INTRATUBAL TRANSFER SETS

K983591 · Cook Ob/Gyn · MQF · Dec 21, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K983591
• Device Name: INTRATUBAL TRANSFER SETS
• Applicant: Cook Ob/Gyn
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Dec 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.

Device Story

Intratubal Transfer Sets facilitate assisted reproduction by delivering sperm, gametes, or embryos into the fallopian tube. Device consists of a catheter system used via transvaginal approach; ultrasound guidance employed for placement into uterine ostium. Operated by clinicians in a clinical setting. Device is sterile and intended for single use. Benefits include precise delivery of reproductive materials to the fallopian tube to support fertilization or implantation.

Clinical Evidence

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

Technological Characteristics

Materials: TFE, echosight polyethylene, polyethylene, stainless steel. Form factor: Catheter set for transvaginal delivery. Energy source: None (manual). Sterilization: Sterile (single-use).

Indications for Use

Indicated for the injection of sperm, gametes, or embryos into the uterine ostium of the fallopian tube via transvaginal ultrasound 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

• Embryo and Gamete Intratubal Transfer Sets (Cook Australia)

Submission Summary (Full Text)

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510(k) Premarket Notification Intratubal Transfer Sets Cook OB/GYN

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

0EC 2 1 1998

K983591

Submitted By:

,

I.

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

Device

Trade Name: Proposed Classification Name: Intratubal Transfer Sets Assisted Reproduction Catheters Class II 85MQF

### 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 Intratubal Transfer Sets are substantially equivalent to other sperm, gametes or embryo transfer sets in terms of indications for use, design, construction and materials equivalence. Specifically, these sets are similar to the Embryo and Gamete Intratubal Transfer Sets manufactured by Cook Australia.

### Device Description:

The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via a transvaginal approach utilizing ultrasound guidance. The materials used in these sets are TFE, echosight polyethylene, polyethylene, and stainless steel. All materials are widely used in the medical field and biocompatibility testing has been 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/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest. The profiles are surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1998

Debbie Schmitt Cook Ob/Gyn 1100 West Morgan Street Spencer, IN 47460

Re: K983591 Transvaginal Intratubal Transfer Sets Dated: October 13, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF

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 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"(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,

J. J. T.

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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K983
K983591

# PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

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

Device Name: Intratubal Transfer Sets

The Intratubal Transfer Sets are used to inject either sperm, gametes Indications for Use: or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.

(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

Simil h. Srymm

(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.