<GENX> SPERM WASHING MEDIA

K991022 · <Genx> Intl., Inc. · MQL · Sep 9, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991022
• Device Name: <GENX> SPERM WASHING MEDIA
• Applicant: <Genx> Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).

Device Story

Sperm Washing Media is a liquid medium based on Modified Human Tubal Fluid (HTF) formulation. Used in clinical laboratory settings by embryologists or technicians to prepare sperm samples for assisted reproductive procedures (GIFT, IVF, IUI). The media facilitates the washing and incubation of sperm, removing seminal plasma and debris to isolate motile sperm for insemination or fertilization. The healthcare provider uses the media to process patient semen samples; the resulting prepared sperm is then used in clinical procedures to assist in achieving pregnancy.

Clinical Evidence

Bench testing only. Quality control includes Mouse Embryo Assay (MEA), Endotoxin (LAL) testing, sterility testing, and physicochemical analysis (pH and osmolality).

Technological Characteristics

Modified Human Tubal Fluid (HTF) based formulation. Liquid media supplied in 250mL and 500mL volumes. Quality control parameters include pH and osmolality testing.

Indications for Use

Indicated for use in sperm washing and incubation procedures prior to assisted reproductive technologies including GIFT, IVF, and IUI.

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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## 9 1999 SEP

<genX> international, inc. 510(K) Submission

510K Summary

K991022

- 1. Device Name: Propriety Name: <genX> Sperm Washing Media
Classification: Reproductive Media

- 2. Submission Date: March 26, 1999
- Submitted by: 3.

<genX> international, inc 170 Fort Path Road Madison, CT 06443

Establishment Registration No .: 9003605

Tel: [phone] Fax: [phone] E-mail: [e-mail]

Contact Individual: Michael D. Cecchi President

- 4. Classification: Class II Assisted Reproductive Media Product: <genX> Sperm Washing Media Procode: 85 MQL CFR#: 884.6180
- ട. Performance Standards:

No Performance Standards have been developed by Food and Drug Administration under Section 514 of the Act for this device. However, certain Special Controls have been identified in order to provide reasonable assurance of the safety and effectiveness of the device used in assisted reproduction procedures.

- 6. Proposed labels, Labeling and Advertising: The product labeling is included in this application in the appropriate section. The catalogue number for <genX> Sperm Washing Media is GMSW-250 for 250mL and GMSW-500 for 500 mL, etc.

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- 7. Substantially Equivalence Comparison
This product is substantially equivalent to several products currently sold in the market See Section 2.0 for this data.

- 8. Device Description, Intended Use
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).

<gen>> Sperm Washing Media is based upon the formulation of <gen>> Modified Human Tubal Fluid (HTF).

- 9. Quality Control Testings and Report
Each lot of Sperm Washing Media undergoes the following: Mouse Embryo Assay (MEA) Testing Endotoxin (LAL) Sterility Physicochemical tests which includes pH and Osmolality tests.

We will provide clear information to the user about each testing, method, criteria and result in the label and in the Quality Control report enclosed with the product.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1999

Mr. Michael D. Cecchi President <genX> International, Inc. 170 Fort Path Road, Unit 14 Madison, CT 06443

Re: K991022 <genX> Sperm Washing Media Dated: June 14, 1999 Received: June 16, 1999 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Mr. Cecchi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, 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 Names: <genX> Sperm Washing Media

Indication for Use:

Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).

The indications for use of this media is based on the general procedures for preparation of semen for Intrauterine Insemination described by Paul S. Weatherbee, Ph.D. and Lawrence B. Werlin, M.D., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Invine Medical Center.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the Counter Use _

David A. Seymor

or

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D

Radiological E
510(k) Number K991022

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