THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476

K021042 · Thermo Forma, Inc. · MQG · May 15, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021042
• Device Name: THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476
• Applicant: Thermo Forma, Inc.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Indications for Use

The Thermo Forma CryoMed ® Controlled Rate Freezers are intended to be used to freeze gametes and/or embryos at a user determined rate. This device is not intended for long-term storage.

Device Story

Bench-top controlled rate freezer; uses liquid nitrogen (LN2), electric heater, and air-circulating fan to regulate temperature. Microprocessor-based control system manages freezing profiles and alarm functions. Users select preloaded profiles or define custom programs via integrated interface or optional PC software. PC software allows program creation and download to freezer memory; freezer executes stored parameters independently. Used in clinical settings for assisted reproduction; operated by trained personnel. Device provides precise thermal control during freezing process; intended for short-term processing rather than long-term storage. Benefits patient by optimizing cooling rates to enhance gamete/embryo viability.

Clinical Evidence

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

Technological Characteristics

Bench-top unit; utilizes liquid nitrogen (LN2) cooling, electric heating, and air-circulating fan. Microprocessor-controlled. Connectivity via optional PC software for program download. No specific material standards or software architecture class provided.

Indications for Use

Indicated for freezing gametes and/or embryos at user-determined cooling rates and temperatures to improve viability in assisted reproduction procedures.

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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K021042

MAY 1 5 2002

# Thermo Forma

P.O. Box 649 • 401 Millcreek Road Marietta, OH 45750

740-373-4763 Fax: [phone] www.thermoforma.com

## 510(k) SUMMARY

Submitted By:

Richard L. Miller, CQE Manager of Regulatory Compliance Thermo Forma, Inc. 401 Millcreek Road Marietta, Ohio 45750

March 28, 2002

#### Names of Devices:

Trade Name: Common/Usual Name: Classification Name:

CryoMed ® IVF Controlled Rate Freezer IVF Controlled Rate Freezer IVF Controlled Rate Freezer 21 CFR 884.6120

Predicate Device:

63 FR 48428, September 10, 1998

#### Device Description:

The CryoMed controlled rate freezers are bench top units. They control temperature and temperature The ce your the use of liquid nitrogen (LN2), an electric heater and an air-circulating fan. Freezing parameters and alarm functions are controlled by a microprocessor built into the controlled rate freezer itself. The freezer is supplied with several preloaded freezing profiles as well as allowing the user to define their own profiles. Optional PC resident software, supplied with each unit, allows user defined programs to be written on a personal computer and downloaded to the freezer. The freezer then stores these parameters in its memory and takes over control of the run.

#### Intended Use:

The Thermo Forma CryoMed ® Controlled Rate Freezers are intended to be used to freeze gametes and/or embryos at a user determined rate. This device is not intended for long-term storage.

#### Substantial Equivalence:

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

### Discussion of Tests and Test Results:

Thermo Forma's CryoMed ® Controlled Rate Freezers were subjected to electrical safety, electromagnetic compatibility and operating performance tests. The freezers passed all these tests.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

MAY 1 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard L. Miller, CQE Manager of Regulatory Compliance Thermo Forma, Inc. P.O. Box 649 401 Millcreek Road MARIETTA OH 45750

Re: K021042

Trade/Device Name: Thermo Forma Controlled Rate Freezers Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG Dated: March 27, 2002 Received: April 1, 2002

Dear Mr. Miller:

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. Iisting 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 (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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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. Brogdon

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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Page 1 of 1

510(k) Number (if known):

Device Name: IVF Controlled Rate Freezer

1021042

Indications For Use:

The intended use of these freezers is to freeze gametes and/or embryos. The I he intendou doo on the freezer is designed to allow the user to select the desired cooling rate and temperature, for the purpose of improved viability.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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

(Per 21 CFR 801.109)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number