MEDIA CULTURE SYSTEM

K040530 · <Genx> Intl., Inc. · MQL · Jun 25, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040530
• Device Name: MEDIA CULTURE SYSTEM
• Applicant: <Genx> Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction. global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction. PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis.

Device Story

Device consists of three specialized culture media: HTF with HEPES, Global with HEPES, and PGD Biopsy Medium. Used in clinical embryology laboratories by trained embryologists. HTF with HEPES serves as holding media for gametes/embryos; Global with HEPES serves as holding and transfer media; PGD Biopsy Medium serves as holding media during cell biopsy for pre-implantation genetic diagnosis. Media provide stable environment for gametes/embryos outside of incubator during manipulation. Benefits include maintenance of viability and physiological integrity of specimens during assisted reproductive technology (ART) procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reproductive media containing HEPES buffer for pH maintenance in atmospheric conditions. Formulated for holding, transfer, and biopsy of human gametes and embryos. Class II device under 21 CFR 884.6180.

Indications for Use

Indicated for use as holding, transfer, or biopsy media for human gametes and embryos during assisted reproduction procedures.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2004

Mr. Michael D. Cecchi President & CEO <genX> International, Inc. 393 Soundview Rd. GUILFORD CT 06443

Re: K040530

Trade/Device Name: HTF with HEPES, Global with HEPES, and PGD Biopsy Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements

Regulatory Class: II Product Code: 85 MQL Dated: June 7, 2004 Received: June 14, 2004

Dear Mr. Cecchi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowoned your be your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for discussion in the encreat 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 I ou may) a 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 (PMA), it If your device is exablied (tional 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 r loase vo devisou and I termination that your device complies with other requirements of the Act that i Dri has maste 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 Section 510(k) I mo lotter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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 If you desire specifice of Compliance at one of the following numbers, based on the regulation number at the top of the 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 Other or othernation as a stimation" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responser 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. Brygden

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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K040530/
B

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

# INDICATIONS FOR USE

510 (k) Number (if known)_____________________________________________________________________________________________________________________________________________________

Device Names: global with HEPES

Indication for Use:

#### HTF with HEPES

HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction.

#### Global with HEPES

global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction.

### PGD Biopsy Medium

PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis.

Prescription Use X

Over-the Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Lyons
(Division Sign-Off)

or ·

Division of Reproductive, Abdomina and Radiological Devic 510(k) Number

sk12