FERTILOSCOPY KIT FH 1.29/FTO 1.40

{0}------------------------------------------------ # MAR 1 3 2000 ### 510(k) SUMMARY ### Soprane S.A. Fertiloscopy Kit® FH 1.29 / FTO 1.40 ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Thierry Loubens Président Directeur Général Soprane S.A. 102 Rue Duguesclin 69006 Lyon France Telephone: (011) (33) 4 72 74 40 75 Facsimile: (011) (33) 4 75 74 04 91 Howard M. Holstein, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: (202) 637-5813 Facsimile: (202) 637-5910 ## Date Prepared: August 6, 1999 # Name of Device and Name/Address of Sponsor Soprane S.A, Fertiloscopy Kit® FH 1.29 / FTO 1.40 Thierry Loubens Président Directeur Général Soprane S.A. 102 Rue Duguesclin 69006 Lyon France Telephone: (011) (33) 4 72 74 40 75 Facsimile: (011) (33) 4 75 74 04 91 #### Common or Usual Name Intrauterine Balloon Catheter and Transvaginal Cannula #### Classification Name Rigid culdoscope and accessories (21 C.F.R. § 884.1640); semi-rigid hysteroscope and accessories (21 C.F.R. § 884.1690); cannula. manipulator/injector, uterine; and reposable surgical trocar (21 C.F.R. \$ 884.1720) ## Predicate Devices - Circon Corporation's ("Circon") Transvaginal Hydro® Laparoscopy . ("THLTM") System; {1}------------------------------------------------ - Cook OB/GYN's ("Cook") Intrauterine Balloon Access Catheter ("IBA . Catheter"): - Imagyn Medical, Inc.'s ("Imagyn") MicroSpan Hysteroscope Sheath . ("MicroSpan"); and - Origin Medsystems, Inc.'s ("Origin") Blunt Tip Trocar. . #### Intended Use The Fertiloscopy Kit is intended to be used for transvaginal hydrolaparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tuboperitoneal infertility. #### Technological Characteristics and Substantial Equivalence The Fertiloscopy Kit has the same general intended use and similar principles of operation and technological characteristics as a combination of Circon's cleared THL, Cook's cleared IBA Catheter, Imagyn's cleared MicroSpan, and Origin's cleared Blunt Tip Trocar. The minor technological differences between the Fertiloscopy Kit and the Imagyn MicroSpan, Cook IBA Catheter, Circon THL, and Origin Blunt Tip Trocar do not raise any new questions of safety or effectiveness. Therefore, the Fertiloscopy Kit is substantially equivalent to its predicate devices. #### Performance Data Soprane has conducted leak testing of the balloon during inflation and sterility testing of the materials following sterilization. In a clinical study of 160 patients, Fertiloscopy was shown to provide a "diagnostic sequence giving, in a one time procedure, a complete and informative status of the uterus, tubes, ovary, and peritoneum." #### Conclusion The Fertiloscopy Kit's substantial equivalence is based on a narrative comparison of this device and its predicate devices' intended use, principles of operation and technological characteristics and bench testing and clinical testing. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its head turned to the left, overlaid with a human profile. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle and profile. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 3 2000 Soprane S.A. c/o Mr. Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004 Re: K992655 Fertiloscopy Kit ® FH 1.29/FTO 1.40 Dated: January 18, 2000 Received: January 19, 2000 Requiatory Class: II 21 CFR §884.1640/Procode: 85 HEW 21 CFR §884.1690/Procode: 85 HIH 21 CFR §884.1720/Procode: 85 HET Dear Mr. Holstein: 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 Cosmelic Ad (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 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 equivalion 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 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 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) 594-4591. 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" (21CFR 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/dsmaldsmamain.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) {3}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Soprane S.A.'s Fertiloscopy Kit® FH 1.29 / FTO 1.40 Device Name: Indications for Use: The Fertiloscopy Kit is intended to be used for transvaginal hydro-laparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tubo-peritoneal infertility. (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 C.F.R. 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) Tamil U. Seymore (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number \\\DC - 69874/1 - 0919534.01