(108 days)
Not Found
No
The document describes standard physiological monitoring and data acquisition, with no mention of AI or ML technologies for analysis or interpretation.
No
The primary function of the devices described (Smart Cable NMT Module, Life Scope BSM-6000 Series, Life Scope CSM-1901, Life Scope PT BSM-1700 Series, and AY Series) is monitoring, displaying, and recording physiological data, not providing therapy. While they assist in determining the dose of muscle relaxants or anesthetics, they do not administer treatment themselves.
No
This device is described as a "Bedside Monitoring System" intended to monitor, display, and record physiological data. While it collects and displays various physiological parameters, its primary function is monitoring, not diagnosing conditions or diseases.
No
The device description clearly outlines hardware components such as the NMT Module, Main Cable, Holder, EMG Electrode, and the connection to bedside monitoring systems which are also described as hardware devices. While software is involved in processing and displaying data, the device is not solely software.
Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics). Here's why:
-
IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
-
Device Descriptions: All the devices described (Smart Cable NMT Module, Life Scope BSM-6000 Series, Life Scope CSM-1901, Life Scope PT BSM-1700 Series, and AY Series) are intended for direct patient monitoring of physiological signals (electrical impulses, blood pressure, oxygen saturation, temperature, etc.). They acquire data directly from the patient's body, not from in vitro examination of specimens.
Therefore, these devices fall under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of:
AF-201P NMT Module with Smart Cable Disposable Electrodes Main cable Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
Life Scope® BSM-6000 Series Bedside Monitoring Systems:
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® CSM-1901 Bedside Monitoring Systems:
The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane.
The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.
The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® PT BSM-1700 Series and Accessories:
The Life Scope® PT BSM-1700 Series Beside Monitor and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series has both an input and transport/standalone mode. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits or when disconnected from the core unit of the input unit can be removed from one core unit and connected to another device's core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device by using with or with or without WLAN technology. In standalone mode, the device does not require a core unit. The BSM-1700 Series can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). When the BSM-1700 Series is used in transport or standalone mode, the following can be analyzed and displayed: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS).
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
AY Series and Accessories:
AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems.
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.
Product codes
KOI, MHX
Device Description
The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical persomel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, or intensive care unit. NMT Module is a system comprised of NMT Module. Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via Main Cable. The electrode is a single-use electrode array, and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode. TheNMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. The captured 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 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 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 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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
Patient Age: ALL ages
12 Lead Interpretation: 3 Years and older
Intended User / Care Setting
medical personnel in clinical settings
medical personnel in the operating room, or intensive care unit
medical personnel on patients within a medical facility
trained medical personnel within a medical facility
health professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, en vironmental, sa fety, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2022
Nihon Kohden Corporation % Sunita Teekasingh Principal Regulatory Consultant - GSA2 Group LLC Nihon Koden America, Inc 15353 Barranca Parkway Irvine, California 92618
Re: K220976
Trade/Device Name: Life Scope PT BSM-1700 Series Bedside Monitor Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI Dated: June 14, 2022 Received: June 16, 2022
Dear Sunita Teekasingh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220976
Device Name
Smart Cable NMT Module and Accessories; Life Scope® BSM-6000 Series Bedside Monitoring Systems; Life Scope® CSM-1901 Bedside Monitoring Systems; AY Series And Life Scope® BSM-1700 Series PT Bedside Monitor
Indications for Use (Describe)
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of:
AF-201P NMT Module with Smart Cable Disposable Electrodes Main cable Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
Life Scope® BSM-6000 Series Bedside Monitoring Systems:
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® CSM-1901 Bedside Monitoring Systems:
The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane.
The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.
3
The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Life Scope® PT BSM-1700 Series and Accessories:
The Life Scope® PT BSM-1700 Series Beside Monitor and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series has both an input and transport/standalone mode. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits or when disconnected from the core unit of the input unit can be removed from one core unit and connected to another device's core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device by using with or with or without WLAN technology. In standalone mode, the device does not require a core unit. The BSM-1700 Series can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). When the BSM-1700 Series is used in transport or standalone mode, the following can be analyzed and displayed: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS).
