(240 days)
K#020046, K#040188
K#020046,K#040188
No
The summary describes a gas analysis module that measures gas concentrations using an OEM gas analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device measures gases but does not directly treat a patient or disease; it provides diagnostic information.
No
Explanation: The device measures gas concentrations (CO2, N2O, O2, anesthetic agents) within a patient's respiratory circuit during anesthesia and displays the results. This function is for monitoring physiological parameters and drug levels, not for diagnosing a disease or condition.
No
The device description explicitly states it is an "enclosure that contains an OEM Gas Analyzer" and mentions hardware verification and validation in the performance studies summary, indicating it is a hardware device with integrated software.
Based on the provided information, the Nihon Kohden GR-210R Multi-Gas Module is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device measures gases from a patient undergoing anesthesia. This is a direct measurement of physiological parameters within the patient's respiratory system, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device samples gas from an anesthetic or respiration circuit, which is connected to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Nihon Kohden GR-210R is a patient monitoring device that measures gases directly from the patient's respiratory circuit.
N/A
Intended Use / 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.
Product codes
CCK
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
any patients
Intended User / Care Setting
qualified medical personnel within a hospital or clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Nihon Kohden System with the MS-120BK was performed in compliance with the Nihon Kohden Corporation design control process. Testing included:
-
- Software and hardware verification and validation, and
-
- Safety standard compliance
A summary of data supporting the safety of the Nihon Kohden GF-201R was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nihon Kohden AG-920RA K#020046, Draeger SC 6802XL w/Scio K#040188
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Nihon Kohden America, Inc. September 14, 2011
510(k) Summary
| Company Name: | Nihon Kohden Corporation
90 Icon Street
Foothill Ranch, CA 92610 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors |
| 510(k) Sponsor,
Contact: | Nihon Kohden America, Inc.
90 Icon Street
Foothill Ranch, CA 92610
Steve Geerdes
Director Quality Assurance and Regulatory Affairs
Phone: (949) 580-1555 Ext. 3325
Fax: (949) 580-1550 |
| Summary Date: | 9/14/2011 |
| Common Name: | Gas Analyzer, carbon dioxide, oxygen, nitrous oxide, enflurane, and
halothane Gas analyzer |
Classification Name:
| 868.1400 | Analyzer, Gas, Carbon dioxide, | was a final from the first of the county of the county of
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
1
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
or specification | Predicate device
(K#020046)
Nihon Kohden AG-
920RA | Predicate device
(K040188) Draeger
SC 6802XL w/Scio | New device
Nihon Kohden
GF-210R | Comments |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| Host | Nihon Kohden
"LifeScope" patient | Infinity Nodular
Monitors | Nihon Kohden
"LifeScope" | |
| | monitors | ( SC7000, SC8000, SC9000XL) | patient monitors | |
| Power input | 100 to 240 VAC | 100-240 V, 50/60
Hz | Same | |
| Power
Consumption | 40VA | from specified
power supply | 70VA | |
| Operating
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
mm | 280 x 100 x 200
mm | |
| Weight | 3.4 kg | 3.457Kg | 4.2 kg | |
| measurement> | | | | |
| OEM manufacturer
of gas module | Artema Medical | | Draeger Medical | |
| Measurement
Parameters | Fi/ET CO2, N2O, O2,
Anesthetic agents
(Halothane, Isoflurane,
Enflurane, Sevoflurane,
Desflurane),
Respiration Rate | Fi/ET CO2, N2O,
O2, Anesthetic
agents
(Halothane,
Isoflurane,
Enflurane,
Sevoflurane,
Desflurane),
Respiration Rate | Same | |
| Sampling Rate | Selectable : 70 to 200
mL/min
Auto : 100 or 200
mL/min | 200 mL/min | 200 mL/min | |
| Warm-up time | 45 Sec (Startup)
10 min (Full accuracy) | 1 min (CO2 Startup)
6 min (Full
accuracy) | 1 min (CO2
Startup)
6 min (Full
accuracy) | |
| CO2 Measurement | | | | |
| Measurement
method | Non-Dispersive
Infrared Ray absorption | Non-Dispersive
Infrared Ray
absorption | Same | |
| Measuring range | 0 to 76 mmHg | 0 to 10 % | 0 to 10 Vol.%
(Ref. 0 to 76
mmHg @ambient
pressure
760mmHg) | The value using Vol.
% is the spec by
Draeger.
See the value, which
is converted to
mmHg for reference. |
| Measuring
accuracy | ± 2 mmHg (0 to 40
mmHg)
± 3 mmHg (40 to 55
mmHg)
± 4 mmHg (55 to 76
mmHg) | ± (0.5 Vol% or
±12% rel) | ± (0.43 Vol.% +
8 % rel.)
(Ref.±(3.3
mmHg + 8 % rel.)
@ambient
pressure 760
mmHg) | The value using Vol.
% is the spec by
Draeger.
See the value, which
is converted to
mmHg for reference.
Essential
performance in
EMC standard |
| Rise Time (10 to
90%) | 250 ms @ 200mL/min | 60
counts/min) | Same | |
| MAC Calculation | available (only when
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:
-
- Software and hardware verification and validation, and
-
- 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.
6
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.
7
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 (800) 638-2041 or (301) 796-7100 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
8
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