EMBRYOGLUE

K031015 · Vitrolife Sweden AB · MQL · Jun 23, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031015
• Device Name: EMBRYOGLUE
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jun 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Medium for In Vitro Fertilization Procedures

Device Story

EmbryoGlue™ is a bicarbonate-buffered assisted reproduction medium used during embryo transfer procedures. It consists of a base medium supplemented with hyaluronan and recombinant human albumin (Recombumin). The device is intended for use by clinical professionals in assisted reproduction settings. It functions as a transfer medium to facilitate the placement of embryos. The inclusion of hyaluronan and pre-supplemented albumin distinguishes it from previous formulations, aiming to support the transfer process. It is provided as a ready-to-use product, eliminating the need for additional albumin supplementation by the clinician.

Clinical Evidence

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

Technological Characteristics

Bicarbonate-buffered medium containing hyaluronan and recombinant human albumin (Recombumin). Formulated as a ready-to-use solution; does not require additional albumin supplementation. Class II device (21 CFR 884.6180).

Indications for Use

Indicated for embryo transfer.

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-2™ version 3, supplemented with G-MM™

Submission Summary (Full Text)

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# Ko31015

### PREMARKET NOTIFICATION SUMMARY X.

| Submitted by: | Vitrolife Sweden AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenburg<br>SWEDEN |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Nina Arvidsson<br>Vitrolife Sweden AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenburg<br>SWEDEN |
| | Mr. Gary L. Yingling<br>Mr. Michael H. Hinckle<br>Kirkpatrick & Lockhart, LLP<br>1800 Massachusetts Avenue, NW<br>Washington, DC 20036-1800 |
| Date Prepared: | March 27, 2003 |
| Trade Name: | EmbryoGlue™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | G-2™ version 3, supplemented with G-MM™ |
| Description of the Device: | Bicarbonate buffered medium containing<br>Hyaluronan and Recombinant Human Albumin |
| Intended Use: | Medium for <i>In Vitro</i> Fertilization Procedures |
| Indications for Use: | Medium for embryo transfer |

## Technological Characteristics:

The EmbryoGlue™ device is a modification of G-2™ version 3, supplemented with G-MM™. The technological characteristics of EmbryoGlue are essentially similar to those of the predicate device. The EmbryoGlue contains Recombumin and is not intended to be supplemented with albumin prior to use. Other changes are the product packaging and the fact that EmbryoGlue contains a higher concentration of I-Iyaluronan. None of these differences raise new questions of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2003

Ms. Nina Arvidsson Regulatory Affairs Officer Vitrolife Sweden AB Mölndalsvägen 30 SE-412 63 Gothenburg SWEDEN

Re: K031015

Trade/Device Name: EmbryoGlue™ Assisted Reproduction Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: March 27, 2003 Received: March 31, 2003

Dear Ms. Arvidsson:

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. Iisting 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 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon

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 XI.

KU31015 510(k) Number:

Device Name:

EmbryoGluc™ Assisted Reproduction Media

Indications For Use:

Medium for embryo transfer

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

OR

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

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

510(k) Number

( )ver-the Counter Use_

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