OVUM PICK-UP ASPIRATION NEEDLES

K983593 · Cook Ob/Gyn · MQE · Jan 21, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983593
• Device Name: OVUM PICK-UP ASPIRATION NEEDLES
• Applicant: Cook Ob/Gyn
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ovum Pick-Up Aspiration Needles are used for aspiration and flushing of oocytes from ovarian follicles.

Device Story

The Ovum Pick-Up Aspiration Needle is a medical instrument used for the retrieval of oocytes from ovarian follicles. It is designed for use during transvaginal ultrasound-guided or laparoscopic procedures. The needle facilitates the aspiration and flushing of follicles to collect oocytes for assisted reproductive technology. It is operated by a physician in a clinical setting. The device is a mechanical tool; it does not involve electronic signals, software, or automated processing. Its use directly enables the collection of oocytes, which is a critical step in fertility treatments, potentially benefiting patients by allowing for subsequent in vitro fertilization or other reproductive interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a mechanical aspiration needle. Materials and physical construction are equivalent to predicate devices. No energy source, software, or connectivity features are present.

Indications for Use

Indicated for the aspiration and flushing of oocytes from ovarian follicles in patients undergoing assisted reproductive 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).

Predicate Devices

• Ovum Pick-Up Aspiration Needles (Cook Australia)

Submission Summary (Full Text)

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# K983593

### JAN 2 1 1999

9

510(k) Premarket Notification Ovum Pick-Up Aspiration Needle Cook OB/GYN

#### I. 510(k) SUMMARY

Submitted By:

Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 [phone] October 13, 1998

Device

| Trade Name: | Ovum Pick-Up Aspiration Needle |
|-------------------------------|--------------------------------|
| CFR Reference: | 884.6100 |
| Proposed Classification Name: | Class II 85 MQE |

#### Predicate Devices:

Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness.

The Ovum Pick-Up Aspiration Needle is substantially equivalent to predicate Ovum Pick-Up Aspiration Needles in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Ovum Pick-Up Aspiration Needles manufactured by Cook Australia.

#### Device Description:

The Ovum Pick-Up Aspiration Needle is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocytes from ovarian follicles.

#### Substantial Equivalence:

This device will be manufactured according to specified controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird with three wing-like shapes above a wavy line, representing the department's mission related to health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Debbie Schmitt Regulatory Affairs Manager Cook Ob/Gyn® 1100 W. Morgan Street Spencer, IN 47460

Re: K983593

Ovum Pick-up Aspiration Needles Dated: December 11, 1998 Received: December 12, 1998 Regulatory Class: II 21 CFR 884.6100/Procode: 85 MQE

Ms. Debbie Schmitt:

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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it mav 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 Compliance 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 regulation 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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# PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

K983593 510(k) Number (if known): Not yet assigned Ovum Pick-Up Aspiration Needles Device Name: The Ovum Pick-Up Aspiration Needles are used for aspiration and Indications for Use: flushing of oocytes from ovarian follicles.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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