TRANSMYOMETRIAL EMBRYO TRANSFER SET

{0}------------------------------------------------ Jan-26-99 01:08P 2/8/99 510(k) Premarket Notification Tronsinvasmetelal Embryo Transfer Se Cook OB/GYN .983595 9 #### I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### Submitted By: Brenda Davis Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 October 13, 1998 #### Device Trade Name: Proposed Classification Name: Transmyometrial Embryo Transfer Sct Assisted Reproduction Catheters Class II 85 MOF #### 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 effectivencss. The Transmyometrial Embryo Transfer Set is substantially equivalent to other Transmyometrial Embryo Transfer Sets in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Intra-Endometrial Embryo Transfer Set manufactured by Cook Australia. #### Device Description: The Transmyometrial Embryo Transfer Set is used for transferring IVF embryo(s) into the endometrial cavity through the myometrial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted discase, a recent uterine perforation, cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarean section, a recent pregnanty (or is currently program), or if the patient currently has an intrauterine device. The materials used in this device are TFE and 300 Series Stainless Steel. Both materials are widely used in the medical field and biocompatibility is assured. #### 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 this section 510(k) substantial equivalence. {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 8 1999 Brenda Davis Regulatory Affairs Cook Ob/Gyn 1100 West Morgan Street Spencer, Indiana 47460 Re: K983595 Transmyometrial Embryo Transfer Set Dated: December 1, 1998 Received: December 4, 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 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 requlation 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 requlations. 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 {2}------------------------------------------------ ## PREMARKET NOTIFICATION # INDICATIONS FOR USE STATEMENT K983595 510(k) Number (if known): Transmyometrial Embryo Transfer Sets Device Name: The Transmyometrial Embryo Transfer Sets are used for Indications for Use: transferring IVF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for one time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarcan section, a recent pregnancy (or is currently pregnant), or if a patient currently has an intrauterine device. (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 (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number