs or 300µs | Square wave, constant current: 200µs or 300µs | Constant current, 0- 60 mA, monophasic 200µsec pulse width | | Power source | Power is supplied from the Monitoring System. | Battery operated | AC Power Supply | | Compatibility | Works only with Nihon Kohden Monitoring System: BSM-6000, BSM- 3000 CSM-1901 | Tetragraph Neuromuscular Transmission Monitor consists of a monitor, electrode, and other components. | The ToFscan system is composed of the monitor, the hand sensor, and the US AC power supply unit. | | General Safety | IEC 60601-1, IEC- 60601-1-2, IEC 60601-2- 40 | IEC 60601-1, IEC-60601- 1-2, IEC 60601-2-40 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | | Intended Use | There are differences in the indications for use statement, but the differences do not result in new intended use.…