(119 days)
The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.
The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected.
The devices are intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.
The Nihon Kohden OLG-3800A is a compact CO2 monitor with a 7-inch display and is designed so the operator can directly touch the screen from the operator position. The CO2 monitor displays the patient's vital signs (CO2, RR, SpO2, PR) on the screen and generates an alarm according to the setting. Alarms are indicated with a screen message, sound, blinking or lighting of the alarm indicator. The device is used with commercially available sensors for intubated and non-intubated patients. The CO2 monitor is intended to be used in an ER, OR, ICU, CCU or general ward on all patient populations, depending on the accessories used with the device. The OLG-3800A is AC and/or battery operated.
When the operation mode is set to Network mode, the CO2 monitor can connect to a Nihon Kohden monitoring system network and communicate with the central monitor and bedside monitor on the network.
A new optional accessory, single-use adult cap-ONE Biteblock YG-227T can be used together with OLG-3800. YG-227T is inserted between the patient's teeth to prevent closure of the patient's jaws. It connects to a specified Nihon Kohden CO2 sensor kit to measure the partial pressure of the expired CO2 of a patient. Also, it allows oxygen (including an oxygen-air mixture) to be provided to the patient during endoscopy.
This document describes the Nihon Kohden CO2 Monitor, Model OLG-3800A, and its substantial equivalence to predicate devices. However, it does not contain a typical study design with the elements requested (acceptance criteria, device performance, sample size, ground truth, expert involvement, etc.) for an AI/ML-based medical device. Instead, it details the device's technical specifications, indications for use, and compliance with various international standards for medical electrical equipment and a brief section on performance testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of regulatory submission (a 510(k) for a hardware medical device with standard electrical and performance testing against a predicate device, not an AI/ML algorithm requiring a clinical validation study with human readers or standalone performance metrics).
However, I can extract information related to the device's stated performance and compliance with relevant standards, which serve as its "acceptance criteria" in this context.
Here's the information that can be extracted or inferred based on the provided document:
1. A table of acceptance criteria (from standards) and the reported device performance:
| Acceptance Criteria (from Standards) | Reported Device Performance (from text) |
|---|---|
| CO2 Measurement Accuracy (with specific sensors): | Nihon Kohden CO2 Monitor, Model OLG-3800A (New Device) |
| TG-900P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) | TG-900P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) |
| ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) | ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) |
| ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) | ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) |
| TG-920P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) | TG-920P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) |
| ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) | ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) |
| ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) | ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) |
| TG-970P, TG-980P: ±2 mmHg (0 ≤ CO2 ≤ 40 mmHg) | TG-970P, TG-980P: ±2 mmHg (0 ≤ CO2 ≤ 40 mmHg) |
| ±5 % reading (40 |
§ 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).