EMBRYOASSIST

K061309 · Medicult A/S · MQL · Feb 8, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K061309
• Device Name: EMBRYOASSIST
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

Device Story

EmbryoAssist™ is a defined sterile culture medium for assisted reproduction. It consists of a physiological salt solution supplemented with Synthetic Serum Replacement (SSR), Human Serum Albumin (HSA), amino acids, L-glutamine, vitamins, and antibiotics. Used by assisted reproduction professionals in clinical laboratory settings to support oocyte fertilization and embryo development up to the 4-8 cell stage. The medium provides the necessary chemical environment for embryo viability. It is supplied in 10 ml polyethylene vials.

Clinical Evidence

Human study conducted; results demonstrated safety and effectiveness for the intended use. No registered complaints or serious adverse events reported during the study period. Bench testing included sterility, osmolality, pH, endotoxin levels, and Mouse Embryo Assay (MEA).

Technological Characteristics

Defined sterile medium; physiological salt solution base; contains SSR, HSA, amino acids, L-glutamine, vitamins, and antibiotics. Supplied in 10 ml polyethylene plastic vials with screw top closures. No electronic or software components.

Indications for Use

Indicated for the culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 post-insemination) and for the fertilization of oocytes in assisted reproduction 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

• Universal IVF Medium (K991279)
• BlastAssist®System (K003156)

Submission Summary (Full Text)

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# 1061309

#### 510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

FEB 8 2007

| Submitted by: | MediCult a/s<br>Møllehaven 12<br>4040 Jyllinge<br>Denmark<br>Telephone: + 45 46 79 02 00<br>Fax: + 45 46 79 03 00 |
|-----------------|-------------------------------------------------------------------------------------------------------------------|
| Contact person: | Ronald G. Leonardi, Ph.D. |

Date Submitted: September 8, 2006

## Device Identification

Trade name: EmbryoAssist™ Common name: EmbryoAssist™ Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)

#### Predicate device:

Universal IVF Medium (K991279) and BlastAssist®System (K003156) from MediCult.

#### Description

EmbryoAssist™ is a defined sterile medium, used by assisted reproduction professionals and intended for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

The design of EmbryoAssist™ is based on BlastAssist Medium 1 (MediCult's BlastAssist®System K003156). The EmbryoAssist™ medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml polyethylene plastic vials with screw top closures

## Intended use

EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

#### Technological Characteristics

The technological characteristics of EmbryoAssist™ are essentially similar to those of the predicate devices they have the same intended use and are based on a physiological salt solution with SSR and amino acids. However, EmbryoAssist™ differs in the composition in containing vitamins. This change does not affect the safety or effectiveness of the device.

#### Performance data

EmbryoAssist™ has been tested in a human study. The results showed that the product is effective and safe for its intended use. During our studies there have been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with the intended use.

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## Product Testing Controls

Frouner resulting Colliers for sterility, osmolality, pH, endotoxin and Mouse embryo Assay (MEA). Stability studies have been performed.

## Conclusion

It is concluded that the safety and the effectiveness of the product for its intended use is shown in the present submission and that the product is substantial equivalence to the predicated device MediCult's Universal IVF Medium (K991279) and MediCult's BlastAssist®System (K0013156).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a three-lined globe.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MediCult a/s % Ronald G. Leonardi, Ph.D. President R & R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131

2007 FEB

Re: K061309

Trade/Device Name: EmbryoAssistTM Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: January 19, 2007 Received: January 22, 2007

Dear Dr. Leonardi:

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 (Premarket Approval), 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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*Protecting and Promoting Public Health*

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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). 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/cdrlvindustry/support/index.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

510(k) Number (if known):

Kob 1309

Device Name:

EmbryoAssist™

Indications For Use:

EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

AND/OR Over-The-Counter Use Prescription Use x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Daniel Ro. Segmann

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