MONA LISA ASPIRATION NEEDLE

K032208 · Fertility Technology Resources, Inc. · MQE · Dec 9, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032208
• Device Name: MONA LISA ASPIRATION NEEDLE
• Applicant: Fertility Technology Resources, Inc.
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Dec 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.

Device Story

Mona Lisa Aspiration Needle is a medical device used for the transvaginal recovery and collection of oocytes from ovarian follicles. The procedure is performed under ultrasound guidance by a physician or trained clinician in a clinical setting. The needle facilitates the aspiration of follicular fluid containing oocytes, which are then collected for use in assisted reproduction technologies. The device is designed to assist in the retrieval process, potentially improving the efficiency of oocyte collection for patients undergoing fertility treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Assisted reproduction needle; transvaginal aspiration design; intended for use with ultrasound guidance. Class II device under 21 CFR 884.6100.

Indications for Use

Indicated for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles in patients undergoing assisted reproduction procedures.

Regulatory Classification

Identification

Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 9 2003

Ms. Constance W. Sturgeon President Fertility Technology Resources, Inc. 4343 Shallowford Road, Suite D-4 MARIETTA GA 30062

Re: K032208

Trade/Device Name: Mona Lisa Aspiration Needle Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted reproduction needle Regulatory Class: II Product Code: 85 MQE Dated: October 28, 2003 Received: October 29, 2003

Dear Ms. Sturgeon:

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 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.

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 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 the 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" (21CFR Part 807.97) you may obtain. 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,

Nancy C. Brogdon

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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## Indications for Use

510(k) Number (if known): K032208

Device Name: Mona Lisa Aspiration Needle

Indications For Use: The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David B. Lymm

Sit. 17-017 DIV Kadjoice cal Dev SLO (jz) Number

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