(240 days)
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.
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
The provided text describes the Nihon Kohden GF-210R Multi-Gas Module, a medical device for measuring various gases during anesthesia. The crucial detail is that this submission is a 510(k) Premarket Notification, which means the device is being compared to already legally marketed predicate devices to establish substantial equivalence, rather than providing completely new clinical performance data. Therefore, the "study" demonstrating that the device meets acceptance criteria is primarily an equivalence comparison to predicate device specifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the technical characteristics of the predicate devices. The reported device performance is the specifications of the Nihon Kohden GF-210R. The table below excerpts the key measurement parameters and their reported performance for both the new device and the predicate devices, highlighting where the new device meets or is equivalent to the predicates.
| Parameter | Predicate Device (K#020046) Nihon Kohden AG-920RA | Predicate Device (K040188) Draeger SC 6802XL w/Scio | New Device Nihon Kohden GF-210R | Comments |
|---|---|---|---|---|
| CO2 Measurement | ||||
| 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 | < 350 ms @ 150mL/min | 350 ms | |
| N2O Measurement | ||||
| Measuring range | 0 to 100 % | 0 to 100 % | Same (0 to 100 %) | |
| Measuring accuracy | ± 3 vol.% | ± (2 Vol. % + 8 % rel.) | ± (2 Vol.% + 8 % rel.) | |
| Rise Time (10 to 90%) | 250 ms @ 200mL/min | < 500 ms | 500 ms | |
| O2 Measurement | ||||
| Measuring range | 0 to 100 % | 0 to 100 % | 5 to 100 % | |
| Measuring accuracy | +/- 2 vol.% (0 to 55 %)+/- 3 vol.% (55 to 100 %) | +/- 3 vol.% | +/- (2.5 Vol.% + 2.5 % rel.) | Essential performance in EMC standard |
| Rise Time (10 to 90%) | 500 ms | < 600 ms @150mL/min | Same (500 ms) | |
| Anesthetic Agent Measurement | ||||
| Measuring range (Halothane) | 0 to 5 % | 0 to 8.5 % | 0 to 8.5 % | |
| Measuring accuracy | +/- 0.2 vol.% (0 to 5 %)+/- 0.4 vol.% (5 to 10 %)+/- 0.6 vol.% (10 to 15 %)+/- 1.0 vol.% (15 to 18 %) | +/- (0.15 Vol% +15 % rel.) | +/- (0.2 vol% +15.0 % rel.) | Essential performance in EMC standard |
| Rise Time (10 to 90%) | 300 ms (Halothane, Isoflurane, Sevoflurane, Desflurane) @ 200mL/min500 ms (Enflurane) @ 200mL/min | < 500 ms @ 150mL/min | 500 ms | |
| Respiration Rate | ||||
| Measuring range | 4 to 60 counts/min | 0 to 90 Counts/min | Same (0 to 90 Counts/min) | |
| Measuring accuracy | 1 counts/min | 1 Counts/min (0 to 60 counts/min) not specified (>60 counts/min) | Same (1 Counts/min (0 to 60 counts/min) not specified (>60 counts/min)) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical study with patients or distinct data samples. For a 510(k) submission based on substantial equivalence to predicate devices, the primary "test" is the comparison of technical specifications.
The provided data is a table of technical specifications. There is no information about country of origin of data or whether it is retrospective or prospective, as it's not a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The ground truth for this type of device (gas analyzer) is established by the accuracy/precision of its physical measurements against known gas concentrations, as detailed in the technical specifications. This typically involves laboratory testing and calibration against NIST-traceable standards, rather than expert human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess cases and their disagreements need to be resolved. This device measures gas concentrations, not subjective interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a multi-gas module, not an AI-powered diagnostic tool for image analysis or other human interpretation tasks where a MRMC study would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a physical gas measurement device. The device's "standalone" performance is its ability to accurately measure gas concentrations as per its technical specifications, which are implicitly studied and verified during product development and regulatory testing. The provided data summaries indicate "Software and hardware verification and validation" and "Safety standard compliance" testing were performed, which covers the device's standalone functional performance.
7. The Type of Ground Truth Used
The ground truth for this device's performance relies on calibration gases with known concentrations for accuracy and precision measurements. This is a form of objective, physical measurement standard. It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The device is not based on machine learning models that require a "training set" in the conventional sense. Its functionality is based on established physical principles of gas analysis (infrared ray absorption, paramagnetic detection) and engineered hardware/software.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set" for this type of device.