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AY Series and Accessories:
AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems.
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/1 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. The text is in a sans-serif font and is slightly blurred.
510(k) Summary
1 GENERAL PROVISIONS
| ADMINISTRATIVE INFORMATION | |
|---|---|
| Sponsor | Nihon Kohden Corporation |
| 1-31-4 Nishiochiai, Shinjuku-Ku | |
| Tokyo, Japan 161-8560 | |
| Initial Importer | Nihon Kohden America |
| 15353 Barranca Parkway | |
| Irvine, CA | |
| Primary Contact/Official | |
| Correspondent | Sunita Teekasingh RN, BSN, CCRN, MSc |
| GSA2 Group LLC | |
| Mobile: 612-814-7999 | |
| Email: Sunita_Teekasingh@nihonkohden.com | |
| Secondary Contact/Company | |
| Representative | Sandra Gadeyne, MBA, ASQ-CQA |
| Sr. Director, Quality Assurance and Regulatory Affairs | |
| 15353 Barranca Parkway | |
| Irvine, CA | |
| Office Phone: 949-268-7708 | |
| Mobile Phone: 949-356-3401 | |
| Email: Sandra_Gadeyne@nihonkohden.com | |
| SUBMISSION INFORMATION | |
| Submission Type | Specia1510(k) |
| Product Names | Life Scope® PT BSM-1700 Series Bedside Monitor and Accessories |
| Life Scope® BSM-6000 Series Bedside Monitoring Systems | |
| Life Scope® G5 Series Bedside Monitoring Systems | |
| Life Scope® G7 Series Bedside Monitoring Systems | |
| Life Scope® CSM-1901 Bedside Monitoring Systems | |
| AY Series and Accessories, Data Acquisition Unit | |
| Smart Cable™ NMT Module and Accessories | |
| Common Names | Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor |
| Stimulator, Nerve, Peripheral, Electric | |
| Classification | Class II |
| Predicate 510(k) | K213316 |
| Product Code | KOI |
| Primary Product Code | |
| KOI Products | KOI: |
| Smart Cable™ NMT Module and Accessories | |
| Secondary Product Code | |
| MHX Products | MHX: |
| Life Scope® BSM-6000 Series Bedside Monitoring Systems | |
| Life Scope® G5 Series Bedside Monitoring Systems | |
| Life Scope® G7 Series Bedside Monitoring Systems | |
| Life Scope® CSM-1901 Bedside Monitoring Systems | |
| AY Series and Accessories, Data Acquisition Unit | |
| Life Scope® PT BSM-1700 Series and Accessories | |
| Submission Basis | Labeling Modification to Nihon Kohden's legally authorized device: Life Scope® PT BSM-1700 Series Bedside Monitor |
| Submission Date | 1 June 2022 |
6
2 KOI: SMART CABLE NMT MODULE AND ACCESSORIES
The Smart Cable NMT Module and Accessories were previously cleared under K213316. This system requires a compatible monitoring system for the MMT Module to work. There has been no modification to the Smart Cable NMT Module's intended Use, safety or performance to as a result of the inclusion of standalone for the BSM-1700 Series la beling update.
2.1 Device Description
The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical persomel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, or intensive care unit. NMT Module is a system comprised of NMT Module. Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via Main Cable. The electrode is a single-use electrode array, and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode. TheNMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. Thecaptured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are a lso sent to the monitoring system to display.
The AF-201P NMT Module is used to control the electrical stimulation and to measure theresponse. The operational setting is controlled via buttons on the module or a touch screen.
2.2 Indications for Use/Intended Use
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of :
- AF-201P NMT Module with Smart Cable •
- Disposable Electrodes
- Main cable .
- Holder (optional) .
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are a vailable by prescription only.
2.3 Equivalent device
There ha ve been no modifications the Smart Cable NMT Module and Accessories in this submission and this device is the equivalent to the device presented under K213316.
