(101 days)
The Nihon Kohden TG-970P Series 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 Nihon Kohden CO2 Sensor Kit, model number TG-970P Series, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory (end tidal CO2) status. The device measuring technique is through absorption of infrared radiation. The airway adapter is a Single -Patient Use disposable product.
The device is intended as an indicator of patient carbon dioxide concentration during expiration for intubated patients. The device is intended for use with patients weighing 7kg or more. The device is not recommended for patients with low tidal volume such as patients weighing less than 7kg or patients with a respiration rate greater than 150 breaths per minute.
This document is a 510(k) Summary for a medical device (CO2 Sensor Kit) and does not contain detailed information about a specific study with acceptance criteria and reported device performance. It primarily focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information from the given text. The document states:
- "The device performance and specifications are consistent with all requirements for this device type."
- "To date, no performance standards or special controls are known or established for this type of device."
- "The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the safety and efficacy of the device under intended operation for this device."
However, it does not provide the specific acceptance criteria, reported device performance data, sample sizes, ground truth establishment, or details of efficacy studies (such as MRMC or standalone performance) that typically accompany such claims in a detailed study report. The intent of this 510(k) summary is to assert equivalence rather than present original performance study data against specific criteria.
§ 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).