(293 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 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.
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.
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.
The Life Scope BSM-3000 Series Bedside Monitoring System 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 visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (O2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2 monitors, rSO2 monitors and external devices with output analog voltage signal and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
The Life Scope BSM-6000 Series Bedside Monitoring System 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 visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radiofrequency.
The Nihon Kohden CSM-1901Series is a device 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. This bedside monitor is placed near the patient and is intended to display patient's vital signs. This device can also be connected to other external patient monitoring devices. In addition, this device can communicate patient's data to a central monitoring station via network to monitor multiple patients.
The provided text describes the acceptance criteria and study data for the Smart Cable NMT Module and Accessories, as well as the Life Scope BSM-3000, BSM-6000, and CSM-1901 Bedside Monitors. However, the document is a 510(k) summary for substantial equivalence, which primarily focuses on comparing the new device to existing predicate devices and demonstrating that it is as safe and effective. It does not contain an explicit table of acceptance criteria and reported device performance in the format typically used for a detailed study report.
Instead, the document states that various tests were performed and that the devices "met all the acceptance criteria" or "performed within specifications." It also notes that "No clinical tests have been submitted, referenced or relied on in the premarket notification submission for a determination of substantial equivalence." This implies that the acceptance criteria for performance were likely derived from industry standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ANSI/AAMI EC12:2000), internal company specifications, and comparison to predicate devices, rather than from a standalone clinical study with an explicit set of primary and secondary endpoints and predefined performance metrics.
Therefore, many of the requested details such as sample size for the test set, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment from actual patient data (for algorithm training/testing) are not present in this 510(k) summary. This is typical for a 510(k) submission where substantial equivalence is demonstrated through non-clinical performance and engineering validation rather than through new clinical studies, especially for devices where modifications are minor or where performance can be adequately assessed through bench testing and comparisons to established technological characteristics of predicates.
Below is an attempt to address the request based on the information available in the provided text, while also explicitly stating what information is not provided.
Acceptance Criteria and Device Performance (Based on available information):
The document does not present a formal table of acceptance criteria with corresponding device performance results for each specific metric. Instead, it broadly states that the devices underwent various non-clinical tests and met the acceptance criteria. The acceptance criteria were primarily based on compliance with relevant industry standards and comparison to the performance specifications of predicate devices.
Summary of Device Performance and Acceptance (Inferred from the document):
| Acceptance Criteria Category | Device Performance (Based on statements in the document) |
|---|---|
| Smart Cable NMT Module and Accessories | |
| Electrical Safety | Conformance to IEC 60601-1 3rd edition clause 8.5.2.3. |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 and IEC 60601-2-40. |
| Software Validation & Verification (V&V) | Testing verified and validated the proper operation of the system. |
| Operational Performance | Testing verified and validated the proper operation of the system; met all acceptance criteria. |
| Operational and Storage Environmental Performance | Testing verified and validated the proper operation of the system; met all acceptance criteria. |
| Biocompatibility | Patient contacting accessories demonstrated acceptable biocompatibility (in accordance with ISO 10993-1). |
| Shelf Life | Demonstrated acceptable shelf life where applicable. |
| Performance testing of electrodes (tensile strength, electrical performance) | Met acceptance criteria (as specified in ANSI/AAMI EC12:2000 standard). |
| Life Scope BSM-3000, BSM-6000, and Nihon Kohden CSM-1901 Bedside Monitors (after integration of Smart Cable NMT Module software) | |
| Software Integration Testing | Confirmed the operation of the device when the Smart Cable NMT software was integrated into the system. Results confirmed the device performed within specifications. |
| Electromagnetic Compatibility (EMC) | Subjected to tests (e.g., IEC60601-1-2:2014 for BSM-6000/3000, IEC 60601-1-2:2007 for CSM-1901). Results confirmed performance within specifications. |
| Environmental and Safety Testing | Subjected to tests. Results confirmed performance within specifications. |
| Overall Performance | Confirmed the device performed within specifications. |
Details Regarding the Study/Testing:
-
A table of acceptance criteria and the reported device performance:
- As noted above, a formal table is not provided. The document states that various tests (electrical safety, EMC, software V&V, operational performance, environmental performance, biocompatibility, shelf life, electrode performance for NMT module; and software integration, EMC, environmental, safety for Bedside Monitors) were conducted and that the devices "met all the acceptance criteria" or "performed within specifications." The specific quantitative pass/fail thresholds for each test are not detailed in this summary.
-
Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the performance tests (e.g., how many devices were tested, how many signal samples were used for performance evaluation).
- Data Provenance: The tests are described as non-clinical (bench testing, software validation). There is no indication of patient data being used for device performance validation as part of this 510(k) submission. The document explicitly states: "No clinical tests have been submitted, referenced or relied on in the premarket notification submission for a determination of substantial equivalence."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study or expert-adjudicated ground truth dataset is described for device performance validation. The ground truth for engineering and performance tests would be defined by the measurement standards and validation protocols themselves (e.g., a calibrated instrument reading as ground truth for a measurement accuracy test).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical study or expert adjudication process for a test set is described.
-
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 MRMC study was done, as explicitly stated: "No clinical tests have been submitted, referenced or relied on in the premarket notification submission." The device is a monitor, not an AI-assisted diagnostic tool that would typically involve human reader improvement studies.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Performance validation was conducted via non-clinical testing against specifications and standards, which generally assesses the algorithm's (or device's) performance in isolation under controlled conditions (e.g., accuracy of readings, alarm thresholds). Specific "standalone performance" metrics (like sensitivity/specificity for a diagnostic algorithm) are not detailed as the device is a measurement and monitoring system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests described, the "ground truth" would be the known inputs or reference values from calibrated test equipment, as per engineering and quality assurance standards. No medical "ground truth" (e.g., expert consensus, pathology, outcomes data) from patients was used for device verification or validation in this submission.
-
The sample size for the training set:
- Not applicable. The document describes a medical device (monitor) with firmware/software, not an AI/ML algorithm that would typically require a distinct training set (beyond standard software development and testing).
-
How the ground truth for the training set was established:
- Not applicable, as there is no specific "training set" described for an AI/ML algorithm.
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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.
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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 (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
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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.
