SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)

K060699 · Medicult A/S · MQL · May 10, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060699
• Device Name: SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI).

Device Story

SynVitro Cumulase™ is a sterile, non-preserved solution containing 80 U/mL recombinant human hyaluronidase (rHuPH20) in a HEPES-buffered salt solution with synthetic serum replacement. Used by assisted reproduction professionals in clinical laboratory settings to enzymatically remove cumulus and corona radiata cells from oocytes prior to ICSI. The solution acts on the extracellular matrix of the cumulus complex to facilitate cell removal. Effectiveness is assessed by the clinician via microscopic observation of the oocyte following treatment. The device benefits patients by preparing oocytes for successful fertilization during ICSI procedures.

Clinical Evidence

Prospective, randomized clinical study comparing SynVitro®Cumulase™ to the predicate device (SynVitro®Hyadase). Study evaluated the efficiency of cumulus cell removal from oocytes prior to ICSI. Results demonstrated that both products were equally effective. No serious adverse events or complaints were reported during the study.

Technological Characteristics

Sterile, non-preserved solution; 80 U/mL recombinant human hyaluronidase (rHuPH20); HEPES-buffered salt solution; synthetic serum replacement (SSR). Quality control testing includes Ph. Eur. and USP standards for sterility, osmolality, pH, and cytotoxicity (Mouse Embryo Assay).

Indications for Use

Indicated for the removal of the cumulus and corona radiata cell complex surrounding oocytes in preparation for intracytoplasmatic sperm injection (ICSI) 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

• MediCult's SynVitro®Hyadase (K031228)

Submission Summary (Full Text)

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MAY 10

K060699

#### 510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

SynVitro®Cumulase™ is a sterile non preserved solution containing 80 U/mL of recombinant Synther Camandase (rHuPH20) in a HEPES buffered salt solution with SSR (Synthetic serum replacement) added.

#### Intended Use

SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI).

#### Biocompatibility testing

The product is not in contact with the patient, thus, biocompatibility studies have not been performed.

#### Product Testing Controls

SynVitro Cumulase™ has been cytotoxicity tested. Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH and cytotoxicity using the Mouse embryo Assay (MEA). Stability studies have been performed.

#### Clinical Documentation

Chilical Doculidentation
The predicated device is MediCult's SynVitro®Hyadase (K031228). The efficiency of removing the cumulus from the oocytes have been compared to the predicated device in a prospective, randomised clinical study .The study showed that the two products were equally effective for removal of cumulus cells prior to ICSI.

There has been no registered complaints and no evidence of any serious adverse events in connection with the intended use, during these studies.

It is concluded that SynVitro™Cumulase is substantially equivalent to the predicated device SynVitro Hyadase.

Prevared and Submitted for Medi

March 14, 2006
Date

Ronald G. Leonardi, Ph.D. President R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92131 858-586-0751

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 10 2006

MediCult a/s % Ronald G. Leonardi, Ph.D. President R&R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131

Re: K060699

Trade/Device Name: SynVitro® Cumulase™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: March 14, 2006 Received: March 17, 2006

Dear Dr. Leonardi:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image shows a logo with the letters FDA in bold, surrounded by the words "Centennial" and "2006-2006". There are three stars below the word Centennial. The logo is surrounded by a circular border with text. Below the logo is the phrase "Protecting and Promoting Public Health".

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely vours.

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

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# K060.699

## Indications for Use

510(k) Number (if known):

Device Name:

SynVitro®Cumulase™

Indications For Use:

SynVitro Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.

60699

AND/OR Over-The-Counter Use _ Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

Nancy C. Broadon

Division Sign-Off Division of Reprod ctive. and Radiological Dev 510(k) Number

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