§ 884.6195 Assisted Reproduction Embryo Image Assessment System.

(a) Identification. An Assisted Reproduction Embryo Image Assessment System is a prescription device that is designed to obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing.

(b) Classification. Class II (special controls). The special control(s) for this device are:

(1) Clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be assessed at the subject and embryo levels.

(2) Software validation, verification, and hazard analysis must be provided.

(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:

(i) Total light exposure and output testing;

(ii) A safety analysis must be performed based on maximum (worst-case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device;

(iii) Simulated-use testing;

(iv) Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage;

(v) Cleaning and disinfection validation of reusable components;

(vi) Package integrity and transit testing;

(vii) Hardware fail-safe validation;

(viii) Electrical equipment safety and electromagnetic compatibility testing; and

(ix) Prediction algorithm reproducibility.

(4) Labeling must include the following:

(i) A detailed summary of clinical performance testing, including any adverse events;

(ii) Specific instructions, warnings, precautions, and training needed for safe use of the device

(iii) Appropriate electromagnetic compatibility information;

(iv) Validated methods and instructions for cleaning and disinfection of reusable components; and

(v) Information identifying compatible cultureware and explain how they are used with the device.

[80 FR 10332, Feb. 26, 2015]