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – General Provisions 5.0
| Manufacturer Name: | Nihon Kohden Corporation | |
|---|---|---|
| Address: | 1-31-4 Nishiochiai, Shinjuku-KuTokyo 161-8560, Japan | |
| General Provisions | Submitter Name: | Nihon Kohden America |
| Address: | 15353 Barranca ParkwayIrvine, California, USA 92618 | |
| Contact: | Sandra GadeyneSr. Director of Quality and Regulatory Affairs | |
| Phone Number | 949-356-3401 | |
| Fax Number: | 949-580-1550 | |
| 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 CableNMT Pod, with EMG Support; NMT PodTOF 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 TransmissionMonitor |
| 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 |
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| Subject DeviceDescription | The Nihon Kohden Smart Cable NMT Module (NMT Module) andAccessories is an optional accessory for the Nihon Kohden bedsidemonitoring systems. The Smart Cable NMT Module and Accessories TOF(Train of Four) are based on EMG technology. With this system, the usercan apply electrical stimulation on the ulnar nerve to detect the muscle'saction potential. The reaction to the electrical impulse can be visualizedon the connected monitoring system. The Smart Cable NMT Module andAccessories can assist medical personnel to quantitatively determine thelevel of muscle relaxation. This information can be used to determine thedose of muscle relaxants and regional anesthetics when performinganesthesia in a clinical setting. It is intended for use by medical personnelin 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 anelectrode via Main Cable. The electrode is a single-use electrode arrayand each array includes two stimulating electrodes, two recordingelectrodes, and one ground electrode. The NMT module can transmit anelectrical stimulation pulse to the patient and can receive EMG signals viathe electrode array. The captured data from the disposable electrode issent to the monitoring system via the Smart Cable interface connector.The various stimulation settings are also sent to the monitoring system todisplay. | |
| The AF-201P NMT Module is used to control the electrical stimulationand to measure the response. The operational setting is controlled viabuttons on the module or a touch screen. | |
| Indications forUse andIntended Use | The Smart Cable NMT Module and Accessories are indicated for monitoringthe relaxation of the patient when neuromuscular blockades areadministered. |
| 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 usedas a system that requires Nihon Kohden compatible electrodes andbedside monitoring systems. The Smart Cable NMT Module andAccessories are intended for use by medical personnel in clinical settingsand are available by prescription only. |
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| Characteristics | Subject Device:Smart Cable NMTModule andAccessories | Predicate Device:TetragraphNeuromuscularTransmission Monitor(K#190795) | Reference Device:ToFscan NeuromuscularTransmission Monitor(K#172690) |
|---|---|---|---|
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology |
| Classification Name | 21 CFR 868.2775Electrical PeripheralNerve Stimulator | 21 CFR 868.2775Electrical Peripheral NerveStimulator | 21 CFR 868.2775Electrical Peripheral NerveStimulator |
| Regulatory Class | Class II | Class II | Class II |
| Product Code | KOI | KOI | KOI |
| Indications for Use | The Smart Cable NMTModule and Accessoriesare indicated formonitoring the relaxationof the patient whenneuromuscularblockades areadministered.The Smart CableModule and Accessoriesare comprised of:AF-201P NMT Modulewith Smart CableDisposableElectrodesMain cableHolder (optional)The Smart Cable NMTModule and Accessoriesare intended to be usedas a system thatrequires Nihon Kohdencompatible electrodesand bedside monitoringsystems. The SmartCable NMT Module andAccessories areintended for use bymedical personnel inclinical settings and areavailable by prescriptiononly. | The TetraGraphNeuromuscularTransmission (NMT)Monitor is indicated formonitoring the relaxationof the patient whenneuromuscular blockade isadministered. | ToFscan is aneuromusculartransmission monitor formonitoring theneuromuscular block of apatient in the operatingtheatre, recovery room orintensive care unit. Theeffect of neuromuscularblocking agents (NMBA) ismonitored by measuring theacceleration of the musclemovement(acceleromyography) or byvisually observing musclecontractions consequent toelectrical stimulation. TheToFscan has a three-dimensional accelerationsensor (accelerometer) todetect and quantify apatient's thumb movement(contracting adductorpollicis). The sensor isdirectly integrated into thefinger's splint, making itpossible to obtain its optimaland reproducible positioning |
| Device Description | The Smart CableNMT Module andAccessories arecomprised of:• AF-201P NMTModule withSmart Cable• DisposableElectrodes• Main cable• Holder (optional)The Smart Cable NMTModule andAccessories areintended to be used asa system that requiresNihon Kohdencompatible electrodesand bedside monitoringsystems. The SmartCable NMT Module andAccessories areintended for use bymedical personnelinclinical settings and areavailable byprescription only. | The TetraGraphNeuromuscularTransmission (NMT)Monitor (TetraGraph) is aportable, battery-operatedEMG-based neuromusculartransmission monitor foruse perioperative and inrecovery and critical careenvironments following orduring the application ofNeuromuscular block.NeuromuscularTransmission (NMT) is thetransfer of an electricalimpulse between a motornerve and its associatedmuscle. The NMT isblocked by neuromuscularblocking agents ("NMBAs")which cause transientmuscle paralysis preventingthe patient from moving andbreathing spontaneously.Muscle relaxation is usedduring general anesthesiato enable endotrachealintubation and mechanicalventilation and to provideoptimal surgicalconditions. Musclerelaxation may also beused in critical care duringmechanical ventilation. Inthese circumstances,TetraGraph can be usedas an objective monitor ofneuromusculartransmission. TetraGraphundertakes this function byelectrical stimulation of theperipheral nerve anddirectly measuring theevoked response of themuscles (Muscle ActionPotential (MAP)), thusproviding a quantitativeand automaticmeasurement of muscleresponse to a stimulususing electromyography(EMG). The TetraGraph isa prescription-only medicaldevice and is indicated foruse in hospitals.TetraGraph supplementsthe use of clinicalinformation/data obtainedfrom other monitors, such | The effect ofneuromuscular blockingagents (NMBAs) ismonitored by measuringthe acceleration of themuscle movement(acceleromyography) orby visually observingmuscle contractionsconsequent to electricalstimulation. The ToFscanhas a three-dimensionalacceleration sensor(accelerometer) to detectand qualify a patient'sthumb movement(contracting adductorpollicis). The sensor isdirectly integrated intothe finger's splint, makingit possible to obtain it'soptimal and reproduciblepositioning. |
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| saturation (SpO2), end-tidal carbon dioxide(ETCO2), as well asclinical assessment, todetermine the adequacy of | ||
|---|---|---|
| ventilation.The level ofneuromuscular block is | ||
| routinely measured bystimulating a peripheralnerve, usually in theforearm and by evaluating | ||
| the muscle responsetypically in the thumb orlittle finger. TheTetraGraph controls the | ||
