(14 days)
Incubators series CB provide suitable growth-conditions for NaHCO3 -buffered cell cultures of ova or embryos with controlled temperature at or near 37°C (98.6°F) and carbon-dioxide atmosphere (optional additionally at hyper oxide or hypo oxide atmosphere) at a high humidity. A automatic dry heat decontamination process of the empty incubator, applicable between different loadings assists to avoid contaminations of the cell cultures.
BINDER incubators series CB are bench top or floor standing units. There are two different sizes available. One of approximately 5.3 cubic feet inner volume (150 liters) and one with 7.4 cubic feet volume (210 liters). One multi-channel controller with a large area LCD screen controls the growth parameters temperature and inner carbon-dioxide (CO2) concentration and provide elevated humidity. The inner chamber volume is closed against the environment. Optionally the units are equipped with a control channel for Oxygen (O2). Temperature, CO2 concentration (optional also O2 concentration) are microprocessor controlled. Constant and reliable temperatures are achieved by the patented air-jacked heating system. The air-jacket provides highly precise and homogeneous temperatures within the incubator which is ideal for long term culturing. The system has very short recovery times upon door openings. The concentration of CO2 is controlled by a single beam infrared (IR) difference detector. The IR sensor has an auto correction function and is characterized by minimal reaction latencies. The detection system for the optional Oxygen control bases on the amperometric system of a Zirconium-Dioxide (ZrO2) electrode.
The incubator is equipped with a dry-heat decontamination function at 187°C (368.6°F).
This document is a 510(k) summary for the BINDER CO2 incubator series CB. It describes a medical device, its intended use, and its comparison to a predicate device. It also includes the FDA's clearance letter.
Here's an analysis based on your request, highlighting that this document is not about an AI/ML device, and therefore several requested categories are not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with reported performance values in a table format. However, it indicates successful completion of various tests.
| Test Category | Reported Performance / Outcome (Implicit Acceptance) |
|---|---|
| Electrical Safety | Successfully passed |
| Electromagnetic Compatibility | Successfully passed |
| Operating Performance | Successfully passed |
| Decontamination Testing | Successfully passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are engineering and functional tests on the device itself, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests mentioned (electrical safety, EMC, operating performance, decontamination) are engineering and regulatory compliance tests. They do not involve expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human assessment or adjudication of data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a CO2 incubator, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a CO2 incubator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (electrical safety, EMC, operating performance, decontamination), the "ground truth" would be established by relevant engineering standards, regulatory requirements, and the expected functional specifications of the incubator. For example, for temperature control, the ground truth would be the specified temperature range and stability.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The tests relate to the physical device's performance.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 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.