G-2 V5

K081117 · Vitrolife Sweden AB · MQL · Sep 16, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081117
• Device Name: G-2 V5
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

G-2TM v5/G-2TM v5 PLUS is intended for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.

Device Story

G-2 v5/G-2 v5 PLUS are IVF culture media used in clinical laboratory settings by embryologists. These media support embryo development from day 3 through the blastocyst stage and facilitate embryo transfer. The device is a modification of the G-2 version 3 predicate, designed to improve robustness of the culture environment. It provides the necessary chemical environment for ex vivo embryo maintenance prior to implantation.

Clinical Evidence

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

Technological Characteristics

Reproductive media and supplements (21 CFR 884.6180). The device is a chemical culture medium for embryo support. No specific materials, energy sources, or software components are described.

Indications for Use

Indicated for the culture of embryos from day 3 to the blastocyst stage and for embryo transfer in patients undergoing 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-2TM version 3 (K021890)

Submission Summary (Full Text)

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and the comments of the comments of

:

| 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]<br>SEP 1 6 2008 |
| Date Prepared: | 7 July 2008 |
| Trade Name: | G-2TM v5/G-2TM v5 PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | G-2TM version 3 (K021890) |
| Description of the Device: | The IVF Media GIII Series have been on the market<br>for a number of years and Vitrolife Sweden AB has<br>now made some product changes in order to further<br>improve the robustness of these media. These<br>improved media are called IVF Media G5 Series.<br><br>G-2TM v5/G-2TM v5 PLUS is used for culture of<br>embryos from day 3 to the blastocyst stage, and for<br>embryo transfer. |
| Intended Use: | G-2TM v5/G-2TM v5 PLUS is intended for culture of<br>embryos from day 3 to the blastocyst stage, and for<br>embryo transfer. |

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## Technological Characteristics:

G-2™ v5/G-2™ v5 PLUS is a device used for the culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.

The product G-2™ v5/G-2™ v5 PLUS is a modification of the device G-2™ version 3 (K021890). The technological characteristics of G-2™ v5/G-2™ v5 PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-2™ v5/G-2™ v5 PLUS do raise any new questions of safety or effectiveness.

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Image /page/2/Picture/0 description: The image is a seal for 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 image of an eagle with its wings spread.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 6 2008

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

Rc: K081117

> Trade Name: G-2TM v5 and G-2TM v5 PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 13, 2008 Received: August 15, 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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Page 2

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 vours.

hope M.Nhang

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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## XI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K081117

Device Name:

G-2™ v5

Indications for Use:

G-2™ v5 is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer

#### (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)

Hulut lemm

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

Radiological Devices
510(k) Number K081117

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## XI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K081117

Device Name:

G-2™ v5 PLUS

Indications for Use:

G-2™ v5 PLUS is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer

#### (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)

Hulun Remen

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