GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS

K110594 · Nihon Kohden Corp. · CCK · Oct 28, 2011 · Anesthesiology

Device Facts

• Record ID: K110594
• Device Name: GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
• Applicant: Nihon Kohden Corp.
• Product Code: CCK · Anesthesiology
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nihon Kohden GR-210R Multi-Gas Module is intended to measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and following anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor. The GF-210R can measure two anesthetic agents simultaneously. The system is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patients as determined by the qualified medical personnel.

Device Story

GF-210R Multi-Gas Module is an integrated anesthesia gas detection unit; samples gas from anesthetic/respiration circuits via exhaust tube. Uses infrared ray absorption for CO2, N2O, and anesthetic agents; paramagnetic detection for O2. Measures gas concentrations on real-time, breath-by-breath basis; detects inspired/expired phases from CO2 concentration; calculates respiration rate. Contains OEM Draeger gas analyzer module. Connects to Nihon Kohden bedside monitors for display of numerics, waveforms, and alarms. Used by qualified medical personnel in hospitals/clinics. Provides continuous monitoring of patient gas levels during anesthesia; assists clinicians in assessing patient respiratory status and anesthetic depth.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated through software and hardware verification and validation, and compliance with safety standards.

Technological Characteristics

Enclosure containing OEM Draeger gas analyzer. Measurement methods: Non-Dispersive Infrared (NDIR) for CO2, N2O, and anesthetic agents; Paramagnetic for O2. Connectivity: Multi-link connector to Nihon Kohden bedside monitors. Power: 100-240 VAC. Dimensions: 280 x 100 x 200 mm. Weight: 4.2 kg. Operating temperature: 10-40°C.

Indications for Use

Indicated for patients of any age undergoing anesthesia in hospital or clinical settings. Used to monitor CO2, N2O, O2, and anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, Desflurane) and respiration rate.

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

• Nihon Kohden AG-920RA (K020046)
• Draeger SC 6802XL w/Scio (K040188)

Submission Summary (Full Text)

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K110594

Nihon Kohden America, Inc. September 14, 2011

## 510(k) Summary

| Company Name: | Nihon Kohden Corporation<br>90 Icon Street<br>Foothill Ranch, CA 92610 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors |
| 510(k) Sponsor,<br>Contact: | Nihon Kohden America, Inc.<br>90 Icon Street<br>Foothill Ranch, CA 92610<br><br>Steve Geerdes<br>Director Quality Assurance and Regulatory Affairs<br>Phone: [phone] Ext. 3325<br>Fax: [phone] |
| Summary Date: | 9/14/2011 |
| Common Name: | Gas Analyzer, carbon dioxide, oxygen, nitrous oxide, enflurane, and<br>halothane Gas analyzer |

## Classification Name:

| 868.1400 | Analyzer, Gas, Carbon dioxide, | was a final from the first of the county of the county of<br>CCK |
|-------------------------------------------------------|--------------------------------|------------------------------------------------------------------|
| · Production Million March Justice March March Market | Gaseous-Phase | |

## Predicate Device(s):

| Nihon Kohden AG-920RA | K#020046 |
|--------------------------|----------|
| Draeger SC 6802XL w/Scio | K#040188 |

### 1.0 Description of Device

The GF-210R Multi-Gas Module is a fully integrated anesthesia gas detection unit that measures Carbon dioxide (CO2), nitrous oxide (N20), oxygen (O2), and five anesthetic agents and displays the results on a Nihon Kohden bedside monitor.

The GF-210R is an enclosure that contains an OEM Gas Analyzer (Draeger Module # 6871620). There is a sample gas exhaust port that allows the GF-210R to sample gas from a anesthetic or respiration circuit through exhaust gas tube. A multi-link connector allows the GF-210R to comunicate the measured gas value and display the value on a Nihon kohden bedside monitor

### Clinical Application 1.1

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The GF-210R Multi-Gas Module is used to measure Carbon dioxide (CO2), nitrous oxide (N2O), The OI -2101 Maili Oas Mesthetic agents and display the results on a bedside monitor.

This anesthesia gas detection unit samples and measures the concentration of gases administered to and respired by the patient during anesthesia. Infrared ray absorption detection method is used for carbon dioxide (CO2), nitrous oxide (N2O), and anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane). Paramagnetic detection method is used for oxygen (O2). Gases are monitored on a real time, breath-by-breath basis and the measured inspired and (32). Case an entrations are displayed on the Nohon Kohden bedside monitor. The inspired and expired phases are detected from the instantaneous CO2 concentration and respiration rate is counted from these phases.

