MULTIBLAST MEDIUM

K034063 · Irvine Scientific Sales Co., Inc. · MQL · Apr 26, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K034063
• Device Name: MULTIBLAST MEDIUM
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Apr 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. MultiBlast Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation.

Device Story

MultiBlast Medium is a synthetic, defined culture medium containing salts, amino acids, minerals, and nutrients. It is used in clinical laboratory settings by embryologists to support the in vitro development of human embryos from day three to day five postfertilization. Following initial culture in a simpler medium, embryos are transferred to MultiBlast Medium (with protein supplementation) and incubated until the blastocyst stage is reached. The medium facilitates blastocyst formation, after which the embryo is removed for implantation. The device benefits patients by providing a controlled environment for embryonic development, increasing the likelihood of successful blastocyst formation prior to transfer.

Clinical Evidence

No clinical data. Performance is supported by mouse embryo assays to ensure functionality and absence of toxic components, alongside historical clinical use as a standard medium in sequential culture protocols.

Technological Characteristics

Synthetic, defined medium containing salts, amino acids, minerals, and nutrients. Liquid form factor. Requires protein supplementation. Sterilized via standard manufacturing processes. No electronic or software components.

Indications for Use

Indicated for the culture of human embryos to the blastocyst stage of development, specifically for use as the second stage of a sequential in vitro embryo culture protocol from day three through day five postfertilization.

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

• Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Submission Summary (Full Text)

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

Invine Scientific

APR 2 6 2004

December 24, 2003

K034063

Page 1 of 3

## 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Submitted by:

Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

Telephone: [phone] Facsimile: [phone]

Contact: Wendell Lee

Date Submitted: November 21, 2003

#### Device Identification:

| Trade Name: | MultiBlast Medium |
|----------------------|---------------------------------------|
| Common Name: | In vitro embryo culture medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |

#### Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

#### Description:

MultiBlast Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.

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

December 24, 2003

K034065
003
Page 2 of 3

## Intended Use:

MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. MultiBlast Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation.

## Technological Characteristics:

After allowing the fertilized zygote to develop in vitro in a less complex, glucose- and phosphate-free culture medium (usually through day three, postfertilization), the embryo is removed from the culture dish. It is placed into a fresh dish containing MultiBlast Medium, and protein supplementation. The dish is then returned to the incubator, and allowed to continue development, in vitro, until the desired stage of development has been achieved (usually day five postfertilization). At that time, the embryo is removed from the medium, placed into a HEPES-buffered transport medium, and implanted into the patient.

## Performance Data:

MultiBlast Medium is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation. MultiBlast Medium has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become the one of the standard media used as the second, more complex stage of a sequential media protocol.

#### Additional Information:

Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.

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

K034063
December 24, 2003 Page 3 of 3

# Conclusion:

The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that MultiBlast Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 6 2004

Wendell Lee, Pharm. D. Vice President Regulatory Affairs/Quality Systems Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K034063

Trade/Device Name: MultiBlast Medium Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: April 5, 2004 Received: April 9, 2004

Dear Dr. Lec:

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 Devicc 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 (sec above) into cither 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 sct 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.

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

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

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

# Indications for Use

510(k) Number (if known): K034063

MultiBlast Medium Device Name:

Indications For Use: MultiBlast Medium is intended for use in the culture of human embryos to the blastocyst stage of development.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Segerson

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K034063