HYALURONIDASE SOLUTION

K022931 · Irvine Scientific Sales Co., Inc. · MQL · Nov 4, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022931
• Device Name: HYALURONIDASE SOLUTION
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Nov 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Hyaluronidase Solution is intended for use in assisted reproductive technology procedures involving the manipulation of gametes or embryos. Specifically, Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.

Device Story

Hyaluronidase Solution is an enzymatic solution used in clinical ART laboratories. It consists of 80 U/mL bovine-derived hyaluronidase in HEPES-buffered HTF medium, supplemented with 5.0 mg/mL therapeutic grade human serum albumin and 10µg/mL gentamicin sulfate. The solution is used by embryologists to enzymatically digest and remove cumulus cells surrounding freshly retrieved oocytes. The procedure involves a 30-60 second exposure, followed by immediate washing and transfer of denuded oocytes to appropriate media for fertilization (e.g., ICSI) and subsequent development. The device facilitates the preparation of oocytes for fertilization, potentially improving the success of ART procedures.

Clinical Evidence

No clinical data. Performance is supported by bench testing, specifically the mouse embryo assay (MEA) to confirm the product supports embryonic growth and lacks toxic components. Additional release testing includes enzyme activity, endotoxin, and sterility testing.

Technological Characteristics

Enzymatic solution containing 80 U/mL bovine-derived hyaluronidase, HEPES-buffered HTF medium, 5.0 mg/mL human serum albumin, and 10µg/mL gentamicin sulfate. Operates via enzymatic digestion of cumulus cells. No software or electronic components.

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures to remove cumulus cells (denudation) from oocytes in preparation for ICSI or other ART procedures.

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

| Submitted by: | Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705-5588<br><br>Telephone: [phone]<br>Facsimile: [phone]<br><br>Contact: Wendell Lee, Pharm. D.<br><br>Date Submitted: October 9, 2000 | NOV 4 2002 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
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#### Device Identification:

| Trade Name: | Hyaluronidase Solution |
|----------------------|---------------------------------------|
| Common Name: | Hyaluronidase Solution |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |

#### Predicate Device:

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

## Description:

Hyaluronidase Solution is a enzymatic solution containing 80 U/mL of bovine derived hyaluronidase in a HEPES buffered HTF Medium supplemented with 5.0 mg/mL (or 0.5%) therapeutic grade human serum albumin (HSA) and 10µg/mL gentamicin sulfate.

## Intended Use:

Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.

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## Technological Characteristics:

Enzymatic digestion and removal of cumulus cells surrounding freshly retrieved oocytes will occurred within a 30 - 60 second exposure to Hvaluronidase Solution. Denuded oocytes should be immediately washed and transferred to appropriate medium for subsequent fertilization (by ICSI) and onqoing development.

## Performance Data:

Hyaluronidase Solution is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present. The equivalent of Hyaluronidase Solution has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for denuded oocytes.

# Additional Information:

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

## Conclusion:

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV : 4 2002

Wendall Lee, PharmD Vice President Quality Systems and Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

#### Re: K022931

Trade/Device Name: Hyaluronidase Solution Regulation Number: 21 CFR 884.6180 · Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL

Dated: August 23, 2002 Received: September 4, 2002

#### Dear Dr. Lee:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec 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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Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Irvine Scientific .

#### August 23, 2002

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

KO22931 510(K) Number:

Device Name: Hyaluronidase Solution

Indications for Use:

Hyaluronidase Solution is intended for use in assisted reproductive technology procedures involving the manipulation of gametes or embryos. Specifically, Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use_

David A. Siegmann

(Division Sign-Off) Division of Reproductive, Abd and Radiological Device 510(k) Number