PLANER BT37 INCUBATOR

K121566 · Planer Plc · MQG · Nov 29, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K121566
• Device Name: PLANER BT37 INCUBATOR
• Applicant: Planer Plc
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Nov 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

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 Story

Bench-top incubator for IVF/ART; provides controlled environment (temperature, humidity, gas mixture of CO2, O2, N2) for gamete/embryo development. Inputs: premixed gas supply (150 kPa); electrical power (with 120-minute internal battery backup). Operation: gas bubbled through heated humidification bottle; dual independently controlled chambers; constant or pulsed gas flow regimes. Output: stable incubation environment; visual feedback of gas flow via front panel; LCD display of parameters; remote monitoring via external communication port. Used in clinical IVF laboratories by embryologists/technicians. Benefits: provides stable, repeatable culture conditions; reduces condensation via inlet routing guide; allows remote monitoring of system status.

Clinical Evidence

Bench testing only. Evaluated stability and recovery for temperature, humidity, and CO2; accuracy of temperature and flow; alarm functionality; cleaning/disinfection protocols. Accelerated aging tests validated 29-month shelf-life for sterile humidification bottles. Electrical safety (EN61010-1, BS EN 61010-2-010) and EMC (EN 61236-1) testing performed.

Technological Characteristics

Benchtop unit; aluminum chambers with hinged lid and O-ring seal. Gas supply: 6% CO2, 5% O2, 89% N2. Flow: 0-450 mL/min (constant or pulsed). Temperature range: ambient +5°C to +20°C (max 40°C). Connectivity: external communication port for remote monitoring. Display: 2-line LCD. Power: AC with internal backup battery. Sterilization: humidification bottles supplied sterile.

Indications for Use

Indicated for use in IVF/ART treatments to provide a controlled environment (temperature, gas mixture, humidity) for the development of human gametes and embryos.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• COOK Mini-Incubator (K983642)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail] 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 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 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:

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.

#### 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. Aluminium<br>chambers, with hinged lid.<br>Simple cam mechanism to<br>clamp lid shut and sealed with<br>an O-ring seal. | Construction is similar. | Yes |
| Indication for<br>use | The Planer BT37 Incubator is<br>intended to be used to provide<br>an environment with controlled<br>temperature at or near body<br>temperature, CO2, O2 and N2<br>gases, and elevated humidity for<br>the development of gametes and<br>embryos during in vitro<br>fertilization (IVF) / assisted<br>reproductive technology (ART)<br>treatments. | Intended to be used to<br>store and preserve<br>gametes and/or embryos<br>at or near body<br>temperature. | Yes. The Planer BT37 Incubator<br>statement explicitly states the gases<br>used and the fact that the humidity is<br>elevated. This does not represent a<br>change in use but merely reflects the<br>fact that statements for devices<br>raised after clearance of the<br>predicate device have tended to<br>provide more detail. |
| Gas supply | Blend of 6% CO2, 5% O2,<br>89% N2 | Similar | Yes |
| Gas supply<br>pressure | 150 kPa +/- 15 kPa | Same | Yes |
| Gas flow rate<br>capability per<br>side | 0 mL/min to 450 mL/min.<br>Normal bleed set to 15 mL/min<br>and purge at 180 mL/min for<br>3 minutes. Flows fully<br>adjustable in 1 mL/minute<br>increments. | 15 mL/min to25 mL/min<br>in 5 mL/min increments.<br>Purge at 175 mL/min<br>per chamber for<br>3 minutes. | Yes. The Planer BT37 provides finer<br>flow adjustment across a wider range<br>of values. |
| Gas flow rate<br>accuracy<br>(normal flow) | ±10% of flow per chamber | ±15% of flow per<br>chamber (normal flow)<br>±18 ml/min per chamber<br>(purge) | Yes. Flow accuracy of the BT37 is<br>slightly better during normal flow. |
| Gas flow<br>pattern | Pulsed or non-pulsed (constant)<br>flow pattern. | Non-pulsed (constant) | Yes, although the BT37 also supports<br>a pulsed-flow operating mode. |
| Chamber<br>temperature<br>capability | (ambient + 5 °C) to (ambient +<br>20 °C)<br>Upper temperature must not<br>exceed 40 °C. | 35.0 °C to 40.0°C in<br>0.1°C increments in an<br>ambient temperature<br>range of +20 °C to<br>+28 °C. At set point of<br>37 °C, the ambient<br>temperature range is<br>extended to +18 °C to<br>+32 °C | Yes. Although phrased differently,<br>the control ranges are equivalent. |
| Chamber<br>temperature<br>accuracy | ±0.2 °C at calibration point | ±0.2 °C at calibration<br>point | 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 [phone] or [phone] 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:

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.

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