OIL FOR EMBRYO CULTURE

{0}------------------------------------------------ # JUL 1 8 2001 2011938 p. 1 of 2 June 15, 2001 # 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c) Irvine Scientific Sales Co., Inc. Submitted by: 2511 Daimler Street Santa Ana, CA 92705-5588 > Telephone: (800) 437-5706 Facsimile: (949) 261-6522 Contact: Wendell Lee, Pharm. D. Date Submitted: June 15, 2001 ### Device Identification: | Trade Name: | Oil for Embryo Culture | |----------------------|--------------------------------------| | Common Name: | Oil for Embryo Culture | | Classification Name: | Reproductive Media (21 CFR 884.6180) | #### Predicate Device: Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 #### Description: Oil for Embryo Culture is a solution intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation. {1}------------------------------------------------ K011938 p. 2 of 2 June 15, 2001 ## Intended Use: Oil for Embryo Culture is intended for use in as an overlay to cover small volumes of culture media during embryo and gamete manipulation. ### Technological Characteristics: Oil for Embryo Culture is primarily used as an accessory solution to ina overlay medium to support in vitro fertilization and post fertilization embryo growth. The embryo is allowed to grow in the solution until the desired state of development is reached. #### Performance Data: Oil for Embryo Culture is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present. ### Additional Information: Mouse embryo, endotoxin and sterility testing will be performed as a condition of release for this product. Results of all release assays performed will be indicated on the labeling and reported on a lot-specific certificate of analysis. ### Conclusion: The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Oil for Embryo Culture is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. # JUL 1 8 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Wendell Lee, Pharm. D. Vice President, Quality Systems and Regulatory Affairs IRVINE SCIENTIFIC 2511 Daimler Street SANTA ANA CA 92705-5588 Re: K011938 OIL FOR EMBRYO CULTURE Dated: June 15, 2001 Received: June 21, 2001 Regulatory Class: II 21 CFR 884.6180/Procode: 85 MQL Dear Dr. Lee: 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 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 Regulations, 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 OS 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours. Nancy C. Bogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure (s) {3}------------------------------------------------ K011938 Irvine Scientific June15, 2001 # INDICATIONS FOR USE STATEMENT (page 1 of 1) 510(K) Number:_KO11938 Device Name: Oil for Embryo Culture Indications for Use: Oil for Embryo Culture is intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation. (Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *Prescription Use* ✓ Nancy C. Broadlon