EARLY CLEAVAGE MEDIUM (ECM)

K033462 · Irvine Scientific Sales Co., Inc. · MQL · Jan 15, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033462
• Device Name: EARLY CLEAVAGE MEDIUM (ECM)
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Early Cleavage Medium is intended for assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include the use of Early Cleavage Medium as a culture medium through day three of development.

Device Story

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

Clinical Evidence

Bench testing only. Performance validated via mouse embryo assay to confirm functionality and lack of toxicity. Parallel studies compared ECM to P-1 Medium (K983589) to ensure performance consistency. Release criteria include endotoxin and sterility testing.

Technological Characteristics

Synthetic, defined medium; balanced mixture of salts and nutrient substances. Requires protein supplementation. Used in CO2 incubators. Quality control via mouse embryo assay, endotoxin testing, and sterility testing.

Indications for Use

Indicated for use in assisted reproductive procedures involving gamete and embryo manipulation, specifically as a culture medium for embryos through day 3 of 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

Reference Devices

• P-1 Medium (K983589)

Submission Summary (Full Text)

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Irvine Scientific

3462

October 31, 2003

Page 1 of 3

JAN 1 5 2004

## 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: October 31, 2003

#### Device Identification:

| Trade Name: | Early Cleavage Medium (ECM) |
|----------------------|----------------------------------------|
| 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:

Early Cleavage Medium 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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October 31, 2003

#### Intended Use:

Early Cleavage Medium is intended for assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include the use of Early Cleavage Medium as a culture medium through day three of development.

#### Technological Characteristics:

After retrieval of oocytes from the patient, the oocytes are placed in a culture dish containing 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 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:

Early Cleavage 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. Parallel mouse embryo studies have been performed on P-1 and ECM to assure the performance of ECM. These studies are similar to those previously performed, and submitted for 510K of P-1 Medium (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

October 31, 2003

assays performed will be reported on a lot-specific certificate of analysis, and will 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 Early Cleavage Medium is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a depiction of an abstract eagle or bird-like figure, with three curved lines representing the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

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

Re: K033462

Trade/Device Name: Early Cleavage Medium (ECM) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II

Product Code: 85 MQL Dated: October 31, 2003 Received: October 31, 2003

Dear Mr. 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, 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 (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,

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,

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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. Ixxx | [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

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# Indications for Use

510(k) Number (if known): X o 3 3 46 2

Device Name:__Early Cleavage Medium (ECM)

Indications For Use:

Early Cleavage Medium (ECM) is intended for use in assisted reproductive procedures,
the use of Early Cleavage Medium (ELM) is Intended to use in assisted to procedures include the use of
which include gamete and embryo manipulation. These procedures include the use of which include gamete and embrys mailip
ECM as a culture medium through day 3 of development.

Prescription Use _ X (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)

**Prescription Use**
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033462

Radiological Devices

510(k) Number K033462