ANEURYSM CLIPS

{0}------------------------------------------------ มาราคลางอิง แบบแลนด์ เจ เข (ญ) รันมาแรงเขา บา Pemecky และแนท Aneurysm Ulps NOV 2 6 2001 # KO13136 PREMARKET NOTIFICATION [510(k)] SUMMARY #### A. SUBMITTER INFORMATION: establishment registration no .: date of summary: submitted by: 11-04-00 VON ZEPPELIN CHIRURGISCHE INSTRUMENTE GMBH Gististrasse 99 82049 Pullach- Germany -Tel.: +49 / 89 / 7936880 Fax: +49 / 89 / 7938545 8010947 Mr. von Zeppelin, President ## B. DEVICE INFORMATION Perneczky Titanium Aneurysm Clips Trade Name Aneurysm Clips: see "Appendix 3" Common Name: contact person: Class of Device: Classification Name: Equivalent Device: "Aneurysm Clips" Class II Aneurysm Clip Clips Yasargil Titanium Aneurysm (#K983758) by Aesculap Spetzler Ti 100 Aneurysm Clips (#K955064) bv Elekta Sugita Aneurysm clips (#K782040) by Down Surgical, by Mizuho Medical Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips. ## C. DEVICE DESCRIPTION: These titanium alloy aneurysm clips will be available as temporary or permanent in STANDARD OR MINI/ MICRO models. #### D. INTENDED USE OF DEVICE: The intended use of the Perneczky Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Zeppelin clip appliers. {1}------------------------------------------------ # E. TECHNOLOGICAL CHARACTERISTICS The additional patterns of Perneczky Titanium Alloy aneurysm clips do not The adultional patterns of 1 ornocity when compared to Zeppelin's Incorporate any new cennologiour characterism clips, or to other legally current Femeczky Titanium of marketed devices. The thanian and oney one onent Phynox and Titanium aneurysm clips. ## F. MATERIAL COMPOSTION / BIOCOMPATIBILITY The material composition is titanium alloy (Ti6AL4V). The alloy composition and The Thatehall Composition is thankam and (170) "Implants for Surgery Metallic propentes conformio with to Titanium 6-Aluminium 4-Vanadium Alloy" and ASTM Matenals - Frant of Vrrought Titanian for Wrought Titanium-6 Aluminium-4 Stardalum ELI (Extra Long Interstitial) Alloy (UNS R56401) for Surgical Implants Applications". {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 6 2001 Mr. Dieter von Zeppelin President von Zeppelin Chirurgische Instrumente GmbH Gistlstrasse 99 82049 Pullach / Germany Re: K013136 Trade/Device Name: Perneczky Titanium Aneurysm Clips Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: Class II Product Code: HCH Dated: August 23, 2001 Received: September 19, 2001 Dear Mr. von Zeppelin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## Page 2 – Mr. Dieter von Zeppelin This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and w you've begal finding of substantial equivalence of your device to a legally premarket notineation: "The President on 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 807.10 Idditionally, for questions on the promotion and advertising of Compliance at (301) 597-1857 Fridates Compliance at (301) 594-4639. Also, please note the your device, prodo volinareading by reference to premarket notification" (21CFR Part 807.97). Ingulation onlined, "Nilostanang one responsibilities under the Act may be obtained from the Other general information of the mational and Consumer 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, Susan Walker, MD \$\ell\$ Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Page 1 of 1 K013138 510(k) Number (if known): _ Pemeczky Titanium Aneurysm Clips Device Name: _ Indications for Use: The Perneczky Titanium Aneurysm Clips are devices used to occlude an intracranial The Pemeczky Titanium Aneurysin Clips are nessely to prevent it from bleeding or aneurysm (a balloon like Sac lonned on a blood vossaly to provide in the success or permanent devices. (Signature) Dieter von Zeppelin (Type Name) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use _ Susan Walker, m (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K013136