G-FERT, MODEL 10033

K022245 · Vitrolife Sweden AB · MQL · Sep 6, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022245
• Device Name: G-FERT, MODEL 10033
• 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 preparation and handling of gametes and for in vitro fertilization.

Device Story

G-FERT is a bicarbonate-buffered medium containing hyaluronan used in assisted reproduction. It serves as a culture medium for gamete handling and in vitro fertilization. The device requires supplementation with G-MM or HSA-solution and pre-equilibration at 37°C and 6% CO2 prior to use. It is intended for clinical use by trained professionals in fertility clinics. The device supports the fertilization process by providing an optimized environment for gametes.

Clinical Evidence

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

Technological Characteristics

Bicarbonate-buffered medium containing hyaluronan. Requires supplementation with albumin (G-MM or HSA-solution) prior to use. Designed for use at 37°C and 6% CO2. No software or electronic components.

Indications for Use

Indicated for the preparation and handling of gametes and for in vitro fertilization 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

• IVF (no number provided)

Submission Summary (Full Text)

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## SEP 6 2002

## IX. PREMARKET NOTIFICATION SUMMARY

| 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: | July 10, 2002 |
| Trade Name: | G-FERT™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | IVF™ |
| Description of the Device: | Bicarbonate buffered medium containing<br>Hyaluronan. For use after the addition of G-MM™<br>or HSA-solution™ and pre-equilibration at +37°C<br>and 6 % CO2 |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Technological Characteristics: | The technological characteristics of G-FERT™<br>are essentially similar to those of the predicate<br>device. The G-FERT is a modification of the<br>predicate device and is intended to be<br>supplemented with albumin prior to use. Other<br>formulation changes were made to improve the<br>performance of the G-FERT device. None of<br>these differences raise new questions of safety or<br>effectiveness. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 6 200

Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022245 Trade/Device Name: G-FERT™ Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: July 10, 2002 Received: July 12, 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,

Henry C. Brigdon

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 STATEMENT X. . :

510(k) Number:

and the same of the same of the same

.

.

KD2245

Device Name:

G-FERTTM Assisted Reproduction Media

Indications For Use:

Medium for preparation and handling of gametes and for in vitro fertilization.

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(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 5 D(k) Number ________________________________________________________________________________________________________________________________________________________________

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

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