(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 | 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.
§ 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).