OIL FOR TISSUE CULTURE

K991380 · Advanced Reproductive Technologies · MQL · Apr 19, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991380
• Device Name: OIL FOR TISSUE CULTURE
• Applicant: Advanced Reproductive Technologies
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Apr 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

Device Story

Oil for Tissue Culture is a specialized medium overlay used in clinical embryology laboratories. It functions as a protective barrier over culture media during in-vitro fertilization (IVF), embryo culture, and micromanipulation procedures (e.g., ICSI, assisted hatching). The oil prevents evaporation of the culture medium, maintains stable pH and temperature, and protects embryos from environmental contaminants. It is applied by embryologists or laboratory technicians in a clinical setting. By providing a stable microenvironment, the device supports embryo viability and development during laboratory handling.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oil-based medium overlay for tissue culture. Formulated for use in IVF and micromanipulation. Sterile, non-toxic, and chemically inert to support embryo development.

Indications for Use

Indicated for covering tissue culture during in-vitro fertilization, embryo culture, and micromanipulative procedures including ICSI and assisted hatching.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2000

Sage BioPharma, Inc. c/o Mr. Grea Holland Consultant Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606

Re: K991380 Oil for Tissue Culture Dated: February 14, 2000 Received: February 15, 2000 Regulatory Class: II 21 CFR \$884.6180/Procode: 85 MQL

Dear Mr. Holland:

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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either dass 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 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 notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication 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 [phone]. Additionally, for question 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 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/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

DEPARTMENT OF HEA

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_K 991380

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K991380 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use<br>(Optional Format 1-2-96) |
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