| level of electricalstimulation applied to thenerve and monitors themuscle response by the | ||
| use of Electromyography(EMG) detected byelectrodes on the muscle. | ||
| TetraGraph consists of thefollowingmain components | ||
| TetraGraph MonitorThe TetraGraph Monitor isused to control the electricalstimulation and to measurethe EMG- response. TheMonitor is controlled via a | ||
| touch screen and a powerbutton. The Senzime ABTraditional 510(k)Premarket SubmissionTetraGraph Page 005- | ||
| 3TetraGraph Monitor isconnected to the electrodevia a cable (the TetraCordCable). The battery in theTetraGraph Monitor is | ||
| charged via acommunication portconnected to a USB- supplyadapter. | ||
| TetraSens ElectrodeThe TetraSens Electrode isa single-use electrodearray. Each array includes | ||
| two stimulating electrodes(applied along the ulnarnerve at the wrist) and tworecording electrodes | ||
| (applied on the hand). TheTetraGraph Monitor cantransmit stimulation pulsesto the patient and can | ||
| receive EMG signals via theelectrode array. Theelectrodes are neithersupplied sterile norintended to be sterilized by |
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| Electrode forStimulation | Single-useelectrode array (5electrodes on an | Single-use electrode array(4 electrodes on an array) | Uses 3D AccelerometerSensor to measure thumbmovement instead of |
|---|---|---|---|
| Electrode Connection | Reusable Cable | Reusable Cable | Reusable Cable |
| movementdetectiontechnology | (EMG) | ||
| Muscle | Electromyography | from the Tetragraph kit.Rechargeable lithium-polymer batteryA re-chargeable lithium-polymer battery is includedin the TetraGraph, and alsoavailable as spare part. Therechargeable battery ischarged using the USBpower supply adapter.USB power supply adapterand USB cableThe rechargeable battery ischarged using the USBpower supply adapter. Theadapter is configured forlocal power outlets andconnects to the TetraGraphusing a USB cable. Datacan also be transferred to aPC via the USB-port byusing theUSB-cable.Electromyography (EMG) | Acceleromyography |
| TetraGraph Pole Clamp kitA Pole clamp kit is availablefor mounting theTetraGraph on a polestand. The kit includes amounting device and anattachment to theTetragraph. The Pole clampkitis supplied separately | |||
| TetraCord CableThe TetraCord Cable isconnected to theTetraGraph Monitor via aportand is connected to theTetraSens Electrodevia the cable connector atthe other end of theTetraCord Cable. TheTetraCord Cable is suppliedin together with theTetraGraph monitor as partof the kit and can also besold separately as a sparepart. | |||
| the user. The TetraSensElectrodes are soldseparately from theTetraGraph monitor and areavailable in boxes of 20pcs. | |||
| array) | electrode | ||
| Electrode applied part | Total of 5:Two stimulatingelectrodes are appliedalong the ulnar nerve atthe wrist and tworecording electrodes areapplied on the hand.One grounding electrodeapplied on the hand | Total of 4:Two stimulating electrodesare applied along the ulnarnerve at the wrist and tworecording electrodes areapplied on the hand. | Not Applicable (Uses DAccelerometer Sensor tomeasure thumbmovement instead of theelectrode) |
| Stimulation Patterns | Single stimulation,TOF (Train Of Four),PTC (Post TetanicCount), TET (tetanicstimulation), DBS(Double BurstStimulation) | Single Twitch (ST),Train-of-Four (TOF),Post-tetanic Count(PTC) | TOF (Train Of Four)- PTC (PostTetanic Count)- ATP (AutomatedTOF PTC)- DBS (DoubleBurst) (3,3) (3,2)- ST (Single Twitch)0.1 Hz and 1 Hz- TET (Tetanus) 50 Hz |
| StimulatingCurrent Range | 10-60 mA | 10-60 mA | 0-60 mA |
| Stimulation Pulse Width | Square wave, constantcurrent: 200µs or300µs | Square wave, constantcurrent: 200µs or 300µs | Constant current, 0-60 mA, monophasic200µsecpulse width |
| Power source | Power is supplied fromthe MonitoringSystem. | Battery operated | AC Power Supply |
| Compatibility | Works only withNihon KohdenMonitoring System:BSM-6000, BSM-3000 CSM-1901 | Tetragraph NeuromuscularTransmission Monitorconsists of a monitor,electrode, and othercomponents. | The ToFscan system iscomposed of the monitor,the hand sensor, and theUS 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 thedifferences do not result in new intended use. | ||
| TechnologicalCharacteristics | Both Smart Cable NMT Module and Accessories and the predicate device,Tetragraph Neuromuscular Transmission Monitor, measure muscleresponse based on electromyography (EMG) technology and have reusablecables for the electrode connection. The electrode used for the stimulationare single use. There are minor technological differences in number ofelectrodes and stimulation settings. Both devices utilize two stimulatingelectrodes which are applied along the ulnar nerve at the wrist and tworecording electrodes are applied on the hand. One grounding electrodeapplied on the hand.The Smart Cable NMT Module and Accessories incorporates thestimulation patterns of both the predicate and the reference device. |
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| Safety &PerformanceTests | The Smart Cable NMT Module and Accessories have been subjected todesign verification and validation testing for electrical safety,electromagnetic compatibility, software V&V, operational performance, andoperational and storage environmental performance. These tests verifiedand validated the proper operation of the system. Conformance to 21 CFRPart 898 Performance Standard for Electrode Lead Wires and PatientCables was met with compliance to IEC 60601-1 3rd edition clause 8.5.2.3.Patient contacting accessories have demonstrated acceptablebiocompatibility and where applicable, shelf life.Performance testing has been made for the TetraGraph which supportssubstantial equivalence between the TetraGraph and the predicate device.The performance testing for the Smart Cable NMT Module andAccessories are summarized below:Software performance testing Electrical safety (in accordance with IEC 60601-1) Electromagnetic compatibility (in accordance with IEC 60601-1-2 and IEC60601-2-40) Biocompatibility testing (in accordance with ISO10993-1) Mechanical strength Environmental testing Usability testing Shelf life testing Performance testing of electrodes; including tensile testing as well aselectrical performance (as specified in the ANSI/AAMI EC12:2000standard) The performance testing shows that Smart Cable NMT Module andAccessories has met all the acceptance criteria and are equivalent orsimilar to the predicate device's specifications. Thus, the test datademonstrates that Smart Cable NMT Module and Accessories is as safeand as effective in monitoring the relaxation of the patient whenneuromuscular blockade is administered as the predicate.No clinical tests have been submitted, referenced or relied on in thepremarket notification submission for a determination of substantialequivalence. The device and the components are not MR compatible. |
|---|---|
| Summary ofSubstantialEquivalence | The device comparison and the results of the safety and performance testsindicate that the Nihon Kohden Smart Cable NMT Module and Accessoriesis substantially equivalent to the predicate device, the TetraGraphNeuromuscular Transmission Monitor. |
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Life Scope BSM-3000 Series Bedside Monitoring System 5.2
| Trade Name: | Life Scope BSM-3000 Series BedsideMonitoring System | |
|---|---|---|
