10.2.1 EDF IOL as a modification of an approved monfocal parent: At least 100 subjects in the EDF IOL and control arm shall be included in a bilateral implantation study and followed up for 6 months postoperatively. Bilateral implantation shall not be implemented until initial safety and performance has been confirmed Note: Typically, bilateral implantation of the EDF IOL in 30 subjects may be adequate for a pilot study. 10.2.2 EDF IOL without approved monofocal parent: In cases where no previously approved monofocal parent exists for the EDF IOL, the safety and effectiveness requirements described below shall be integrated into clinical design of a monofocal IOL described in ISO 11979-7. 10.3 Effectiveness Requirements The effectiveness of the EDF IOL be evaluated. The following criteria shall be met: The EDF IOL demonstrates statistical superiority over the control group on mean, monocular distance corrected intermediate visual acuity at 66 cm. The EDF IOL demonstrates at least 0.5 D greater monocular photopic depth of focus compared to the monofocal control IOL at 0.2 logMAR visual acuity threshold. The median, monocular distance-corrected photopic intermediate visual acuity at 66 cm is at 0.2 logMAR. The mean, monocular best corrected distance acuity for the EDF IOL is statistically non-inferior to the control using a non-inferiority margin of 0.1 logMAR. Annex B contains suggested detail concerning a clinical investigation. 11 Labeling The requirements of ISO 11979-4 shall apply, with the following additions. A graph of the spectral transmittance through the EDF IOL Dioptric power A graph of the MTF through focus response of the EDF IOL in the model eye compared to a monofocal and multifocal IOL. Instructions for use, including power constant and a statement that only validated folders/ injectors shall be used. Summary of clinical including defocus curves for EDF IOL and control. trial trial
Annex D (informative) Labeling D.1 This provides recommendations for labeling of EDF IOLs in addition to the requirements stated in clause 11. D.2 Information to be found on the outer container applicable, the following items should be provided on the outer lens container: Name and address of manufacturer Trade name number Diopter Lot/serial number Overall diameter and optic body diameter (minimum and maximum if non-symmetric) Drawing/diagram depicting configuration of the lens Anatomical placement Expiration date “Single Use” statement or symbol “Sterile” statement or symbol Method of sterilization Storage conditions D.3 Labeling for inner container and/or pouch The inner container and/or pouch should provide the following information: Name of manufacturer number Diopter Lot/serial number Overall diameter and optic body diameter (minimum and maximum if non-symmetric) The following statements: “Sterile,” “Do not reuse,” “Do not resterilize” D.4 Physician package insert The package insert for the implanting physician should include the following information: Prescription device statement: “Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.” Indications for use Contraindications Warnings Precautions Adverse events experienced during the clinical investigation
7. U.S. Food and Drug Administration; “Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers,” April 19, 2001. 8. Lin, S.C.; “Sample size for therapeutic equivalence based on confidence interval,” Drug Information Journal Vol. 1995; 29, 45-50.