(86 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions focus on standard physiological monitoring and electrical stimulation/response measurement.
No
The device is indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered and for monitoring and displaying physiological data, not for providing therapy.
Yes
The included devices (Smart Cable NMT Module, Life Scope BSM-6000 Series, Life Scope CSM-1901, and Life Scope PT BSM-1700 Series) are intended to monitor, display, and record physiological data, and in some cases, to generate alarms when measured rates fall outside preset limits or when an arrhythmia exists. This collection and interpretation of physiological data for health assessment and monitoring purposes falls under the definition of a diagnostic device. For example, the Smart Cable NMT Module "can assist medical personnel to quantitatively determine the level of muscle relaxation," and the Life Scope systems are stated to "monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility."
No
The device description explicitly states that the system is comprised of hardware components including the NMT Module, Main Cable, Holder, and EMG Electrode. It also describes the function of these hardware components in transmitting electrical stimulation and receiving EMG signals.
Based on the provided text, the devices described are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Device Function: The devices described (Smart Cable NMT Module and Accessories, Life Scope Bedside Monitoring Systems) are used for monitoring physiological data directly from the patient's body. They apply electrical stimulation to a nerve and measure the muscle's response (EMG), or they monitor vital signs like heart rate, blood pressure, oxygen saturation, etc. This is done in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
- Specimen Collection: There is no mention of collecting and analyzing specimens from the patient.
Therefore, these devices fall under the category of patient monitoring devices rather than 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 heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired anesthetic agents and anesthetic gases including N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors. TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® CSM-1901 Bedside Monitoring Systems
The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arthythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators. TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® PT BSM-1700 Series and Accessories
The Life Scope® PT BSM-1700 Series and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits when discomected from the core unit of the device. The input unit can be removed from one core unit and connected to another devices core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device to another device by using with or without WLAN technology. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS).
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The Reys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.
AY Series and Accessories
AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems.
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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-6000 Series Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, 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 system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
The Life Scope® CSM-1901 Bedside Monitoring Systems are 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 addition these systems can communicate patient's data to a central monitoring station via network to monitor multiple patients.
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.
Intended User / Care Setting
medical personnel in clinical settings
medical personnel in the operating room, recovery room, or intensive care unit
medical personnel on patients within a medical facility
trained medical personnel within a medical facility
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)
Software verification and validation testing were conducted, and documentation are provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Software verification and validation were conducted that included software unit testing, integration level testing, and systemlevel testing. A system test was also performed based on the software requirements specification. Testing to compliance standards for electrical and electromagnetic safety was also performed.
Electrical safety and electromagnetic compatibility (EMC) testing were conducted. The devices comply with the applicable requirements within the ANSI AAMI ES60601-1 / IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
The Life Scope® BSM-6000 Series Bedside Monitoring Systems incorporated all software changes in the integration testing. The testing confirmed the operation of the device when the Smart Cable NMT software was integrated into the system. The results confirmed that the device performed within specifications. No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence.
The Life Scope® CSM-1901 Bedside Monitoring Systems incorporated all software changes in the integration testing. The testing confirmed the operation of the device when the Smart Cable NMT software was integrated into the system. The results confirmed that the device performed within specifications. No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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December 29, 2021
Nihon Kohden Corporation % Sunita Teekasingh Sr. Regulatory Affairs Consultant - GSA2 Group LLC Nihon Kohden America. Inc 15353 Barranca Parkway Irvine, California 92618
Re: K213316
Trade/Device Name: Life Scope PT BSM-1700 Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI, MHX Dated: November 26, 2021 Received: November 29, 2021
Dear Sunita Teekasingh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213316
Device Name
Smart Cable™ NMT Module and Accessories; Life Scope® BSM-6000 Series Bedside Monitoring Systems; Life Scope® CSM-1901 Bedside Monitoring Systems; Life Scope ® PT BSM-1700 Series and AY Series And Accessories.
Indications for Use (Describe)
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of:
- · AF-201P NMT Module with Smart Cable
- · Disposable Electrodes
- · Main cable
- · Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only. ==============================================================================================================================================================================
Life Scope® BSM-6000 Series Bedside Monitoring Systems
The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired anesthetic agents and anesthetic gases including N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors. TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® CSM-1901 Bedside Monitoring Systems
The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arthythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2),
3
non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators. TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.
