(108 days)
The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.
The COOK Mini-Incubator is a small microprocessor-controlled, carbon dioxide (CO2) incubator that provides two separate humidified incubation chambers, each accepting up to four NUNC® or FALCON® 4-well culture trays. Designed for bench top use, the COOK Mini-Incubator provides controlled temperature and CO2 gas flow.
The provided text describes the COOK Mini-Incubator, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a comprehensive study description as requested.
The document states: "The COOK Mini-Incubator was subjected to testing to assure satisfactory operating performance. The COOK Mini-Incubator passed the requirements of all tests." This is a high-level statement without specific outcomes or methodology.
Therefore, I cannot provide the requested information from the given text.
Here's why and what's missing:
- Acceptance Criteria Table: The document doesn't list any specific performance metrics or their acceptable ranges (e.g., temperature stability, CO2 concentration accuracy, humidity levels).
- Reported Device Performance: No actual performance data (e.g., "temperature maintained at 37°C +/- 0.5°C") is provided.
- Sample Size (Test Set): The document does not mention the number of devices or experimental replicates used in the testing.
- Data Provenance: No information about the origin of the data (e.g., country, retrospective/prospective).
- Number of Experts/Qualifications (Ground Truth): This type of device (an incubator) typically doesn't involve expert readers for ground truth in the way medical imaging AI devices do. The "ground truth" would be objective measurements from calibrated instruments. The document doesn't describe who conducted the tests or their qualifications (e.g., "engineers with X years of experience in thermal dynamics").
- Adjudication Method: Not applicable for this type of device testing as described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is relevant for AI-assisted image analysis where human readers interpret medical images. It is not applicable to a device like an incubator.
- Standalone Performance: While the "algorithm only" concept doesn't apply, the device's standalone performance was assessed (it underwent testing to assure satisfactory operating performance). However, the details of that performance are absent.
- Type of Ground Truth: For an incubator, ground truth would be established by calibrated sensors and instruments measuring temperature, CO2, and humidity. This is not explicitly stated, nor are the specific methods.
- Sample Size (Training Set): Not applicable for this type of device where performance is validated through physical testing, not a machine learning model.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided FDA 510(k) summary is a high-level regulatory document confirming substantial equivalence, but it does not contain the detailed technical study results or acceptance criteria that would typically be found in a design verification and validation report for the 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.