EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED

K080473 · Medicult A/S · MQL · Sep 3, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080473
• Device Name: EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.

Device Story

EmbryoAssist™ and EmbryoAssist™ with Phenol Red are sterile, defined salt-solution media used by reproductive professionals in clinical settings. The media contains Synthetic Serum Replacement (SSR), Human Serum Albumin (HSA), amino acids, L-glutamine, vitamins, and antibiotics. The device supports fertilization and embryo culture up to the 2-8 cell stage, as well as embryo transfer at day 2 or 3. It is supplied in polyethylene plastic vials. The media provides a controlled environment for embryo development, facilitating successful assisted reproduction outcomes.

Clinical Evidence

Human clinical study conducted to evaluate the product as both a culture and transfer medium. Results indicated the product is effective and safe for its intended use. No registered complaints or serious adverse events reported during the study period.

Technological Characteristics

Physiological salt solution containing Synthetic Serum Replacement (SSR), HSA, amino acids, L-glutamine, vitamins, and antibiotics. Supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures. Batch testing performed per Ph. Eur. and USP standards for sterility, osmolality, pH, endotoxin, and Mouse Embryo Assay (MEA).

Indications for Use

Indicated for use in assisted reproduction procedures for fertilization, culture of embryos until the 2-8 cell stage, and embryo transfer at day 2 or 3.

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)
• EmbryoAssist™ (K061309)
• ISM1™ (K030490)

Submission Summary (Full Text)

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K080473

SEP - 3 2008

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

| Submitted by: | MediCult a/s |
|-----------------|------------------------------|
| | Møllehaven 12 |
| | 4040 Jyllinge |
| | Denmark |
| | Telephone: + 45 46 79 02 00 |
| | Fax: + 45 46 79 03 00 |
| Contact person: | Ronald G. Leonardi, Ph.D. |
| | R&R Registrations |
| | 9919 Cam. Chirimolla |
| | San Diego CA 92131 |
| | Date Submitted: 2008, August |

#### Device Identification

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

#### Predicate device:

Universal IVF Medium (K991279), EmbryoAssist™ (K061309) and ISM1™ (K030490) from MediCult.

### Description

EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.

The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication.

The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.

#### Intended use

EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.

### 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.

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## Performance data

EmbryoAssist™ has been tested as both culture and transfer medium 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.

## Product Testing Controls

Each batch is tested according to Ph. Eur. and USP 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 products are substantial equivalent to the predicate device MediCult's Universal IVF Medium (K991279), MediCult's EmbryoAssist™ (K061309)and MediCult's ISM1™ (K030490).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP - 8 2008

MediCult A/S c/o Ronald G. Leonardi, Ph.D. R&R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131

Re: K080473

Trade/Device Name: EmbryoAssist™ and EmbryoAssist™ with Phenol Red Regulation Number: 21 CFR §884.6180 Regulation Name: Reproduction Media and Supplements Regulatory Class: II Product Code: MQL Dated: July 29, 2008 Received: July 30, 2008

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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial."

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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.

Nancy 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): K080473

Device Name:

EmbryoAssist™ with Phenol Red

Indications for Use:

EmbryoAssist™ with Phenol Red is for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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

Julius Helmer

livision S Division of Reproductive, Abdomin and Radiological De 510(k) Number

010

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# Indications for Use

510(k) Number (if known): K080473

Device Name:

EmbryoAssist™

Indications for Use:

EmbryoAssist™ is for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ can also be used for embryo transfer at day 2 or 3.

Prescription Use __________ AND/OR Over-The-Counter Use ______________________________________________________________________________________________________________________ (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

eproductive, Abdominal, Radiological Device

510(k) Number K080477

011