G-1 V5

K081114 · Vitrolife Sweden AB · MQL · Sep 16, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081114
• Device Name: G-1 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-1TM v5/G-1TM v5 PLUS is intended for culture of embryos from the pronucleate stage to day 2 or day 3

Device Story

G-1 v5/G-1 v5 PLUS are reproductive media used in IVF laboratories for the culture of human embryos. The media supports embryo development from the pronucleate stage through day 2 or day 3. Used by embryologists in clinical settings to provide a controlled environment for embryo growth prior to implantation. The device is a chemical formulation; it does not involve electronic inputs, algorithms, or software processing. It serves as a supportive environment for biological development.

Clinical Evidence

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

Technological Characteristics

Reproductive media for embryo culture. Chemical formulation. Class II device (21 CFR 884.6180). No electronic, software, or mechanical components.

Indications for Use

Indicated for the culture of embryos from the pronucleate stage to day 2 or day 3 in a clinical setting.

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-1TM version 3 (K022244)

Submission Summary (Full Text)

{0}------------------------------------------------

# K081114

.

#### PREMARKET NOTIFICATION SUMMARY X.

:

SEP 1 6 2008

| Submitted by: | Vitrolife Sweden AB<br>Faktorv\u00e4gen 13<br>SE-434 37 Kungsbacka<br>SWEDEN |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Kjell Kj\u00f6rk<br>Vitrolife Sweden AB<br>Faktorv\u00e4gen 13<br>SE-434 37 Kungsbacka<br>SWEDEN<br>Phone [phone]<br>Fax [phone]<br>Mail [e-mail] |
| Date Prepared: | 7 July 2008 |
| Trade Name: | G-1TM v5/G-1TM v5 PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. \u00a7 884.6180) |
| Predicate Device: | G-1TM version 3 (K022244) |
| 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 medias are called IVF Media G5 Series.<br>G-1TM v5/G-1TM v5 PLUS is used for culture of<br>embryos from the pronucleate stage to day 2 or day 3 |
| Intended Use: | G-1TM v5/G-1TM v5 PLUS is intended for culture of<br>embryos from the pronucleate stage to day 2 or day 3 |

{1}------------------------------------------------

#### Technological Characteristics:

G-1™ v5/G-1™ PLUS is a device used for the culture of embryos from the pronucleate stage to day 2 or day 3.

The product G-1™ v5/G-1™ v5 PLUS is a modification of the device G-1™ version 3 (K022244). The technological characteristics of G-1™ v5/G-1™ v5 PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-1™ v5/G-1™ v5 PLUS do raise any new questions of safety or effectiveness.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes emanating from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 6 2008

Vitrolife Sweden AB c/o Mr. Kjell Kjörk Pharmacist; Regulatory Affairs Manager Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

K081114 Re:

Trade Name: G-1" v5 and G-1" 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.

{3}------------------------------------------------

#### 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 yours,

Jozpu 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

{4}------------------------------------------------

#### XI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K081114

Device Name: G-1™ v5

:

:

## Indications for Use:

G-1™ v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3

:

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

| Prescription Use<br>(Per 21 C.F.R. § 801.109) | X |
|-----------------------------------------------|---|
| OR Over-the Counter Use | |

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | KD81114 |
|---------------|---------|
|---------------|---------|

{5}------------------------------------------------

## XI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K081114

Device Name:

G-1™ v5 PLUS

Indications for Use:

G-1™ v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use<br>(Per 21 C.F.R. § 801.109) | X |
|-----------------------------------------------|---|
| OR<br>Over-the Counter Use | |

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices,

| 510(k) Number | K081114 |
|---------------|---------|
|---------------|---------|