ICSI CUMULASE

K081639 · Medicult A/S · MQL · Sep 19, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081639
• Device Name: ICSI CUMULASE
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

The removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

Device Story

ICSI Cumulase is a sterile, ready-to-use reproductive media containing recombinant human hyaluronidase and human serum albumin (HSA). Used by assisted reproduction professionals in clinical settings to enzymatically remove the cumulus complex and corona radiata from oocytes prior to Intracytoplasmic Sperm Injection (ICSI). The media facilitates the preparation of the oocyte for the injection procedure. Supplied in 0.5 ml polypropylene vials.

Clinical Evidence

No clinical data. Safety and effectiveness were supported by a review of relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme, alongside bench testing for sterility, osmolality, pH, endotoxin, enzyme activity, and Mouse Embryo Assay (MEA).

Technological Characteristics

Reproductive media containing recombinant human hyaluronidase and HSA. Supplied in 0.5 ml transparent polypropylene vials with screw top closures. Tested for sterility, osmolality, pH, endotoxin, enzyme activity, and Mouse Embryo Assay (MEA) per Ph. Eur. and USP standards.

Indications for Use

Indicated for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI in patients undergoing assisted reproduction 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

• SynVitro®Cumulase® (K060699)
• Cumulase® (K042495)

Submission Summary (Full Text)

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SEP 1 9 2008

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

| Submitted by: | MediCult a/s<br>Møllehaven 12<br>4040 Jyllinge<br>Denmark<br>Telephone: + 45 46 79 02 00<br>Fax: + 45 46 79 03 00 |
|-----------------|-------------------------------------------------------------------------------------------------------------------|
| | K-30 |
| Contact person: | Ronald G. Leonardi, Ph.D. |
| | R&R Registrations |
| | 9919 Cam. Chirimolla |
| | FDA CDRH DMC |
| | San Diego CA 92131 |
| | JUN 1 1 2008 |
| | Received |
| | Date Submitted: June 2, 2008 |

### Device Identification

Trade name: ICSI Cumulase® Common name: ICSI Cumulase® Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code 85 MQL)

#### Predicate devices:

SynVitro®Cumulase® (K060699) from MediCult a/s and Cumulase® (K042495) from Halozyme.

### Description

ICSI Cumulase is a defined sterile, ready to use media used by professionals within assisted reproduction and intended for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

ICSI Cumulase is a modified version of SynVitro® Cumulase ( K060699) and is based on a salt solution containing a recombinant hyaluronidase and HSA (US license No 1716). ICSI Cumulase is supplied in transparent polypropylene plastic vials with screw top closures in a volume of 0.5 ml.

### Intended use

The removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

### Technological Characteristics

The technological characteristics of ICSI Cumulase® are essentially similar to those of the predicate devices. They have the same intended use and contain the recombinant human hyaluronidase enzyme Cumulase®.

### Performance data

In order to evaluate the safety and efficiency of ICSI Cumulase an evaluation of all relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme has been performed. The review showed that the product is effective and safe for its intended use.

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# Product Testing Controls

Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin, enzyme activity and Mouse Embryo Assay (MEA). Stability studies have been performed.

# Conclusion

It is concluded that the safety and the effectiveness of the product for its intended use is shown in the present submission and that the products are substantially equivalent to the predicate devices MediCult's SynVitro®Cumulase® (K060699) and Halozyme's Cumulase® (K042495).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2008

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

Re: K081639

> Trade Name: ICSI Cumulase® Regulation Number: 21 CFR \$884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: September 3, 2008 Received: September 4, 2008

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 (PMA), 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.

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# Page 2

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.

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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Jose M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name:

ICSI Cumulase®

Indications For Use:

ICSI Cumulase® is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use x x (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 ____________________________________________________________________________________________________________________________________________________________________

Helena Plumer

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