(86 days)
THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.
The THERMOPLATE is a device automatically controls the temperature of specimens under the microscopes. The THERMOPLATE is made up of two sections: the plate section and the controller section. The plate section is to be set on the stage of a microscope. The specimen placed on the plate section can be maintained at an optimum temperature by the function of the heating element and the heating control unit. As a clear heating material is being coated inside the plate section, sufficient insulation is provided for the heating mechanism.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves it meets any criteria. The document is a 510(k) summary for a medical device (THERMOPLATE Stage Warmer) and primarily focuses on its description, intended use, and substantial equivalence to a predicate device for regulatory clearance. It mentions "This product's electrical safety and accuracy had been proven by conforming to UL/CE standards" but does not detail the specific acceptance criteria or study results for accuracy, nor does it provide information about sample sizes, ground truth, expert qualifications, or MRMC studies.
§ 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). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.