| Subject Device | Common Name: | Bedside Monitor, Patient Monitor, CardiacMonitor, Vital Signs Monitor and AnesthesiaMonitor |
| Classification Name | Monitor, Physiological Patient Monitor withArrhythmia Detection and Alarms | |
| Classification: | Class II | |
| Product Code: | MHX | |
| Regulation Number: | 21 CFR 870.1025 | |
| Predicate Device | Trade Name: | Life Scope BSM-6000 Series BedsideMonitoring System |
| Common Name: | Bedside Monitor, Patient Monitor, CardiacMonitor, Vital Signs Monitor and AnesthesiaMonitor | |
| Classification Name | Monitor, Physiological Patient Monitor withArrhythmia Detection and Alarms | |
| Classification: | Class II | |
| Product Code: | MHX | |
| Regulation Number: | 21 CFR 870.1025 | |
| 510(K): | K080342 | |
| Device Description | The Life Scope BSM-3000 Series Bedside Monitoring System is intendedto monitor, display and record physiological data to provide cardiac andvital signs monitoring within a medical facility. The device is intended toproduce a visual record of the electrical signals produced by the heart andmonitor the electrocardiogram to generate visible and/or audible alarmswhen an arrhythmia exists. The device is also intended to monitor heartrate, pulse rate, blood oxygen saturation (SpO2), non-invasive bloodpressure (NIBP), invasive blood pressure (IBP), body temperature,Cardiac Output (CO), oxygen concentration (O2), CO2 and EtCO2,respiratory rate, BIS and inspired and expired anesthetic agents andgases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane,Sevoflurane and Desflurane. Anesthetic agents and gases are detectedusing the cleared AG-920RA Anesthetic Agent Detection System. Thedevice can interface to external equipment to display numerical andwaveform data and alarms from the external devices. Supported externaldevices include AG-920RA Anesthetic Agent Detection System,Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2Monitors, EEG monitoring device, tcPO2 monitors, rSO2 monitors andexternal devices with output analog voltage signal and continuous NIBPMonitors. The device may generate an audible and/or visual alarm whena measured rate falls outside preset limits. This device may also be usedto condition and transmit physiological signals via radio frequency. | |
| Indications for Useand Intended Use | The Life Scope BSM-3000 Series Bedside Monitor is intended to monitordisplay and record physiological data to provide cardiac and vital signsmonitoring within a medical facility. The device is intended to produce avisual record of the electrical signals produced by the heart and monitorthe electrocardiogram to generate audible and/or visible alarms when anarrhythmia exists.The device is also intended to monitor heart rate, pulse rate, bloodoxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasiveblood pressure (IBP), body temperature, BIS, cardiac output (CO),oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2,respiratory rate, and inspired and expired anesthetic agents andanesthetic gases including N2O, Halothane, Isoflurane, Enflurane,Sevoflurane, and Desflurane.The device may generate an audible and/or visual alarm when ameasured rate falls outside preset limits. The device may also beused to condition and transmit physiological signals via radiofrequency. The device can interface to external equipment to displaynumerical 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, EEGmonitoring device, tcPO2/tcPCO2 monitors, rSO2 monitors andexternal devices which output analog voltage signal. | |
| The device will be available for use by medical personnel on patientswithin a medical facility on all patient populations. | ||
| TechnologicalCharacteristics | The BSM-3000 Bedside Monitoring System was a letter to file to theBSM-6000 Bedside Monitoring Systems. The dimensions and weightof the monitoring systems are different, but the performance,technological features are the same. The difference between thesystems are that the BSM-3000 has an integrated input system, andBSM-6000 has a interchangeable input unit. Each of the monitoringsystems measure the same parameters and interface with the sameaccessories. There have been no significant hardware changes. | |
| The indications for use statement/intended use statement have beenupdated to include the interface with other external devices. Therehave been software updates to the system to integrate the SmartCable NMT Module and accessories. The performance of the deviceis listed in Section 5.5 of this document. | ||
| Safety &Performance Tests | The Life Scope BSM-3000 Series Bedside Monitoring Systemincorporated all software changes in the integration testing. Thetesting confirmed the operation of the device when the Smart CableNMT software was integrated into the system. The results confirmedthat the device performed within specifications. No clinical tests havebeen submitted, referenced or relied on in this premarket notificationsubmission for a determination of substantial equivalence. |
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5.3 Life Scope BSM-6000 Series Bedside Monitoring System
| Trade Name: | Life Scope BSM-6000 Series BedsideMonitoring System | |
|---|---|---|
| Subject Device | Common Name: | Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitorand Anesthesia Monitor |
| Classification Name | Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms | |
| Classification: | Class II | |
| Product Code: | MHX | |
| Regulation Number: | 21 CFR 870.1025 | |
| Predicate Device | Trade Name: | Life Scope BSM-6000 Series BedsideMonitoring System |
| Common Name: | Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitor andAnesthesia Monitor | |
| Classification Name | Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms | |
| Classification: | Class II | |
| Product Code: | MHX | |
| Regulation Number: | 21 CFR 870.1025 | |
| 510(K): | K080342 |
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| DeviceDescription | The Life Scope BSM-6000 Series Bedside Monitoring System isintended to monitor, display and record physiological data to providecardiac and vital signs monitoring within a medical facility. The device isintended to produce a visual record of the electrical signals produced bythe heart and monitor the electrocardiogram to generate visible and/oraudible alarms when an arrhythmia exists. The device is also intendedto monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), bodytemperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2and EtCO2, respiratory rate, BIS and inspired and expired anestheticagents and gases including CO2, O2, N2O, Halothane, Isoflurane,Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gasesare detected using the cleared AG-920RA Anesthetic Agent DetectionSystem. The device can interface to external equipment to displaynumerical and waveform data and alarms from the external devices.Supported external devices include AG-920RA Anesthetic AgentDetection System, Ventilators, CO2 Monitors, TOF Monitors, BISMonitors, CCO/SvO2 Monitors and continuous NIBP Monitors. Thedevice may generate an audible and/or visual alarm when a measuredrate falls outside preset limits. This device may also be used to conditionand transmit physiological signals via radiofrequency. |
|---|---|
