BIOPSY MEDIUM, MODEL REF 1062

K060983 · Medicult A/S · MQL · Jul 28, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060983
• Device Name: BIOPSY MEDIUM, MODEL REF 1062
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)

Device Story

Biopsy Medium is a sterile, defined media used by assisted reproduction professionals for blastomere biopsy of cleavage stage embryos during PGD. The formulation consists of a HEPES-buffered HTF solution containing amino acids, human serum albumin (HSA), and Synthetic Serum Replacement (SSR), specifically formulated without calcium and magnesium ions. The absence of these ions reversibly reduces cellular connections between blastomeres, facilitating excision without fatal trauma. The device is supplied in 10 ml polyethylene vials. It is used in clinical laboratory settings by embryologists to assist in the genetic diagnosis process.

Clinical Evidence

Clinical study performed; results demonstrated effectiveness for intended use. Marketed in Europe since 2002 with no registered complaints or serious adverse events reported. Bench testing included cytotoxicity, sterility, osmolality, pH, endotoxin, and Mouse Embryo Assay (MEA) per Ph. Eur. and USP standards.

Technological Characteristics

Physiological salt solution (HEPES-buffered HTF) containing amino acids, human serum albumin, and Synthetic Serum Replacement (SSR). Formulated without calcium and magnesium ions. Supplied in 10 ml polyethylene vials. Tested for sterility, osmolality, pH, endotoxin, and MEA per Ph. Eur. and USP standards.

Indications for Use

Indicated for blastomere biopsy of cleavage stage embryos for pre-implantation genetic diagnosis (PGD).

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

• Embryo Biopsy Medium from Irvine Scientific (K021358)
• Sydney IVF Embryo Biopsy Medium from Cook (K023850)

Submission Summary (Full Text)

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## 510(k) summary

| 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 | K060983 |
|-----------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| Contact person: | Ronald G. Leonardi, Ph.D.<br>Date Submitted: June 15, 2006 | JUL 28 2006 |

### Device Identification

Trade name: Biopsy Medium Common name: Biopsy Medium Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)

#### Predicate device:

Embryo Biopsy Medium from Irvine Scientific (K021358) and the Sydney IVF Embryo Biopsy Medium from Cook (K023850).

#### Description

MediCult Biopsy Medium is a defined sterile media used by professionals within assisted reproduction and designed for blastomere biopsy of cleavage stage embryos for pre-implantation genetic diagnosis (PGD). The formulation is based on a HEPES-buffered HTF solution added SSR (Synthetic Serum Replacement: ART supplement), human serum albumin (HSA) and amino acid but without calcium and magnesium ions to facilitate the process of biopsy. The absence of calcium and magnesium ions reversibly reduces the cellular connection between the blastomeres making it easy to excise a blastomere from the embryo without fatal trauma.

Biopsy Medium is supplied in 10 ml polyethylene plastic vials with screw top closures.

#### Intended use

Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)

#### Technological Characteristics

The technological characteristics of Biopsy Medium are essentially similar to those of the predicate devices they have the same intended use and are based on a physiological salt solution with amino acids and like the predicate devices without calcium and magnesium. However, Biopsy Medium differs in the composition in containing SSR. This change does not affect the safety or effectiveness of the device.

#### Performance data

Biopsy Medium has been tested in a human study. The results showed that the product is effective for its intended use.

If has been marketed in Europe since 2002 and there has been no registered complaints and no evidence of any serious adverse events in connection with the intended use.

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## Product Testing Controls

Biopsy Medium has been cytotoxicity tested. Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin and MEA. The results are reported on a certificate of analysis. Stability studies have been performed.

# Conclusion

Thus based on the performance testing presented and our experience with the Biopsy Medium product, we feel that the safety and the effectiveness of the product for its intended use is shown in the present submission and that the product is substantial equivalence to the predicated device.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, composed of three curved lines that suggest the wings and body of a bird. The seal appears to be a logo or emblem, likely representing the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

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

Re: K060983

Trade/Device Name: Biopsy Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: July 10, 2006 Received: July 11, 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/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "DA" in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.

oting Public

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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 (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 \$10(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). 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. Hogdon

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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## INDICATIONS FOR USE

KO60983 510(k) Number (if known)

Biopsy Medium Device Name:

# Indications for Use:

Biopsy Medium is indicated for blastomere biopsy of cleavage stage embryos for PGD (pre-implantation genetic diagnosis)

(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Dennis Harrison

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