G-MOPS, MODEL 10030

K021893 · Vitrolife Sweden AB · MQL · Sep 6, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021893
• Device Name: G-MOPS, MODEL 10030
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Medium for handling and manipulating oocytes and embryos in ambient atmosphere.

Device Story

G-MOPS is a MOPS-buffered culture medium used in assisted reproduction. It serves as a medium for oocyte collection and the subsequent manipulation of gametes and embryos. The device is intended for use in an ambient atmosphere after temperature equilibration to 37°C. It requires the addition of G-MM or HSA-solution prior to use. The medium is utilized by clinicians in a laboratory setting to maintain oocyte and embryo viability during handling procedures outside of a CO2-controlled incubator environment.

Technological Characteristics

MOPS-buffered culture medium. Designed for use at 37°C in ambient atmosphere. Classified as Reproductive Media and Supplements (21 C.F.R. § 884.6180).

Indications for Use

Indicated for the handling and manipulation of oocytes and embryos in an ambient atmosphere 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.

Predicate Devices

• ASPTM -100
• GAMETE™ -20
• GAMETE™ -100

Submission Summary (Full Text)

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K021893

## 6 2002 SEP

## PREMARKET NOTIFICATION SUMMARY IX.

| Submitted by: | Vitrolife Sweden AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenburg<br>SWEDEN |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson<br>Vitrolife Sweden AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenburg<br>SWEDEN |
| Date Prepared: | June 7, 2002 |
| Trade Name: | G-MOPSTM |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | ASPTM -100, GAMETE™ -20/ -100 |
| Description of the Device: | MOPS buffered medium.<br>For oocyte collection after temperature<br>equilibration at +37°C and ambient atmosphere.<br>For gamete and embryo manipulation after the<br>addition of G-MM or HSA-solution and<br>temperature equilibration at +37°C and ambient<br>atmosphere. |
| Intended Use: | Medium for handling and manipulating oocytes<br>and embryos in ambient atmosphere. |
| Technological Characteristics: | The technological characteristics of G-MOPSTM<br>are identical to other legally marketed culture<br>media classified under 21 C.F.R. § 884.6180,<br>Reproductive Media and Supplements. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

SEP 6 2002

Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K021893 Trade/Device Name: G-MOPSTM Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media

and supplements

Regulatory Class: II Product Code: 85 MQL Dated: June 7, 2002 Received: June 10, 2002

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 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. Snigdon

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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## X. - INDICATIONS FOR USE STATEMENT

510(k) Number:

.

KO21893

Device Name:

G-MOPS™ Assisted Reproduction Media

Indications For Use:

Medium for handling and manipulating oocytes and embryos in ambient atmosphere.

Rate Philly f. NCS
(Division Sign Off)

of Reproductive, Abdominal, ological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__ (Per 21 C.F.R. § 801.109)

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