| Indications forUse andIntended Use | The Life Scope BSM-6000 Series Bedside Monitor is intended tomonitor, display and record physiological data to provide cardiac andvital signs monitoring within a medical facility. The device is intended toproduce a visual record of the electrical signals produced by the heartand monitor the electrocardiogram to generate audible and/or visiblealarms when an arrhythmia exists.The device is also intended to monitor heart rate, pulse rate, bloodoxygen 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 anestheticagents and anesthetic gases including N2O, Halothane, Isoflurane,Enflurane, Sevoflurane, and Desflurane.The device may generate an audible and/or visual alarm when ameasured rate falls outside preset limits. The device may also be usedto condition and transmit physiological signals via radio frequency. Thedevice can interface to external equipment to display numerical andwaveform data and alarms from the external devices. Supportedexternal devices include CO2 monitors, BIS monitors, Anestheticagents/gases detection system, Anesthesia machine, Ventilators, CCOmonitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device,tcPO2/tcPCO2 monitors, rSO2 monitors and external devices whichoutput analog voltage signal.The device will be available for use by medical personnel on patientson all patient populations. |
| TechnologicalCharacteristics | The indications for use/intended use statement have been updated toinclude the interface with other external devices. There are no hardwarechanges compared to the predicate devices. There have been softwareupdates to the system to integrate the Smart Cable NMT Module andaccessories. |
| Safety &PerformanceTests | The Life Scope BSM-6000 Series Bedside Monitoring Systemincorporated all software changes in the integration testing. The testingconfirmed the operation of the device when the Smart Cable NMTsoftware was integrated into the system. The results confirmed that thedevice performed within specifications. No clinical tests have beensubmitted, referenced or relied on in this premarket notificationsubmission for a determination of substantial equivalence |
| Summary ofSubstantialEquivalence | The Life Scope BSM-6000 Series is equivalent to the Life Scope BSM-6000 Series. The indications for Use have been updated to include theinterface with other external devices. The BSM-6000 and the BSM-6000 Bedside Monitoring System can measure oxygen concentration,the BSM-6000 when connected to an external device, can alsomeasure fractionated oxygen. |
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5.4 CSM 1901 Bedside Monitoring System
| Trade Name: | Nihon Kohden CSM-1901 BedsideMonitor | |
|---|---|---|
| Subject Device | Common Name: | Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitorand Anesthesia Monitor |
| Classification Name | Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms | |
| Classification: | Class II | |
| Product Code: | MHX | |
| Regulation Number: | 21 CFR 870.1025 | |
| 510(K): | K151080 | |
| PredicateDevices | Trade Name | Nihon Kohden CSM-1901 BedsideMonitor |
| Common Name: | Bedside Monitor, Patient Monitor,Cardiac Monitor, Vital Signs Monitor andAnesthesia Monitor | |
| Classification Name | Monitor, Physiological Patient Monitorwith Arrhythmia Detection and Alarms | |
| Classification: | Class II | |
| Product Code: | MHX | |
| Regulation Number: | 21 CFR 870.1025 | |
| 510(K): | K151080 | |
| DeviceDescription | The Nihon Kohden CSM-1901Series is a device which continuouslymonitors physiological information of a patient and is used in an operationroom, a recovery room, general wards, ICU, CCU, HCU, NICU and anemergency room. This bedside monitor is placed near the patient and isintended to display patient's vital signs. This device can also be connected |
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| Indications forUse and IntendedUse | to other external patient monitoring devices. In addition, this device cancommunicate patient's data to a central monitoring station via network tomonitor multiple patients.The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor,display and record physiological data to provide cardiac and vital signsmonitoring within a medical facility. The device is intended to produce avisual record of the electrical signal produced by the heart and monitor theelectrocardiogram to generate visible and/or audible alarms when anarrhythmia exists. The device is also intended to monitor heart rate, pulserate, 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 andanesthetic gases including N2O, halothane, isoflurane, enflurane,sevoflurane and desflurane. The device also displays patient data fromexternal devices such as ventilators, TOF monitors, CCO/SvO2 monitors,and EEG measuring unit.The device may generate and audible and/or visual alarm when ameasured rate falls outside preset limits. The device will be available foruse by trained medical personnel within a medical facility on all patientpopulations, including adult, neonate, infant, child, and adolescentsubgroups. |
|---|---|
| TechnologicalCharacteristics | There are no hardware changes to the predicate devices. Both thepredicate and the subject device measure the same functions. Bothdevices can measure Oxygen concentration but when connected to anexternal adapter (JO-900P) can measure FiO2. The JO-900P is not beenvalidated on the BSM-3000. There have been software updates to thesystem to integrate the Smart Cable NMT Module and accessories. |
| Safety &PerformanceTests | The Nihon Kohden CSM-1901 Bedside Monitoring System incorporated alsoftware changes in the integration testing. The testing confirmed theoperation of the device when the Smart Cable NMT software wasintegrated into the system. The results confirmed that the deviceperformed within specifications. No clinical tests have been submitted,referenced or relied on in this premarket notification submission for adetermination of substantial equivalence. |
| Summary ofSubstantialEquivalence | The Nihon Kohden CSM-1901 Series is equivalent to the Nihon KohdenCSM-1901 Series. There have been no changes on the indications foruse. The software was updated to incorporate the Smart Cable NMTModule and Accessories |
5.5 Bedside Monitoring Systems Technological Specifications
The compatible bedside Monitoring systems features were unchanged as a result of the incorporation of the Smart Cable NMT Module and Accessories. See table below for the product features and technological specifications.
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| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
|---|---|---|---|
