We offer testing services of medical endoscopes and provide test reports to use in 510(k) submissions to the FDA as well as in international regulatory submissions for medical device approval and registration. Measurements are aimed to evaluate device effectiveness for its intended use and to assess if the subject endoscope provides equivalent or better performance than predicate endoscopes. Sigma Scientific Services is an A2LA and FDA accredited medical safety and performance test laboratory.
Test Methods
Testing of medical endoscope systems as per the following relevant international optics and photonics standards for medical endoscopes and endotherapy devices:
ISO 8600-1: General requirements
ISO 8600-3: Determination of field of view and direction of view
ISO 8600-4: Maximum width of insertion point
ISO 8600-5: Determination of optical resolution
ISO 15739: Noise measurements
ISO 12233: Resolution and spatial frequency responses