HUMAN SERUM ALBUMIN

K991392 · Advanced Reproductive Technologies · MQL · Feb 7, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991392
• Device Name: HUMAN SERUM ALBUMIN
• Applicant: Advanced Reproductive Technologies
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.

Device Story

Human Serum Albumin (HSA) in Normal Saline functions as a macromolecular supplement for assisted reproductive technology (ART) media. It is used by clinicians in laboratory settings to support gamete and embryo handling, culture, and processing. The device provides necessary protein supplementation to culture media, facilitating procedures such as IVF, GIFT, ICSI, embryo transfer, cryopreservation, and sperm washing for IUI. By maintaining an appropriate environment for reproductive cells, the device assists in the success of fertility treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Macromolecular supplement consisting of Human Serum Albumin in Normal Saline. Formulated for use as an additive in reproductive culture media.

Indications for Use

Indicated for use as a macromolecular supplement in culture media for assisted reproductive technology (ART) procedures, including IVF, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation, and sperm washing for IUI.

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)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is black and white.

FEB 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K991392

Human Serum Albumin in Normal Saline Dated: November 29, 1999 Received: December 1, 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 (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 requlation (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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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

{1}------------------------------------------------

Page__________________________________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.

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

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="height:15px"></div> |
|--------------------------------------------------|---------------------------------|
| OR | |
| Over-The-Counter Use<br>(Optional Format 1-2-96) | |

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

| 510(k) Number | K991392/5 ⁰⁰¹ |
|---------------|--------------------------|
|---------------|--------------------------|

Page 91

Concurrence of CDRH, Office of Device Evaluation (ODE)