TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM

{0}------------------------------------------------ GBB 8 8 7 1900 # 510(k) Summary #x992544 - Submitter: Circon Corporation 1) 6500 Hollister Avenue Santa Barbara, CA 93117 Dr. Ronald J. Ehmsen Contact: (805) 961-3290 July 23, 1999 Date Prepared: - 2) Name of Device: Rigid Operative Culdoscopy Accessories Proprietary/Trade Name: Transvaginal Hydro Laparoscopy (THL") System Common/Usual Name: Culdoscope and Accessories Classification: Class II (21 CFR §884.1640) Classification Name: Culdoscope and Accessories #### 3) Names of Predicate or Legally Marketed Devices: Circon's Rigid Operative Culdoscopy Accessories are substantially equivalent to ACMI's Decker Operating Culdoscope and accessories and to Circon's Rigid Culdoscope and Accessories. The Decker devices were legally marketed for the same intended use (i.e., culdoscopy) prior to May 28, 1976, and the Circon devices were cleared under 510(k) #K980972 on June 12, 1998. #### 4) Description of Device: Circon's Rigid Operative Culdoscopy Accessories consist of several tubular stainless steel components. During culdoscopy, light from a high intensity light source is transmitted to a rigid culdoscope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the evepiece, or the scope may be connected to a video system via a standard endoscopic video coupler. In order to perform operative procedures, the operative cannula of the subject system replaces the smaller diagnostic cannula of the predicate system, and an operative sheath replaces the smaller diagnostic sheath of the predicate system. A channel is formed between the culdoscope and the operative sheath, thereby allowing passage of small instruments for a variety of operative procedures. {1}------------------------------------------------ 510(k) Summary #K Circon Corporation Rigid Operative Culdoscopy Accessories July 23, 1999 Page 2 ### ર) Intended Use of Device: Circon's Rigid Operative Culdoscopy Accessories are intended to be used with Circon's Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are: - Unexplained pelvic pain (acute, chronic) ● - Menstrual abnormalities ● - Infertility and sterility ● - Indefinite pelvic mass ● - . Ectopic pregnancy - . Pelvic endometriosis - Polycystic ovaries ● - Pelvic inflammatory disease (PID) ● - . Pain mapping - Congenital anomalies of the pelvic organs ● - Lysis of adhesions ● - Cytology sampling . - Biopsy ### 6) Comparison of Technological Characteristics: ● Circon's Rigid Operative Culdoscopy Accessories are substantially equivalent' to the ACMI Decker Operating Culdoscope and to the Circon Rigid Culdoscopes and Accessories. Circon's operative accessories employ the same design considerations and operating pripines as the legally marketed predicate devices, and each can be cleaned, sterilized and reused. Any differences between these devices do not raise new questions regarding safety or effectiveness. ^'The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the circumference of the circle, with the bird image positioned in the center. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 26 1999 Ronald J. Ehmsen, Sc.D. Vice President Regulatory Affairs CIRCON CORPORATION 6500 Hollister Avenue Santa Barbara, CA 93117-3019 Re: K992544 Rigid Operative Culdoscopy Accessories Dated: July 28, 1999 Received: July 30, 1999 Regulatory Class: Il 21 CFR 884.1630/Procode: 85 HEX Dear Dr. Ehmsen: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have have have have have have have have have have have have We have reviewed your obsert of the indications for use stated in the endsure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enecting of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the paperly only Federal Food, Drug, and Cosmelic Act (Act). You may, therefore, market the devices for englatedian, licing Federal Pool, Drug, and Cosment Act (rul): Too they, the Act include requirements for annual registration, listing of provisions of the Act. The general obtins of the or notibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may If your device to such additional controls. Existing major regulations affecting your device can be found in the Code of be subject to such additional controls: Existing major regalization assumes compliance with rederal Regulations, Thic 21, 1 and 600 to equirements, as set forth in the Quality System Regulation (CS) for the Ourient Ooo Indialableing Praction (21 CFR Part 820) and that, through periodic QS inspections, the Food and Medial Devices: "Ocheral rogulation (ED) Sissumptions. Failure to comply with the GMP regulation may result in Drug Administration (1 Drily voter boor asses as a seen as concerning your device in the Federal regulatory action. In addition, TDA may publicit and mission submission does not affect any obligation your negate: 7 lease fore: This respense to your promotion 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 for for This reter will billy you to bogin 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 or in il you uestic spealit advice to your device 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, the promotive and advonting of your abonect in be 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 {3}------------------------------------------------ # 510(k) Number: K992544 Device Name: Circon Rigid Operative Culdoscopy Accessories Indications for Use: Circon's Rigid Operative Culdoscopy Accessories are intended to be used with Circon's Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are: - Unexplained pelvic pain (acute, chronic) . - Menstrual abnormalities . - Infertility and sterility . - . Indefinite pelvic mass - . Ectopic pregnancy - . Pelvic endometriosis - Polycystic ovaries . - . Pelvic inflammatory disease (PID) - . Pain mapping - Congenital anomalies of the pelvic organs . - Lysis of adhesions . - . Cytology sampling - Biopsy . PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office od Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801.109) OR On Sign-Off Over-The-Counter Use *_*_ (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K992544