2.4 Performance Results
The device performance and software have not changed from the original submission K213316.
2.5 Summary
Based on the intended use, product, performance and software information provided in this notification, the subject devicehas been shown to be substantially equivalent to the currently marketed predicate devices.
3 MHX:BSM-6000 Series
There are no changes to the Life Scope® BSM-6000 from K2 133 16.
7
3.1 Device Description:
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardial signs monitoring within a medical facility. The device is intended to produce a visualrecord of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is a lso intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non- invasive blood
pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired a nesthetic a gents and a nesthetic gases including CO2, O2, N2O, Halothane, Isoflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920R A Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and a larms from the external devices. Supported external devices include AG-920RA Anestheic Agent Detection System, Ventilators, CO2 Monitors, BIS Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The devicemay generate anaudible and or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signa ls via radio frequency. The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
| Compatible Parent Bedside Monitoring Configurations | |||
|---|---|---|---|
| Core Unit | Input Model | Multi- | |
| Connector | Spo2 Probe | ||
| Life Scope® BSM-6000 | |||
| Series Bedside | |||
| Monitoring Systems | AY-631P | 1 | Masimo |
| AY-633P | 3 | ||
| BSM-1733 | 3 | ||
| AY-651P | 1 | Nellcor | |
| AY-653P | 3 | ||
| BSM-1753 | 3 | ||
| AY-661P | 1 | ||
| AY-663P | 3 | ||
| BSM-1763 | 3 | Nihon Kohden | |
| AY-671P | 1 | ||
| AY-673P | 3 | ||
| BSM-1773 | 3 | ||
| Data | |||
| Acquisition | |||
| Unit | JA 690PA | N/A | N/A |
| JA-694PA | 4 | N/A |
Table 1: Compatible Input Unit and Core Units
3.2 Indications For Use/Intended Use
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, andrecord physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to genera te visible and/or audible alarms when an arrhythmia ex ists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired a nesthetic a gents and a nesthetic gases including N2O , Halothane, I soflurane, En flurane and Desflurane.
The device may generate an audible and/or visual a larm when a measured rate falls outside preset limits. The device may a lso be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and wa veform data and a larms from theexternal devices.
8
K220976 Nihon Kohden BSM-1700 Series- Special 510(k)
Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detectionsystem, Anesthesia machine, Ventilators, CCO monitors, CCO/SvO2 Monitors, EEG monitoring device, tc PO2/tcPCO2 monitors, rSO2 monitors and external devices which output analog voltage signal. The device will be a vailable for use by medical personnel on patients within a medical facility on all pa tient populations.
The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
3.3 Equivalent device
There ha ve been no modifications the Life Scope® BSM-6000 Series in this submission and this device is the equivalent to the device presented under K213316.
3.4 Performance Results
The device performance and software have not changed from the original submission K213316.
3.5 Summary
Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
3.6 Summary
Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
MHX: LIFE SCOPE® CSM-1901 BEDSIDE MONITORING SYSTEMS ব
There have been no modifications to the Life Scope® CSM-1901 as a result of the standalone mode on the BSM-1700 Series. The technological, Safety and Performance is the same o the previous submission K213316.
4.1 Device Description
The Life Scope® CSM-1901 Bedside Monitoring Systems which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU. HCU. NICU and an emergency room. These systems are placed near the patient and is intended to display patient's vital signs. These systems can also be connected to other external patient monitoring devices. In a ddition, these systems can communicate patient's data to a central monitoring station via network to monitor multiple patients.
The input unit is common to NK parent devices that require both a core unit and input unit. NK manufactures the input units with three (3) SpO2 options. The Life Scope® CSM-1 901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data a cquisition unit is required to transmit data from the input unit to the core unit.
The bedside monitoring systems require both a coreunit and an input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.
