G-MOPS G5 SERIES

K081115 · Vitrolife Sweden AB · MQL · Sep 17, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081115
• Device Name: G-MOPS G5 SERIES
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

G-MOPSTM is intended for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere. G-MOPS™ PLUS is intended for handling/manipulating oocytes and embryos in ambient atmosphere.

Device Story

G-MOPS and G-MOPS PLUS are reproductive media used in IVF laboratories. They provide a stable environment for oocytes and embryos during collection and manipulation procedures performed in ambient atmosphere. These media are intended for use by trained embryologists or clinical staff in a laboratory setting. By maintaining appropriate conditions outside of a CO2 incubator, the media facilitate the handling of gametes and embryos, supporting clinical decision-making and procedural success in assisted reproductive technology.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design modifications to a previously cleared predicate device.

Technological Characteristics

Reproductive media for oocyte/embryo handling. Modification of G-MOPS GIII Series (K021893). Designed for use in ambient atmosphere. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for oocyte collection and handling/manipulation of oocytes and embryos in ambient atmosphere during IVF 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-MOPSTM (K021893)

Submission Summary (Full Text)

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#### PREMARKET NOTIFICATION SUMMARY x.

## SEP 1 7 2008

| Submitted by: | Vitrolife Sweden AB<br>Faktorvägen 13<br>SE-434 37 Kungsbacka<br>SWEDEN |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Kjell Kjörk<br>Vitrolife Sweden AB<br>Faktorvägen 13<br>SE-434 37 Kungsbacka<br>SWEDEN<br>Phone [phone]<br>Fax [phone]<br>Mail [e-mail] |
| Date Prepared: | 3 September 2008 |
| Trade Name: | G-MOPSTM/G-MOPSTM PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | G-MOPSTM (K021893) |
| Description of the Device: | The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved media are called IVF Media G5 Series.<br><br>G-MOPSTM is used for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.<br><br>G-MOPSTM PLUS is used for handling/manipulating oocytes and embryos in ambient atmosphere. |

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### Intended Use:

G-MOPSTM is intended for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

G-MOPS™ PLUS is intended for handling/manipulating oocytes and embryos in ambient atmosphere.

## Technological Characteristics:

G-MOPSTM/G-MOPSTM PLUS is a device used for handling and manipulating oocytes and embryos in ambient atmosphere.

The product G-MOPS™/G-MOPS™ PLUS is a modification of the device G-MOPS™ GIII Series (K021893). The technological characteristics of G-MOPSTM/G-MOPSTM PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-MOPS™ / G-MOPS™ PLUS do raise any new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2008

Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

Re: K081115

Trade Name: G-MOPSTM and G-MOPSTM PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: September 5, 2008 Received: September 5, 2008

Dear Mr. Kjörk:

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.

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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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Jose M. Whang

Joyce M. Whang, Ph.D. Acting 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 STATEMENT XI.

510(k) Number (if known): K081115

Device Name:

G-MOPSTM

Indications for Use:

G-MOPS™ is indicated for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

## (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)

OR

Over-the Counter Use.

Huld Reume

vision Sign-Off) ivision of Reproductive, Abdomina and Radiological Devices 510(k) Number

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#### INDICATIONS FOR USE STATEMENT XI.

510(k) Number (if known): K081115

Device Name:

G-MOPS™ PLUS

Indications for Use:

G-MOPS™ PLUS is indicated for handling/manipulating oocytes and embryos in ambient atmosphere.

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

Prescription Use
OR
Over-the Counter Use
(Per 21 C.F.R. \$ 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K081115