SYDNEY IVF HYALURONIDASE

K023353 · Cook Urological, Inc. · MQL · Dec 20, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023353
• Device Name: SYDNEY IVF HYALURONIDASE
• Applicant: Cook Urological, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sydney IVF Hyaluronidase is intended for use to facilitate removal of the cumulus cells surrounding oocytes in assisted reproduction technology (ART) procedures.

Device Story

Sydney IVF Hyaluronidase is an aqueous solution containing electrolytes and buffering agents used in assisted reproduction technology (ART) procedures. The device is supplied in 1 mL glass vials with silicone rubber stoppers. It is used by clinicians in a laboratory setting to facilitate the enzymatic removal of cumulus cells surrounding oocytes. The solution acts as a chemical reagent to assist in the preparation of oocytes for further ART processes. No complex instrumentation, software, or electronic processing is involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Aqueous solution containing electrolytes and buffering agents. Provided in 1 mL glass vials with silicone rubber stoppers. Non-electronic, chemical reagent.

Indications for Use

Indicated for use in assisted reproduction technology (ART) procedures to facilitate the removal of cumulus cells surrounding oocytes.

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

• 63 FR 48428 (September 10, 1998)

Submission Summary (Full Text)

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Sydney IVF Hyaluronidase - 510(k) Premarket Notification

DEC 2 0 2002

#### த 510(k) Summary

KO23353

Submitted By: Debbie Schmitt, Regulatory Affairs COOK OB/GYN™ 1100 West Morgan Street Spencer, Indiana, 47460 812 829-6500

October 4, 2002

#### Names of Device:

| Trade Name: | Sydney IVF Hyaluronidase |
|----------------------|--------------------------------------------------------------------------|
| Common/Usual Name: | Hyaluronidase Solution |
| Classification Name: | Reproductive media and supplements<br>21 CFR §884.6180 (87MQL); Class II |
| Predicate Device: | 63 FR 48428, September 10, 1998 |

### Device Description:

Sydney IVF Hyaluronidase is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Hyaluronidase will be available in 1 mL fill volumes.

#### Intended Use:

Sydney IVF Hyaluronidase is intended for use as to facilitate removal of the cumulus cells surrounding oocvtes in assisted reproduction technology (ART) procedures.

#### Substantial Equivalence:

Sydney IVF Hyaluronidase is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

#### Discussion of Tests and Test Results:

Sydney IVF Hyaluronidase was subjected to testing to assure satisfactory operating parameters. Sydney IVF Hvaluronidase passed the requirements of all tests.

#### Conclusions Drawn from Tests:

This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a central emblem. The emblem consists of three stylized human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

### Public Health Service

DEC 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Debbie Schmitt Regulatory Affairs Manager COOK OB/GYNTM 1100 West Morgan Street SPENCER IN 47460

Re: K023353 Trade/Device Name: Sydney IVF Hyaluronidase Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: October 4, 2002 Received: October 7, 2002

Dear Ms. Schmitt:

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 (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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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/cdrlv/dsma/dsmamain.html.

Sincerely vours.

Henry C. Grigdon

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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Page 1 of .

## 510(k) Number (if known): K0233333

| Device Name: | Sydney IVF Hyaluronidase |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Sydney IVF Hyaluronidase is intended for use to facilitate removal of the cumulus cells surrounding oocytes in assisted reproduction technology (ART) procedures. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Khrist G. Boyum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 3355 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)