Table 2:Compatible Input Unit and Core Units
| Compatible Parent Bedside Monitoring Configurations | |||
|---|---|---|---|
| Core Unit | Input Model | Multi-Connector | SpO2 Probe |
| AY-631P | 1 | Masimo |
9
| Life Scope® CSM-1901 | AY-633P | 3 | |
|---|---|---|---|
| Bedside Monitoring | BSM-1733 | 3 | |
| Systems | AY-651P | 1 | Nellcor |
| AY-653P | 3 | ||
| BSM-1753 | 3 | ||
| AY-661P | 1 | Nihon Kohden | |
| AY-663P | 3 | ||
| BSM-1763 | 3 | ||
| AY-671P | 1 | ||
| AY-673P | 3 | ||
| BSM-1773 | 3 | ||
| Data Acquisition Unit | Multi-Connector | SpO2 Probe | |
| JA 690PA | N/A | N/A | |
| JA-694PA | 4 | N/A |
4.2 Indications for Use/Intended Use
The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia ex ists.
The device is a lso intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired a nesthetic a gents and a nesthetic gases including N2O, halothane, isoflurane, en flurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, CCO/SvO2 monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a mea sured rate falls outside preset lim its.
The device will be a vailable for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
4.3 Equivalent device
There have been no modifications the Life Scope® CSM-1901 and Accessories in this submission and this device is the equivalent to the device presented under K213316.
4.4 Performance Results
The device performance and software have not changed from the original submission K2 133 16.
4.5 Summary
Based on the intended use, product, performance and software information provided in this notification, the subject devicehas been shown to be substantially equivalent to the currently marketed predicate devices.
5 MHX: AY SERIES AND ACCESSORIES
5.1 Device Description
The AY Series Input unit is used with the monitoring systems platforms, when connected to the core unit of the parent device, the inputunit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
10
5.2 Indications for Use/Intended Use
AY Series and Accessories are intended to a cquire and transfer electrical impulses from the patient to the core unit of the device. The inputunit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (ImpResp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration(CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit a dds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems.
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
5.3 Equivalent device
There ha ve been no modifications the AY Series and Accessories in this submission and this device is the equivalent to the device presented under K213316.
5.4 Performance Results
The device performance and software have not changed from the original submission K213316.
ર .5 Summarv
Based on the intended use, product, performance and software information provided in this notification, the subject devicehas been shown to be substantially equivalent to the currently marketed predicate devices.
6 MHX:BSM-1700 SERIES BEDSIDE MONITOR
Forthis submission the BSM-1700 Bedside Monitor la s been updated to include the standalone mode. There are no specification changes, technological changes or sa fety and Performance claims. The indications for use and labeling have been updated to include the standalone mode
6.1 Device Description
The BSM-1700 Series Bedside Monitor is a multifunctional device used as an input unit, transport/standalone monitor.
· Input unit for other monitoring systems platforms, when connected to the core unit of the parent device, the input unit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
· When the patient needs to be transported, the BSM-1700 Series can be removed from the core unit, transport mode can be enabled and can be used with or without WLAN. When WLAN is enabled real time data viewing on the Nihon Kohden network or if it is disabled the BSM-1700 Series will display monitoring data and store the review data.
• When the device is removed from the coreunit it functions as a standalone or independent monitoring system.
The BSM-1700 Series has a display monitor that is disabled when connect to a core unit. Each monitor has a cobr display and is intended for one patient. When used as an inputunit with the coreunit, the system monitors a dvanced parameters. The intended populations are all patient populations under the care of health professionals.
In all modes, the BSM-1700 Series uses the Smart Cable technology that is used to connect to other accessories used to collect electrical impulses. The BSM-1700 Series interprets the electrical impulses from the patient's body. When connected to a core unit, advanced calculations can be achieved. The device may generate a naudible and/or visual a larm when a measured rate falls outside preset lim its
11
When the inputunit is connected to a core unit calculates and displays the electrical impulses.