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Nihon Kohden America, Inc. September 14, 2011
510(k) Summary
| Company Name: | Nihon Kohden Corporation90 Icon StreetFoothill 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 StreetFoothill Ranch, CA 92610Steve GeerdesDirector Quality Assurance and Regulatory AffairsPhone: (949) 580-1555 Ext. 3325Fax: (949) 580-1550 |
| Summary Date: | 9/14/2011 |
| Common Name: | Gas Analyzer, carbon dioxide, oxygen, nitrous oxide, enflurane, andhalothane Gas analyzer |
Classification Name:
| 868.1400 | Analyzer, Gas, Carbon dioxide, | was a final from the first of the county of the county ofCCK |
|---|---|---|
| · 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 featureor specification | Predicate device(K#020046)Nihon Kohden AG-920RA | Predicate device(K040188) DraegerSC 6802XL w/Scio | New deviceNihon KohdenGF-210R | Comments |
|---|---|---|---|---|
| Host | Nihon Kohden"LifeScope" patient | Infinity NodularMonitors | Nihon Kohden"LifeScope" | |
| monitors | ( SC7000, SC8000, SC9000XL) | patient monitors | ||
| Power input | 100 to 240 VAC | 100-240 V, 50/60Hz | Same | |
| PowerConsumption | 40VA | from specifiedpower supply | 70VA | |
| OperatingTemperature | 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 270mm | 280 x 100 x 200mm | |
| Weight | 3.4 kg | 3.457Kg | 4.2 kg | |
| measurement> | ||||
| OEM manufacturerof gas module | Artema Medical | Draeger Medical | ||
| MeasurementParameters | Fi/ET CO2, N2O, O2,Anesthetic agents(Halothane, Isoflurane,Enflurane, Sevoflurane,Desflurane),Respiration Rate | Fi/ET CO2, N2O,O2, Anestheticagents(Halothane,Isoflurane,Enflurane,Sevoflurane,Desflurane),Respiration Rate | Same | |
| Sampling Rate | Selectable : 70 to 200mL/minAuto : 100 or 200mL/min | 200 mL/min | 200 mL/min | |
| Warm-up time | 45 Sec (Startup)10 min (Full accuracy) | 1 min (CO2 Startup)6 min (Fullaccuracy) | 1 min (CO2Startup)6 min (Fullaccuracy) | |
| CO2 Measurement | ||||
| Measurementmethod | Non-DispersiveInfrared Ray absorption | Non-DispersiveInfrared Rayabsorption | Same | |
| Measuring range | 0 to 76 mmHg | 0 to 10 % | 0 to 10 Vol.%(Ref. 0 to 76mmHg @ambientpressure760mmHg) | The value using Vol.% is the spec byDraeger.See the value, whichis converted tommHg for reference. |
| Measuringaccuracy | ± 2 mmHg (0 to 40mmHg)± 3 mmHg (40 to 55mmHg)± 4 mmHg (55 to 76mmHg) | ± (0.5 Vol% or±12% rel) | ± (0.43 Vol.% +8 % rel.)(Ref.±(3.3mmHg + 8 % rel.)@ambientpressure 760mmHg) | The value using Vol.% is the spec byDraeger.See the value, whichis converted tommHg for reference.Essentialperformance inEMC standard |
| Rise Time (10 to90%) | 250 ms @ 200mL/min | < 350 ms @150mL/min | 350 ms | |
| N2O Measurement | ||||
| Measurementmethod | Non-DispersiveInfrared Ray absorption | Non-DispersiveInfrared Rayabsorption | Same | |
| Measuring range | 0 to 100 % | 0 to 100 % | Same | |
| Measuringaccuracy | ± 3 vol.% | ± (2 Vol. % + 8 %rel.) | ± (2 Vol.% + 8% rel.) | |
| Rise Time (10 to90%) | 250 ms @ 200mL/min | < 500 ms | 500 ms | |
| 02 Measurement | ||||
| Measurementmethod | Paramagnetic | Paramagnetic sensor | Same | |
| Measuring range | 0 to 100 % | 0 to 100 % | 5 to 100 % | |
| Measuringaccuracy | +/- 2 vol.% (0 to 55 %)+/- 3 vol.% (55 to 100%) | +/- 3 vol.% | +/- (2.5 Vol.% +2.5 % rel.) | Essentialperformance inEMC standard |
| Rise Time (10 to90%) | 500 ms | < 600 ms@150mL/min | Same | |
| Anestetic AgentMeasurement | ||||
| Measurementmethod | Non-DispersiveInfrared Ray absorption | Non-DispersiveInfrared Rayabsorption | Same | |
| AgentIdentification | Auto | Auto | Same | |
| Mixed AgentMeasure. | Primary and Secondary | Primary andSecondary | 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 % | |
| Measuringaccuracy | +/- 0.2 vol.% (0 to 5 %)+/- 0.4 vol.% (5 to 10%)+/- 0.6 vol.% (10 to 15%)+/- 1.0 vol.% (15 to 18%) | +/- (0.15 Vol% +15% rel.) | +/- (0.2 vol%+15.0 % rel.) | Essentialperformance inEMC standard |
| Rise Time (10 to90%) | 300 ms (Halothane,Isoflurane, Sevoflurane,Desflurane) @200mL/min500 ms (Enflurane) @200mL/min | < 500 ms @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 RateMeasurement | ||||
|---|---|---|---|---|
| Measuring range | 4 to 60 counts/min | 0 to 90 Counts/min | Same | |
| Measuringaccuracy | 1 counts/min | 1 Counts/min (0 to60 counts/min)not specified (>60counts/min) | Same | |
| MAC Calculation | available (only whenused 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.
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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 (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
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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
§ 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).