(169 days)
The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status.
Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital, ambulatory care, transport, or any other clinical environment.
The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.
The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.
The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.
This FDA 510(k) clearance letter pertains to a hardware device (CO2 Sensor Kit) and not an AI/ML software. Therefore, many of the requested criteria regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study) are not applicable.
However, I can extract the relevant acceptance criteria and details of the non-clinical performance studies conducted for the device.
Acceptance Criteria and Device Performance (Non-AI Device)
1. A table of acceptance criteria and the reported device performance
The document provides the performance specifications for the CO2 Sensor Kit, rather than explicit "acceptance criteria" in the typical sense of a target for a specific study. The reported device performance is compared to the predicate device's performance.
| Performance Characteristic | Acceptance/Predicate Specification | Subject Device (TG-980P/TG-980P1) Reported Performance |
|---|---|---|
| Trade/Device Name | Nihon Kohden TG-970P Series CO2 Sensor Kit | Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit |
| Regulatory Class | Class II | Class II |
| Product Code | CCK (868.1400) | CCK (868.1400) |
| Intended Use | To be used under the control of a healthcare professional to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status; an indicator of patient carbon dioxide concentration during expiration. | Equivalent, with slightly changed wording but same meaning. |
| Indications for Use | To measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status; an indicator of patient carbon dioxide concentration during expiration. For use by qualified medical personnel within a hospital or clinical environment. | Same as predicate, but with clarification of intended use environments to include "ambulatory care, transport, or any other clinical environment." |
| Type of Use | Prescription Device Only | Prescription Device Only |
| Intended Population | Adult and children patients 7 kg or more (Predicate) / Adults, children, infants and neonates (Reference) | Neonates to adults. All types of genders, races, and languages. (Same as Reference device's broader population) |
| Patient Contact | Intubated (Predicate) / Intubated/Non-intubated (Reference) | Intubated/Non-intubated (Same as Reference device) |
| Configuration | CO2 sensor, Connector, Sensor cable, CO2 adapter | CO2 sensor, Connector, Sensor Cable (CO2 adapter removed) |
| Dimension (CO2 sensor) | 37 x 8.3 x 13.7 mm ±10% | 37 x 8.3 x 13.7 mm ±10% |
| Weight (Sensor part) | 4 g ±1 g | 4 g ±2 g (Weight tolerance adjusted) |
| Sampling method | Mainstream infrared absorption | Mainstream infrared absorption |
| Measurement principle | Single-wave spectroscopic method (Non-dispersive infrared gas analyzing method (NDIR)) | Single-wave spectroscopic method (Non-dispersive infrared gas analyzing method (NDIR)) |
| CO2 measurement method | Quantitative method | Quantitative method |
| Calibration | YES | YES |
| EtCO2 determination | YES | YES |
| No Breath detect limit | CO2 |
§ 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).