| BSM-1700 Series with Core Units | |||
|---|---|---|---|
| Core Units | Input Model | Configuration | |
| Multi-Connector | SpO2 Probe | ||
| Life Scope® BSM 6000 | |||
| Series Bedside Monitoring | |||
| Systems (K213316) | BSM-1733 | 3 | Masimo |
| Life Scope® CSM-1901 | |||
| Series Bedside Monitoring | |||
| Systems (K213316) | BSM-1753 | 3 | Nellcor |
| Life Scope® G5 Series | |||
| Bedside Monitoring Systems | |||
| (K203435) | BSM-1763 | ||
| BSM-1773 | 3 | Nihon Kohden | |
| Life Scope® G7 Series | |||
| Bedside Monitoring Systems | |||
| (K203435) | |||
| Data Acquisition Unit Life | |||
| Scope® CSM-1901 Bedside | |||
| Monitoring Systems | |||
| (K213316) | JA 690PA | ||
| JA-694PA | N/A | Unit only used with | |
| CSM-1901 and BSM- | |||
| 6000 | |||
| 4 |
Table 3 BSM-1700 Serieswith Compatible Core Units
As an input unit, the device can interface with external accessories to display numerical and wa veform data and a la rms from the external a ccessories. The Core unit supports external devices including CO2 monitors, BIS monitors. Anesthetic agents/gases detection system. Anesthesia machine. Ventilators. CCO monitors. TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors andexternal devices which output analog voltage signal.
When used as an inputunit, the device can be removed from the core unit, and transport mode can be enabled. The device in transport mode can be used with or without WLAN is enabled, real time data can be seen on the Nihon Kohden network monitors. When WLAN is disabled, the BSM-1700 Series will display the monitoring data and store the review data. When used in a transport/standalone mode, the device can store the review data while transferring the patient. The review data can be transmitted via a direct network connection when the device is connected to a host monitor. When used in transport/standalone mode, the following can be analyzed and displayed: Electrocardiogram(ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP). Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS).
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
Table 4: Predicate Device Comparison
12
| | Subject Device: Life Scope BSM-1700
Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System
K213316- | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | | Input Unit and Transport Mode | |
| Intended Use/
Indications for Use | The Life Scope® PT BSM-1700 Series
Bedside 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
device. 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 to another device by using 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 (NIBP), 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. | The Life Scope® PT BSM-1700
Series and Accessories are intended
acquire and transfer electrical
impulses from the patient to the main
unit of the device. The BSM-1700
Series input unit monitors
physiological data and may generate
an audible and/or visual alarm when
a measured rate falls outside preset
limits when disconnected from the
core unit of the device. The input unit
can be removed from one core unit
and connected to another devices
core unit. The Life Scope® PT BSM-
1700 Series can be used in transport
mode where data is transferred from
one device to another device by using
with or without WLAN technology.
The input unit can acquire the
following parameter signals:
Electrocardiogram (ECG),
Impedance respiration (Imp Resp),
Non-invasive blood pressure (NIBP),
Arterial oxygen saturation (SpO2),
Carbon dioxide concentration (CO2),
Invasive blood pressure (IBP),
Temperature (Temp), Cardiac Output
(CO), TOF and Bispectral Index
(BIS).
The Data Acquisition Unit (DAU) is
an optional accessory. The DAU is
used to communicate between the
compatible parent core unit and the
input unit using connection cables.