| Device Description | The Life Scope 6000 SeriesBedside Monitoring is intended tomonitor, display, and recordphysiological data to providecardiac and vital signs monitoringwithin a medical facility. Thedevice is intended to produce avisual record of the electricalsignals produced by the heart andmonitor the electrocardiogram togenerate visible and/or audiblealarms when an arrhythmia exists.The device is also intended tomonitor heart rate, pulse rate,blood oxygen saturation (SpO2),non-invasive blood pressure(NIBP), invasive blood pressure(IBP), body temperature, CardiacOutput (CO), oxygenconcentration (FiO2), CO2 andEtCO2, respiratory rate, BIS andinspired and expired anestheticagents and gases including CO2,O2, N20, Halothane, Isoflurane,Enflurane, Sevoflurane, andDesflurane. Anesthetic agents andgases are detected using thecleared AG-920RA AnestheticAgent Detection System. Thedevice can interface to externalequipment to display numericaland waveform data and alarmsfrom the external devices.Supported external devicesinclude AG- 920RA AnestheticAgent Detection System,Ventilators, CO2 Monitors, TOFMonitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBPMonitors. The device maygenerate an audible and/or visualalarm when a measured rate fallsoutside preset limits. This devicemay also be used to condition andtransmit physiological signals viaradio frequency | The Life Scope BSM-3000Series Bedside MonitoringSystem is intended tomonitor, display and recordphysiological data to providecardiac and vital signsmonitoring within a medicalfacility. The device isintended to produce a visualrecord of the electricalsignals produced by theheart and monitor theelectrocardiogram togenerate visible and/oraudible alarms when anarrhythmia exists. Thedevice is also intended tomonitor heart rate, pulserate, blood oxygen saturation(SpO2), non-invasive bloodpressure(NIBP), invasiveblood pressure (IBP), bodytemperature, Cardiac Output(CO), oxygen concentration(O2), CO2 and EtCO2,respiratory rate, BIS andinspired and expiredanesthetic agents and gasesincluding CO2, O2, N2O,Halothane, Isoflurane,Enflurane, Sevoflurane andDesflurane. Anestheticagents and gases aredetected using the clearedAG-920RA Anesthetic AgentDetection System. Thedevice can interface toexternal equipment todisplay numerical andwaveform data and alarmsfrom the external devices.Supported external devicesinclude AG-920RAAnesthetic Agent DetectionSystem, Ventilators, CO2Monitors, TOF Monitors, BISMonitors, CCO/SvO2Monitors, EEG monitoringdevice, tcPO2 monitors,rSO2 monitors and externaldevices with output analogvoltage signal andcontinuous NIBP Monitors.The device may generate anaudible and/or visual alarmwhen a measured rate fallsoutside preset limits. This | The Nihon KohdenCSM-1901 is a devicewhich continuouslymonitors physiologicalinformation of apatient and is used inan operation room, arecovery room,general wards, ICU,CCU, HCU, NICU andan emergency room.This bedside monitoris placed near thepatient and isintended to displaypatient's vital signs.This device can alsobe connected to otherexternal patientmonitoring devices. Inaddition, this devicecan communicatepatient's data to acentral monitoringstation via network tomonitor multiplepatients. |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| device may also be used tocondition and transmitphysiological signals viaradio frequency. | |||
| Intended Use | The Life Scope BSM-6000 SeriesBedside Monitor is intended tomonitor, display and recordphysiological data to providecardiac and vital signs monitoringwithin a medical facility. Thedevice is intended to produce avisual record of the electricalsignals produced by the heart andmonitor the electrocardiogram togenerate audible and/or visiblealarms when an arrhythmia exists.The device is also intended tomonitor heart rate, pulse rate,blood oxygen saturation (SpO2),non-invasive blood pressure(NIBP), invasive blood pressure(IBP), body temperature, BIS,cardiac output (CO), oxygenconcentration (FiO2), carbondioxide concentration (CO2),EtCO2, respiratory rate, andinspired and expired anestheticagents and anesthetic gasesincluding N2O, Halothane,Isoflurane, Enflurane, Sevofluraneand Desflurane.The device may generate anaudible and/or visual alarm whena measured rate falls outsidepreset limits. The device may alsobe used to condition and transmitphysiological signals via radiofrequency. The device caninterface to external equipment todisplay numerical and waveformdata and alarms from the externaldevices. Supported externaldevices include CO2 monitors,BIS monitors, Anestheticagents/gases detection system,Anesthesia machine, Ventilators,CCO monitors, TOF monitors,CCO/SvO2 Monitors, EEGmonitoring device, tcPO2/tcPCO2monitors, rSO2 monitors andexternal devices which output | The Life Scope BSM-3000Series Bedside Monitor isintended to monitor, displayand record physiologicaldata to provide cardiac andvital signs monitoring withina medical facility. The deviceis intended to produce avisual record of the electricalsignals produced by theheart and monitor theelectrocardiogram togenerate audible and/orvisible alarms when anarrhythmia exists.The device is also intendedto monitor heart rate, pulserate, blood oxygen saturation(SpO2), non-invasive bloodpressure (NIBP), invasiveblood pressure (IBP), bodytemperature, BIS, cardiacoutput (CO), oxygenconcentration (O2), carbondioxide concentration (CO2),EtCO2, respiratory rate, andinspired and expiredanesthetic agents andanesthetic gases includingN2O, Halothane, Isoflurane,Enflurane, Sevoflurane, andDesflurane.The device may generate anaudible and/or visual alarmwhen a measured rate fallsoutside preset limits. Thedevice may also be used tocondition and transmitphysiological signals viaradio frequency. The devicecan interface to externalequipment to displaynumerical and waveformdata and alarms from theexternal devices. Supportedexternal devices includeCO2 monitors, BIS monitors, | The Nihon KohdenCSM-1901 BedsideMonitor is intended tomonitor, display andrecord physiologicaldata to providecardiac and vital signsmonitoring within amedical facility. Thedevice is intended toproduce a visualrecord of the electricalsignal produced bythe heart and monitorthe electrocardiogramto generate visibleand/or audible alarmswhen an arrhythmiaexists. The device isalso intended tomonitor heart rate,pulse rate, bloodoxygen saturation(SpO2), non-invasiveblood pressure(NIBP), invasive bloodpressure (IBP), bodytemperature, BIS,cardiac output (CO),oxygen concentration(FiO2), carbon dioxideconcentration (CO2),EtCO2, respiratoryrate, inspired andexpired anestheticagents and anestheticgases including N2O,Halothane, Isoflurane,Enflurane, Sevofluraneand Desflurane. Thedevice also displayspatient data fromexternal devices suchas ventilators, TOFmonitors, CCO/SvO2monitors, and EEGmeasuring unit.The device maygenerate and audibleand/or visual alarm |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| analog voltage signal.The device will be available for useby medical personnel on patientswithin a medical facility on all patientpopulations. | Anesthetic agents/gasesdetection system,Anesthesia machine,Ventilators, CCO monitors,TOF monitors, CCO/SvO2Monitors, EEG monitoringdevice, tcPO2/tcPCO2monitors, rSO2 monitors andexternal devices whichoutput analog voltage signal.The device will be availablefor use by medical personnelon patients within a medicalfacility on all patientpopulations. | when a measuredrate falls outsidepreset limits.The device will beavailable for use bytrained medicalpersonnel within amedical facility onall patientpopulations,including adult,neonate, infant,child, andadolescentsubgroups. | |
| Display | |||
| Type | TFT Color LCD, 10.4" (BSM-6301A) TFT Color LCD, 12.1"(BSM-6501A) TFT Color LCD,15.0" (BSM-6701A) | TFT Color LCD, 12.1" (BSM-35xx) TFT Color LCD, 15.0"(BSM-37xx) | TFT Color LCD,19.0" |
| Resolution | 800 x 600 (BSM-6301A/BSM-6501A)1024 x 768 (BSM-6701A) | 800 x 600 (BSM-35xx)1024 x 768 (BSM-37xx) | 1680 x 1024, 1280x 1024 |
| Number OfTraces | 15 | 15 | 17 |
| TraceMovement | Moving or fixed | Same | Same |
| WaveformDisplay | ECG (12 leads), respiration,SpO2, CO2, Cardiac output,external input, O2, N2O,anesthesia agents, EEG(BISx),IBP (7) | ECG (12 leads), respiration,Sp02, CO2, Cardiac output,external input, O2, N2O,anesthesia agents,EEG(BISx),IBP (2) (BSM-35xx)IBP (3) (BSM-37xx) | ECG, respiration curve,IBP waveform, SpO2pulse waveform, CO2partial pressure curve,EEG waveform,respiratory flow curve,airway pressure curve,respiratory volumecurve,EEG waveform (BIS),O2 concentrationcurve, CO2concentration curve,anesthetic agentconcentration curve. |
