1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI

K991390 · Sage Biopharma · MQL · Jan 18, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991390
• Device Name: 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
• Applicant: Sage Biopharma
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.

Device Story

Quinn's Cryopreservation Media is a chemical solution used in clinical assisted reproduction laboratories. It facilitates the preparation of human embryos for cryopreservation, specifically supporting both freezing and thawing processes. The media is intended for use by embryologists or trained laboratory personnel in a clinical setting. By providing a controlled environment for embryo preservation, the device enables the storage of embryos for future use in fertility treatments, potentially increasing the success rates of assisted reproductive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical media solution for embryo cryopreservation. Class II device (21 CFR 884.6180).

Indications for Use

Indicated for use in assisted reproduction procedures for the preparation, freezing, and thawing of human embryos.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2000

Advanced Reproductive Technologies, Inc. c/o Greg Holland Holland & Associates 3722 Avenue Sausalito Invine, CA 92606

Re: K991390

Quinn's ® Cryopreservation Media, 1.5M Dated: December 6, 1999 Received: December 7, 1999 Requlatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Mr. Holland:

'We have reviewed vour 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 pror 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. 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 regult 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 Compirance at [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" (21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification - Advanced Reproductive Technologies, Inc. - Cryopreservation Media

Page

510(k) Number (if known):_K991390

Cryopreservation Media Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.

(PLEASE 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 D 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use (Optional Format 1-2-96)

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