BLASTOCYST MEDIUM

K983580 · Irvine Scientific Sales Co., Inc. · MQL · Feb 18, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983580
• Device Name: BLASTOCYST MEDIUM
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Blastocyst Medium is intended for use in assisted reproductive technology procedures that include gamete and embryo manipulation. Specifically, Blastoycst is intended for use as an in vitro culture medium from day three through day five of embryo development.

Device Story

Blastocyst Medium is a synthetic, defined culture medium containing salts, amino acids, vitamins, and minerals. It serves as the second stage in a sequential in vitro embryo culture protocol. Following initial development in a simpler medium through day three post-fertilization, embryos are transferred into Blastocyst Medium supplemented with protein. The medium supports continued embryonic growth and blastocyst formation in an incubator until day five. Once the desired developmental stage is reached, the embryo is removed, placed in a transport medium, and implanted into the patient. The device is used in clinical laboratory settings by embryologists or trained laboratory personnel to facilitate embryo development, potentially improving outcomes in assisted reproductive technology procedures.

Clinical Evidence

No clinical data. Performance is supported by mouse embryo assay (MEA) to ensure functionality and absence of toxic components. Endotoxin and sterility testing are performed as part of lot-specific release criteria.

Technological Characteristics

Synthetic, defined medium containing salts, amino acids, vitamins, and minerals. Formulated for use as a second-stage sequential culture medium. Requires protein supplementation. Subject to mouse embryo assay, endotoxin testing, and sterility testing prior to release.

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures involving gamete and embryo manipulation, specifically for in vitro culture of human embryos from day three through day five post-fertilization to support blastocyst development.

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)

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2/18/99
Irvine Scientific

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# 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: Roberta L. Johnson

Date Submitted: October 9, 1998

# Device Identification:

| Trade Name: | Blastocyst 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:

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

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#### Intended Use:

Blastocyst Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. Blastocyst 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 Blastocyst 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:

Blastocyst 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. Blastocyst 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.

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# Conclusion:

The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Blastocyst 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705

Re: K983580 Blastocyst Medium Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 884.6180/Procode: 85MOL

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel C. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: K983580

Device Name:_Blastocyst Medium

Indications for Use:

Blastocyst Medium is intended for use in assisted reproductive technology procedures that include gamete and embryo manipulation. Specifically, Blastoycst is intended for use as an in vitro culture medium from day three through day five of embryo development.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983580/S⁰⁰¹

Blastocyst Medium