The 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. | |
| | Subject Device: Life Scope BSM-1700
Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System
K213316-
Input Unit and Transport Mode | |
| Compatible Core Unit
Options: requires Input
Unit | Life Scope® BSM-6000 Bedside Monitoring
Systems; Life Scope® CSM-1901 Bedside
Monitoring Systems; Life Scope® G5 Series
Bedside Monitoring System, Life Scope® G7
Series Bedside Monitoring System. | Same | |
| BSM-1700 Touchscreen
Display | Disabled | Same | |
| Measuring Parameters as
a Bedside Monitoring
System
(Core unit + Input Unit) | 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). | Same | |
| Touchscreen Display | Default to Core unit Monitor | Same | |
| Resolution | Default to Core unit Monitor Resolution | Same | |
| | System Configuration - Transport mode/Standalone Mode only | | |
| BSM-1700 Touchscreen
Display | Enabled | Same | |
| BSM-1700 Resolution | 640 x 480 | Same | |
| Number Of Traces in | 9 | Same | |
| transport/standalone | 12 (when 12 leads ECG is displayed) | | |
| Waveform Display | Electrocardiogram (ECG),
Impedance respiration (Imp Resp),
Non-invasiveblood pressure (NIBP),
Arterial oxygen saturation (SpO2),
Carbon dioxide concentration (CO2),
Invasiveblood pressure (IBP),
Temperature (Temp), Cardiac Output (CO),
and Bispectral Index (BIS). | Same | |
| | Functions - Transport mode/Standalone Modeonly | | |
| Trace Movement | Fixed | Same | |
| Numeric Data Display | Heart Rate, Pulse Rate, VPC rate, ST level
(12 leads), Respiration Rate, NIBP
(sys/dia/mean), Temperature (2), SpO2,
EtCO2, FiCO2, Cardiac output,
BIS, IBP (3) (sys/dia/mean) | Same | |
| Alarm Display | Alarm sound, highlighted alarm display,
alarm lamp | Same | |
| Alarm Suspend/ Silence
Function | Yes | Same | |
| | ECG- All Modes | | |
| Number Of ECG
Electrodes | 3, 6 or 10 | Same | |
| Defibrillation Discharge
Protection | Yes | Same | |
| | | Subject Device: Life Scope BSM-1700
Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System
K213316- |
| | | | Input Unit and Transport Mode |
| | Electrosurgery Interface
filter | Yes | Same |
| | Pacing detection | Yes | Same |
| | Heart Rate Counting
Method | Average, instantaneous
(Beat to beat) | Same |
| | Heart Rate Counting
Range | 0, 15 to 300 bpm | Same |
| | Counting Accuracy | $\pm$ 2 bpm | Same |
| | Alarm Limits:
Upper
Lower | 16 to 300 bpm, OFF
15 to 299 bpm, OFF | Same |
| | ST Level Measuring
Range | -2.5 to +2.5 mV | Same |
| | QRS Sync Tone | Yes | Same |
| | Detection Method | Multi-template software algorithm multi-
lead analysis | Same |
| | VPC Counting Range | 0 to 99 per min | Same |
| | Arrhythmia Alarm | Yes | Same |
| | Arrhythmia Recall | Yes | Same |
| | Number of Arrhythmia
Recall files as input unit | Defaults to core unit | Defaults to core unit |
| | Number Of Arrhythmia
Recall Files in
transport/standalone
mode | 32768 items, 72hours (Standalone Mode)
8192 items, 24hours (Transport Mode) | 8192 items, 24hours (Transport
Mode) |
| | | Respirations- All modes | |
| | Respiration | Yes | Same |
| | Respiration Rate
Display | 0 to 150 bpm | Same |
| | Alarm Limits:
Upper
Lower | 2 to 150 bpm, OFF
0 to 148 bpm, OFF | Same |
| | No breath time Limit | 5 to 40 seconds, OFF | Same |
| | Waveform Display | Yes | Same |
| | Connector Insertion
Detection | Yes | Same |
| Apnea Detection | | Yes | Same |
| | | SpO2 - All modes | |
| | Probe Type | Nihon Kohden, Nellcor (NL) or Masimo