| Numeric DataDisplay | Heart Rate, Pulse Rate, VPC rate,ST level (12 leads), RespirationRate, NIBP (sys/dia/mean),Temperature (4), SpO2, EtCO2, | Heart Rate, Pulse Rate,VPC rate, ST level (12leads), Respiration Rate,NIBP (sys/dia/mean), | Heart rate, VPC rate(per minute), ST level,respiration rate, NIBP(Sys, Dia, MAP), |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| Anesthesia agents, BIS,IBP (7) (sys/dia/mean) | EtCO2, Cardiac output, O2,N2O, Anesthesia agents,BIS,IBP (2) (sys/dia/mean)(BSM-35xx)IBP (3) (sys/dia/mean)(BSM-37xx) | SpO2, pulse rate,temperature, cardiacoutput (CO), cardiacindex (CI), injectatetemperature (Ti), bloodtemperature (Tb), O2concentration (02),end tidal CO2 partialpressure (ETCO2), BIS,inspired/expired N2Oconcentration,inspired/expired CO2partial pressure,inspired/expired CO2concentration, inspired/xpired O2 concentration,inspired/expiredanesthetic agentconcentration(Halothane,Enflurane, Isoflurane,Sevoflurane,Desflurane), minimumalveolar concentration(MAC),peak airway pressure(Ppeak), positive endexpiratory pressure(PEEP),mean airway pressure(Pmean), minute volume(MV), inspiratory tidalvolume (TVi),expiratory tidal volume(TVe), compliance (C),airway resistance (R),inspiratory airwayresistance (Ri),expiratory airwayresistance (Re),inspiration expirationratio (I:E),90 or 95% spectral edgefrequency (SEF),median frequency(MDF), peak powerfrequency (PPF),total power (TP), powerof frequency (Abs δ,Abs 0, Abs a, Abs ß,Abs y),power ratio of frequency(% δ, | |
| Alarm Display | Alarm sound, highlighted alarmdisplay, alarm lamp | Same | Same |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| Alarm Suspend/Silence Function | Yes | Same | Same |
| ECG | |||
| Number Of ECGElectrodes | 3, 6 or 10 | Same | Same |
| DefibrillationDischargeProtection | Yes | Same | Same |
| ElectrosurgeryInterface filter | Yes | Same | Same |
| Pacing detection | Yes | Same | Same |
| Heart RateCounting Method | Average, instantaneous(beat to beat) | Same | Same |
| Heart RateCounting Range | 0, 15 to 300 bpm | Same | Same |
| CountingAccuracy | ±2 bpm | Same | Same |
| Alarm Limits:UpperLower | 16 to 300 bpm, OFF15 to 299 bpm, OFF | Same | Same |
| ST LevelMeasuring Range | -2.5 to +2.5 mV | Same | Same |
| QRS Sync Tone | Yes | Same | Same |
| Arrhythmia Detection | |||
| Detection Method | Multi-template software algorithmMulti-lead analysis | Same | Same |
| VPC CountingRange | 0 to 99 per min | Same | Same |
| Arrhythmia Alarm | Yes | Same | Same |
| Arrhythmia Recall | Yes | Yes | Yes |
| Number OfArrhythmia RecallFiles | Up to 72 hours | Up to 72 hours | 168 hours |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| Number ofarrhythmia type | 23 | 23 | 25 |
| ArrhythmiaGraphic Trend | Yes | Same | Same |
| Respiration | |||
| Method | Impedance, thermistor, CO2 | Impedance, CO2 | Impedance,thermistor, CO2 |
| Respiration RateDisplay | 0 to 150 bpm | Same | Same |
| Alarm Limits:UpperLower | 2 to 150 bpm, OFF0 to 148 bpm, OFF | Same | Same |
| No breath timeLimit | 5 to 40 seconds, OFF | Same | Same |
| WaveformDisplay | Yes | Same | Same |
| ConnectorInsertionDetection | Yes | Same | Same |
| Apnea Detection | Yes | Same | Same |
| SpO2 | |||
| Probe Type | Nihon Kohden, Nellcor (NL) orMasimo (MS) | Same | Same |
| Displayed RangeNK type | 0 to 100% | Same | Same |
| Displayed Range,NL type | 1 to 100% | Same | Same |
| Displayed Range,MS type | 1 to 100% | Same | Same |
| Declared Range,NK type andAccuracy withsensor | 70 to 100% (with sensor)80 to 100% ±2 %SpO270 to 80% ±3 %SpO2 | Same | Same |
| Declared Range,NL type andAccuracy with | 70 to 100%70 to 100% ±2 digits(adult) | Same | Same |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| sensor | 70 to 100% ± 3 digits (neonatal) | ||
| Declared Range,MS type andAccuracy withsensor | no motion condition70 to 100% ± 2 digits(adult)70 to 100% ± 3 digits(neonatal)motion condition70 to 100% ± 3 digits(adult)70 to 100% ± 3 digits(neonatal) | Same | Same |
| Pulse Sync Tone | Yes | Same | Same |
| Audible Indicationto SpO2 Variation | Yes | Same | Same |
| SpO2 AlarmLimits:UpperLower | 51 - 100%, OFF50 - 99%, OFF | Same | Same |
| Pulse Rate CountRange: | 0, 30-300 bpm (NK)0, 20-300 bpm (NL)0, 25-240 bpm (MS) | Same | Same |
| Non-Invasive Blood Pressure (NIBP) | |||
| MeasuringMethod | Oscillometeric | Same | Same |
| Pressure DataDisplay | Systolic, Diastolic, Mean, Cuffpressure | Same | Systolic, Diastolic,Mean,Cuff pressure,Pulse Rate |
| Measuring Range,Adult/ Pediatric | 0 - 300 mmHg | Same | Same |
| MeasuringRange, Neonates | 0 - 150 mmHg | Same | Same |
| MeasuringAccuracy | ± 3 mmHg ≤ 200mmHg± 4 mmHg >200mmHg | Same | Same |
| Invasive Pressure (IBP) | |||
| MeasuringMethod | Pressure transducer | Same | Same |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| Measuring Range | -50 to 300 mmHg | Same | Same |
| MeasuringAccuracy | ±1mmHg, ±1digit (-50 to 100 mmHg)± 1%, ±1 digit (100 to 300 mmHg) | Same | Same |
| ConnectorInsertionDetection | Yes | Same | Same |
| Alarm Limits:UpperLower | -48 - 300 mmHg, OFF-50 - 298 mmHg, OFF | Same | Same |
| Pulse Svnc Tone | Yes | Same | Same |
| Pulse Rate CountRange: | 0, 30 - 300 bpm | Same | Same |
| Temperature | |||
| Number ofchannels | Up to 4 | Up to 2 | Up to 8 |
| Measuring Range | 0 to 45°C | Same | Same |
| Display Units | °C or °F | Same | Same |
| Accuracy | ± 0.1 °C (25 to 45°C)± 0.2 °C (0 to 25°C) | Same | Same |
| ConnectorInsertionDetection | Yes | Same | Same |
| Numeric Display | Yes | Same | Same |
| Alarm Limits:UpperLower | 0.1 to 45°C,0.2 OFF 0 to 44.9°C, OFF | Same | Same |
| Carbon Dioxide (CO2) | |||
| MeasuringMethod | Main Stream | Same | Main Stream, SideStream (when GF-210RA connected) |
| Response Time | Depends on CO2 unit160msec (TG-900P) | Same | Same |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| 120msec (TG-920P/970P)< 60msec (TG-980P) | |||
| MeasuringRange, CO2 | Depends on CO2 unit0to 100mmHg(TG-900P/920P)0 to 150mmHg(TG-970P/980P) | Same | Same |
| Displayed Values | EtCO2, CO2, Resp. rate | Same | EtCO2, CO2,Resp. rateInspired CO2 |
| MeasuringRange,Respiration | Depends on CO2 unit3 to 150 counts/min(TG-900P/920P)0 to 150 counts/min(TG-970P/980P) | Same | Same |
| Accuracy | Depends on CO2 unitTG-900P/920P+/- 3 mmHg (0-10mmHg),+/- 4 mmHg (10-40mmHg),+/- 10% reading (40-100mmHg)TG-970P/980P+/- 2 mmHg (0-40mmHg),+/- 5% reading (40-70mmHg),+/- 7% reading (70-100mmHg),+/- 10% reading (100-150mmHg) | Same | Same |
| Alarm Limits,CO2: UpperLower | 2 to 99mmHg, OFF1 to 98 mmHg, OFF | Same | Same |
| Apnea AlarmLimits | 5 to 40 seconds, OFF | Same | Same |
| Anesthetic FiO2 | |||
| Measuring range | 10 to 100% O2 | Not Available | 10 to 100% O2 |
| Accuracy | + 3% Full Scale | Not Available | + 3% Full Scale |
| Alarm Limits:UpperLower | 19 to 100%,18 to 99% | Not Available | 19 to 100%,18 to 99% |
| Cardiac Output (CO) | |||
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| MeasuringMethod | Thermodilution | Same | Same |
| MeasuringRange: CardiacOutput InjectionTemp. BloodTemp. | 0.5 to 20 L/min 0 to 27 °C15to 45 °C | Same | Same |
| Accuracy:Cardiac OutputInjection Temp.Blood Temp. | ±5%± 0.2 deg C± 0.2% (15 to 45 deg C)± 0.1% (25 to 45 deg C) | Same | Same |
| CatherCoefficient | Auto or Manual | Same | Same |
| InjectionTemperatureMeasurementMethod | Temperature probe or inlinesensor | Same | Same |
| Alarm Limits,Blood Temp:UpperLower | 15.1 to 45.0 deg C,15.0 to 44.9 deg C, | Same | Same |
