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The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments. The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

The G210 InviCell Plus with SignipHy™ pH Monitoring System is an assisted reproduction incubator that includes an accessory pH monitoring feature. The incubator component of this device (G210 Invicell) is regulated under 21 CFR 884.6120, product code PBH (exempt). The incubator includes 10 incubation chambers and one larger preparation chamber that is used for the equilibration of plates/oil before use. The tri-gas incubator provides a controlled environment (temperature, CO2/O2/N2) for gametes and embryos in the incubation chambers. The pH monitoring feature of the G210 InviCell Plus with SignipHy™ pH Monitoring System is controlled separately and does not impact the operation or incubator functions of the device. The SignipHy™ pH Monitoring System consists of the following components: - . SignipHy™ TrakPod – An LED-based, optical pH measurement instrument. The SignipHy TrakPod is physically supported within the chassis of the incubator and allows monitoring of one incubator chamber. It is a USB connected fluorescent measurement device with a fiber optic cable and fixture that connects to the SignipHy sv2 Sensor inside an incubator chamber. The SignipHy TrakPod and SignipHy sv² Sensor together detect the pH of a liquid sample. - . SignipHy™ sv2 Sensor – The SignipHy sv2 Sensor is a single-use, polystyrene, ethylene oxide sterilized vessel that is loaded with a sample of bicarbonate-buffered assisted reproduction technology (ART) media with a pH between 6.8 and 7.2 for pH tracking. The bottom of the sensor includes a membrane that is impregnated with a dye that is affected by the pH of the media sample. The sensor fits into the SignipHy TrakPod fiber optic fixture located in an incubation chamber. SignipHy sv2 Sensors can be used for measuring pH at one-minute intervals for three days or 30-minute intervals for seven days. - . SignipHy™TrakStation – A tablet computer running proprietary software that initiates pH readings, displays results, and stores pH measurement data over time. Up to eight SignipHy TrakPods can be connected to a single SignipHy TrakStation. - SignipHy™ qc² Alignment Tool - A fluorescent reference device for use in system alignment and quality control. To make a pH measurement, the SignipHy TrakPod sends green light flashes (peak 518 nm) through the fiber optic fixture. The dye in the membrane reacts by sending back flashes of light at a different wavelength (peak 600 nm). The SignipHy TrakPod reads this result and calculates the pH of the media sample that is then displayed on and stored in the SignipHy™TrakStation.

The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.