(MS) | Same |
| | Displayed Range, | 0 to 100% | Same |
| N
K | Declared Range,
NK
type and Accuracy
with sensor | 70 to 100% (with sensor)
80 to 100% $\pm$ 2 %SpO2
70 to 80% $\pm$ 3 %SpO2 | Same |
| | | Subject Device: Life Scope BSM-1700 Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System K213316-
Input Unit and Transport Mode |
| | | | |
| N | Displayed Range,
Declared Range,
NL type and
Accuracy with
sensor | 1 to 100%
70 to 100%
70 to 100% ± 2 digits(adult)
70 to 100% ±3 digits (neonatal) | Same |
| M | Displayed Range,
Declared Range,
MS type and
Accuracy with
sensor | 1 to 100%
no motion conditions
70 to 100% ± 2 digits(adult)
70 to 100% ±3 digits(neonatal) motion
condition
70 to 100% ±3 digits(adult)
70 to 100%±3 digits(neonatal) | Same |
| | Pulse Rate Count | Yes | Same |
| | Pulse Sync Tone | Yes | Same |
| | Audible Indication to
SpO2 Variation | Yes | Same |
| | SpO2 Alarm Limits:
Upper
Lower | 51 - 100%, OFF
50 - 99%, OFF | Same |
| | Pulse Rate Count Range: | 0, 30-300 bpm (NK)
0, 20-300 bpm (NL)
0, 25-240 bpm (MS) | Same |
| | | NiBP-All modes | |
| | Measuring Method | Oscillometeric | Same |
| | Pressure Data Display | Systolic, Diastolic, Mean, Cuff pressure | Same |
| | Measuring Range,
Adult/ Pediatric | 10 - 280 mmHg | Same |
| | Measuring Range,
Neonates | 10 - 140 mmHg | Same |
| | NIBP Measuring
Accuracy | ± 3 mmHg | Same |
| | Alarm Limits: Adult/
Pediatric
Upper
Lower | 15 - 260 mmHg, OFF
10 - 255 mmHg, OFF | Same |
| | Alarm Limits: Neonate
Upper
Lower | 15 - 140 mmHg, OFF
10 - 135 mmHg, OFF | Same |
| | | IBP | |
| | Measuring Method | Pressure transducer | Same |
| | Number Of Channels | Up to 3 | Same |
| | Measuring Range | -50 to 300 mmHg | Same |
| | Measuring Accuracy | ±1mmHg±1digit (-50 to 100 mmHg)
±1%±1 digit (100 to 300 mmHg) | Same |
| | Connector Insertion
Detection | Yes | Same |
| | Subject Device: Life Scope BSM-1700
Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System
K213316-
Input Unit and Transport Mode | |
| | | Same | |
| Alarm Limits: | | Same | |
| Upper | -48 - 300 mmHg, OFF | Same | |
| Lower | -50 - 298 mmHg, OFF | Same | |
| Pulse Svnc Tone | Yes | Same | |
| Pulse Rate Count Range: | 0, 30 - 300 bpm | Same | |
| | Temperature -All modes | | |
| Number of channels | Up to 2 | Same | |
| Measuring Range | 0 to 45°C | Same | |
| Display Units | °C or °F | Same | |
| Accuracy | ±0.1 °C (25 to 45°C)
± 0.2 °C (0 to 25°C) | Same | |
| Connector Insertion
Detection | Yes | Same | |
| Numeric Display | Yes | Same | |
| Alarm Limits: | | Same | |
| Upper | 0.1 to 45°C, OFF | Same | |
| Lower | 0 to 44.9ºC, OFF | Same | |
| | Carbon Dioxide-All modes | | |
| Measuring Method | Mainstream | Same | |
| Response Time | Depends on CO2 unit
160msec (TG-900P)
120msec (TG-920P/970P)
± 3 mmHg(0 to10mmHg),
± 4 mmHg(10 to 40mmHg),
± 10% reading (40 to 100mmHg)
±2 mmHg(0 to 40mmHg),
± 5% reading(40 to 70mmHg),
± 7% reading(70 to 100mmHg),
± 10% reading (100 to 150mmHg) | Same | |
| Alarm Limits, CO2: | | Same | |
| Upper | 2 to 99mmHg, OFF | Same | |
| Lower | 1 to 98 mmHg, OFF | Same | |
| Apnea Alarm Limits | 5 to 40 seconds, OFF | Same | |
| | Cardiac Output- All modes | | |
| Measuring Method | Thermodilution | Same | |
| Measuring Range:
Cardiac Output | 0.5 to 20 L/min | Same | |
| | Subject Device: Life Scope BSM-1700
Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System
K213316- | |
| | | Input Unit and Transport Mode | |
| Injection Temp.
