LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT

K072607 · Irvine Scientific Sales Co., Inc. · MQL · Jan 25, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072607
• Device Name: LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jan 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Lyophilized Early Cleavage Medium Kit is intended for assisted reproductive technology (ART) that involves the manipulation of gametes and embryos. Specifically Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium through day three (3) of embryo development.

Device Story

Lyophilized Early Cleavage Medium Kit is a synthetic, defined culture medium containing salts and nutrients; supports early embryonic growth up to three days post-fertilization. Used in clinical ART laboratories by embryologists; oocytes retrieved from patients are placed in reconstituted medium with protein supplementation in culture dishes. Fertilization occurs in the medium; zygotes are transferred to fresh medium and incubated in CO2 incubators. Output is a supportive environment for embryo development; enables subsequent embryo transfer or transition to more complex media. Benefits include standardized, defined conditions for in vitro embryo culture.

Clinical Evidence

No clinical data. Performance validated via mouse embryo assay (MEA) to ensure functionality and absence of toxic components. Parallel MEA studies performed comparing subject device to predicate Early Cleavage Medium (K033462) and P-1 (K983589) to confirm performance consistency.

Technological Characteristics

Synthetic, defined medium; lyophilized form for reconstitution. Components include balanced salts and nutrient substances. Supports in vitro embryo culture up to day three. Sterility and endotoxin testing performed as release criteria.

Indications for Use

Indicated for use in assisted reproductive technology (ART) involving manipulation of gametes or embryos; intended as a culture medium from fertilization through day three (3) of embryo 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

• Early Cleavage Medium (K033462)

Reference Devices

• P-1 (K983589)

Submission Summary (Full Text)

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Irvine Scientific

September 14, 2007

K072607
pq. 102

# 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]

JAN 25

Contact: Wendell Lee

Date Submitted: September 14, 2007

#### Device Identification:

| Trade Name: | Lyophilized Early Cleavage Medium (ECM) Kit |
|----------------------|---------------------------------------------|
| Common Name: | In vitro embryo culture medium |
| Product Code: | MLQ |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |

#### Predicate Device:

Early Cleavage Medium (K033462)

### Description:

Lyophilized Early Cleavage Medium Kit is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).

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K072607
pg. 2 of 3

#### Intended Use:

Lyophilized Early Cleavage Medium Kit is intended for assisted reproductive technology (ART) that involves the manipulation of gametes and embryos. Specifically Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium through day three (3) of embryo development.

# Technological Characteristics:

After retrieval of oocytes from the patient, the oocytes are placed in a culture dish containing the reconstituted Lyophilized Early Cleavage Medium and the desired type and amount of protein supplementation. Fertilization is allowed to take place, and the zygote is removed to a fresh dish containing fresh Lyophilized Early Cleavage Medium and protein. This culture dish is placed into a carbon dioxide incubator, and the embryo is allowed to develop, in vitro, until the desired stage of development has been achieved, usually up to three days post fertilization. At that time, the embryo may be transferred to the patient, or to a second, more complex medium for continued growth.

#### Performance Data:

The Lyophilized Early Cleavage Medium Kit 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. Parallel mouse embryo studies have been performed on Early Cleavage Medium (K033462) and P-1 (K983589) to assure the performance of the Lyophilized Early Cleavage Medium Kit. These studies are similar to those previously performed, and submitted for the 510(k) of Early Cleavage Medium (K033462) and P-1 (K983589).

#### Additional Information:

Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing. Results of all release

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## Irvine Scientific

K072607
Pg. 3 of 3

assays performed will be reported on a lot-specific certificate of analysis, and wil be indicated on the labeling.

# Conclusion:

The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that the Lyophilized Early Cleavage Medium Kit is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. References are presented in Appendix F of this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

JAN 25 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072607

Trade Name: Lyophilized Early Cleavage Medium (ECM) Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: January 3, 2008 Received: January 4, 2008

Dear Dr. Lee:

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, 1796, 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 (PMA), 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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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 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 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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Irvine Scientific

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

072607 510(K) Number:_

Device Name: Lyophilized Early Cleavage Medium Kit

Indications for Use:

Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Helentewner

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

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Lyophilized Early Cleavage Medium Kit