(78 days)
The K-SYSTEMS Work Station is intended for maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with steribenair.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "K-SYSTEMS Work Station." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a detailed submission summary.
The letter is primarily focused on regulatory clearance and states the intended use of the device: "maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with sterilized air."
Therefore, I cannot provide the requested information. The necessary details for answering your questions are not present in the provided FDA clearance letter.
§ 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.