ENHANCE HUMAN SERUM ALBUMIN

K030850 · Conception Technologies · MQL · Apr 8, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030850
• Device Name: ENHANCE HUMAN SERUM ALBUMIN
• Applicant: Conception Technologies
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Apr 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.

Device Story

Enhance-HSA is a protein supplement for in-vitro mammalian-cell culture media. Used in clinical laboratory settings by embryologists or laboratory technicians during assisted reproductive technology (ART) procedures; including IVF, gamete washing, embryo culture, micromanipulation, and cryopreservation. The device functions as a media additive to support cell viability and development in vitro. It is provided for professional use in a clinical environment to facilitate successful embryo handling and development.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human Serum Albumin (HSA) protein supplement for in-vitro mammalian-cell culture media. Classified under 21 CFR 884.6180 (Reproductive media and supplements).

Indications for Use

Indicated for use as a protein supplement in in-vitro mammalian-cell culture media for procedures including in vitro fertilization, gamete washing, embryo culture, micromanipulation, and embryo cryopreservation.

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

## APR 0 8 2003

Conception Technologies, L.P. % Grace Holland. Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K030850

Trade/Device Name: Enhance-HSA Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MOL Dated: March 13, 2003 Received: March 17, 2003

Dear Ms. Holland:

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. Ilsting 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 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.

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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.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

Page 2

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Indications for Use Statement

Page 1 of _________________________________________________________________________________________________________________________________________________________________________ 1

510(k) Number (if known): k030850

HSA Device Name:_

Indications For Use:

HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

(Division Sign Off)
Division of Reproductive. Abdominal,
and Radioingical Devices
510(k) Number `12030850`

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

REGULATORY SPECIALISTS, INC.