THERMOPLATE

K991263 · Tokai Hit Co., Ltd. · MQG · Jul 8, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991263
• Device Name: THERMOPLATE
• Applicant: Tokai Hit Co., Ltd.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Indications for Use

THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.

Device Story

THERMOPLATE is a microscope stage warmer consisting of a plate section and a controller unit. The plate section, placed on a microscope stage, features a clear heating material coated inside to maintain specimen temperature. It is designed to match specific microscope configurations (upright, inverted, stereo). The device provides uniform heating from beneath the specimen, allowing for simultaneous observation of multiple specimens without replacement. It is intended for use by laboratory personnel in clinical or research settings to maintain optimal conditions for gametes and embryos during microscopic examination. The clear construction ensures visibility, while the dual-glass structure with silicone bonding prevents glass fragmentation in case of breakage. The device is designed for electrical safety and accurate temperature regulation.

Clinical Evidence

No clinical data. Bench testing only; electrical safety and accuracy confirmed via UL/CE standards compliance.

Technological Characteristics

Plate section composed of rigid glass and clear heating material; resin frame. Dual-glass structure bonded with silicone. External surface covered with non-conductive heat-resisting glass and resin. Heating control unit provides temperature regulation. Designed for specific microscope stage configurations. Electrical safety per UL/CE standards.

Indications for Use

Indicated for temperature control of gametes and embryos during microscopic observation.

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.

Submission Summary (Full Text)

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JUL -8 1900

K99/263
p. 1 of 2

Microscopc-stage Automatic Thermocontrol System

TOKAI HI 306-1 Gendoji-cho. Fujinomiy TELEFHONE: 1811544 24 6699 E-mail: tokaihit@tokai.c

510(k) Summary of THERMOPLATE Stage Warmer

(As required by 21 CFR 807.92(c))

July 5, 1999

Submitter: Tokai Hit Co., Ltd.

Address: 306-1, Gendoji-cho,

Fujinomiya City, Shizuoka Pref.,

Japan 418-0074

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Contact Person: Hideharu Tsuchiya, Director of Tokai Hit Co., Ltd.

Trade Name of the Device: THERMOPLATE

Common Name: Stage Warmer

Classification Name: Assisted Reproduction Accessories (CFR#:884.6120)

Legally Marketed Device: 63 FR 48428 97N-0335 September 10,1998, Effective Date October 13,1998

# 1. Description of Device

The THERMOPLATE is a device automatically controls the temperature of specimens under the microscopes. The THERMOPLATE is made up of two sections: the plate section and the controller section. The plate section is to be set on the stage of a microscope. The specimen placed on the plate section can be maintained at an optimum temperature by the function of the heating element and the heating control unit. As a clear heating material is being coated inside the plate section, sufficient insulation is provided for the heating mechanism.

This product's electrical safety and accuracy had been proven by conforming to UL/CE standards.

# 2. Indication for Use

THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.

# 3. Technological Characteristics

# 1) Design features

with individual The plate section is designed specifically to match type, upright/inverted/stereo, and configuration of the microscopes.

07/05/99 510(k) Summary 1 of 2

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## 2) Safety features

The external surface of the plate section is covered by non-electric conductible material, such as heat resisting rigid glass and resin. Accordingly hazardous events i.e. leakage of electricity and/or electric shock will not take place.

i

The plate is made of two pieces of rigid glass paste together with clear sillicone. Accordingly, the plate has dual structure which prevents breakage of glass and by any possibility the event takes place fragment of the broken glass will not fly apart for the glasses are paste together with silicone.

### 3) Other features

The prime characteristic of TEHRMOPLATE is that the plate section is composed of clear materials excluding the resin frame.

As a consequence of adopting clear heating plate, the device had acquired two significant features, accurate temperature control of the specimens and wide efficient area.

THERMOPATE has very strict accuracy in temperature control of the specimens for the optimum heat is supplied from right beneath the specimens regardless of the area one is placed on the plate. (Refer the drawings below) The wide efficient area allows multiple specimens to be heated at the same time and observed without replacing them as the heating plate is made of clear materials.

Along with quick start up and the most reliable accurate temperature control, THERMOPLATE provides the user easy operation and the accurate temperature control.

Image /page/1/Figure/8 description: The image compares two different types of heating plates: a perforated metal stage warmer and a clear glass heating plate. Each plate has a slide glass and a specimen placed on top of the heated area. The perforated metal stage warmer has a perforated area with a diameter of 20mm, while the clear glass heating plate does not have any perforations.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1999

Mr. Hideharu Tsuchiya Director Tokai Hit Co., Ltd. 306-1 Gendoji-cho Fuiinomiya-shi Shizuoka-ken JAPAN 418-0074

Re: K991263 Thermoplate Stage Warmer Dated: April 10, 1999 Received: April 13, 1999 Regulatory Class: II 21 CFR §884.6120/Procode: 85 MQG

Dear Mr. Tsuchiya:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1

| 510(k) Number (if known): | K991263 |
|---------------------------|-------------|
| Device Name: | THERMOPLATE |

Indications For Use:

THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.

(Optional Format 3-10-98)

**Prescription Use**
(Per 21 CFR 801.109)