MICRO STAMPING LIGATING CLIP

{0}------------------------------------------------ ### Micro Stamping Corporation (Pre-market Notification) Page 14 # NOV 2 9 2001 ## Appendix A (Summary of Safety And Effectiveness) #### Submitter: John Gagliardi. President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net Trade Name: Micro Stamping Corporation (MSC) Ligating Clip Common Name: Ligating Clip Classification Name: Implantable Clip (21 CFR, Part 878.4300) #### Summary of Safety and Effectiveness: The MSC Ligating Clip is substantially equivalent in function and intended use to the Edward Weck and Company Hemoclip Ligating Clip (see example of labeling in Appendix E of products presently on the market) and the Ethicon Ligaclip. Specifically: the MSC Ligating Clip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices mentioned above. The packaging methods and packaging materials are exactly the same, respectively. The MSC Ligating Clip is indicated for use as to connect internal tissues to aid in healing. This device is for prescription use only. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized symbol consisting of three curved lines, which is the department's official emblem. The overall design is simple and conveys a sense of authority and professionalism. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 9 2001 Micro Stamping Corporation MidWest Process Innovation, LLC C/o John Gagliardi President 7736 Woodside Court Maineville, Ohio 45039 Re: K013264 Trade/Device Name: MSC Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: September 25, 2001 Received: October 1, 2001 #### Dear Mr. Gagliardi: 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 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) 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 {2}------------------------------------------------ (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807); labelling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (QD) rogulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000- This letter will allow you to begin marketing your device as described in your Section 510(k) The same of the first of the success of section with assisses of your device to I his letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA initing of backandary of 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 CFF) Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 607.10 for his rate under in the promotion and advertising of Compliance at (301) 594-4037. Thursday, 16 - 410-1463. Also, please note the your device, prease comate and of the reference to premarket notifications be obtained from the Other general information on your responsibilities under the Act may be obtained from the Other general mionnation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (800) 056-2041 61 (501) vs (501) vs (400 http://www.fda.gov/cdrh/dsmamain.html Sincerely yours, Susan Walker, MD \${\$ Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Micro Stamping Corp. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the phrase "the stamp of quality". There is also a handwritten note at the top of the image that says "P. 7 of 12". Page 1 of 1 ## Attachment II ## Indications for Use Re: K013264 Device Name: MSC Ligating Clip #### Indications for Use: Indications for Use: A clip like device intended to connect internal tissues to aid in healing. These clips are A clip like device intended to contect internal Lisate to the many of surgeon judgement. (please do not write below this line - continue on another page if needed) Prescription Use_X (Per 21 CFR, Part 801.109) or Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ Susan Walker (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number Optional Format 1-2-96