(108 days)
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered. The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors and external devices which output analog voltage signal. The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
The Life Scope® PT BSM-1700 Series Beside Monitor and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series has both an input and transport/standalone mode. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits or when disconnected from the core unit of the input unit can be removed from one core unit and connected to another device's core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device by using with or with or without WLAN technology. In standalone mode, the device does not require a core unit. The BSM-1700 Series can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). When the BSM-1700 Series is used in transport or standalone mode, the following can be analyzed and displayed: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS). The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems. The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.
The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical persomel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, or intensive care unit. NMT Module is a system comprised of NMT Module. Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via Main Cable. The electrode is a single-use electrode array, and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode. TheNMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. Thecaptured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are a lso sent to the monitoring system to display. The AF-201P NMT Module is used to control the electrical stimulation and to measure theresponse. The operational setting is controlled via buttons on the module or a touch screen.
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardial signs monitoring within a medical facility. The device is intended to produce a visualrecord of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is a lso intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired a nesthetic a gents and a nesthetic gases including CO2, O2, N2O, Halothane, Isoflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920R A Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and a larms from the external devices. Supported external devices include AG-920RA Anestheic Agent Detection System, Ventilators, CO2 Monitors, BIS Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The devicemay generate anaudible and or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signa ls via radio frequency. The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
The Life Scope® CSM-1901 Bedside Monitoring Systems which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU. HCU. NICU and an emergency room. These systems are placed near the patient and is intended to display patient's vital signs. These systems can also be connected to other external patient monitoring devices. In a ddition, these systems can communicate patient's data to a central monitoring station via network to monitor multiple patients. The input unit is common to NK parent devices that require both a core unit and input unit. NK manufactures the input units with three (3) SpO2 options. The Life Scope® CSM-1 901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data a cquisition unit is required to transmit data from the input unit to the core unit. The bedside monitoring systems require both a coreunit and an input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.
The AY Series Input unit is used with the monitoring systems platforms, when connected to the core unit of the parent device, the inputunit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
The BSM-1700 Series Bedside Monitor is a multifunctional device used as an input unit, transport/standalone monitor.
· Input unit for other monitoring systems platforms, when connected to the core unit of the parent device, the input unit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
· When the patient needs to be transported, the BSM-1700 Series can be removed from the core unit, transport mode can be enabled and can be used with or without WLAN. When WLAN is enabled real time data viewing on the Nihon Kohden network or if it is disabled the BSM-1700 Series will display monitoring data and store the review data.
• When the device is removed from the coreunit it functions as a standalone or independent monitoring system.
The BSM-1700 Series has a display monitor that is disabled when connect to a core unit. Each monitor has a cobr display and is intended for one patient. When used as an inputunit with the coreunit, the system monitors a dvanced parameters. The intended populations are all patient populations under the care of health professionals. In all modes, the BSM-1700 Series uses the Smart Cable technology that is used to connect to other accessories used to collect electrical impulses. The BSM-1700 Series interprets the electrical impulses from the patient's body. When connected to a core unit, advanced calculations can be achieved. The device may generate a naudible and/or visual a larm when a measured rate falls outside preset lim its.
Here's a breakdown of the acceptance criteria and related study information, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily a detailed clinical study report proving performance against novel acceptance criteria. In this specific case, the submission emphasizes that there are no new acceptance criteria because the device (Life Scope PT BSM-1700 Series Bedside Monitor) is being updated to include a "standalone mode," but its underlying technology and performance characteristics are unchanged from its previously cleared version (K213316). Therefore, the "study that proves the device meets the acceptance criteria" largely relies on the prior clearance and non-clinical testing for the updated mode.
1. Table of Acceptance Criteria and Reported Device Performance
Since the document explicitly states there are no new technological changes or safety/performance claims, the acceptance criteria are effectively the performance specifications of the predicate device (K213316). The reported device performance is stated to be "the same" as the predicate.