The measured data is transferred to and displayed on a Nihon Kohden bedside monitor. User interface for controlling and displaying alarms, setting sampling rates and calibration are provided through the bedside monitor. All measured data (numerics and waveforms) are displayed and recorded through the bedside monitor.

### Intended Use of Device 2.0

The Nihon Kohden GR-210R Multi-Gas Module is intended to measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and following anesthetic agents (Halothane, Isoflurane, mirous only (120), only get (22ffurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor. The GF-210R can measure two anesthetic agents simultaneously.

The system is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patients as determined by the qualified medical personnel.

### Technical Characteristics 3.0

The technical characteristics of the GF-210R are equivalent to those of the predicate devices. The following tables summarizes equivalence.

| Comparison feature<br>or specification | Predicate device<br>(K#020046)<br>Nihon Kohden AG-<br>920RA | Predicate device<br>(K040188) Draeger<br>SC 6802XL w/Scio | New device<br>Nihon Kohden<br>GF-210R | Comments |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <general></general> | | | | |
| Host | Nihon Kohden<br>"LifeScope" patient | Infinity Nodular<br>Monitors | Nihon Kohden<br>"LifeScope" | |
| | monitors | ( SC7000, SC8000, SC9000XL) | patient monitors | |
| Power input | 100 to 240 VAC | 100-240 V, 50/60<br>Hz | Same | |
| Power<br>Consumption | 40VA | from specified<br>power supply | 70VA | |
| Operating<br>Temperature | 10 to 35 deg C | 10 to 40 deg C | 10 to 40 deg C | |
| Dimension | 180 x 140 x 220 mm | 115 x 190 x 270<br>mm | 280 x 100 x 200<br>mm | |
| Weight | 3.4 kg | 3.457Kg | 4.2 kg | |
| measurement> | | | | |
| OEM manufacturer<br>of gas module | Artema Medical | | Draeger Medical | |
| Measurement<br>Parameters | Fi/ET CO2, N2O, O2,<br>Anesthetic agents<br>(Halothane, Isoflurane,<br>Enflurane, Sevoflurane,<br>Desflurane),<br>Respiration Rate | Fi/ET CO2, N2O,<br>O2, Anesthetic<br>agents<br>(Halothane,<br>Isoflurane,<br>Enflurane,<br>Sevoflurane,<br>Desflurane),<br>Respiration Rate | Same | |
| Sampling Rate | Selectable : 70 to 200<br>mL/min<br>Auto : 100 or 200<br>mL/min | 200 mL/min | 200 mL/min | |
| Warm-up time | 45 Sec (Startup)<br>10 min (Full accuracy) | 1 min (CO2 Startup)<br>6 min (Full<br>accuracy) | 1 min (CO2<br>Startup)<br>6 min (Full<br>accuracy) | |
| CO2 Measurement | | | | |
| Measurement<br>method | Non-Dispersive<br>Infrared Ray absorption | Non-Dispersive<br>Infrared Ray<br>absorption | Same | |
| Measuring range | 0 to 76 mmHg | 0 to 10 % | 0 to 10 Vol.%<br>(Ref. 0 to 76<br>mmHg @ambient<br>pressure<br>760mmHg) | The value using Vol.<br>% is the spec by<br>Draeger.<br>See the value, which<br>is converted to<br>mmHg for reference. |
| Measuring<br>accuracy | ± 2 mmHg (0 to 40<br>mmHg)<br>± 3 mmHg (40 to 55<br>mmHg)<br>± 4 mmHg (55 to 76<br>mmHg) | ± (0.5 Vol% or<br>±12% rel) | ± (0.43 Vol.% +<br>8 % rel.)<br>(Ref.±(3.3<br>mmHg + 8 % rel.)<br>@ambient<br>pressure 760<br>mmHg) | The value using Vol.<br>% is the spec by<br>Draeger.<br>See the value, which<br>is converted to<br>mmHg for reference.<br>Essential<br>performance in<br>EMC standard |
| Rise Time (10 to<br>90%) | 250 ms @ 200mL/min | < 350 ms @<br>150mL/min | 350 ms | |
| N2O Measurement | | | | |
| Measurement<br>method | Non-Dispersive<br>Infrared Ray absorption | Non-Dispersive<br>Infrared Ray<br>absorption | Same | |
| Measuring range | 0 to 100 % | 0 to 100 % | Same | |
| Measuring<br>accuracy | ± 3 vol.% | ± (2 Vol. % + 8 %<br>rel.) | ± (2 Vol.% + 8<br>% rel.) | |
| Rise Time (10 to<br>90%) | 250 ms @ 200mL/min | < 500 ms | 500 ms | |
| 02 Measurement | | | | |
| Measurement<br>method | Paramagnetic | Paramagnetic sensor | Same | |
| Measuring range | 0 to 100 % | 0 to 100 % | 5 to 100 % | |
| Measuring<br>accuracy | +/- 2 vol.% (0 to 55 %)<br>+/- 3 vol.% (55 to 100<br>%) | +/- 3 vol.% | +/- (2.5 Vol.% +<br>2.5 % rel.) | Essential<br>performance in<br>EMC standard |
| Rise Time (10 to<br>90%) | 500 ms | < 600 ms<br>@150mL/min | Same | |
| Anestetic Agent<br>Measurement | | | | |
| Measurement<br>method | Non-Dispersive<br>Infrared Ray absorption | Non-Dispersive<br>Infrared Ray<br>absorption | Same | |
| Agent<br>Identification | Auto | Auto | Same | |
| Mixed Agent<br>Measure. | Primary and Secondary | Primary and<br>Secondary | Same | |
| Measuring range | | | | |
| Halothane | 0 to 5 % | 0 to 8.5 % | 0 to 8.5 % | |
| Isoflurane | 0 to 5 % | 0 to 8.5 % | 0 to 8.5 % | |
| Enflurane | 0 to 5 % | 0 to 10 % | 0 to 10.0 % | |
| Sevoflurane | 0 to 8 % | 0 to 10 % | 0 to 10.0 % | |
| Desflurane | 0 to 18 % | 0 to 20 % | 0 to 20.0 % | |
| Measuring<br>accuracy | +/- 0.2 vol.% (0 to 5 %)<br>+/- 0.4 vol.% (5 to 10<br>%)<br>+/- 0.6 vol.% (10 to 15<br>%)<br>+/- 1.0 vol.% (15 to 18<br>%) | +/- (0.15 Vol% +15<br>% rel.) | +/- (0.2 vol%<br>+15.0 % rel.) | Essential<br>performance in<br>EMC standard |
| Rise Time (10 to<br>90%) | 300 ms (Halothane,<br>Isoflurane, Sevoflurane,<br>Desflurane) @<br>200mL/min<br>500 ms (Enflurane) @<br>200mL/min | < 500 ms @<br>150mL/min | 500 ms | |

