G-OOCYTE

K032877 · Vitrolife Sweden AB · MQL · May 7, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K032877
• Device Name: G-OOCYTE
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

For the support of the oocyte during intracytoplasmic sperm injection.

Device Story

G-OOCYTE is a MOPS-buffered assisted reproduction medium used in clinical laboratory settings. It supports oocytes during intracytoplasmic sperm injection (ICSI). The device requires the addition of G-MM or HSA-solution and temperature equilibration at 37°C in an ambient atmosphere prior to use. It functions as a specialized culture environment to maintain oocyte viability during the ICSI procedure. It is intended for use by trained embryologists or clinical laboratory personnel in fertility clinics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and formulation similarity to the predicate device.

Technological Characteristics

MOPS-buffered medium for assisted reproduction. Designed for use with G-MM or HSA-solution. Requires temperature equilibration at 37°C. Class II medical device.

Indications for Use

Indicated for the support of the oocyte during intracytoplasmic sperm injection (ICSI) 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.

Predicate Devices

• G-MOPS™ (K021893)

Submission Summary (Full Text)

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Ko3 2877/51

MAY = 7 2004

## PREMARKET NOTIFICATION SUMMARY X.

| Submitted by: | Vitrolife Sweden AB<br>Faktorv\u00e4gen 13<br>SE-434 37 Kungsbacka<br>SWEDEN |
|---------------|------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------|

Contact Person:

Ms. Nina Arvidsson Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

Mr. Gary L. Yingling Kirkpatrick & Lockhart, LLP 1800 Massachusetts Avenue, NW Washington, DC 20036-1800

Date Prepared:

Trade Name:

Common Name:

Classification Name:

Predicate Device:

Description of the Device:

Intended Use:

Indications for Use:

Technological Characteristics:

September 10, 2003

G-OOCYTE™

Assisted Reproduction Media

Reproductive Media and Supplements (21 CF.R. § 884.6180)

G-MOPS™ (K021893)

MOPS buffered medium. For use after the addition of G-MM™ or HSA-solution™ and temperature equilibration at +37°C and ambient atmosphere.

Medium for In Vitm Fertilization Procedures

For the support of the oocyte during intracytoplasmic sperm injection.

The technological characteristics of G-OOCYTE are essentially similar to those of the predicate device. Formulation changes were made with the needs of the denuded unfertilized oocyte in mind. None of these changes raise new questions of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular fashion around a stylized eagle. The eagle is depicted with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

Vitrolife Sweden AB % Gary L. Yingling, Esq. Consultant Kirkpatrick & Lockhart, L.L.P. 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800

Re: K032877 Trade/Device Name: G-OOCYTETM - Assisted Reproductive Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: February 19, 2004 Received: February 23, 2004

## Dear Mr. Yingling:

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 (PMA), 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.

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 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 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 by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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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## Indications for Use

510(k) Number (if known): K032877

Device Name: G-OOCYTE™ Assisted Reproduction Media

Indications For Use: For the support of the oocyte during intracytoplasmic sperm injection

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David H. Legman

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