OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING

K994417 · Cook Urological, Inc. · MQE · Mar 1, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K994417
• Device Name: OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
• Applicant: Cook Urological, Inc.
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Mar 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

The Aspiration/Ovum Pick-Up Aspiration Needles with AQ Coating are used for general irrigation/aspiration and flushing of oocytes from ovarian follicles.

Device Story

The device consists of aspiration needles featuring an AQ (hydrophilic) coating. It is used by clinicians for transvaginal ultrasound or laparoscopic procedures to aspirate and flush oocytes from ovarian follicles, or for general irrigation and aspiration. The hydrophilic coating is intended to facilitate device movement. The device is a manual surgical instrument; it does not involve electronic processing, software, or automated decision-making. It is used in clinical settings by physicians.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to predicate devices.

Technological Characteristics

Needles with AQ (hydrophilic) coating. Manual surgical instrument. No energy source, software, or electronic components. Sterilization and manufacturing follow established Quality System Regulation (21 CFR Part 820) controls.

Indications for Use

Indicated for general irrigation/aspiration and the 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

• Cook OB/GYN Ovum Pick-Up Needles
• Cook OB/GYN Aspiration Needles
• Cook OB/GYN Hydrophilic Dilators
• Cook OB/GYN Hydrophilic catheters

Submission Summary (Full Text)

{0}------------------------------------------------

**MAR - 1 2000**

K99 4417

9

510(k) Premarket Notification Ovum Pick-Up Aspiration Needles with AQ Cook OB/GYN

#### L 510(k) SUMMARY

Submitted By:

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

| Device | 85MQE<br>79GAA |
|-------------------------------|---------------------------------------------------------------------------------------|
| Trade Name: | Ovum Pick-Up Aspiration Needles with AQ Coating<br>Aspiration Needles with AQ Coating |
| CFR Reference: | 884.6100<br>878.4800 |
| Proposed Classification Name: | Ovum Pick-Up Aspiration Needles with AQ Coating<br>Aspiration Needles with AQ Coating |

### Predicate Devices:

The Ovum Pick-Up Aspiration Needles with AQ Coating and the Aspiraiton Needles with AQ Coating are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Cook OB/GYN Ovum Pick-Up Needles and the Aspiration Needles. The predicate AQ devices include the Hydrophilic Dilators, and Hydrophilic catheters manufactured and marketed by Cook OB/GYN (Cook Urological).

### Device Description:

The Ovum Pick-Up Aspiration Needles with AQ coating is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocves from ovarian follicles. The Aspiration Needles with AQ coating are used for general aspiration and irrigation.

### Substantial Equivalence:

These devices 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, these devices meet the requirements for section 510(k) substantial equivalence.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping lines forming the face. The seal is black and white.

# MAR - 1 ZUUL

Ms. Debbie Schmitt Requlatory Affairs Manager COOK® Urological 1100 W. Morgan Street Spencer. IN 47460

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K994417

Ovum Pick-Up Aspiration Needles with AQ (Hydrophilic) Coating and Aspiration Needles with AQ (Hydrophilic) Coating Dated: December 23, 1999 Received: December 29, 1999 Regulatory Class: Il 21 CFR §884.6100/Procode: 85 MQE

Dear Ms. 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 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 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" (21CFR 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,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{2}------------------------------------------------

# PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

K994417 510(k) Number (if known):

| Device Name: | Aspiration Needles/Ovum Pick-Up Aspiration Needles<br>with AQ Coating |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Aspiration/Ovum Pick-Up Aspiration Needles<br>with AQ Coating are used for general irrigation/aspiration<br>and flushing of oocytes from ovarian follicles. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Jt

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number_