CFR

884.6120—Assisted reproduction accessories.

(a) Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:

(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).

(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.

(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.

(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.

(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.

(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

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