(209 days)
For Models HF90, HF240, the intended use of these incubators is to provide an environment with controlled temperature, CO2 elevated humidity, and an automatic disinfection mode, for the development of ova or embryos at or near body temperature.
The HEAL FORCE CO2 Incubator is a piece of assisted reproductive laboratory equipment used for incubation of ova and embryos.
Structure:
- The outer casing is made of electrolytically galvanized steel sheet and lacquered white (RAL 9002).
- The control elements are made of plastic.
- The inner casing is made of stainless steel.
Internal Fittings: - The pullout shelves are tilt-proof and adjustable over a height of 50 mm. Removal of shelves, carrier requires no tools, and they can be taken out together at a time.
Heating System: - Large-surface heating cables are arranged on the outside of the inner casing, to heat the interior space. The heating cables are placed beneath the water reservoir, on the ceiling, on the upper part of the rear wall and in front of the outer door.
- When the outer door is heated, condensation will not precipitate on the glass door. Therefore, the interior remains clearly visible in spite of the prevailing high humidity. Condensation may be formed if the outer door is left open for some time.
The provided document is a 510(k) Summary for a medical device (CO2 Incubator). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It is crucial to understand that a 510(k) submission for a non-AI/ML medical device like a CO2 incubator does not typically involve the kinds of studies or acceptance criteria that would be found for an AI/ML diagnostic or therapeutic device. The acceptance criteria are primarily focused on engineering and performance specifications, and the "study" is a comparison to a predicate device and adherence to recognized safety and performance standards for the incubator's function.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training set ground truth) are not applicable to this type of device and submission.
Here's the information that is applicable based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are derived from the performance specifications of the predicate device, which the new device aims to match or demonstrate substantial equivalence to. "Reported device performance" refers to the specifications of the submitted device.
| Element of Comparison | Predicate Device (HERAcell CO2 Incubator) Performance (Acceptance Criteria) | Submitted Device (HEAL FORCE CO2 Incubator) Performance |
|---|---|---|
| Temperature | ||
| Range | Ambient Temperature +3°C - +55°C | Ambient Temperature +3°C - +55°C |
| Time deviation | ± 0.1 °C | ± 0.1 °C |
| Spatial deviation | ± 0.5 °C | ± 0.5 °C |
| Recovery time (at 37°C) | ≤10min (30 sec. door open, to 98% of initial value) | ≤10min (30 sec. door open, to 98% of initial value) |
| CO2 Control | ||
| Set range | 0-20% | 0-20% |
| Control accuracy | ± 0.1% | ± 0.1% |
| Recovery time (5%CO2) | ≤5min (HERAcell 150) | ≤5min (HF90) |
| ≤10min (HERAcell 240) | ≤10min (HF240) | |
| Relative Humidity | ||
| Constant humidity at 37°C (high-humidity mode) | Approx. 95% rH | Approx. 95% rH |
| Constant humidity at 37°C (low-humidity mode) | Approx. 90% rH | Approx. 90% rH |
| Power requirements | AC 230V, AC 120V | AC 230V, AC 120V |
| Ambient temperature | +18 °C to + 33 °C | +18 °C to + 33 °C |
| Energy used | HERAcell 150: 640W, HERAcell 240: 640W | HF 90: 650W, HF 240: 710W |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is an incubator, not an AI/ML diagnostic device that operates on a "test set" of data in the sense implied by the question. The "testing" involves engineering verification and validation of the physical device's performance against its specifications and relevant standards. The document doesn't provide details on the number of physical units tested or the data generated during performance verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of an AI/ML device refers to a definitive correct answer for a diagnostic or classification task. For a CO2 incubator, the "ground truth" is adherence to physical/chemical parameters (temperature, CO2 concentration, humidity), which are measured by calibrated instruments, not established by human experts in this manner.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic tasks. This is not relevant to the performance verification of an incubator.
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. MRMC studies assess human performance (e.g., radiologists interpreting images) with and without AI assistance. This is entirely outside the scope of evaluating a CO2 incubator, which is a laboratory equipment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm with standalone performance in the sense of AI/ML. Its performance is measured as a fully contained physical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of the CO2 incubator is based on physical measurements using calibrated sensors and instrumentation to verify parameters such as temperature stability, CO2 concentration accuracy, humidity levels, and recovery times against established engineering specifications and product claims.
8. The sample size for the training set
- Not Applicable. This device does not have a "training set" in the context of AI/ML algorithms.
9. How the ground truth for the training set was established
- Not Applicable. Since there is no training set, there is no ground truth for a training set to be established.
Study that proves the device meets the acceptance criteria:
The document describes the following "study" and evidence of meeting acceptance criteria for substantial equivalence:
- Comparison to Predicate Devices: The primary method for proving the device meets acceptance criteria and is safe and effective is a direct comparison table (Table 01 for Model HF90, HF240) against legally marketed predicate devices (Kendro Heracell CO2 Incubator - K002805 and K023465). The comparison demonstrates that the submitted device has identical or substantially similar technological characteristics and performance specifications for key parameters like temperature control, CO2 control, humidity, recovery times, and physical construction.
- Safety and Performance Data: "Electrical, mechanical, environmental safety and performance testing have been accomplished according to standard EN/IEC 60601-1-2 for EMC considerations and EN/IEC 61010 for product safety." This indicates that the device underwent engineering verification and validation against recognized international standards to ensure its safety and performance. This is the "study" that supports the device specifications and, by extension, its substantial equivalence to predicate devices, thus meeting "acceptance criteria."
In summary, for a non-AI/ML medical device like a CO2 incubator, the "acceptance criteria" are its technical specifications matching those of a predicate device and adherence to general safety and performance standards. The "study" is the verification and validation testing against these standards and the demonstration of substantial equivalence through comparison with a predicate 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.