HUMAN SERUM ALBUMIN (HSA)

K983584 · Irvine Scientific Sales Co., Inc. · MQL · Feb 8, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983584
• Device Name: HUMAN SERUM ALBUMIN (HSA)
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Human Serum Albumin is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth, and embryo cryopreservation.

Device Story

Human Serum Albumin (HSA) is a protein supplement derived from therapeutic-grade human serum (10mg/mL) in sterile saline. Used in clinical embryology laboratories during in vitro fertilization (IVF), embryo culture, and cryopreservation. Clinicians add prewarmed, equilibrated HSA to culture dishes containing support media to facilitate embryo development. HSA does not contact the patient directly; it supports the environment for gametes and embryos prior to transfer. Product quality is verified via mouse embryo assay, endotoxin testing, and sterility testing prior to release.

Clinical Evidence

No clinical data. Performance is supported by historical use in clinical settings and bench testing, specifically mouse embryo assay to ensure functionality and absence of toxic components, alongside endotoxin and sterility testing.

Technological Characteristics

Human serum albumin (10mg/mL) in sterile saline solution. Liquid form factor. Non-patient contacting. Quality control via mouse embryo assay, endotoxin testing, and sterility testing.

Indications for Use

Indicated for use as a protein supplement in assisted reproductive procedures, including in vitro fertilization, embryo culture, 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.

Predicate Devices

• Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Submission Summary (Full Text)

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K983584

Irvine Scientific

October 9, 1998

Image /page/0/Picture/3 description: The image shows the logo for Irvine Scientific. The logo consists of a stylized, blocky design that appears to be a combination of the letters 'I' and 'S', enclosed within a square border. Below the logo, the words 'IRVINE SCIENTIFIC' are printed in a simple, sans-serif font.

FEB 8 1999

# 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Submitted by: Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

> Telephone: [phone] Facsimile: [phone]

Contact: Roberta L. Johnson

Date Submitted: October 9, 1998

#### Device Identification:

| Trade Name: | Human Serum Albumin (HSA) |
|----------------------|------------------------------------------------|
| Common Name: | Protein supplement for in vitro embryo culture |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |

#### Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

#### Description:

Human Serum Albumin consists of human serum albumin from therapeutic-grade source material (10mg/mL) in a sterile saline solution.

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October 9, 1998

## Intended Use:

Human Serum Albumin is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth, and embryo cryopreservation.

## Technological Characteristics:

Depending upon the procedure used, an appropriate amount of prewarmed, equilibrated HSA is withdrawn, and added to the culture dish and support medium. After the desired stage of embryo development is achieved, the embryo is removed from the culture dish, placed into a HEPES-buffered transfer medium, and implanted into the patient. HSA is not intended to contact the patient.

## Performance Data:

HSA is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation. Human Serum Albumin has been used in a variety of clinical settings, for their intended use, for a number of years. In that time, the product has become one of the standard protein supplements used for the in vitro fertilization, growth and cryopreservation of human gametes and embryos.

### Additional Information:

Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.

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# Conclusion:

The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Human Serum Albumin is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 8 1999

Ms. Roberta Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, California 92705-5588 Re: K983584 Human Serum Albumin Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 884.6180/Procode: 85 MQL

Dear Ms Johnson:

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 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 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 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 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 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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Irvine Scientific

ン,

#### INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number:

Device Name: Human Serum Albumin (HSA)

Indications for Use:

Human Serum Albumin (HSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular. HSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \$\underline{ \checkmark }\$

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983584 / 5⁰⁰¹

Human Serum Albumin (HSA)