MULTIGAS UNIT, MODEL AG-920RA

K020046 · Nihon Kohden America, Inc. · CCK · Jul 25, 2002 · Anesthesiology

Device Facts

• Record ID: K020046
• Device Name: MULTIGAS UNIT, MODEL AG-920RA
• Applicant: Nihon Kohden America, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and is available for use by medical personnel on patients within a medical facility including adults, children and infants. The optional AG-920RA module will measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and any of five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a bedside monitor.

Device Story

BSM-4100A Bedside Monitor with AG-920RA option; monitors physiological data including cardiac signals and vital signs. AG-920RA module adds gas analysis capabilities; measures CO2, N2O, O2, and five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, Desflurane) for patients undergoing anesthesia. Device displays real-time data on bedside monitor; provides alarms for abnormal physiological states. Used by medical personnel in clinical settings. Facilitates clinical decision-making by providing continuous patient status updates during monitoring and anesthesia. Benefits include improved patient safety through continuous surveillance and early detection of physiological changes.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electromagnetic, environmental, safety, and performance procedures to verify operation. Software validation confirmed performance within specifications.

Technological Characteristics

Bedside patient monitor with integrated gas analysis module. Complies with IEC 60601-1, IEC 60601-1-2, and CISPR11 standards. Non-sterile. Not patient-contacting. Software-based monitoring and alarm system.

Indications for Use

Indicated for cardiac and vital signs monitoring, including arrhythmia detection and gas analysis (CO2, N2O, O2, and anesthetic agents), for adult, pediatric, and infant patients in medical facilities.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• 90518 Multi-gas Analyzer (K954962)
• SC9000/SC9015 Multi-gas Module (K965062)

Submission Summary (Full Text)

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NIHON KOHDEN AMERICA, INC. January 3, 2002

K 020046

510(k) NOTIFICATION BSM-4100A Series with AG-920RA Option

JUL 2 5 2002

#### SECTION 2 - 510(K) SUMMARY

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

Phone: [phone] Fax: [phone]

Common names for the device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor. The functions of the device added by the AG-920RA option are classified as Class II per the Anesthesiology Device Classification Panel per 21 CFR 868.1500, "Analyzer, Gas, Enflurane, Gaseous-Phase", CBQ; 21 CFR 868.1620, "Analyzer, Gas, Halothane, Gaseous-Phase", CBS; and 21 CFR 868.1700, "Analyzer, Gas, Nitrous-Oxide, Gaseous-Phase", CBR.

The AG-920PA module is equivalent to the 90518 Multi-gas Analyzer per K954962 and the SC9000/SC9015 Multi-gas Module per K965062.

The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and alarms within a medical facility. With the new AG-920PA option, the device will measure and display Carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and any of five anesthetic agents (Halothane, Isofilurane, Enflurane, Sevoflurane, and Desflurane).

The device complies with IEC 601-1 subclause 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 device is not sterile.

The device does not directly contact patients, therefore, good laboratory practice studies were not required per 21 CFR part 58.

The device 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 device software. The results confirmed that the device performed within specifications.

The device is designed to comply with the following voluntary industrial standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-2 (1993-05) and CISPR11 Group 1, Class A

Therefore, Nihon Kohden believes that the device is substantially equivalent to the predicate.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, suggesting a person in profile.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JUL 25 2002**

Ms. Serrah Namini Regulatory Affairs Manager Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610

Re: K020046

Trade/Device Name: Multigas Unit, Model AG-920RA Regulation Number: 868.1400; 868.1720; 868.1700; 868.1500; 868.1620 Regulation Name: Carbon dioxide gas analyzer: Oxygen gas analyzer: Nitrous oxide gas analyzer; Enflurane gas analyzer; Halothane gas analyzer Regulatory Class: II Product Code: CCK; CCL; CBR; CBQ; NHO, NHP, NHQ; CBS Dated: May 2, 2002 Received: May 2, 2002

Dear Ms. 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.

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.

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Page 2 - Ms. Namini

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. I Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# NIHON KOHDEN AMERICA, INC. January 3, 2002

### 510(k) NOTIFICATION BSM-4100A Series with AG-920RA Option

G. Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: BSM-4100A Bedside Monitor with AG-920RA Option

The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and is available for use by medical personnel on patients within a medical facility including adults, children and infants.

The optional AG-920RA module will measure carbon dioxide (CO2), nitrous oxide (N₂O), oxygen (O₂), and any of five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a bedside monitor.

Prescription Use

R.W. Wisham

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -