Clinical Trial: Prizma Pulse Oximeter Evaluation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational



Official Title: Prizma Pulse Oximeter Evaluation

Brief Summary:

This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically:

  • SpO2 value range 70% to 100%
  • 10 or more subjects, at least 3 of dark pigmentation
  • At least 200 data points
  • Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:

  • 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:

    • 4.1. ACCURACY OF PULSE OXIMETERS
    • 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS

  • ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2

    • 201.12.1.101 SpO2 accuracy of pulse oximeter equipment
    • 201.12.1.101.2 Determination of SpO2 accuracy