VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

K070135 · Fertipro NV · MQL · Aug 16, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070135
• Device Name: VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
• Applicant: Fertipro NV
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

VitriFreeze Media are intended for ultra-rapid freezing of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. VitriThaw media are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing for Assisted Reproductive Technology (A.R.T.) procedures.

Device Story

VitriFreeze and VitriThaw are reproductive media kits for cryopreservation of human blastocysts. VitriFreeze consists of three sequential media (Pre-incubation, Medium 1, Medium 2) for blastocyst equilibration and vitrification. VitriThaw consists of four sequential media (Medium 1, 2, 3, 4) for thawing and recovery. Used in clinical laboratory settings by embryologists or trained technicians during A.R.T. procedures. Media facilitate ultra-rapid freezing to preserve blastocyst viability during cryostorage and subsequent recovery. Clinical benefit is the preservation of blastocysts for future implantation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing, formulation comparison, and performance testing.

Technological Characteristics

Reproductive media for cryopreservation. Sequential liquid media formulations. Class II device (21 CFR 884.6180).

Indications for Use

Indicated for use in Assisted Reproductive Technology (A.R.T.) procedures for the ultra-rapid freezing and subsequent recovery of human blastocysts.

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

• VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT (K060168)

Submission Summary (Full Text)

{0}------------------------------------------------

# 5.5

Image /page/0/Picture/2 description: The image shows a logo for FertiPro N.V. On the left side of the image, there is a cartoon drawing of a baby with wings. To the right of the baby, the text "FertiPro N.V." is displayed in a light-colored font. Below the text, there are several round objects, possibly eggs or spheres, arranged in a row.

park Noord 32 - 8730 Beernem - Belgium - Tel [phone] - Fax +32 50

Submitter's name: Address:

Phone: Fax number: FertiPro N.V. Industriepark Noord 32 Beernem West-Vlaanderen, Belgium 8730 [phone] [phone]

Name of contact person:

Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] Email: [e-mail]

Date the summary was prepared: August 13, 2007

Name of the device: VitriFreeze Trade or proprietary name: VitriFreeze Media, Pre incubation, 1 and 2 Vitrification freezing media Common or usual name: Classification name: Reproductive media Name of the device:

Trade or proprietary name: Common or usual name: Classification name:

VitriThaw VitriThaw Media 1, 2, 3, and 4 Vitrification thawing media Reproductive media

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| Device | Ref# | Applicant | Decided |
|-----------------------------------------------------|---------|----------------------------|------------|
| VITRIFICATION FREEZE KIT,<br>VITRIFICATION THAW KIT | K060168 | Irvine Scientific<br>Sales | 04/24/2006 |

AUG 16 2007

{1}------------------------------------------------

Description of the devices:

The seven (7) media that comprise the two (2) VitriFreeze and VitriThaw media are all based upon a modified formulation of other media.

The three (3) freeze media in VitriFreeze are intended for use sequentially and are named Pre-incubation medium, VitriFreeze Medium 1 and VitriFreeze Medium 2. These media are used for preparation for and cryopreservation of human blastocysts. Preincubation medium is used to equilibrate the blastocysts. VitriFreeze, Medium 1 is used for the preparation to the vitrification. VitriFreeze, Medium 2 is the actual vitrification medium that is used during cryostorage.

The four (4) thawing media in VitriThaw are also for sequential use in the thawing and recovery of cryopreserved human blastocysts. VitriThaw media includes VitriThaw Medium 1, VitriThaw Medium 2, VitriThaw Medium 3, VitriThaw Medium 4

Indications:

VitriFreeze is intended for ultra-rapid freezing of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures.

VitriThaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing using FertiPro's VitriFreeze, for Assisted Reproductive Technology (A. R.T.) procedures.

Summary of the technological characteristics of our device compared to the predicate device:

The predicates and these devices were compared in the following areas and found to have similar technological characteristics and to be equivalent.

> Formula Special controls Packaqinq Performance Testing

REGULATORY SPECIALISTS, INC.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central symbol consists of three curved lines that resemble a stylized human figure or a flowing design. The image appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 6 2007

FertiPro N.V. c/o Ms. Grace Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

K070135 Re:

Trade Name: VitriFreeze Media and VitriThaw Media Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 1, 2007 Received: August 2, 2007

Dear Ms. Holland:

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 shows a circular logo with the text "1826-1926" at the top. Below that is the text "PA" in large, bold letters. Underneath "PA" is the word "Centennial" in a cursive font. At the bottom of the logo are four stars. The logo appears to be a commemorative emblem for a centennial celebration.

clasing and Promoting Public Hoalth

{3}------------------------------------------------

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 or any I 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) I mis letter notification. The FDA finding of substantial equivalence of your device to a legally prechance troundate 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 If you desire 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]

on at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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

Enclosure

{4}------------------------------------------------

# Indications for Use Statements

### Indications for Use

510(k) Number (if known): __K070135

Device Name: VitriFreeze Media

VitriFreeze Media are intended for ultra-rapid freezing of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

--------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhang

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

Page _ 1 _ of

REGULATORY SPECIALISTS, INC.

{5}------------------------------------------------

K070135, FertiPro VitriFreeze and VitriThaw Media, Response 3

### Indications for Use

510(k) Number (if known): K07g135

Device Name: VitriThaw Media

VitriThaw media are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing for Assisted Reproductive Technology (A.R.T.) procedures.

#### AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

--------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhang

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

Page _ 1 _ of 1

REGULATORY SPECIALISTS, INC.