(182 days)
The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer.
The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site.
The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.
Within the United states market, the use of this device should be limited to 72 hours.
The Neotrend Sensor (N7004S) is a modified version of the currently legally marketed device, the Paratrend 7 sensor (MPS7004). The measurement of pO2 using an electrochemical sensor (Clark electrode) in the predicate Paratrend 7 sensor has been replaced in the Neotrend device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The application has been expanded to include umbilical artery access.
The provided text describes the Neotrend Multiparameter Sensor, a modified version of the Paratrend 7 sensor. It details the device's technical characteristics, intended use, and claims substantial equivalence to previously cleared devices. However, the document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria.
Instead, it presents a comparison of the Neotrend sensor's accuracy to its predicate device, the Paratrend 7. This comparison focuses on bias and precision for pO₂, pCO₂, and pH measurements. The study methodology is outlined, but specific acceptance criteria (e.g., maximum allowable bias or standard deviation) are not provided. Therefore, it's impossible to report whether the device "meets" acceptance criteria based on this document.
Here's a breakdown of the information that is available and the parts that are missing based on your request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: NOT PROVIDED. The document states "The data presented above satisfies product accuracy claims and shows comparable results for both Senior and Satellite," but it does not specify what those "product accuracy claims" are in terms of concrete numerical acceptance criteria (e.g., ΔpO₂
§ 868.1150 Indwelling blood carbon dioxide partial pressure (P
2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”