Blood Temp. | 0 to 27 °C
15 to 45 °C | | |
| Accuracy:
Cardiac Output
Injection Temp.
Blood Temp. | ±5%
± 0.2 °C
± 0.2% (15 to 25 °C)
± 0.1% (25 to 45 °C) | Same | |
| Catheter Coefficient | Auto or Manual | Same | |
| Injection Temperature
Measurement Method | Temperature probe or inline sensor | Same | |
| Alarm Limits, Blood
Temp:
Upper
Lower | 15.1 to 45.0 °C, OFF
15.0 to 44.9 °C, OFF | Same | |
| | Network Connection | | |
| Central Station
Communications | Yes (Standard) | Same | |
| Communication Method | Ethernet
WLAN | Same | |
| | Others | | |
| ECG Output | Yes | Same | |
| IBP Output | Yes | Same | |
| Connector for
Transmitter | No | Same | |
| External Display
Connector | No | Same | |
| Serial Data Interface | No | Same | |
| Touchscreen | Yes | Same | |
| Alarm Indicator Lamp | Yes | Same | |
| Dedicated Function
Keys | Yes | Same | |
| Full Disclosure Storage | 72hours, 5 waves (Standalone Mode)
24hours, 5 waves (Transport Mode) | 24hours, 5 waves (Transport Mode) | |
| Trend Display Time | 1, 2, 4, 8, 24, 72* hours
(72 hours: Standalone Mode) | 1, 2, 4, 8, 24 hours | |
| Vital Sign List Interval | 1, 5, 10, 15, 30, 60 minute
NIBP list (Triggered by NIBP
measurement) | Same | |
| List Capacity | 72hours (Standalone Mode)
24hours (Transport Mode) | 24hours (Transport Mode) | |
| Recorder Type | Network printer | Same | |
| Battery Type | Li-ion (Option) | Same | |
| Number of batteries | 1 | Same | |
| Battery Operation Time | 5 hours | Same | |
| Charge time | 4.5 hours Typical | Same | |
| Acquisition and
Processing | Simultaneous Acquisition and Processing
for 12 Lead Development with Calculations
and Resting ECG Analyses | Same | |
| | Subject Device: Life Scope BSM-1700
Series Bedside Monitor
Input Unit and Transport/Standalone Mode | Predicate Device: BSM 1700 Series
Bedside Monitoring System
K213316-
Input Unit and Transport Mode | |
| ECG Interpretation
Program | ECAPS12C | Same | |
| 12 lead ST Analysis | Yes | Same | |
| Patient Age:
12 Lead Acquisition
12 Lead Interpretation | ALL ages
3 Years and older | Same | |
| Line Voltage | 100 to 240V | Same | |
| Power Consumption | 80VA | Same | |
| Operating Temperature | 10 to 40 deg C | Same | |
| Operating Relative
Humidity | 30 to 85% RH | Same | |
| Operating Atmospheric
Pressure | 70 to 106 kPa | Same | |
| Dimensions, mm (W, H,
D) | 147 x 194 x 94
(without the wireless LAN station)
147 x 210 x 94
(with the wireless LAN station) | Same | |
| Weight, kg (without
options) | 1.4 (without the battery and options)
1.57 (with the battery pack) | Same | |
| General Safety | IEC 60601-1:2005+Amd.1:2012
ANSI/AAMI/ES 60601-1:2005 (R2012) | Same | |
| EMC | IEC60601-1-2:2014 | Same | |
13
14
15
16
17
18
Technological Characteristics 6.2
There are no technological changes to the predicate devices. Both the predicate and the subject device measure the same functions.
6.3 Safety & Performance Tests
The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, en vironmental, sa fety, 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.
6.4 Summary of Substantial Equivalence
The Life Scope BSM 1700 Series Bedside Monitor is equivalent to the Life Scope BSM-1700 Series and Accessories. The indications for Use ha ve been updated to include the standalone mode.