(184 days)
The Planer BT37 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature, CO2, O2 and N2 gases, and elevated humidity for the development of gametes and embryos during in vitro fertilization (IVF) / assisted reproductive technology (ART) treatments.
The BT37 Incubator has been designed as a bench-top incubator to provide a electronically controlled environment (temperature and humidified-gas (premixed gas; typically 6% CO2, 5% O2, balance N2)) for use in cell culture as part of In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments. The BT37 Incubator overall dimensions are 420mm wide x 270mm deep x 210mm high, with a weight of 15,5 kg. The BT37 Incubator has two chambers each of which have been designed to hold a variety of dishes. In case of external power failure, the BT37 incubator is equipped with an internal backup battery to maintain functionality for up to 120 minutes. The BT37 Incubator provides an environment with elevated humidity by bubbling the incoming gas through a heated humidification bottle containing water. This gas this then passed to the left and right incubation chambers. In its default configuration, the BT37 normally provides gas at a constant flow rate of 30 mL/min. After closing the lids, an increased gas flow at 360 ml./min is provided for 3 minutes to purge the systems. After fitting a new bottle, a triple length purge of 360 ml /min for 9 minutes is provided. An alternative pulsed flow regime is available, where the normally constant flow of 30 mL/min can be replaced by a flow that pulses between a high and low rate. The default for these settings are normally 60 mL/min and 20 mL/min respectively with a time ratio designed to provide a mean flow of 30 mL/min. This flow approach is not normally used.
The Planer BT37 Incubator is a bench-top incubator designed for use in In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments. It provides an electronically controlled environment (temperature and humidified-gas) for cell culture.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Function / Parameter | Acceptance Criteria (Predicate or BT37) | Reported Device Performance (BT37) |
|---|---|---|
| Indication for Use | Storage and preservation of gametes and/or embryos at or near body temperature. | Provides an environment with controlled temperature, CO2, O2, N2 gases, and elevated humidity for the development of gametes and embryos during IVF/ART. |
| Gas Supply Blend | Similar (Implicitly 6% CO2, 5% O2, 89% N2) | 6% CO2, 5% O2, 89% N2 |
| Gas Supply Pressure | 150 kPa +/- 15 kPa | 150 kPa +/- 15 kPa |
| Gas Flow Rate Capability (per side) | 15 mL/min to 25 mL/min (normal) | 0 mL/min to 450 mL/min (fully adjustable) |
| Gas Flow Rate Accuracy (normal flow) | ±15% of flow per chamber | ±10% of flow per chamber |
| Gas Flow Pattern | Non-pulsed (constant) | Pulsed or non-pulsed (constant) |
| Chamber Temperature Capability | 35.0 °C to 40.0°C (with specific ambient temp ranges) | (ambient + 5 °C) to (ambient + 20 °C), not to exceed 40 °C |
| Chamber Temperature Accuracy | ±0.2 °C at calibration point | ±0.2 °C at calibration point |
| Humidification System | Similar (Preheated bottle, gas bubbled through water) | Preheated bottle, gas bubbled through water prior to chambers |
| Accelerated Ageing (Humidification Bottle) | Not explicitly stated (predicate) | Justified shelf-life of 29 months at room temperature |
| Software Functionality | Not explicitly stated (predicate) | All functions operated correctly with no significant anomalies |
| Electrical Safety | Compliance with relevant standards (Implicitly) | EN61010-1:2001 and BS EN 61010-2-010 |
| Electromagnetic Compatibility (EMC) | Compliance with relevant standards (Implicitly) | EN 61236-1:2006 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical or evaluation studies with human data. The "tests" described are engineering and performance validation tests of the device itself.
- Sample Size for performance tests: Not explicitly stated, as these are likely repeat measurements on the device itself.
- Data Provenance: The tests were conducted internally by Planer plc and, for electrical safety and EMC, by accredited testing bodies. The testing is prospective in nature, as it's directly evaluating the performance of the BT37 Incubator. The country of origin of the data is United Kingdom (where Planer plc is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for this device's performance tests would be established by validated scientific and engineering principles, and measurement standards, rather than expert consensus on medical images or diagnoses. No human experts were used to establish ground truth for a clinical "test set" in the context of the provided text.
4. Adjudication Method for the Test Set
Not applicable. There was no "adjudication" necessary as the tests were objective performance measurements against defined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not relevant for this type of device (an incubator). Such studies are typically performed for diagnostic devices (e.g., AI for medical imaging) to assess how human readers perform with and without AI assistance on a set of clinical cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The "tests and test results" section describes the standalone performance of the BT37 Incubator in achieving its specified operational parameters for temperature, humidity, gas concentration, and flow. These tests evaluated the device's inherent capabilities without human intervention or judgment as part of the performance measurement.
7. The Type of Ground Truth Used
The ground truth used for the performance tests was based on:
- Engineering specifications and design requirements: The device was tested against its own design parameters for temperature control, gas flow, humidification, etc.
- Industry and regulatory standards: Electrical safety (EN61010-1:2001, BS EN 61010-2-010) and EMC (EN 61236-1:2006) tests confirm compliance with established external benchmarks.
- Physical measurements: Using calibrated equipment to measure temperature, gas flow, humidity, etc., provides objective ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device's control system would be part of its engineering design and calibration, not a data-driven learning process.
9. How the Ground Truth for the Training Set Was Established
As above, this concept is not applicable here as it refers to a device which is not an AI/ML algorithm.
§ 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.