PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a stylized text graphic with the words "KAHIOOZ" in bold, black brushstroke-like letters. Below the word, centered horizontally, is the text "Page 12" in a smaller, simpler font. The overall impression is that of a title or heading, possibly for a document or publication. ## SECTION 6 510(k) SUMMARY Submitter Name: Submitter's Address: Contact Person: Phone Number: Facsimile Number: Date Prepared: Device Trade Name: Device Common Name: Classification Name: Predicate Device: Device Description: Intended Use: Pacific Surgical Innovations, Inc. 360 Industrial Road, Unit H San Carlos, CA 94070 Terry Johnston, President 650-802-6988 650-802-0120 March 12, 1999 PSI Titanium Micro-Ligation Hemostatic Clip Micro-Ligation Hemostatic Clip Implanted Malleable Clip Vitalitec International Titanium Hemostatic Clip Spetzler Titanium Aneurysm Clip Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient. Especially designed to prevent slippage when properly applied. The Pacific Surgical Innovations, Inc. Titanium Micro-Ligation Hemostatic Clip is designed for temporary or permanent implantation for use in ligating blood vessels. The clip has applications in many surgical procedures including where hemostasis is required or radiographic marking is necessary, in general or intracranial procedures. {1}------------------------------------------------ # Page 13 . | Technological Characteristics<br>and Comparison to Predicate | The PSI Titanium Micro-Ligation Hemostasis Clip<br>is manufactured from the same materials, meeting<br>the same standards and dimensional specifications<br>and manufactured by the same contract manu-<br>facturer as the predicate hemostasis clip. | |--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data: | When used with the appropriate clip applier, as<br>used with the predicate device, the PSI hemostasis<br>clip functions in the same manner as the predicate<br>device in occluding blood vessels. | | Conclusion: | The PSI Titanium Micro-Ligation Hemostatic<br>Clip is safe and effective for its intended use and<br>meets all regulatory requirements to be found<br>substantially equivalent to the predicate device. | . : {2}------------------------------------------------ Public Health Service JUN 11 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Terry Johnston President Pacific Surgical Innovations, Inc. 360 Industrial Road, Unit H San Carlos, California 94070 Re: K991002 > Trade Name: Titanium Micro-Ligation Hemostatic Clip Regulatory Class: II Product Code: FZP Dated: March 19, 1999 Received: March 25, 1999 Dear Mr. Johnston: 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 (OS) 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. {3}------------------------------------------------ Page 2 - Mr. Terry Johnston 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) 594-4595. 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, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K991002 Page 11 ## SECTION 5 ## INDICATIONS FOR USE #### PSI Titanium Micro-Ligation Hemostatic Clip Temporary or Permanent Occlusion of Blood Vessels Including Intracranial Blood Vessels bcollefa (Division Sign-Off) Division of General Restorative Devices 510(k) Number - Prescription ! !s: (Per 21 CFR 801.109) X