<GENX> SPERM WASHING MEDIA

• K Number: K991022
• Device Name: <GENX> SPERM WASHING MEDIA
• Manufacturer: <GENX> INTL., INC.
• Date Cleared: 1999-09-09 ( 164 days)
• Product Code: MQL
• Regulation Number: 884.6180

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 Description

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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a chemical media used for sperm washing and incubation, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
This device is a culture medium used for processing sperm prior to assisted reproductive procedures; it is not a therapeutic device that directly treats a condition.

Diagnostic

No

Explanation: The device is a "Sperm Washing Media" used for sperm washing and incubation procedures in assisted reproductive technologies (ART) like IVF and IUI. It is described as a formulation, not as a tool that provides diagnostic information about a patient's health condition. Its purpose is to prepare biological material for a medical procedure, not to diagnose a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is "Sperm Washing Media," which is a liquid substance used in laboratory procedures, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the media is used for "in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI)." These procedures are performed outside of the body (in vitro) and involve handling biological samples (sperm) for diagnostic or therapeutic purposes related to fertility.
• Device Description: The description reinforces the in vitro use for sperm washing and incubation.
• Performance Studies: The performance studies listed (Mouse Embryo Assay, Endotoxin, Sterility, Physicochemical tests) are typical quality control tests for media used in assisted reproductive technologies, which are inherently in vitro procedures.

While the device itself is a media and not a diagnostic test that provides a specific result about a patient's condition, it is a critical component used in vitro as part of diagnostic and therapeutic procedures related to fertility. Therefore, it falls under the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

85 MQL

Device Description

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).

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
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.).(b)
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.

Summary

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9 1999 SEP

international, inc. 510(K) Submission

510K Summary

K991022

• 1. Device Name: Propriety Name: Sperm Washing Media
     Classification: Reproductive Media
• 2. Submission Date: March 26, 1999

• Submitted by: 3.

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: 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 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).

Sperm Washing Media is based upon the formulation of > 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human face in profile, composed of three curved lines. To the left of the face is the text "DEPARTMENT OF HEALTH & HUM." arranged vertically.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1999

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

Re: K991022 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: 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

B