HYSTEROSCOPIC GIFT CATHETER SETS

K983587 · Cook Ob/Gyn · MQF · Dec 16, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K983587
• Device Name: HYSTEROSCOPIC GIFT CATHETER SETS
• Applicant: Cook Ob/Gyn
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hysteroscopic GIFT Catheter Sets are used to transfer gametes directly into the fallopian tube via hysteroscopic guidance. These catheters and sets are intended for one time use and will be marketed sterile.

Device Story

Hysteroscopic GIFT Catheter Sets facilitate gamete transfer into fallopian tubes. Device used under hysteroscopic guidance. Single-use, sterile. Physician-operated in clinical setting. Enables assisted reproduction procedures.

Clinical Evidence

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

Technological Characteristics

Materials: TFE and stainless steel. Form factor: Catheter set for hysteroscopic gamete transfer. Sterilization: Sterile (single-use).

Indications for Use

Indicated for the transfer of gametes directly into the fallopian tube via hysteroscopic guidance in 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).

Predicate Devices

• Lee Hysteroscopic Intrafallopian Transfer Catheter (Cook Australia)

Submission Summary (Full Text)

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510(k) Premarket Notification Hysteroscopic GIFT Catheter Sets ( ook OB/GYN

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 1.

#### Submitted By:

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

Device

Trade Name Proposed Classification Name: Hysteroscopic GIFT Catheter Sets Assisted Reproduction Catheters Class II 85 MQF

### Predicate Devices:

Cook OB/GYN understands due to the recent reclassificaton there are not predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness. The Hysteroscopic GIFT Catheter Sets are substantially equivalent to other GIFT catheters in terms of indications for use, design, construction and materials equivalence. Specifically, these catheters are similar to the Lee Hysteroscopic Intrafallopian Transfer Catheter manufactured by Cook Australia.

#### Device Description:

The Hysteroscopic GIFT Catheter Sets are used to transfer gametes directly into the fallopian ube. The materials used in these devices are TFE and Stainless Steel. Materials used in these sets are widely used in the medical field and biocompatibility is assured.

#### Substantial Equivalence:

These sets will be manufactured according to specified process controls and a Quality Assurance Program. These sets 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 sets meet the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is drawn with thick, black lines, and its head is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

DEC 1 6 1398

Ms. Brenda Davis Regulatory Affairs Technical Writer Cook Ob/Gyn® 1100 West Morgan Street Spencer, Indiana 47460

Re: K983587 Hysteroscopic GIFT Catheter Sets Dated: October 13, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.6110/Procode:85 MQF

Dear Ms. Davis:

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 III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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,

Daniel C. Schultz, M.D.

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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K983587

# PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Not yet assigned

Hysteroscopic GIFT Catheter Sets Device Name: The Hysteroscopic GIFT Catheter Sets are used to transfer gametes Indications for Use: directly into the fallopian tube via hysteroscopic guidance. These catheters and sets are intended for one time use and will be marketed sterile.

(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 ------

David G. Stygem

(Division Sign-Off Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number