TUCKER EMBRYO CATHETER

K023017 · Fertility Technology Resources, Inc. · MQF · Dec 13, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023017
• Device Name: TUCKER EMBRYO CATHETER
• Applicant: Fertility Technology Resources, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for the introduction of embryo(s) into the uterine cavity.

Device Story

The Tucker Embryo Catheter (Models ftr123 & ftr120) is a medical device designed for the transfer of embryos into the uterine cavity. It is used by clinicians during assisted reproduction procedures. The device functions as a conduit for the placement of embryos, facilitating the clinical goal of implantation. It is a manual instrument used in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Assisted reproduction catheter; manual device; dimensions and materials not specified in the provided text.

Indications for Use

Indicated for the introduction of embryos into the uterine cavity for patients undergoing assisted reproduction procedures.

Regulatory Classification

Identification

Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 13 2002

200 Corporate Boulevard Bockville MD 20850

Mr. Thomas J. Zinnanti President and CEO Fertility Technology Resources, Inc 4343 Shallowford Road, Suite D-4 · MARIETTA GA 30062

## Re: K023017

Trade/Device Name: Tucker Embrvo Catheter (Models ftr123 & ftr120) Regulation Number: 21 CFR 884.61-10 Regulation Name: Assisted Reproduction Catheter Regulatory Class: II

Product Code: 85 MOF Dated: November 19, 2002 Received: November 26, 2002

Dear Mr. Zinnanti:

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 (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); 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Brigdon

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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Section #4
Indications for Use

| 510(k) Number: | 11023017 (to be assigned) |
|----------------|-----------------------------------------------------------------------|
| Device Name: | Tucker Embryo Catheter |
| Intended Use: | To be used for the introduction of embryo(s) into the uterine cavity. |

and the comments of the comments of

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)

OR

Over-the-counter use__________________________________________________________________________________________________________________________________________________________

David A. Segeam

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 023017 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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