OOCYTE ASPIRATION NEEDLE

K991271 · Casmed UK · MQE · Mar 8, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991271
• Device Name: OOCYTE ASPIRATION NEEDLE
• Applicant: Casmed UK
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Mar 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.

Device Story

The Casmed UK Oocyte Collection Needle Sets (Single and Double Lumen) are sterile, single-use medical devices designed for assisted reproduction technology (ART). The needles are used by clinicians to aspirate and flush oocytes from ovarian follicles. The device functions as a mechanical conduit for the retrieval of gametes. It is used in a clinical setting during fertility procedures. The output is the collected oocyte/gamete sample, which is then processed by embryologists for in vitro fertilization or other reproductive techniques. The device facilitates the retrieval process, enabling the collection of viable oocytes for clinical use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device consists of single or double lumen needles designed for oocyte aspiration and flushing. It is a mechanical device used in assisted reproduction. No specific materials, energy sources, or software components are described.

Indications for Use

Indicated for aspiration and flushing of gametes/oocytes from the body 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)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2000

Ms. Debbie Castle CASMED UK Castle House 39 Nork Way Banstead Surrey SM7 1PB ENGLAND

Re: K991271

Oocvte Aspiration Needles Dated: February 8, 2000 Received: February 14, 2000 Requlatory Class: II 21 CFR 884.6100/Procode: 85 MQE

## Dear Ms. Castle:

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 26, 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). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 equivation 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 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 predication 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 question 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 resonsibilities 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.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

## Indications for Use Form

Page____of___

510(k) Number (if known): __

K991271

Device Name:

Indications For Use:

Casmed UK Single Lumen Oocyte Collection Needle Set Casmed UK Double Lumen Oocyte Collection Needle Set Casmed UK Single Lumen Needle Casmed UK Double Lumen Needle

The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1 (

Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K991271 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="text-decoration: overline;">X</div> | OR | Over-The-Counter Use |
|------------------|-------------------------------------------------|----|----------------------|
|------------------|-------------------------------------------------|----|----------------------|

(Per 21 CFR 801/109)(Optional Format 1-2-96)