EMTRAC; DELPHIN; SEMTRAC 2000 SET

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of an eagle with three lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## NOV 3 0 2001 Gynétics Medical Products N.V. % Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606 Re: K013536 Trade/Device Name: Emtrac, Delfin, and Semtrac Embryo Transfer and IUI Catheters Regulation Number: 21 CFR 884.5250 Regulation Name: Cervical cap Product Code: 85 MFD Regulation Number: 21 CFR 884 6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: 85 MQF Dated: October 22, 2001 Received: October 23, 2001 Dear Ms. Holland: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for and of the 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may , atest , visions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 nouthoute 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), please 11 you used of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Other or Compilention" (21 CFR Part 807.97). Other general information on of received to promote the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Delphin Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures. ## (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 (Optional Format 1-2-96) Nancy Brigion (Division Sign-Off) Division of Reproductive, Abdominal, and Radioleglent Devices K013536 {3}------------------------------------------------ Page 1 of 1 of 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------- | 510(k) Number (if known): | K013536 | |---------------------------|---------| |---------------------------|---------| Device Name: Emtrac Catheters Indications For Use: Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ғанынан менен аласында қошылық қалым қарап қарап қарап қарап қарап қарақ қарап қаланы мен қаласын қаласының қаласының қаласының қаласының қаласының қаласының қаласының қа | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use | |----------------------|--------------------------------------------|----|--------------------------| | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | Dansy C Broodon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K013536 | |---------------|---------| |---------------|---------| {4}------------------------------------------------ Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________ ・、 510(k) Number (if known): ماك35353 ما Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures. ## (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 (Optional Format 1-2-96) | | (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K013536 | |---------------|---------| |---------------|---------|