GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT

K092667 · Genx Intl., Inc. · MQL · Jun 3, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K092667
• Device Name: GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
• Applicant: Genx Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jun 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Global DMSO Blastocyst Vitrification Kit: Intended for the vitrification (ultra-rapid freezing) and cryostorage of human blastocysts. Global DMSO Blastocyst Vitrification Warming Kit: Intended for the recovery and rehydration of vitrified human blastocysts. Intended for use with blastocysts that have been vitrified using the Global DMSO Blastocyst Vitrification Kit.

Device Story

The Global DMSO Blastocyst Vitrification Kit and Warming Kit are reproductive media used for the cryopreservation of human blastocysts. The vitrification kit facilitates ultra-rapid freezing and long-term cryostorage, while the warming kit enables the recovery and rehydration of these blastocysts prior to clinical use. These products are intended for use by trained embryologists in clinical reproductive laboratories. The process involves chemical treatment of blastocysts to prevent ice crystal formation during freezing and to restore physiological state during warming. The device benefits patients by allowing for the preservation of embryos for future transfer, supporting assisted reproductive technology procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use characteristics.

Technological Characteristics

Reproductive media and supplements (Product Code MQL). The device consists of chemical solutions formulated for the vitrification and warming of human blastocysts. It is a non-electronic, chemical-based device.

Indications for Use

Indicated for the vitrification, cryostorage, recovery, and rehydration of human blastocysts in a clinical laboratory setting.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Michael D. Cecchi President GenX International, Inc. 393 Soundview Rd. GUILFORD CT 06437

JUN - 3 2010

Re: K092667 Global DMSO Blastocyst Vitrification Kit and Trade Name: Global DMSO Blastocyst Vitrification Warming Kit Regulation Number: 21 CFR §884. 6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 26, 2010 Received: May 27, 2010

Dear Mr. Cecchi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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<genX> international, inc.

## Indications for Use

| 510 (k) N | Annual Comments of Children Comments of Children |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LAND RESERVED. LABORE MARK LEASE LEARNER SEAL FOR AND LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST |
| i Number (it Known) | - 0 0 |
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>FREE OF CLANDLE CONNULE CANADA CARTER CARDED CARDEN CARDED CONCENT |

## Global DMSO Blastocyst Vitrification Kit:

- Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts.
# Global DMSQ Blastocyst Vitrification Warming Kit

- . Intended for the recovery and rehydration of vitrified human blastocysts
- Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-the Counter Use

Herbert Lemm

or

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