(617 days)
The Minitube SC-2000 + 2045 temperature control unit is indicated maintaining the temperature of biological material like gametes and embryos at a certain temperature which is essential to rover multiple applications in reproductive medicine, biology and other areas.
The Minitube Temperature Control Unit SC-2000 & SC-2045 is a temperature control unit. The only distinguishing feature between the SC-2000 and the SC-2045 is that the inserts on the warming plates of the SC-2045 are at a 45 degree angle from a level horizontal plane, whereas the SC-2000 inserts are vertical to that plane.
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Minitube Temperature Control Unit SC-2000 & SC-2045." This letter determines substantial equivalence to a predicate device but does not contain the acceptance criteria, study details, or performance data typically found in a clinical study report.
Therefore, I cannot extract the information required to answer your request. The document explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device's approval is based on its similarity to an already approved device, rather than new clinical trials with specific acceptance criteria and performance studies for this particular device.
To provide the information you've requested, I would need a different type of document, such as a complete 510(k) submission, a clinical study report, or a summary of safety and effectiveness data.
§ 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.