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Nihon Kohden America, Inc. September 14, 2011

## Traditional 510(k) Notification GF-210R Multi Gas Module

.

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| Respiration Rate<br>Measurement | | | | |
|---------------------------------|---------------------------------------------|---------------------------------------------------------------------------|-----------|--|
| Measuring range | 4 to 60 counts/min | 0 to 90 Counts/min | Same | |
| Measuring<br>accuracy | 1 counts/min | 1 Counts/min (0 to<br>60 counts/min)<br>not specified (>60<br>counts/min) | Same | |
| MAC Calculation | available (only when<br>used with BSM-6000) | available | available | |

### 4.0 Data Summary

Testing of the Nihon Kohden System with the MS-120BK was performed in compliance with the Nihon Kohden Corporation design control process. Testing included:

- 1. Software and hardware verification and validation, and
- 2. Safety standard compliance

A summary of data supporting the safety of the Nihon Kohden GF-201R was provided.

### 5.0 Conclusions

The safety and effectiveness of the Nihon Kohden GF-210R was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Nihon Kohden GF-201R is equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

OCT 2 8 2011

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

Mr. Steve Geerdes Director Quality Assurance and Regulatory Affairs Nihon Kohden Corporation 90 Icon Street Foothill Ranch, California 92610

- Re: K110594
Trade/Device Name: Nihon Kohden GF-210R Multi-Gas Module Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: September 14, 2011 Received: September 20, 2011

Dear Mr. Geerdes:

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 ffor 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.

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## Page 2 - Mr. Geerdes

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K110594

Device Name: _______ Nihon Kohden GF-210R Multi-Gas Module_

Indications for Use:

The Nihon Kohden GR-210R Multi-Gas Module is intended to measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and following anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor. The GF-210R can measure two anesthetic agents simultaneously.

The system is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patients as determined by the qualified medical personnel..

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

Over-The-Counter Use CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

Division Sign-Off Office of In Device Evaluation 510(k)

signature

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k/10594