NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES

K080342 · Nihon Kohden America, Inc. · MHX · Feb 26, 2008 · Cardiovascular

Device Facts

• Record ID: K080342
• Device Name: NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (CNIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2) and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on patients within a medical facility on all patient populations.

Device Story

BSM-6000 Series Bedside Monitor provides continuous physiological monitoring in medical facilities. Inputs include ECG leads, SpO2 probes, NIBP cuffs, IBP transducers, temperature probes, and gas/agent sensors (via AG-920RA). Device processes electrical signals and sensor data to display waveforms and numerical values; performs arrhythmia detection; triggers audible/visual alarms for out-of-limit measurements. Operated by medical personnel. Supports external device interfacing (ventilators, BIS, CCO/SvO2 monitors). Enables clinical decision-making through real-time patient status visualization and alarm notification. Benefits include continuous patient surveillance and early detection of physiological instability.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through electromagnetic, environmental, safety, and performance testing procedures per IEC-60601-1 and 21 CFR 868. Software validation confirmed operation within specifications.

Technological Characteristics

Physiological patient monitor; Class II. Components: ECG, SpO2, NIBP, IBP, CO, gas/agent sensors. Connectivity: RF transmission, external device interface. Compliance: IEC-60601-1, 21 CFR 868. Software-based arrhythmia detection and alarm system. Non-sterile.

Indications for Use

Indicated for cardiac and vital signs monitoring of all patient populations within a medical facility. Used by medical personnel for monitoring ECG, heart rate, SpO2, NIBP, CNIBP, IBP, temperature, BIS, CO, FiO2, CO2, EtCO2, respiratory rate, and anesthetic gases/agents.

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

• Nihon Kohden BSM-5130A Beside Monitor (K030105)
• Nihon Kohden ORG-9700 Multiple Patient Receiver (K071058)

Submission Summary (Full Text)

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# NIHON KOHDEN AMERICA, INC.

.. 1880

## 71/3 510(k) PREMARKET NOTIFICATION BSM-6000 SERIES BEDSIDE MONITOR

## SECTION 2- 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610

Contact: Jack Coggan Director, Regulatory Affairs [phone] ex. 3325 Fax: [phone] jack [e-mail]

FEB 2 6 2008

KOSO342

- Trade/Device Name: BSM-6000 Series Bedside Monitor .
- . Common or usual Name: Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor and Anesthesia Monitor
- Classification Name: The device has been classified as Class II by the . Cardiovascular Device Classification Panel under 21 CFR Part 870.1025, Physiological patient Monitor with Arrhythmia Detection and Alarms as MHX and under 21 CFR 870.2340, ECG Analysis System as LOS. Functions of the device have also been classified as Class II by the Anesthesiology Device Classification Panel.

Legally Marketed Predicate: Nihon Kohden BSM-5130A Beside Monitor per 510(k) K030105, commercial distribution certification dated March 4, 2003 and Nihon Kohden ORG-9700 Multiple Patient Receiver as per 510(k) K071058, commercial distribution certification dated June 29, 2007.

## A Description of the Device:

The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.

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# A summary of the technological characteristics of the device compared to the predicate device:

Similarities:

- The indications of use are identical. .
- The fundamental technology has not changed, in that the Beside Monitor technology remains the same.
- I The alarm display, electrosurgery interface filter, heart rate counting method, VPC counting range remain the same.
- The Arrhythmia graphic trend, arrhythmia alarm and arrhythmia recall remains . the same.
- l SpO2 display range, declared range remains the same.
- 트 The NIBP non-invasive blood pressure methods, display measuring range and alarm limits remain the same.
- 트 Invasive Pressure (IBP) measuring method, range accuracy, alarm limits, pulse sync tone, pulse rate count range and counting accuracy remain the same.
- Cardiac Output (CO) measuring method, range, accuracy and alarm limits remain . the same.
- . External communication, user interface, recorder, transmitter, ECG acquisition and analysis and environmental conditions are the same.

Minor Differences:

- Arrhythmia Detection recalls files have 100 files for the predicate and 24 hours I for the new devices.
- li SpO2, there is a slight difference in pulse rate count range, predicate: 0, 30-300 bpm and 0, 20-250 bpm. The new devices have 0, 30-300 bpm, 0, 20-300 bpm and 0. 25-240 bpm.
- . Invasive pressure (IBP) number of channels, there are up to 5 channels for the predicate and up to 7 channels for the new devices.
- 트 External Communication has the following differences:
- Predicate Central Station Communications is optional and new device is standard.
- -External Display Connector is a standard item for the predicate and optional for the new devices.
- ー User Interface full disclosure storage, is 30 hours 5 waves as standard and 24 hours all waves and standard for the new device.
- Dimensions and weight, the predicate device's dimensions are 339 x 315 x -250 and the weight is 10kg, the new devices dimensions are (BSM-6501A) 342 x 353 x 183 and weighs 8.3 kg and the BSM-6701A dimensions are 415 x 392 x 191 and weights 10.3 kg.

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# 510(k) Summary

- The device is not sterile. .
- The device does not directly contact patients. Accessories that contact patients, such as probes and thermistors, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories. Therefore, good laboratory practice studies were not required per 21 CFR Part 58.
- The device complies with the IEC-60601-1 standard and sub-clause 56.3 (c) . implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.
- The BSM-6000 Series device was subjected to tests to electromagnetic, . environmental, safety and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device. The results confirmed that the device performed within specifications.
- Therefore, Nihon Kohden believes that the devices are substantially equivalent to . the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three wing-like shapes.

FEB 26 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nihon Kohden America, Inc. c/o Mr. Jack Coggan Director, Regulatory Systems 90 Icon Street Foothill Ranch, CA 92610

Re: K080342

BSM-6000 Series Bedside Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 06, 2008 Received: February 08, 2007

Dear Mr. Coggan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jack Coggan

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050, This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bummerfor

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

Enclosure

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# 510(k) PREMARKET NOTIFICATION BSM-6000 SERIES BEDSIDE MONITOR

#### G. Indications for Use Statement:

510(K) Number (if known):

Device Name: BSM-6000 Series Bedside Monitors

Indications for Use:

The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (CNIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2) and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.

The device will be available for use by medical personnel on patients within a medical facility on all patient populations.

B. Summer

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)