Nihon Kohden CSM 1901 Bedside Monitor

K151080 · Nihon Kohden · MHX · Nov 5, 2015 · Cardiovascular

Device Facts

• Record ID: K151080
• Device Name: Nihon Kohden CSM 1901 Bedside Monitor
• Applicant: Nihon Kohden
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, enflurane, 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.

Device Story

Bedside monitor for continuous physiological data acquisition; inputs include ECG, SpO2, NIBP, IBP, temperature, BIS, CO, FiO2, CO2, EtCO2, respiratory rate, and anesthetic gases; integrates data from external ventilators, TOF monitors, and EEG units. Device processes signals to display vital signs, generate arrhythmia alarms, and record data; communicates with central monitoring stations via network. Used in OR, recovery, ICU, CCU, HCU, NICU, and emergency rooms by trained medical personnel. Output provides real-time visual/audible alerts and patient data displays; assists clinicians in monitoring patient status and making timely clinical interventions; benefits include continuous surveillance and early detection of physiological instability.

Clinical Evidence

Bench testing only. Evidence includes software unit testing, integration testing, system verification (GUI), and system validation testing. Compliance demonstrated against ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, and specific collateral standards for ECG (60601-2-27), IBP (60601-2-34), respiratory gas (60601-2-55), temperature (60601-2-56), and pulse oximetry (60601-2-61).

Technological Characteristics

Bedside physiological monitor; networked connectivity to central station; supports external device integration (ventilators, EEG, TOF). Standards: ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2007, IEC 60601-1-8:2012, IEC 60601-2-27:2011, IEC 60601-2-34:2011, IEC 60601-2-55:2011, IEC 60601-2-56:2009, IEC 60601-2-61:2009. Features enhanced display resolution, increased trace capacity, and expanded arrhythmia recall storage.

Indications for Use

Indicated for cardiac and vital signs monitoring in medical facilities for all patient populations, including neonates, infants, children, adolescents, and adults.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• BSM-9100A Series Bedside Monitor (K082785)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2015

Nihon Kohden % Al Pacheco Sr. Quality Engineer Certified Compliance Solutions, Inc. 11665 Avena Place, Suite 203 San Diego, California 92128

Re: K151080

Trade/Device Name: Nihon Kohden CSM-1901 Bedside Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX Dated: October 6, 2015 Received: October 7, 2015

Dear Al Pacheco:

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. 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.

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K151080

Device Name Nihon Kohden CSM-1901 Bedside Monitor

#### Indications for Use (Describe)

The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, enflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit.

The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary for Nihon Kohden CSM-1901 Bedside Monitor

| Submitter: | Nihon Kohden Corporation |
|-----------------|---------------------------------------------------------------------|
| Address: | 1-31-4 Nishiochiai, Shinjuku-ku<br>Tokyo, JAPAN 161-8560 |
| Phone number: | [phone] x3324 |
| Fax number: | [phone] |
| Contact person: | Tom Bento |
| Phone number: | [phone] x3324 |
| Fax number: | [phone] |
| Date prepared: | October 2, 2015 |
| Device name: | Nihon Kohden CSM-1901 Patient Monitor |
| Common name: | Monitor Physiological Patient (with Arrhythmia Detection or Alarms) |
| Product Code: | MHX |
| Regulation: | 21 CFR 870.1025 |

Substantial equivalence claimed to: K082785 BSM-9100A Series Bedside Monitor

#### Description:

The Bedside monitor CSM-1901 is a device which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU, HCU, NICU and an emergency room. This bedside monitor is placed near the patient and is intended to display patient's vital signs. This device can also be connected to other external patient monitoring devices. In addition, this device can communicate patient's data to a central monitoring station via network to monitor multiple patients.

#### Indications for Use:

The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or 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, 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.

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## Technological Characteristics - Substantial Equivalence Discussion

The Nihon Kohden CSM-1901 Bedside Monitor is substantially equivalent to the predicate Device, the Nihon Kohden BSM-9100A Bedside Monitor. Differences between the devices are minor and do not raise questions regarding safety or efficacy. These differences include:

- The CSM-1901 includes an interface to the AE-918P EEG monitor Neuro Unit ●
- . The CSM-1901 has modified the ECG display sensitivity including x8 sensitivity and deleting the x4 sensitivity setting
- The CSM-1901 has increased storage capacity for Arrhythmia Recall Files
- The CSM-1901 has added pulse rate display with NIBP data
- . The CSM-1901 has enhanced display features including improved resolution, increased number of traces, increased number of sweep speeds, and the addition of a moving trace capability

#### Test Summary

Performance testing for the Nihon Kohden CSM-1901 Bedside Monitor includes software unit testing, system validation testing, and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between all system specifications to validation test protocols.

Standards testing includes:

- 1. ANSI/AAMI ES 60601-1:2005/(R)2012 and A1 2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- 2. IEC 60601-1-2: 2007-03 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- 3. IEC 60601-1-8:2012-11 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- 4. IEC 60601-2-27:2011-03 Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- 5. IEC 60601-2-34:2011-03 Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- 6. IEC 60601-2-55:2011-12 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- 7. IEC 60601-2-56:2009-10 Medical electrical equipment Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement
- 8. IEC 60601-2-61:2009-10 Medical electrical equipment Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment

Verification and validation testing includes:

- 1. Software unit testing
- 2. Integration test (functional testing)
- 3. System verification test (GUI test)
- 4. System validation test

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### Conclusion:

The performance of the Nihon Kohden CSM-1901 Bedside Monitor is substantially equivalent to the predicate Device, the Nihon Kohden BSM-9100A Bedside Monitor and raises no safety or effectiveness issues and performs as well or better than the predicate device.