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.

Device Description

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.

AI/ML Overview

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.

Summary

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K121566

NOV 2-9 2012

Submitted By:

Company Name: Planer plc Address: 110 Windmill Road, Sunbury-on-Thames, Middlesex, TW16 7HD, United Kinadom. Phone: +44 (0) 1932 755 000 Fax: +44 (0) 1932 755 001 E-mail: cskinner@planer.com Contact Name: Clement Skinner Date of Submission: 22 November 2012

Name of Device.

Trade Name: BT37 Incubator Common Name: IVF Incubator Classification Name: Assisted Reproduction Accessory (21 CFR §884.6120) Product Code: MQG

Predicate Device:

COOK Mini-Incubator (510(k) Number: K983642)

Device Description:

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 with a maximum capacity per chamber as follows:

IVF Petri Dish*	Number per Chamber
NUNC 4 well	4
NUNC 60 mm	4
NUNC 35 mm	10
MINITUB 5 well	4
FALCON 60 mm	4

*This list is an example of available IVF 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.

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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.

Indication for Use:

Substantial Equivalence:

The Planer BT37 Incubator is substantially equivalent with respect to the intended use of the published predicate device description and technological characteristics: a dual chamber format is used; each chamber is independently controlled (temperature); the same gasses are used; the same process of supplying the gasses is used; and an equivalent humidification process is used. In both the predicate device and the BT37 Incubator, a filter is used on the humidification bottle to filter contaminates from the gas and prevent it entering the chambers.

From the viewpoint of the dishes used with the device, the two units are equivalent. The Primary differences are in the technologies used to control the gas flow and the temperatures, and the design of the user interface.

The BT37 Incubator provides the following features that are different from those found on the predicate device. Note that these features do not alter the fundamental function of the equipment and do not impact on the safety of the device.

The unit incorporates an external communication port that enables remote monitoring of the system.

The unit incorporates an inlet routing guide to ensure that the tube routing from the humidification bottle to the chambers is controlled, repeatable and not subject to temperature changes that could cause excessive condensation in the tubes.

The unit incorporates a two line liquid crystal display (LCD) allowing different parameters to be viewed.

The gas flow through the humidification bottle is visible via the front panel which allows visual feedback that the system is operating.

510(k) Number (if known):

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The unit provides a pulsed-flow feature that is not available on the predicate device. In normal use, non-pulsed, both the predicate device and the BT37 Incubator provide a constant flow of 30 mL/min shared between the left and right-hand sides of the incubator. In the BT37 incubator's pulsed-flow mode, the BT37 incubator maintains a mean flow by alternating between a low flow rate and a high flow rate. The default flow pattern is 20 ml/min for 900 s followed by 60 mL/min for 300 s which results in a mean flow of 30 mL/min; identical to that provided using the normal non-pulsed operating mode.

A summary of the device comparison is shown in the table below.

510(k) Number (if known):

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Function	Planer BT37 Incubator	Cook Mini-Incubator	Equivalence
Construction	Benchtop unit. Aluminiumchambers, with hinged lid.Simple cam mechanism toclamp lid shut and sealed withan O-ring seal.	Construction is similar.	Yes
Indication foruse	The Planer BT37 Incubator isintended to be used to providean environment with controlledtemperature at or near bodytemperature, CO2, O2 and N2gases, and elevated humidity forthe development of gametes andembryos during in vitrofertilization (IVF) / assistedreproductive technology (ART)treatments.	Intended to be used tostore and preservegametes and/or embryosat or near bodytemperature.	Yes. The Planer BT37 Incubatorstatement explicitly states the gasesused and the fact that the humidity iselevated. This does not represent achange in use but merely reflects thefact that statements for devicesraised after clearance of thepredicate device have tended toprovide more detail.
Gas supply	Blend of 6% CO2, 5% O2,89% N2	Similar	Yes
Gas supplypressure	150 kPa +/- 15 kPa	Same	Yes
Gas flow ratecapability perside	0 mL/min to 450 mL/min.Normal bleed set to 15 mL/minand purge at 180 mL/min for3 minutes. Flows fullyadjustable in 1 mL/minuteincrements.	15 mL/min to25 mL/minin 5 mL/min increments.Purge at 175 mL/minper chamber for3 minutes.	Yes. The Planer BT37 provides finerflow adjustment across a wider rangeof values.
Gas flow rateaccuracy(normal flow)	±10% of flow per chamber	±15% of flow perchamber (normal flow)±18 ml/min per chamber(purge)	Yes. Flow accuracy of the BT37 isslightly better during normal flow.
Gas flowpattern	Pulsed or non-pulsed (constant)flow pattern.	Non-pulsed (constant)	Yes, although the BT37 also supportsa pulsed-flow operating mode.
Chambertemperaturecapability	(ambient + 5 °C) to (ambient +20 °C)Upper temperature must notexceed 40 °C.	35.0 °C to 40.0°C in0.1°C increments in anambient temperaturerange of +20 °C to+28 °C. At set point of37 °C, the ambienttemperature range isextended to +18 °C to+32 °C	Yes. Although phrased differently,the control ranges are equivalent.
Chambertemperatureaccuracy	±0.2 °C at calibration point	±0.2 °C at calibrationpoint	Yes
Humidification system	Preheated bottle through which the incoming gas is bubbled prior to passing to the left and right chambers.	Similar	Yes

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The Planer BT37 Incubator meets the requirements for 510(k) substantial equivalence.

Discussion of Tests and Test Results:

The Planer BT37 Incubator was subjected to testing to ensure satisfactory operating performance. These tests addressed: stability and recovery for temperature, humidity and carbon dioxide; accuracy of temperature and flow; operation of alarms; and cleaning and disinfection. The Planer BT37 Incubator passed the requirements of all tests.

Accelerating ageing tests were undertaken to justify the shelf-life of the humidification bottle which is supplied sterile. These tests supported a shelf-life of 29 months at room temperature.

All functions of the software were tested and found to operate correctly with no significant anomalies remaining.

Electrical safety was confirmed by successful testing to EN61010-1:2001 and BS EN 61010-2-010. Electromagnetic compatibility (EMC) was confirmed by successful testing to EN 61236-1:2006.

Conclusion drawn from the non-clinical performance data:

From the results of the non-clinical performance data for the Planer BT37 Incubator, the conclusion can be drawn that the Planer BT37 Incubator is equivalent to the predicate device with respect to the intended use and technological characteristics.

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission to protect and promote the health and well-being of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 29, 2012

Planer plc % Eric S. Gruff, Ph.D., MBA Consultant E4 Consulting 15696 Oakstand Road POWAY CA 92064

Re: K121566

Trade/Device Name: BT37 Incubator Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: November 13, 2012 Received: November 14, 2012

Dear Dr. Gruff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 – Eric S. Gruff, Ph.D., MBA

You must comply with all the Act's requirements, including, but not limited to: registration and 1 ou must comply with an the rece orequenting of the reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements medical device-related advorse orchise or chise) regulation (21 CFR Part 820); and if applicable, the as set form in the quality systems (QS) regarations (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your contess ffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp://www.loadiological Health's (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of COTPL C the Center for Devices and reading by reference to premarket notification" (21CFR Part note the regulation emailed of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

510(k) Number (if known): K121566

Device Name: BT37 Incubator

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.11.29 16:03:26 -05'00'

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121566

510(k) Number (if known): K121566

Regulation Number and Section

§ 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.