(119 days)
The Workbench will be used as an accessory item during assisted reproductive procedures.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Workbench™ by ". This document only states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information.
It does not contain any information regarding:
- Acceptance criteria for the device's performance.
- Details of any study conducted to prove the device meets acceptance criteria (such as sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input.
§ 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.