SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M

K013703 · Sanyo North America Corp. · MQG · Dec 14, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013703
• Device Name: SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
• Applicant: Sanyo North America Corp.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

To provide an environment with controlled temperature, CO2, (and other gases), and elevated humidity for the development of ova or embryos.

Device Story

Sanyo CO2 Incubators (Models MCO-17AC, MCO-17AIC, MCO-20AIC, MCO-175M) provide controlled environments for ova/embryo development. Devices utilize microprocessor-based PID control to regulate temperature, CO2 density, and humidity. Inputs include thermistor/Pt 100Ω sensors for temperature and infrared or thermal conductivity probes for CO2; Zirconia sensors monitor O2. Energy is apportioned to independent heating elements via direct heat air jacket or water jacket. Outputs include maintained environmental parameters and alarm notifications (temperature, CO2, door, water level). Used in clinical/laboratory settings by trained personnel. MCO-20AIC features programmable UV decontamination; all models use sub-micron filters and copper-enriched stainless steel interiors to maintain sterility. Data acquisition software and communication ports allow monitoring. Benefits include stable, precise incubation conditions supporting embryo viability.

Clinical Evidence

Bench testing only. Performance and safety testing verified operating specifications, EMC safety, and UV strength.

Technological Characteristics

Microprocessor-controlled; PID algorithm. Interior: stainless steel or copper-enriched stainless steel. Exterior: insulated coated steel. Heating: direct heat air jacket or water jacket. Sensors: thermistor, Pt 100Ω, infrared, thermal conductivity, Zirconia solid-state electrolyte. Connectivity: communication ports, data acquisition software. Power: direct line AC. Sterilization: UV decontamination (MCO-20AIC), sub-micron filters.

Indications for Use

Indicated for the development of ova or embryos in a controlled environment with regulated temperature, CO2, other gases, and humidity.

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

• CO2 Incubators (ThermoQuest Corp., K001524)
• CO2 Incubators (Kendro Laboratory Products, L.P., K002805)

Submission Summary (Full Text)

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K013703

**DEC 1 4 2001**

8.0 510(k) Summary

## 510(k) Summary (As Required by 21 C.F.R. §807.92)

| Submitted by: | Sachi Kataoka<br>Sales & Technical Advisor<br>Sanyo Sales & Supply Company<br>900 N. Arlington Heights Rd., Ste 310<br>Itasca, Il 60143-2844<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Date of summary: | This summary was prepared on October 1, 2001. | |
| Device name: | The device names are the Sanyo CO2 Incubators, Models Nos.<br>MCO-17AC, MCO-17AIC, MCO-20AIC, and MCO-175M. | |
| Common name: | CO2 Incubators | |
| Classification names: | Regulation Number &<br>ProCode<br>21 CFR § § 884.6120<br>ProCode 85 MQG | Classification<br>Name<br>Embryo Incubator/Assisted<br>Reproduction Accessory |
| Predicate Devices | CO2 Incubators cleared for ThermoQuest Corp. (K001524, 7/12/2000)<br>and Kendro Laboratory Products, L.P. (K002805, 11/9/00). | |
| Modifications: | One of the subject devices provides a model equipped with UV-based<br>decontamination control, as opposed to either HEPA filtration or heat<br>disinfection which are the methods employed as the primary means of<br>decontamination control by the predicate devices. | |
| Intended Use | To provide an environment with controlled temperature, CO2 , (other<br>gases), and elevated humidity for the development of ova or embryos at<br>or near body temperature. | |
| Technological<br>Characteristics | The devices are microprocessor controlled to regulate temperature, CO2<br>density, humidity level, alarms, and other parameters. The interior<br>chamber consists of either stainless steel or a copper enriched stainless<br>steel alloy, and housed within an insulated coated steel exterior cabinet. | |
| | Operational accessories include options for an automatic CO2 cylinder<br>switchover system, CO2 regulator, communication ports, and data<br>acquisition software. Each device is a bench top or floor standing unit<br>and direct line AC powered. | |

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K013703
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The microprocessor manages continuous feedback from data entry, set points, and alarm parameters via a PID (proportional, integral, and derivative) algorithm. In response to chamber demand, and ambient temperature, the control system apportions energy to multiple independent heating elements. These are located in various zones around the chamber interior to control CO2, temperature and other parameters.

Depending on the model, temperature is achieved using either a direct heat air jacket (DHA) or water jacket each operated off of a heater unit(s) responding to a thermistor sensor or Pt 100Ω.

Temperature range for all models is from 5°C above ambient to +50°C with 0.1% set-point increments. Chamber temperature uniformity is better than 0.25°C.

Air humidification is achieved by natural vaporization of distilled water. The humidity specification is >95%± 5%.

CO2 control is maintained by infrared sensor or by a thermal conductivity probe, depending on the model. The IR sensor operates independently of RH and temperature changes, and is automatically self-calibrating every 4 hours. A CO2 sensor sampling port allows access for confirmation of CO2 density. The CO2 range is 0 to 20% in 0.1% set-point increments for all Models. The O2 level can be set to 2-18%, or 22-70% using Zirconia solid-state electrolyte sensor technology.

The Sanyo models are equipped with some or all of the following alarms: audible and visual alarms for: temperature, CO2 deviation, door open, overheat, water level, and remote alarm contacts.

The MCO-20AIC incubator is designed with a programmable UV decontamination system, coupled with copper enriched stainless steel walls, autoclavable shelving, and plenum components. Vent intakes are fitted with sub-micron filters.

The remaining models employ either copper enriched stainless steel interior with sub-micron filters or simply sub-micron filters.

Performance and safety testing were performed to verify operating Testing specifications, EMC safety, and UV strength.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2001

SANYO North America Corporation % Mr. Sachi Kataoka SANYO Sales & Supply Company SANYO Scientific 900 N. Arlington Heights Rd. ITASCA IL 60143-2844

Re: K013703 Trade/Device Name: Sanyo CO2 Incubators Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG Dated: October 30, 2001

Received: November 8, 2001

Dear Mr. Kataoka:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled in (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaters of the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-17 accordance with the provisions of the Federal Food, Drug, uc necs that have boon require approval of a premarket approval application (PMA). and Costictly rior (110) that to novice, subject to the general controls provisions of the Act. The r ou may, morelore, manel of the Act include requirements for annual registration, listing of general oonly is free with a practice, labeling, and prohibitions against misbranding and adulteration.

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 it may of Subject to additions, 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 r reaso of acressed alay received that your device complies with other requirements of the Act than i Drings and regulations administered by other Federal agencies. You must or any I vath all the Act's requirements, including, but not limited to: registration and listing eompty with and the received in the Part 801); good manufacturing practice requirements as set (2) or re rate of 1) and 11 (2) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number<br>(if known) | K013703 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sanyo CO2 Incubators Model Nos. MCO-17AC, MCO-17AIC,<br>MCO-20AIC, and MCO-175M |
| Indications for Use | To provide an environment with controlled temperature, CO2, (and<br>other gases), and elevated humidity for the development of ova or<br>embryos. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span></span> </div> |
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| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | <div> <span></span> </div> |
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(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510

008