GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA

K053552 · <Genx> Intl., Inc. · MQL · May 19, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K053552
• Device Name: GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
• Applicant: <Genx> Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

Device Story

global® is a reproductive medium used in clinical laboratory settings during in vitro fertilization (IVF) procedures. It serves as a chemical environment to support the fertilization of human oocytes, the subsequent culture of embryos, and the preparation for embryo transfer. The device is used by embryologists or laboratory technicians in a clinical or laboratory environment. It provides the necessary nutrients and physiological conditions to maintain embryo viability outside the human body. By facilitating these critical stages of assisted reproduction, the medium supports the development of embryos intended for implantation, thereby assisting patients undergoing fertility treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reproductive medium for in vitro fertilization. Class II device (21 CFR 884.6180). Product code: MQL.

Indications for Use

Indicated for use during in vitro fertilization procedures, specifically for the fertilization, culture, and transfer of human embryos.

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 1 9 2006

Mr. Michael D. Cecchi President <genX> International 393 Soundview Road GUILFORD CT 06437

Re: K053552

Trade/Device Name: global®: fertilization, embryo culture and transfer medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 8, 2006 Received: May 10, 2006

Dear Mr. Cecchi:

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, 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Protecting and Promoting Public Health

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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.

出版社会的主要有关系。 中国人民共同意的人民的人民的人民主要的人民主要的

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours.

Nancy C. Brydon

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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<genX>international, inc. 510(K) Submission

## INDICATIONS FOR USE

Ko 5 355 2 510 (k) Number (if known)

Common Name: Assisted Reproductive Media

Classification Name: Assisted Reproductive Media (21 C.F.R. § 886.6180)

のとなっているとなるというとなるなるなのです

global®: fertilization, embryo culture and transfer Device Trade Name: medium

For In Vitro Fertilization Procedures. Intended Use:

Indication for Use:

global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the Counter Use

or

Nancy C Brandon

Division of Reproductive, Abdominal,
and Radiological Devices
K053552

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