FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR

K991408 · Thermoquest Corp. · MQG · Jul 19, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991408
• Device Name: FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
• Applicant: Thermoquest Corp.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Jul 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

The Forma Scientific Universal Water Jacketed Incubators are intended to be used to store, preserve and grow gametes and/or embryos at or near body temperature.

Device Story

Bench top or floor standing incubator; provides controlled environment for gamete/embryo development. Inputs: user-defined setpoints for temperature, CO2, humidity, and O2. Operation: microprocessor-controlled system maintains internal chamber conditions (approx. 184 liters). Output: stable environmental conditions for biological samples. Used in clinical laboratory settings by embryologists/technicians. Healthcare providers monitor chamber conditions via integrated alarm functions to ensure optimal growth environment. Benefits: provides necessary physiological conditions for in vitro fertilization procedures.

Clinical Evidence

Bench testing only. Device subjected to electrical safety, electromagnetic compatibility, and operating performance testing. All tests passed.

Technological Characteristics

Water-jacketed incubator; bench top or floor standing; 184-liter chamber volume. Microprocessor-controlled regulation of temperature, CO2, humidity, and O2. Electrical and electromagnetic compatibility specifications met.

Indications for Use

Indicated for the storage, preservation, and growth of ova or embryos in a controlled environment with regulated temperature, CO2, humidity, and optional suppressed O2 levels.

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

• 63 FR 48428 (September 10, 1998)

Submission Summary (Full Text)

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ma Scientific, Inc.

# SECTION 10

**SECTION 10**

1991408

# 510(k) SUMMARY

Richard L. Miller Submitted By: Manager -- Regulatory Compliance Forma Scientific, Inc. Mill Creek Road Marietta, Ohio 45750

April 20, 1999

## Names of Devices:

| Trade Name: | Forma Scientific Incubator |
|----------------------|-------------------------------------|
| Common/Usual Name: | Embryo Incubator |
| Classification Name: | Embryo Incubator<br>21 CFR 884.6120 |
| Predicate Device: | 63 FR 48428, September 10, 1998 |

# Device Description:

The Forma Scientific incubators are bench top, or floor standing units. They control carbon dioxide (CO2), temperature and provide elevated humidity. Certain models also control O2 at suppressed levels. Controlled parameters and alarm functions are microprocessor controlled. The volume of each chamber is approximately 6.5 cubic feet (184 liters).

#### Intended Use:

The Forma Scientific Universal Water Jacketed Incubators are intended to be used to store, preserve and grow gametes and/or embryos at or near body temperature.

#### Substantial Equivalence:

In accordance with the Final Rule on reclassification of Medical Devices Used for In Vitro Fertilization, Forma Scientific cites the Final Rule as support for substantial equivalence.

## Discussion of Tests and Test Results:

The Forma Scientific Universal Water-Jacketed Incubators were subjected to electrical safety, electromagnetic compatibility acceptability and operating performance. The incubators passed all these tests.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 19 1999

Mr. Richard L. Miller Manager of Regulatory Compliance Forma Scientific, Inc. Box 649, Mill Creek Road Marietta, OH 45750

Re: K991408 ThermoQuest Universal Water-Jacketed Incubators Dated: April 20, 1999 Received: April 22, 1999 Regulatory Class: Il 21 CFR §884.6120/Procode: 85 MQG

Dear Mr. Miller:

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 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 Regulations, 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 requilation 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 Compiiance 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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510(k) Number (if known): K991408

Device Name: Embryo Incubator

Indications For Use:

The intended use of these incubators is to provide an environment with controlled temperature, CO2 and an elevated humidity, for the development of ova or embryos. Certain models also control O2 at suppressed levels.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ે હતું (Per 21 CFR 801.109)

(Optional Format 3-10-98)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Rauloiogical Devices 91408 510(k) Number.