Life Scope® PT BSM-1700 Series and Accessories
The Life Scope® PT BSM-1700 Series and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits when discomected from the core unit of the device. The input unit can be removed from one core unit and connected to another devices core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device to another device by using with or without WLAN technology. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS).
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The Reys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AY Series and Accessories
AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems.
The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
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5
SECTION 5 510(K) SUMMARY OR 510(K) STATEMENT
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Image /page/6/Picture/1 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white abstract design on the left, followed by the text "NIHON KOHDEN" in blue. The text is in a sans-serif font and is slightly blurred.
| 5.1 | General Provisions | Manufacturer Name: | Nihon Kohden Corporation |
|---|---|---|---|
| Address: | 1-31-4 Nishiochiai, Shinjuku-Ku | ||
| Tokyo 161-8560, Japan | |||
| Submitter Name: | Nihon Kohden America | ||
| Address: | 15353 Barranca Parkway | ||
| Irvine, California, USA | |||
| 92618 | |||
| Primary Contact | Sunita Teekasingh | ||
| GSA2 Group LLC Consultant | |||
| Phone Number | 612-814-7999 | ||
| Sunita.Teekasingh@nihonkohden.com | |||
| Secondary Contact: | Sandra Gadeyne | ||
| Sr. Director of Quality and Regulatory Affairs | |||
| Phone Number | 949-268-7708 | ||
| Mobile Number: | 949-356-3401 | ||
| Sandra.Gadeyne@nihonkohden.com | |||
| Date of Preparation | 27-Dec-2021 | ||
| Submission Type | Special 510(K) | ||
| Type of Modification | Software Modification | ||
| Predicate | K201949 – cleared 2 May2021 | ||
| • Life Scope® BSM-6000 Series Bedside | |||
| Monitors; | |||
| • Nihon Kohden CSM-1901 Bedside Monitor |
5.2 INTRODUCTION
This submission is to obtain clearance for the software modification to the input units for Life Scope® PT BSM 1700 Series and A Y Series Input Units , see Table 5-1 for the summary. The input units required an updated software package to work with the Smart Cable NMT Module and Accessories (K201949).
The software modifications on the input units does not change the safety, performance of the predicate devices.
| Smart Cable
NMT Module
and Accessories
K201949 | Parent device Core Unit
software version | Input Unit Software version AY Series or
BSM-1700 Series |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AF-201P
Software
Version 3.0-
no changes to the
original software
under
K201949 | Life Scope®BSM-6000 Series
Bedside Monitoring Systems
(K201949) Software v08-31
Life Scope® CSM-1901
Bedside Monitoring Systems
(K201949) Software v01-32
Life Scope® BSM-3000 Series Bedside Monitors (K201949) Software v08-31 | AY Series v08-31
AY-631P
AY-633P
AY-651P
AY-653P
AY-671P
AY-673P
OR
BSM-1700 Series
v02-66
BSM-1733
BSM-1753
BSM-1773 |
7
In addition to the software changes, Nihon Kohden (NK) is updating the intended use for the Life Scope® BSM-6000 Series Bedside Monitoring Systems, and Life Scope® CSM-1901 Bedside Monitoring Systems:
- A statement was added to the parent devices to clarify these systems require both a core unit and an ● input unit.
- The Life Scope® PT BSM-1700 Input unit and the AY Series Input unit and accessories were added to the parent device intended use.
| Compatible Parent Bedside
| Monitoring Core Units | Input Model | Configuration | |
|---|---|---|---|
| Multi Connector | SpO2 Probe | ||
| Life Scope® BSM 6000 | |||
| Series Bedside Monitoring | |||
| Systems (K201949) | AY-631P | 1 | Masimo |
| AY-633P | 3 | ||
| BSM-1733 | 3 | ||
| Life Scope® CSM-1901 | |||
| Bedside Monitoring Systems | |||
| (K201949) | AY-651P | 1 | Nellcor |
| AY-653P | 3 | ||
| BSM-1753 | 3 | ||
| Life Scope® G5 Series | |||
| Bedside Monitoring Systems | |||
| (K203435) | AY-671P | 1 | Nihon Kohden |
| AY-673P | 3 | ||
| BSM-1773 | 3 | ||
| Life Scope® G7 Series | |||
| Bedside Monitoring Systems | |||
| (K203435) | |||
| Life Scope® CSM-1901 and | |||
| BSM-6000 Series Bedside | |||
| Monitoring Systems | |||
| (K201949) | |||
| Data Acquisition Unit | JA 690PA | N/A | Unit only used |
| with CSM-1901 | |||
| and BSM-6000 | |||
| JA-694PA | 4 |
Table 5-2: Parent Devices: Core Unit and Input unit configurations
- 5.3 SMART CABLE NMT MODULE AND ACCESSORIES
The Smart Cable NMT Module and Accessories were previously cleared under K201949, this system requires a compatible monitoring system for the NMT module to work. The input unit software has been updated to recognize the Smart Cable NMT Module connection. There have been no modifications to the Intended Use, safety or performance for Smart Cable NMT Module and Accessories as a result of the input unit software update.
