(56 days)
The Nihon Kohden TG-920P 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 new TG-920P CO2 Sensor Kit has an airflow cannula where the device can be use for Children patients weighing more than approximately 7kg, where the predicate device TG-920P CO2 Sensor Kit is for weighing more than 10 kg. The new TG-920P CO2 Sensor Kit has a pressure tube for breath detection, where the predicate does and the new device is not sterilized where the predicate device can be sterilized once with ethylene oxide gas before use. The new device is similar to Nihon Kohden predicate device in use with the TG-920P CO2 sensor kit to measure the partial pressure of the expired CO> of the patient for nasal-oral breathing, use frequency, shelf-life, patient contact, storage environment, chemical resistance and safety.
The provided text is a 510(k) summary for a medical device called the "TG-920P CO2 Sensor Kit." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study showing a device meeting specific acceptance criteria with quantifiable performance metrics.
Therefore, it is not possible to complete the requested table and answer many of the questions as the information is not present in the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device complies with IEC-60601-1 standard and sub-clause 56.3 (c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. | Safety tests confirmed the device performed within specifications (specifically a display test for the prototype). |
| Environmental compatibility: Withstands environmental, vibration, and impact tests. | The devices were subjected to tests including safety, environment, vibration and impact. (No specific performance values provided for these tests, only that they were subjected to them and implied to pass for substantial equivalence). |
| Sterilization Status: Device is not sterilized. | The device is not sterile. |
| Intended Use: Measure CO2 concentration in a gas mixture to aid in determining patient's ventilatory status; measure expired CO2 partial pressure and respiratory airflow with a cannula tube. | The new TG-920P CO2 Sensor Kit has the same intended use as the predicate. Measures partial pressure of expired CO2 for nasal-oral breathing. |
| Patient Population (Weight): Children weighing more than approximately 7kg (new device). | The new TG-920P CO2 Sensor Kit is for Children patients weighing more than approximately 7kg. (Predicate was >10kg). |
| Breath Detection Method: Includes a pressure tube for breath detection (new device). | The new TG-920P CO2 Sensor Kit has a pressure tube for breath detection, where the predicate does not. |
| Use Frequency, Shelf-life, Patient Contact, Storage Environment, Chemical Resistance: Similar to predicate device. | The new device is similar to Nihon Kohden predicate device in use with the TG-920P CO2 sensor kit to measure the partial pressure of the expired CO> of the patient for nasal-oral breathing, use frequency, shelf-life, patient contact, storage environment, chemical resistance and safety. |
Missing Information/Not Applicable:
Since this is a 510(k) for substantial equivalence based on a predicate, a detailed clinical "study" with the characteristics you're asking for is typically not required or presented in this summary. The focus is on demonstrating that the new device is as safe and effective as the predicate.
This means the following questions cannot be answered from the provided text:
- 2. Sample size used for the test set and data provenance: No specific test set sample size or data provenance (country, retrospective/prospective) is provided. The tests mentioned ("safety, environment, vibration and impact") are likely internal engineering and bench tests, not clinical studies with patient data.
- 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable, as there's no mention of a ground truth established by experts for a clinical test set.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study is for diagnostic devices where human readers interpret results, which is not the primary function being evaluated here for a CO2 sensor.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For regulatory compliance, the "ground truth" for the tests mentioned would be the defined specifications or standards (e.g., IEC-60601-1). There is no "ground truth" in the sense of clinical outcomes or expert consensus for this type of device performance evaluation in this document.
- 8. The sample size for the training set: Not applicable. This device is not described as involving machine learning or AI that would require a "training set."
- 9. How the ground truth for the training set was established: Not applicable.
§ 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).