SINGLE STEP MEDIUM

K072609 · Irvine Scientific Sales Co., Inc. · MQL · Feb 12, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072609
• Device Name: SINGLE STEP MEDIUM
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

Device Story

Single Step Medium is a synthetic, defined culture medium containing salts, amino acids, minerals, and nutrients. Used in clinical assisted reproductive technology (ART) laboratories by embryologists. The medium supports zygote fertilization and embryo development in vitro up to day 5/6. The process involves placing the embryo in a dish with the medium, incubating, and replenishing the medium after 48 hours. After reaching the desired developmental stage, the embryo is implanted into the patient. The medium provides a controlled environment for embryonic growth, replacing the need for complex sequential media protocols.

Clinical Evidence

Bench testing only. Performance is validated via mouse embryo assay to ensure functionality (support of embryonic growth) and absence of toxic components. Sterility and endotoxin testing are performed as release criteria.

Technological Characteristics

Synthetic, defined medium containing salts, amino acids, minerals, and nutrients. Formulated for in vitro fertilization and embryo culture up to day 5/6. Requires protein supplementation. Non-automated, chemical-based culture medium.

Indications for Use

Indicated for use in assisted reproductive procedures involving gamete and embryo manipulation, specifically as a culture medium for fertilization and embryo development up to day 5/6 in vitro.

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

• MultiBlast Medium (K034063)
• global®: fertilization, embryo culture and transfer medium (K053552)

Submission Summary (Full Text)

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# K072609

## 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: September 14, 2007

#### Device Identification:

| Trade Name: | Single Step Medium |
|----------------------|---------------------------------------|
| Common Name: | In vitro embryo culture medium |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |

### Predicate Device:

Final Rule, 63 FR 48428, Docket number 97N-0335 MultiBlast Medium (K034063) global®: fertilization, embryo culture and transfer medium (K053552)

#### Description:

Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.

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#### Intended Use:

Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

#### Technological Characteristics:

After allowing the fertilized zygote to develop in vitro in Single Step Medium, the embryo is removed from the culture dish. It is placed into a fresh dish containing Single Step Medium, and protein supplementation. The dish is then returned to the incubator, and the embryo is allowed to continue develop in vitro. The media is replenished after forty-eight (48) hours with fresh media and the embryo is further incubated until the desired stage of development has been achieved (up to 5/6 days) in vitro. After the desired stage of development is obtained the embryo is implanted into the patient.

#### Performance Data:

Single Step 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 (K034063) 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 in addition to the comparison to the predicate devices show that Single Step 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. References are presented in Appendix F.

| Product Name | K # | Fertilization<br>Medium | Culture of<br>Embryos<br>from<br>Day 3 to 5/6 | Culture of<br>Embryos<br>up to<br>Day 5/6 | Transfer<br>Medium |
|------------------------------------------------------------------------|---------|-------------------------|-----------------------------------------------|-------------------------------------------|--------------------|
| Single Step<br>Medium | K072609 | ✓ | | ✓ | |
| MultiBlast Medium | K034063 | | ✓ | | |
| global®:<br>fertilization,<br>embryo culture<br>and transfer<br>medium | K053552 | ✓ | | ✓ | ✓ |

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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 lines representing its wings.

FEB 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072609

Trade/Device Name: Single Step Medium Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: January 28, 2008 Received: January 29, 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, 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.

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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/cdrb/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)

510(K) Number: KO7 2609

Device Name: Single Step Medium

Indications for Use:

Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

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)

Janair Brigdon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

**510(k) Number**

Page 1 of

Single Step Medium