(60 days)
The K-Systems Culture bag system is intended for use during Assisted Reproduction Technology (ART).
The K-SYSTEMS Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microenviroment.
The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag.
When the K-Systems Culture Bags have been filled with the appropriate gas mixture the K-Systems Culture Bags are placed in a conventional incubator for maintaining the temperature.
The K-Systems culture bag sytem is a closed system that reduces the risk of cross contamination within the incubator.
The K-Systems Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microenvironment. The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag.
This document is a 510(k) clearance letter from the FDA for the K-Systems Culture Bag Sealer and Culture Bags. It outlines the intended use of the device and confirms its substantial equivalence to a legally marketed predicate device.
This document DOES NOT contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for device performance.
The letter is a regulatory approval, not a scientific study report. Therefore, I cannot provide the requested information from the provided text.
§ 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.