| External Communication | |||
| Central StationCommunications | Yes (Standard) | Same | Same |
| CommunicationMethod | Ethernet | Same | Same |
| ECG Output | Yes | Same | Same |
| IBP Output | Yes | Same | Same |
| Connector forTransmitter | Yes | Same | Same |
| External DisplayConnector | Yes (Option) | Same | Same |
| Serial DataInterface | Yes (Option) | Same | Same |
| User Interface | |||
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | |
| Touchscreen | Yes | Same | Same |
| Alarm IndicatorLamp | Yes | Same | Same |
| DedicatedFunction Keys | Yes | Same | Same |
| Memory | |||
| Full DisclosureStorage | 24hours, 5waves, Standard72hours, 5waves (Option) | Same | 168 hours |
| Trend DisplayTime | 1, 2, 4, 8, 24, (72) hours(Option) | 1, 2, 4, 8, 24, (72) hours(Option) | 15 min, 30 min,1, 2, 4, 6, 8, 12,24, 48, 72, 96,120, 144, 168hours |
| Vital Sign ListInterval | 1, 5, 15, 30, 60 minuteNIBP list (Triggered by NIBPmeasurement) | Same | 1, 5, 10, 15, 30, 60 minute |
| List Capacity | 24hours (Standard) 72hours(Option) | 24hours (Standard)72hours (Option) | 168 hours |
| Recorder (Option) | |||
| Type | Thermal Array | Same | Same |
| Number ofchannels | 3 | Same | Same |
| WaveformsRecorded | ECG, pulse (SpO2), respiration, IBP | ECG, pulse (SpO2),respiration, IBP | ECG, pulse (SpO2),respiration, IBP,CO2, EEG, Gas,waveform fromexternal device |
| Annotationprinting | Patient Name, bed ID, date,recording type, sensitivity,paper speed, parameter data,ECG lead, arrhythmiaclassification, QRSclassification | Same | Same |
| Recorder Speed | 25 mm/sec, 50 mm/sec | 25 mm/sec, 50 mm/sec | 12.5 mm/sec, 25mm/sec, 50mm/sec |
| Battery Operation | |||
| Life Scope BSM-6000 Series Bedside Monitoring System | Life Scope BSM-3000 Series Bedside Monitoring System | Nihon Kohden CSM - 1901 Bedside Monitoring System | |
| Type | Ni-MH (Option) | Same | Same (Option) |
| Number of batteries | 2 | 1 | 1 |
| Operation Time | 90minutes/battery (BSM-6501A/6301A) 60minutes/battery (BSM-6701A) | 90minutes/battery (BSM-35xx) 60 minutes/battery (BSM-37xx) | The battery is for power interruption. |
| Charge time | 12 hours max/battery (monitor on) 6 hours max/2batteries (monitor off) | 10 hours Typical (monitor on) 2 hours Typical (monitor off) | The battery is for power interruption. |
| Transmitter | |||
| Transmitted waveforms | ECG, Respiration or CO2, Pulse (SpO2) or IBP (2) or IBP (3) | Same | Not available |
| Transmitted numerics | SpO2, NIBP (sys/dia/mean), CO2 | Same | Not available |
| 12 Lead ECG Acquisition and Analysis | |||
| Acquisition and Processing | Simultaneous Acquisition and Processing for 12 Lead Development with Calculations and Resting ECG Analyses | Same | Same |
| ECG Interpretation Program | ECAPS12C | Same | Same |
| 12 lead ST Analysis | Yes | Same | Same |
| Patient Age: 12 Lead Acquisition 12 Lead Interpretation | ALL ages 3 Years and older | Same | Same |
| Power Requirements | |||
| Line Voltage | 100 to 240V | Same | same |
| Power Consumption | 140VA(BSM-6301A) 90 VA (BSM-6501A) 100VA (BSM-6701A) | 100VA | 220VA |
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| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | ||
|---|---|---|---|---|
| Environmental Conditions | ||||
| OperatingTemperature | 10 to 40 deg C | 10 to 40 deg C | 5 to 40 deg C | |
| OperatingRelative Humidity | 30 to 85% RH | Same | Same | |
| OperatingAtmosphericPressure | 68 to 106 kPa | 68 to 106 kPa | 700 to 1060 hPa | |
| Dimension and Weight | ||||
| Dimensions, mm(W,H,D) | 316 x 325 x 188 (BSM-6301A)342 x 353 x 183 (BSM-6501A)415 x 392 x 191 (BSM-6701A) | 370 x 310 x 172 (BSM-35xx)430 x 350 x 172 (BSM-37xx) | 141 W × 322 H ×365 D mm (CU-191R, CU-192Rcore unit) | |
| Weight, kg(without options) | 6.6 (BSM-6301A)8.3 (BSM-6501A)10.3 (BSM-6701A) | 6.2 (BSM-35xx)7.4 (BSM-37xx) | 12.5 kg (CU-191R, CU-192Rcore unit) | |
| General Safety | IEC60601-1-2:2014 | IEC60601-1-2:2014 | IEC 60601-1-2:2007 | |
| TechnologicalCharacteristics | There are no technologicalchanges to the predicatedevices. Both the predicate andthe subject device measure thesame functions. Both devicescan measure Oxygenconcentration but whenconnected to an externaladapter (JO-900P) can measureFiO2. The JO-900P is not beenvalidated on the BSM-3000. | The BSM-3000 BedsideMonitoring System wasa letter to file to theBSM-6000 BedsideMonitoring Systems.The dimensions andweight of the monitoringsystems are different,but the performance,technological featuresare the same. Each ofthe monitoring systemsmeasure the sameparameters andinterface with the sameaccessories.The indications for usestatement/intended usestatement have beenupdated to include theinterface with otherexternal devices. Therehave been softwareupdates to the system | There are notechnologicalchanges to thepredicate devices.Both the predicateand the subjectdevice measure thesame functions.Both devices canmeasure Oxygenconcentration butwhen connected toan external adapter(JO-900P) canmeasure FiO2.There have beensoftware updates tothe system tointegrate the SmartCable NMT Moduleand Accessories. | |
| Life Scope BSM-6000 SeriesBedside Monitoring System | Life Scope BSM-3000 SeriesBedside Monitoring System | Nihon Kohden CSM -1901 BedsideMonitoring System | ||
| Safety &PerformanceTests | The Life Scope BSM-6000Series Bedside MonitoringSystem was subjected to teststo electromagnetic,environmental, safety, andperformance testing procedures.These tests verified theoperation of the device. Thesoftware validation tested theoperation of the softwarefunction of the device. Theresults confirmed that the deviceperformed within specifications | to integrate the SmartCable NMT Module andAccessories.The Life Scope BSM-3000 Series BedsideMonitoring Systems wassubjected to tests toelectromagnetic,environmental, safetyand performance testingprocedures. These testsverified the operation ofthe device. Thesoftware validationtested the operation ofthe software function ofthe device. The resultsconfirmed that thedevice performed withinspecifications. Noclinical tests have beensubmitter, referenced orrelied on in thepremarket notificationsubmission for adetermination ofsubstantial equivalence. | The Nihon KohdenCSM-1901 BedsideMonitor wassubjected to tests toelectromagnetic,environmental,safety, andperformance testingprocedures. Thesetests verified theoperation of thedevice. Thesoftware validationtested the operationof the softwarefunction of thedevice. The resultsconfirmed that thedevice performedwithinspecifications. | |
| Summary ofSubstantialEquivalence | The Life Scope BSM-6000Series is equivalent to the LifeScope BSM- 6000 Series. Theindications for Use have beenupdated to include the interfacewith other external devices. TheBSM-6000 and the BSM-6000Bedside Monitoring System canmeasure oxygen concentration,the BSM-6000 when connectedto an external device, can alsomeasure fractionated oxygen. | The Life Scope BSM-3000 Series BedsideMonitoring System isequivalent to the LifeScope BSM- 6000Series BedsideMonitoring System, theonly difference is thatthe indications for Usehave been updated toinclude the interfacewith other externaldevices. | The Nihon KohdenCSM-1901 BedsideMonitor isequivalent to theNihon KohdenCSM-1901 BedsideMonitor. Therehave been nochanges on theindications for use.The software wasupdated toincorporate theSmart Cable NMTModule andAccessories. |
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§ 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).