8
| Subject Device | Trade Name: | Smart Cable NMT Module and Accessories |
|---|---|---|
| Common Name: | Electrical peripheral nerve stimulator | |
| Classification Name | Stimulator, Nerve, Peripheral, Electric | |
| Classification: | Class II | |
| Product Code: | KOI | |
| Regulation Number: | 21 CFR 868.2775 | |
| Predicate Device | Trade Name: | Smart Cable NMT Module and Accessories |
| Marketing Names: | NMT Smart Cable TOF Pod; Smart Cable NMT Pod, with EMG Support; NMT Pod TOF Pod; TOF Smart Pod; NMT Smart Pod, NMT Module, AF-201P, Smart Cable NeuroMuscular Transmission Pod, NMT Pod and Train of Four Pod, Disposable electrodes, EMG electrodes, NMT electrodes | |
| Classification Name: | Electrical peripheral nerve stimulator | |
| Premarket Notification | Stimulator, Nerve, Peripheral, Electric | |
| Product Code: | KOI | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 868.2775 | |
| Manufacturer: | Nihon Kohden | |
| 510K number: | K201949 | |
| Device Description | The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical personnel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, recovery room, or intensive care unit. | |
| 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. | ||
| Indication for Us and | ||
| Intended Use | The Smart Cable NMT Module and Accessories are indicated for | |
| monitoring the relaxation of the patient when neuromuscular blockades | ||
| are administered. | ||
| The Smart Cable NMT Module and Accessories are comprised of: | ||
| • AF-201P NMT Module with Smart Cable | ||
| • Disposable Electrodes | ||
| • Main cable | ||
| • Holder (optional) | ||
| The Smart Cable NMT Module and Accessories are intended to be | ||
| used as a system that requires Nihon Kohden compatible electrodes and | ||
| bedside monitoring systems. The Smart Cable NMT Module and | ||
| Accessories are intended for use by medical personnel in clinical | ||
| settings and are available by prescription only. | ||
| Modification | There are no changes to the Smart Cable NMT Module and | |
| Accessories as a result of the software update to the Life Scope® PT | ||
| BSM-1700 Series and or the AY Series input units. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | The device comparison and the results of the safety and performance | |
| tests indicate that the Nihon Kohden Smart Cable NMT Module and | ||
| Accessories is substantially equivalent to the predicate devices. |
9
- LIFE SCOPE® BSM-6000 SERIES BEDSIDE MONITORING SYSTEM 5.4
The intended Use for BSM-6000 was updated to include the statement "The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series".
The Life Scope® BSM-6000 Series Bedside Monitoring System, the input unit software has been updated to recognize the connection to the Smart Cable NMT Module and Accessories. There are no changes to the specifications or performance from the predicate device under K201949.
The Intended Use further clarifies the addition of Life Scope® BSM-1700 Series and the AY Series Input Units to BSM-6000 Intended Use is substantially equivalent to the predicate K201949.