| Characteristic/Parameter (Acceptance Criteria) | Reported Device Performance (Subject Device: Life Scope BSM-1700 Series Bedside Monitor) |
|---|---|
| Intended Use/Indications for Use | Expanded to include standalone mode functionality for parameters as listed below. (Note: This is a labeling update, not a change in underlying performance for already cleared functions.) |
| Compatible Core Unit Options | Same as predicate (Life Scope® BSM-6000, CSM-1901, G5, G7 Series) |
| BSM-1700 Touchscreen Display (Input Unit) | Disabled |
| Measuring Parameters (Core unit + Input) | ECG, Imp Resp, NIBP, SpO2, CO2, IBP, Temp, CO, TOF, BIS |
| Touchscreen Display (Standalone/Transport) | Enabled |
| Resolution (Standalone/Transport) | 640 x 480 |
| Number of Traces (Standalone/Transport) | 9, 12 (when 12 leads ECG) |
| Waveform Display (Standalone/Transport) | ECG, Imp Resp, NIBP, SpO2, CO2, IBP, Temp, CO, BIS |
| Numeric Data Display (Standalone/Transport) | Heart Rate, Pulse Rate, VPC rate, ST level, Respiration Rate, NIBP (sys/dia/mean), Temp (2), SpO2, EtCO2, FiCO2, Cardiac Output, BIS, IBP (3) (sys/dia/mean) |
| Alarm Display | Alarm sound, highlighted alarm display, alarm lamp |
| Alarm Suspend/Silence | Yes |
| Number of ECG Electrodes | 3, 6 or 10 |
| Defibrillation Discharge Protection | Yes |
| Electrosurgery Interface filter | Yes |
| Pacing detection | Yes |
| Heart Rate Counting Method | Average, instantaneous (Beat to beat) |
| Heart Rate Counting Range | 0, 15 to 300 bpm |
| Heart Rate Counting Accuracy | ± 2 bpm |
| ST Level Measuring Range | -2.5 to +2.5 mV |
| VPC Counting Range | 0 to 99 per min |
| Arrhythmia Alarm | Yes |
| Arrhythmia Recall (Standalone Mode) | 32768 items, 72 hours |
| Respiration Rate Display | 0 to 150 bpm |
| SpO2 Declared Range, Accuracy (NK type) | 70 to 100% (with sensor), 80 to 100% ± 2 %SpO2, 70 to 80% ± 3 %SpO2 |
| NIBP Measuring Method | Oscillometric |
| NIBP Measuring Range (Adult/Pediatric) | 10 - 280 mmHg |
| NIBP Measuring Accuracy | ± 3 mmHg |
| IBP Measuring Range | -50 to 300 mmHg |
| IBP Measuring Accuracy | ±1mmHg±1digit (-50 to 100 mmHg), ±1%±1 digit (100 to 300 mmHg) |
| Temperature Measuring Range | 0 to 45°C |
| Temperature Accuracy | ±0.1 °C (25 to 45°C), ± 0.2 °C (0 to 25°C) |
| CO2 Measuring Range | Depends on CO2 unit (e.g., 0 to 100mmHg for TG-900P/920P) |
| Cardiac Output Measuring Range | 0.5 to 20 L/min |
| Cardiac Output Accuracy | ±5% |
| Full Disclosure Storage (Standalone Mode) | 72 hours, 5 waves |
| Trend Display Time (Standalone Mode) | 1, 2, 4, 8, 24, 72 hours |
| Battery Operation Time | 5 hours |
| General Safety | Meets IEC 60601-1:2005+Amd.1:2012, ANSI/AAMI/ES 60601-1:2005 (R2012) |
| EMC | Meets IEC60601-1-2:2014 |
Study Proving Device Meets Acceptance Criteria
The document states:
- "The device performance and software have not changed from the original submission K213316." (Sections 2.4, 3.4, 4.4, 5.4)
- "For this submission the BSM-1700 Bedside Monitor has been updated to include the standalone mode. There are no specification changes, technological changes or safety and Performance claims. The indications for use and labeling have been updated to include the standalone mode." (Section 6)
- "The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, environmental, safety, and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device, the results confirmed that the device performed within specifications." (Section 6.3 Safety & Performance Tests)
Given this, the "study" is primarily an affirmation that the previously cleared performance for K213316 remains valid, coupled with non-clinical verification and validation testing of the additional "standalone mode" functionality to ensure it operates within the established specifications without altering the core performance characteristics.
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a clinical test set in this 510(k) summary. This type of submission relies heavily on non-clinical (bench) testing to confirm performance when significant changes are not made.
- The data provenance is implied to be from Nihon Kohden's internal testing. The submission is focused on demonstrating substantial equivalence rather than presenting a de novo clinical study with patient data. As such, the data would be laboratory-generated from testing the device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided because no clinical study requiring expert ground truth establishment for a test set is detailed. The "ground truth" for non-clinical performance would be derived from established engineering and metrological standards and test procedures.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable since the submission focuses on non-clinical performance and engineering validation rather than human reader studies.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a physiological monitor, not an AI-powered diagnostic tool, and the submission does not mention AI assistance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The term "standalone" in the provided document refers to a mode of operation for the BSM-1700 device, where it functions independently without being connected to a core unit. It does not refer to a standalone performance study of an algorithm.
- However, the performance tests described in Section 6.3 were likely conducted in a "standalone" fashion for the device's functional parameters, meaning the device itself was tested to ensure its outputs (e.g., heart rate, SpO2 accuracy) met specifications. The submission highlights that "The device performance and software have not changed from the original submission K213316," implying that the standalone performance requirements were met by the previous device and confirmed for this update.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the ground truth would be based on calibrated reference standards and established measurement methodologies for physiological parameters (e.g., known electrical signals for ECG, certified NIBP simulators, calibrated temperature baths, etc.).
- No clinical ground truth (like pathology or outcomes data) is described in this submission, as it's not a clinical study.
-
The sample size for the training set:
- This information is not provided. Medical devices like this (physiological monitors) typically undergo engineering development, verification, and validation testing rather than a "training set" in the machine learning sense. Any underlying algorithms (e.g., for signal processing, arrhythmia detection) would have been developed and validated during earlier stages or for previous clearances.
-
How the ground truth for the training set was established:
- Not applicable for this type of device and submission. If any algorithms involved "training," the ground truth would have been established using rigorously collected physiological data and expert annotation/labeling, but this detail is not present in the 510(k) summary.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).