STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING

{0}------------------------------------------------ ATTACHMENT C Image /page/0/Picture/1 description: The image shows the word "Conceptus" in a stylized, outlined font. Each letter is formed by a double line, creating a hollow effect. The letters are connected, forming a continuous word. 1974028 102 ام - ا JAN 2 1 1998 510(K) SUMMARY As required by 21 CFR section 807.92(c) Submitter's Name, Address, Phone and Fax Number Conceptus, Inc. 1021 Howard Ave. San Carlos, CA 94070 (650) 802-7240 Telephone: (650)508-7600 or (650)610-8363 Fax: Contact Person Connie Acuff Manager Regulatory Affairs & Clinical Research Date Summary Prepared October 21, 1997 Device Names | Trade Name: | Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Set (part of STARRT™ Falloposcopy System) | |----------------------|-------------------------------------------------------------------------------------------------------------------------| | Common Name: | falloposcopy catheter and irrigation tubing | | Classification Name: | Uterotubal carbon dioxide insufflator and accessories (per 21 CFR 884.1300) | Device to Which Substantial Equivalence was Claimed Substantial Equivalence for the Stargate Falloposcopy Catheter was claimed to the Conceptus VS™ Catheter which, as part of the STARRT Falloposcopy System, was previously cleared for the diagnosis of Proximal Tubal Occlusion (PTO). Substantial Equivalence for the Trifurcated Irrigation Tubing was claimed to the Clarus Medical, Model 5150 Tubing Set which was previously cleared for fluid infusion for clearing the field of vision with endoscopes. Device Description The Conceptus Stargate Catheter is a single lumen device with a graded shaft flexibility. The distal end has a diamond shaped wire tip designed to guide the catheter and to keep fallopian tube epithelium away from the falloposcope lens during imaging. The hub located at the proximal end of the Conceptus Stargate Catheter has two ports. The sideport is used for the attachment of the Trifurcated Irrigation Tubing set. The endport serves as a conduit for the introduction of the Conceptus Falloposcopy Guidewire and Falloposcope. > Conceptus, Inc .. 1021 Howard Avenue, San Carlos, CA 94070 Phone:650/802-7240 · Fax:650/610-8363 {1}------------------------------------------------ K974028 P292 #### Device Description, cont. The Conceptus Stargate Catheter and Falloposcopy Guidewire are transcervically delivered into the fallopian tube ostium through the lumen of the Coaxess™ Catheter which is delivered into the uterine cavity through the working channel of a rigid hysteroscope and positioned at the tubal ostium under hysteroscopic guidance. The Conceptus Stargate Catheter and Falloposcopy Guidewire are designed for use within the proximal portion of the fallopian tube (the first 2-3 cm of the tube). #### Intended Use The Stargate Catheter as part of the STARRT Falloposcopy System is intended for use as a secondary diagnostic tool for further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography. ## Technological Characteristics The Conceptus Stargate Catheter is substantially equivalent to the Conceptus VS Catheter and will replace that device in the Conceptus STARRT Falloposcopy System. The primary difference between the Stargate Catheter and VS Catheter is a diamond shaped wire which has been added to the distal tip of the Stargate Catheter. The primary purpose of the wire tip is to keep tubal epithelium away from the falloposcope lens to optimize imaging of the fallopian tube lumen. ### Data Supporting Substantial Equivalence Conceptus conducted laboratory, preclinical and clinical testing to confirm that the Stargate Catheter is safe and effective. The laboratory testing demonstrated that small forces are applied to the wire tip during clinical use. Laboratory testing further demonstrated that the force required to advance the Stargate Catheter is no greater than the force required to advance the VS Catheter. Lastly, laboratory testing confirmed that the Stargate Catheter is less likely to kink as compared to the VS Catheter. A fallopian tube catheterization histology study in rabbits was conducted to demonstrate the safety of the Stargate Catheter. The objective of the study was to use the rabbit model to determine if fallopian tube catheterization as well as anticipated adverse events cause damage to the fallopian tube and if there is any resulting adverse impact on pregnancy rates. Study results demonstrate that their is no significant difference in fallopian tube damage between the catheterized and control tubes. Lastly, clinical testing was conducted to validate the performance of the device. Participating clinicians reported that they were able to make a better diagnosis of tubal health with the Stargate Catheter as compared to the VS Catheter. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three horizontal bars. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the symbol. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Connie Acuff Manager, Clinical Research & Regulatory Affairs Conceptus. Inc. 1021 Howard Avenue San Carlos, CA 94070 JAN 2 1 1998 Re: K974028 Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Dated: October 21, 1997 Received: October 23, 1997 Regulatory Class: II 21 CFR 884.1690/Procode: 85 MKO Dear Ms. Acuff: 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 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, Drog, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, 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. 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 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) 594-4613. 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/dsmamain.html". Sincerely yours h.Liau Yin Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE K974028 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Set (part of STARRT™ Falloposcopy System) Indications for Use: The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography. | • | The STARRT System is <u>only</u> designed to access the <u>proximal</u> portion of the fallopian tube, i.e. the first 2-3 cm. It should only be advanced as far as necessary to achieve a meaningful study, recognizing that possible adverse effects of more distal advancement, particularly upon normal tubes, have not yet been determined. | |---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • | The STARRT System is <u>not</u> intended for tubal recanalization, and there is no data available, in particular, pregnancy data, showing clinical benefit for this use. Studies are underway. | | • | The STARRT System is not to be used for gamete or embryo transfer, or other assisted reproduction techniques. | | • | The STARRT System should only be used by clinicians with experience in tubal evaluation. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert R Ratliff (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K974028 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)