(135 days)
The AT MEDICAL XQ-1 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature and CO2, O2, and N2 gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/ assisted reproduction technology (ART) treatments.
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I apologize, but the provided text from the FDA 510(k) clearance letter for the AT Medical XO-1 device does not contain the detailed information necessary to answer your request.
Specifically, the document focuses on the regulatory clearance for the device, stating its intended use as an incubator for gametes and embryos during in vitro fertilization (IVF)/assisted reproduction technology (ART) treatments. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, it does not include:
- A table of acceptance criteria or specific reported device performance metrics.
- Details about a study that proves the device meets acceptance criteria, such as:
- Sample sizes (test or training sets)
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies or effect sizes
- Standalone algorithm performance
- Type of ground truth used or how it was established.
This type of detailed study information is typically found in the full 510(k) submission, which is not provided here, or in associated clinical or validation reports, rather than the FDA clearance letter itself.
§ 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.