K Number
K053552
Device Name
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
Manufacturer
Date Cleared
2006-05-19

(150 days)

Product Code
Regulation Number
884.6180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.
Device Description
global®: fertilization, embryo culture and transfer medium
More Information

Not Found

Not Found

No
The summary describes a culture medium and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as image processing and performance studies typically associated with AI/ML devices.

No.
The device is a medium used for fertilization, embryo culture, and transfer, which are procedures rather than treatments for a disease or condition.

No
The device is described as a "fertilization, embryo culture and transfer medium," which is used in the process of creating and transferring embryos, not for diagnosing a condition or disease.

No

The device description clearly indicates it is a "fertilization, embryo culture and transfer medium," which is a biological/chemical product, not software.

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

Here's why:

  • Intended Use: The intended use explicitly states "fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer." This describes a product used in vitro (outside the body) to facilitate biological processes related to human reproduction.
  • Device Description: The description "global®: fertilization, embryo culture and transfer medium" further reinforces that this is a substance or product used in a laboratory or clinical setting for these specific purposes.

IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device isn't for diagnosing a disease, it is used in vitro to support a biological process (fertilization and embryo development) which falls under the broader scope of IVD regulation, particularly in the context of assisted reproductive technologies.

N/A

Intended Use / Indications for Use

For In Vitro Fertilization Procedures.

global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

Product codes

MQL

Device Description

Not Found

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

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Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three wavy lines extending upwards, representing growth and vitality. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure. The text is in all caps and is black.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 1 9 2006

Mr. Michael D. Cecchi President International 393 Soundview Road GUILFORD CT 06437

Re: K053552

Trade/Device Name: global®: fertilization, embryo culture and transfer medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 8, 2006 Received: May 10, 2006

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/11 description: The image is a black and white circular logo. The logo has the letters "FDA" in large bold font in the center. Above the letters "FDA" are the numbers "1906-2006". Below the letters "FDA" is the word "Centennial" in cursive font. There are three stars below the word "Centennial".

Protecting and Promoting Public Health

1

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.

出版社会的主要有关系。 中国人民共同意的人民的人民的人民主要的人民主要的

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.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Nancy C. Brydon

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

Enclosure

2

international, inc. 510(K) Submission

INDICATIONS FOR USE

Ko 5 355 2 510 (k) Number (if known)

Common Name: Assisted Reproductive Media

Classification Name: Assisted Reproductive Media (21 C.F.R. § 886.6180)

のとなっているとなるというとなるなるなのです

global®: fertilization, embryo culture and transfer Device Trade Name: medium

For In Vitro Fertilization Procedures. Intended Use:

Indication for Use:

global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the Counter Use

or

Nancy C Brandon

Division of Reproductive, Abdominal,
and Radiological Devices
K053552

B