10
| Subject Device | | Life Scope BSM-6000 Series Bedside
Monitoring Systems |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| | Trade Name: | |
| | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor and
Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| Predicate Device | | Life Scope BSM-6000 Series Bedside
Monitoring System |
| | Trade Name: | |
| | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor and
Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| | Manufacturer | Nihon Kohden |
| | 510(K): | K201949 |
| Device Description | The Life Scope BSM-6000 Series Bedside Monitoring Systems are
intended to monitor, display and record physiological data to provide
cardiac and vital signs monitoring within a medical facility. The device is
intended to produce a visual record of the electrical signals produced by the
heart and monitor the electrocardiogram to generate visible and/or audible
alarms when an arrhythmia exists. The device is also intended to monitor
heart rate, 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 system requires a BSM 6000 core unit with a compatible input unit:
AY Series or Life Scope® PT BSM-1700 Series. | |
11
| Table 5-3: Compatible Input Unit and Core units | ||||
|---|---|---|---|---|
| Compatible Parent Bedside Monitoring Configurations | ||||
| Core | ||||
| Units | 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-671P | 1 | Nihon Kohden | ||
| AY-673P | 3 | |||
| BSM-1773 | 3 | |||
| Life Scope® | ||||
| BSM-6000 | ||||
| Series | JA 690PA | N/A | Unit only used with | |
| BSM-6000 | ||||
| JA-694PA | 4 | |||
| Data | ||||
| Acquisition | ||||
| Unit | ||||
| The input units are common to NK parent devices that require both a core | ||||
| unit and an input unit. NK manufactures the input units with three (3) | ||||
| SpO2 options. The Life Scope® BSM-6000 Series (K201949) have an | ||||
| interchangeable input units that contains the MULTI socket ports. For | ||||
| larger monitoring systems is data acquisition unit is required to transmit | ||||
| data from the input unit to the core unit. | ||||
| The input unit interprets the electrical impulses from the patient's body and | ||||
| transfers this data into the core unit. 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. | ||||
| Proposed Indications | ||||
| for Use and Intended | ||||
| Use | 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, 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 |
12
| | 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 system requires a BSM-6000 core unit with a compatible input unit:
AY Series or Life Scope® PT BSM-1700 Series. |
|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Life
Scope® PT BSM-1700
Series and Accessories
Updated from the
Predicate device | 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. |
| Intended Use: AY
Series and Accessories
Updated from the
Predicate Device | 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 and the AY Series Input Units. |
| Modification | The input units software has been updated to work with the Smart Cable
NMT Module and Accessories. The indication for use was updated to
include a description of the input units and accessories. |
| Technological
Characteristics | The indications for use/intended use statement have been updated to include
the description of the input units and core units. There are no hardware
changes compared to the predicate devices. There has been software
updates to the input units to integrate with the Smart Cable NMT Module
and accessories. |
| Safety & Performance
Tests | The Life Scope® BSM-6000 Series Bedside Monitoring Systems
incorporated all software changes in the integration testing. The testing
confirmed the operation of the device when the Smart Cable NMT software
was integrated into the system. The results confirmed that the device
performed within specifications. No clinical tests have been submitted,
referenced or relied on in this premarket notification submission for a
determination of substantial equivalence. |
| Summary of
Substantial
Equivalence | The Life Scope® BSM-6000 Series Bedside Monitoring Systems are
equivalent to the Life Scope BSM-6000 Series (K201949). The indications
for use have been updated to include a description of the core unit and the
input units, the software verification and validation confirmed performance
and technological equivalency. |
13
LIFE SCOPE® CSM-1901 BEDSIDE MONITORING SYSTEM ર્સ્ટ
The intended Use for CSM-1901 was updated to include the statement, "The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series."
The Life Scope® CSM-1901 Bedside Monitoring System, the input unit software has been updated to recognize the connection to the Smart Cable NMT Module and Accessories. There are no changes to the specifications or performance from the predicate device under K201949.
The Intended Use further clarifies the addition of Life Scope® BSM-1700 Series and the AY Series Input unit and Accessories to CSM-1901 Intended Use. The Life Scope® CSM-1901 Bedside Monitoring System, Intended Use is substantially equivalent to the predicate K201949.
