(88 days)
The Forma Scientific Universal Water Jacketed Incubators are intended to be used to store, preserve and grow gametes and/or embryos at or near body temperature.
The intended use of these incubators is to provide an environment with controlled temperature, CO2 and an elevated humidity, for the development of ova or embryos. Certain models also control O2 at suppressed levels.
The Forma Scientific incubators are bench top, or floor standing units. They control carbon dioxide (CO2), temperature and provide elevated humidity. Certain models also control O2 at suppressed levels. Controlled parameters and alarm functions are microprocessor controlled. The volume of each chamber is approximately 6.5 cubic feet (184 liters).
The provided text describes a 510(k) submission for the Forma Scientific Incubator, an embryo incubator. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance metrics in the way a diagnostic device might.
Therefore, much of the requested information (items 1-9) about a study proving the device meets acceptance criteria is not applicable or not present in the provided text. The incubator is a medical device that requires environmental controls, and the "tests and test results" section refers to engineering and safety verifications rather than clinical performance studies with a "ground truth."
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical safety | Passed all tests |
| Electromagnetic compatibility acceptability | Passed all tests |
| Operating performance | Passed all tests |
| Maintain controlled CO2 | Controls CO2 |
| Maintain controlled temperature | Controls temperature |
| Provide elevated humidity | Provides elevated humidity |
| (Certain models) Control O2 at suppressed levels | (Certain models) Controls O2 at suppressed levels |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The "tests" mentioned are engineering and safety verifications, not clinical trials with "test sets" or "data provenance" in the typical sense of a diagnostic device.
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/Not provided. There is no "ground truth" to be established by experts for the operational performance of an incubator in the context of this document. The "tests" are against predefined technical specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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 an incubator, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an incubator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the performance of an incubator would be its ability to maintain specified environmental parameters (e.g., CO2 concentration, temperature, humidity) within acceptable tolerances. This is measured directly by sensors and calibrated equipment, not by expert consensus or pathology.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.