COOK MINI-INCUBATOR

K983642 · Cook Ob/Gyn · MQG · Feb 1, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983642
• Device Name: COOK MINI-INCUBATOR
• Applicant: Cook Ob/Gyn
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

Device Story

The COOK Mini-Incubator is a bench-top, microprocessor-controlled CO2 incubator designed for IVF laboratory use. It features two separate humidified incubation chambers, each accommodating up to four 4-well culture trays (NUNC or FALCON). The device provides controlled temperature and CO2 gas flow to maintain an environment suitable for gamete and embryo storage. It is operated by laboratory personnel to ensure stable conditions for biological samples. The device benefits patients by providing a controlled environment for the preservation of gametes and embryos during IVF procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bench-top incubator; microprocessor-controlled; two humidified chambers; CO2 gas flow control; temperature regulation. Designed for 4-well culture trays.

Indications for Use

Indicated for the storage and preservation of gametes and/or embryos at or near body temperature.

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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1 1999 FEB

K983642

#### 510(K) SUMMARY ு

Submitted By:

Brenda Davis Regulatory Affairs COOK OB/GYN™ 1100 West Morgan Street Spencer, Indiana, 47460.

October 15, 1998

# Names of Device:

Trade Name: Common/Usual Name: Classification Name:

COOK Mini-Incubator IVF Incubator Embryo incubator 21 CFR §884.6120

Predicate Device:

63 FR 48428, September 10, 1998

# Device Description:

The COOK Mini-Incubator is a small microprocessor-controlled, carbon dioxide (CO2) incubator that provides two separate humidified incubation chambers, each accepting up to four NUNC® or FALCON® 4-well culture trays. Designed for bench top use, the COOK Mini-Incubator provides controlled temperature and CO2 gas flow.

### Intended Use:

The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

#### Substantial Equivalence:

The COOK Mini-Incubator is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

## Discussion of Tests and Test Results:

The COOK Mini-Incubator was subjected to testing to assure satisfactory operating performance. The COOK Mini-Incubator passed the requirements of all tests.

## Conclusions Drawn from Tests:

This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EEB 1 1999

Brenda Davis Regulatory Affairs Cook Ob/Gyn 1100 West Morgan Street Spencer, Indiana 47460

Re: K983642 Cook Mini Incubator Dated: January 7, 1999 Received: January 11, 1999 Regulatory Class: II 21 CFR 884.6120/Procode: 85 MQG

Dear Ms. Davis:

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 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 regult 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 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 Compliance 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):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________ COOK Mini-Incubator

Indications For Use:

The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

مد

Reproductive, Abdominal, BNT 100k) Number

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