KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES

{0} STORZ Tarl Storz Endoscopy # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge. ## Applicant: Karl Storz Endoscopy - America, Inc 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500 ## Contact: Kevin Kennan Regulatory Affairs Specialist ## Device Identification: **Common Name:** Tissue Extractor **Trade Name:** (optional) KSEA C.C.L. Vaginal Extractor ## Indication: The KSEA C.C.L. Vaginal Extractor and accessories are intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery ## Device Description: The KSEA C.C.L. Vaginal Extractor are manual reusable surgical devices (used with the KSEA Extraction Bag and KSEA Take-apart® Rotating Claw Forceps). The KSEA C.C.L. Vaginal Extractor is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are surgical grade stainless steel, HPDE, PTFE, Ultem® and polyurethane film. The non-body contact materials of the C.C.L. Vaginal Extractor are surgical grade stainless steel. ## Substantial Equivalence: The KSEA C.C.L. Vaginal Extractor for tissue extraction procedures during laparoscopic surgery are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA C.C.L. Vaginal Extractor and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices. Signed:  Kevin Kennan Regulatory Affairs Specialist 000087 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 19 1997 Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Re: K962985 C. C. L. Vaginal Extractor and Accessories Dated: November 4, 1997 Received: November 6, 1997 Regulatory class: II 21 CFR §884.1720/Product codes: 85 HET Dear Mr. Kennan: 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, Drug, and Cosmetic Act (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 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. 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 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,  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 {2} 510(k) Number (if known): K962985 Device Name: C.C.L. Vaginal Extractor and Accessories Indications for Use: The C.C.L. Vaginal Extractor is indicated for women undergoing laparoscopic surgery and intended for vaginal extraction of tissue masses as large as 6-7 cm from the peritoneal cavity, following an intra-abdominal peritoneal culdotomy at the posterior vaginal fornix.. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert R. Sitting (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K962985 Prescription Use: ☑ OR Over-The-Counter Use: (Per 21 CFR 801.109)