| Subject Device | Trade Name: | Life Scope CSM-1901 Bedside
Monitoring Systems |
|-------------------|---------------------|-----------------------------------------------------------------------------------------------------|
| | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor
and Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| Predicate Devices | Trade Name | Nihon Kohden CSM-1901 Bedside |
| | | Monitor |
| | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor
and Anesthesia Monitor |
14
| | Classification Name | | | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------|--------------------------------------------------------------------------------|--|
| | Classification: | | Class II | | |
| | Product Code: | MHX | | | |
| | Regulation Number: | | 21 CFR 870.1025 | | |
| | 510(K): | | K201949 | | |
| Device Description | The Life Scope® CSM-1901 Bedside Monitoring Systems are 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 addition
these systems can communicate patient's data to a central monitoring
station via network to monitor multiple patients. | | | | |
| Table 5-4: Compatible Input Unit and Core units | | | | | |
| Compatible Parent Bedside Monitoring Configurations | | | | | |
| | Core
Units | Input
Model | Multi
Connect
or | SpO2 Probe | |
| | Life Scope®
CSM-1901
(K201949) | AY-631P | 1 | Masimo | |
| | | AY-633P | 3 | | |
| | | BSM-1733 | 3 | | |
| | | AY-651P | 1 | Nellcor | |
| | | AY-653P | 3 | | |
| | | BSM-1753 | 3 | | |
| | | AY-671P | 1 | Nihon Kohden | |
| | | AY-673P | 3 | | |
| | | BSM-1773 | 3 | | |
| | Data
Acquisition
Unit Life
Scope® CSM-
1901
(K201949) | JA 690PA
JA-694PA | N/A | Unit only used with
CSM-1901 Data
Acquisition | |
| | | | | | |
| | | | | | |
| | 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-1901 Bedside Monitoring Systems have
interchangeable input units that contains the MULTI socket ports. For
larger monitoring systems is data acquisition unit is required to transmit
data from the input unit to the core unit. | | | | |
| | The bedside monitoring systems require both a core unit and an input unit
The input unit interprets the electrical impulses from the patient's body | | | | |
15
| one patient. The intended populations are all patient populations under the | ||
|---|---|---|
| care of health professionals. | ||
| Proposed Indications | ||
| for Use and 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 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, 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, | ||
| CCO/SvO2 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 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. | ||
| Intended Use: Life | ||
| Scope® PT BSM-1700 | ||
| Series and Accessories | ||
| UPDATED from the | ||
| predicate | 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. | ||
| Intended Use: AY | ||
| Series and Accessories | ||
| UPDATED from the | ||
| predicate | 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). | ||
| 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 and the AY Series Input Units. | |
| Modification | The input unit software has been updated to works with the Smart Cable
NMT Module and Accessories. The indication for use was updated to
include a description of the input units and accessories. | |
| Technological
Characteristics | The indications for use/intended use statement have been updated to
include the description of the input units and core units. There are no
hardware changes compared to the predicate devices. There has been
software update to the input units to integrate with the Smart Cable NMT
Module and accessories. | |
| Safety & Performance
Tests | The Life Scope® CSM-1901 Bedside Monitoring Systems incorporated all
software changes in the integration testing. The testing confirmed the
operation of the device when the Smart Cable NMT software was
integrated into the system. The results confirmed that the device performed
within specifications. No clinical tests have been submitted, referenced or
relied on in this premarket notification submission for a determination of
substantial equivalence. | |
| Summary of
Substantial
Equivalence | The Life Scope® CSM-1901 Bedside Monitoring Systems are equivalent to
the Nihon Kohden CSM-1901 Bedside Monitor. The indications for use
have been updated to include a description of the core unit and the input
units, the software verification and validation confirmed performance and
technological equivalent. | |
16
Software verification and validation testing were conducted, and documentation are provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Software verification and validation were conducted that included software unit testing, integration level testing, and systemlevel testing. A system test was also performed based on the software requirements specification. Testing to compliance standards for electrical and electromagnetic safety was also performed.
Electrical safety and electromagnetic compatibility (EMC) testing were conducted. The devices comply with the applicable requirements within the ANSI AAMI ES60601-1 / IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
ર્ડદર્
17
| No. | Standard |
|---|---|
| 1. | EN/ISO 14971:2012 Medical Devices - Application of Risk Management to |
| Medical Devices | |
| 2. | IEC 60601-1: 2005+Amd.1:2012 Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance. | |
| 3. | ANSI/AAMI/ES 60601-1:2005 (R2012) with amendments |
| Medical electrical equipment - Part 1: General requirements for basic safety and | |
| essential performance (IEC 60601-1:2005, MOD) | |
| (Consolidated Text) (includes ES60601-1:2005/(R)2012 and A1:2012, | |
| C1:2009/(R)2012 and A2:2010/(R)2012) | |
| 4. | IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| 5. | IEC 60601-2-40:2016 Medical electrical equipment - Part 2-40: Particular |
| requirements for the basic safety and essential performance of electromyographs and | |
| evoked response equipment. | |
| 6. | IEC60601-1-6: 2010+Amd.1:2013 Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential performance - Collateral standard: | |
| Usability. | |
| 7. | ISO10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and |
| testing within a risk management process | |
| 8. | IEC62366:2007+Amd. 1 2014 Amendment 1 - Medical devices - Application of |
| usability engineering to medical devices | |
| 9. | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION - Medical device |
| software – Software life cycle processes |
The software input units modifications and labeling modification do not raise different questions of safety and effectiveness when compared to the predicate devices perform as intended, and have the same performance characteristics and are substantially equivalent to the predicate devices under K201949.
5.7