ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A

K030105 · Nihon Kohden America, Inc. · MHX · Mar 4, 2003 · Cardiovascular

Device Facts

• Record ID: K030105
• Device Name: ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
• Applicant: Nihon Kohden America, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The series of device 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 audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (CO2 and EtCO2), and respiratory rate, CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including NJO, Halothane, Isoflurane, 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 including adults, children and infants. The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult. The interpretation is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis and is not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography. Prescription Use Only

Device Story

Bedside monitor system for physiological data acquisition; inputs include ECG, SpO2, NIBP, IBP, temperature, cardiac output, FiO2, CO2/EtCO2, respiratory rate, and anesthetic agents. Device processes signals to display waveforms/numerics and generate audible/visual alarms for arrhythmias or out-of-limit vital signs. Operated by medical personnel in clinical settings; includes RF transmission capability for physiological signals. ECAPS 12 software provides automated ECG rhythm/morphology interpretation to assist physician diagnosis. Output enables real-time patient status monitoring and clinical decision support. Benefits include continuous surveillance of critical physiological parameters and early detection of adverse cardiac events.

Clinical Evidence

Bench testing only. Electromagnetic, environmental, safety, and performance testing procedures were conducted to verify device operation. Software validation confirmed software functions performed within specifications. No clinical data required.

Technological Characteristics

Bedside monitor; non-sterile. Integrates ECG, SpO2, NIBP, IBP, temperature, cardiac output, gas monitoring (CO2, anesthetic agents). Connectivity includes RF transmission of physiological signals. Software includes ECAPS 12 interpretive ECG program. Complies with IEC 601-1 sub-clause 56.3(c) and 21 CFR Part 898 for electrode lead wires/cables.

Indications for Use

Indicated for cardiac and vital signs monitoring in medical facilities for adults, children, and infants. ECAPS 12 interpretive ECG software indicated for patients age 3 years to adult to assist physicians in ECG rhythm and morphology assessment.

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-4100A Monitor (K001693)
• Nihon Kohden Multigas Unit, Ag-920RA (K020046)

Reference Devices

• Anesthesia Monitor by Datex-Ohmeda (K022485)

Submission Summary (Full Text)

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#### NIHON KOHDEN AMERICA, INC.

# 510(k) NOTIFICATION BSM-5130A Series Bedside Monitor

MAR 0 4 2003

### SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 90 Icon St. Foothill Ranch, Ca 92610

Phone: [phone] Fax: [phone]

## Indications for Use:

The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring as well as gas monitoring. The device is intended to produce a visual record of the electrical signals 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 (SpO>), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CQ), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and qases including NxO, Halothane, Isoflurane, 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 yia radio frequency. The device will be available for use by medical personnel on all patient populations within a medical facility.

The device complies with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for this device.

The BSM-5130A series devices are 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, qood laboratory practice studies were not required per 21 CFR Part 58.

The BSM-5130A series Bedside Monitor was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of the results confirmed that the device performed within specifications.

Therefore, Nihon Kohden believes that the device is substantially equivalent to the combination of two Nihon Kohden predicate devices as stated.

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# 510(k) NOTIFICATION BSM-5130A Series Bedside Monitor

Common names for the BSM-5130A device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor and Anesthesia monitor. The device has been classified as Class III per Cardiovascular Device Classification Panel under 21 CFR Part 870.1025, "Physiological Patient Monitor with Arrhytmia 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 and the General Hospital and Personal Use Classification Panel as follows: under 21 CFR 870.2300, "Cardiac Monitor (including cardiotachometer and rate alarms)" per DRT: under 21 CFR 870.2700, "Oximeter" per DQA; under 21 CFR 870.1130, "Noninvasive Blood Pressure Measurement System" per DXN; under 21 CFR 870.1110 and 21 CFR 870.1100, "Blood Pressure Computer and Alarm" per DSK and DSJ; under 21 CFR 880.2910, "Thermometer. Electronic, Clinical" per FLL; under 21 CFR 868.2375, "Breathing Frequency Monitor" per BZQ; under 21 CFR 868.1720, "Oxygen Gas Analyzer" per CCL; under 21 CFR 868.1400, "Carbon Dioxide Gas Analyzer" per CCK; under 21 CFR 870.2910, "Radio Frequency Physiological Signal Transmitter" per DRG.

The predicate devices are the Nihon Kohden BSM-4100A Monitor per 510(k) #K001693, commercial distribution certification dated October 24, 2000 and the Nihon Kohden Multigas Unit, Ag-920RA per 510(k) #K020046, commercial distribution certification dated July 25, 2002. The new device is a combination of the two devices. The predicate device, marketed by other companies, include: Anesthesia Monitor by Datex-Ohmeda, 510k #K022485, which is similar in intended use,

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Nihon Kohden America, Inc. c/o Mr. Serrah Namini Regulatory Affairs Associate Director 90 Icon Street Foothill Ranch, CA 92610

Re: K030105

Trade Name: BSM-5130A Series Bedside Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 12, 2003 Received: January 13, 2003

Dear Mr. Namini:

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. Serrah Namini

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/dsma/dsmamain.html

Sincerely yours.

K. Deletuh

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

Enclosure

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K030105

## NIHON KOHDEN AMERICA, INC.

510(k) NOTIFICATION BSM-5130A Series Bedside Monitor

G. Indications for Use Statement

KO30105 510(k) Number (if known):

Device Name: BSM-5130A Series Bedside Monitors

#### Indications for Use:

The series of device 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 audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (CO2 and EtCO2), and respiratory rate, CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including NJO, Halothane, Isoflurane, 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 including adults, children and infants.

The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult. The interpretation is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis and is not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Prescription Use Only

N. Celentano

510(k) Number K030105