LG SPERM FREEZING

K070689 · Genx Intl., Inc. · MQL · Jul 3, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070689
• Device Name: LG SPERM FREEZING
• Applicant: Genx Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.

Device Story

LG Sperm Freezing Medium is a reproductive medium used for the cryopreservation of human sperm. The device is utilized in clinical laboratory settings by trained embryologists or laboratory technicians. It functions as a cryoprotectant to maintain sperm viability during the freezing process. The healthcare provider uses the medium to prepare sperm samples for long-term storage, facilitating future assisted reproductive technology (ART) procedures. By preserving sperm quality, the device enables patients to store gametes for later use in fertility treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reproductive medium for cryopreservation. Classified as Class II, Product Code MQL. Technical specifications and material composition are not detailed in the provided documentation.

Indications for Use

Indicated for the cryopreservation of human sperm.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Michael D. Cecchi President <gem> International, Inc. 393 Soundview Rd GUILFORD CT 06437

Re: K070689

Trade/Device Name: LG Sperm Freezing Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 31, 2007 Received: June 21, 2007

## 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.

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/0/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-1906" are displayed. Below the letters, the word "Centennial" is written in a curved font. Three stars are located at the bottom of the logo.

Prototing and Promoting Public Hoatth

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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 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). 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/cdrl/industry/support/index.html.

Sincerely yours.

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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<genX> international, inc.

510(K) Submission

INDICATIONS FOR USE

K070689 510 (k) Number (if known)

Device Name: Sperm Freezing Medium

Indications for Use:

LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or Over-the Counter Use

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070689