Period: July – November 2018
Client: Pulse Oximeter
Risk Class: Class IIb
The Clinical Evaluation is made with the outlines of the scope and context of the evaluation; the inputs (clinical data and PMS/PMCF data); the appraisal and analysis stages; and conclusions about the safety and performance of Capnography. It also contains enough information to be read as a standalone document by an independent party.
Currently available scientific literature, both favourable and unfavourable, were selected using keywords, texts and phrases pertaining to the intended use, risk-benefit, clinical evidence of the Pulse Oximeter. Data of similar devices were retrieved from potential sources such as PubMed, PMC, the Cochrane library and so on. Data that did not support the safety or performance were excluded and data that supported the intended purpose, risk-benefit, clinical evidence of the device were included while searching. Once the data were collected, the relevancy of the data was screened again based on the factors that whether the data is concerned with the technology and whether it is discussing the safety and performance of the device. Out of the 18 literatures, only 14 were identified as pertinent data. These data are appraised and analysed
The data generated and held by the manufacturer and the clinical data from the literature were appraised considering the following parameters: identification of the information, quality of the methodology used, scientific validity, relevance and weightage of the contribution of data set to this evaluation. The data identified out of the 18 literature were that of the similar devices, which were high-quality data with appropriate device application on the appropriate patient group that was in line with the intended purpose of the pulse oximeter. Most of the data were also of Level 1 and 2 weights that served the similarity aspects and the mandatory suitability criteria without any deviation. 26 literatures are strong clinical evidence supporting the general safety and performance requirement of the pulse oximeter.
The Clinical Evaluation of capnography with pulse oximeter was conducted as per MDR, MDD/93/42/EEC – Article 15 and MEDDEV 2.7/1 Revision 4 guidelines.
Pulse oximeter was found to be clinical safe through literatures of equivalent device, similar devices, and analysis of clinical data. Preclinical studies on the biocompatibility of Pulse oximeter proves it to be biologically safe.
Note: The team is now working on similar projects in compliance with 2017/745 Article 61 for same type of devices.
- PMS data show that pulse oximeter is clinically safe and efficient.
- PMCF data show that pulse oximeter is clinically safe and efficient.