LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS)

{0}------------------------------------------------ JUL 3 0 2008 # K071759 ## 510(k) SUMMARY Pzei/f~ # Live Tissue Connect Inc.'s VAD System # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Live Tissue Connect, Inc. 2813 Gaviota Street Los Olivos, CA 93441 Phone: 805-686-0937 Facsimile: 805-686-5399 Contact Person: Frank D. D'Amelio Date Prepared: February 10, 2007 #### Name of Device and Name/Address of Sponsor LTC VAD System Live Tissue Connect, Inc. 500 North Shoreline Corpus Christi, Texas 78741 ### Common or Usual Name Electrosurgical Bipolar Device ### Classification Name Electrosurgical Cutting and Coagulation Device and Accessories #### Predicate Devices LigaSure Vessel Sealing System (K981916) LigaSure Advance (K063195) Gyrus General Purpose Electrosurgical System (K050550) Gyrus OPEN FORCEPS (K024286) {1}------------------------------------------------ Page 2 of 2 ### Intended Use / Indications for Use The LTC VAD.400 is an electrosurgical generator coupled with designated LTC electrosurgical instruments for bipolar tissue fusion. The LTC VAD.400 electrosurgical generator and designated LTC electrosurgical instruments (i.e., "the VAD System") are intended for use in open general surgical procedures where ligation of vessels and ducts is desired and as an alternative to mechanical clamping (clips or staples) or suturing. The LTC VAD System can be used on vessels up to 7mm in diameter, on ducts up to 2mm in diameter, and tissue bundles as large as will fit in the jaw electrodes of the instrument. The LTC VAD system has not yet been tested for use in tubal sterilization or tubal coagulation for sterilization procedures; therefore, the company does not recommend the use of the LTC VAD system for such procedures. In addition, LTC recommends against the use of the VAD System for male circumcisions. #### Technological Characteristics The LTC VAD System consists of: a bipolar electrosurgical generator and two distinct and dedicated electrosurgical instruments. #### Performance Data Bench, animal and clinical testing was conducted using the LTC VAD System. In all instances, the LTC VAD System functioned as intended and all results observed were as expected. #### Substantial Equivalence The LTC VAD System is as safe and effective as the predicate devices. The LTC VAD System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the LTC VAD System and its predicate devices raise no new issues of safety or effectiveness. Thus, the LTC VAD System is substantially equivalent. {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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL 30 2008 Live Tissue Connect, Inc. % Hogan & Hartson Mr. Howard M. Holstein 555 Thirteenth Street, NW Washington, District of Columbia 20004 Re: K071759 Trade/Device Name: LTC VAD System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 1, 2008 Received: May 1, 2008 Dear Mr. Holstein: 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 (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. IIoward M. Holstein This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Mulhern Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use Statement 510(k) Number (if known): k071759 Device Name: LTC VAD System Indications for Use: The LTC VAD.400 is an electrosurgical generator coupled with designated LTC electrosurgical instruments for bipolar tissue fusion. The LTC VAD.400 electrosurgical generator and designated LTC electrosurgical instruments (i.e., "the VAD System") are intended for use in open general surgical procedures where ligation of vessels and ducts is desired and as an alternative to mechanical clamping (clips or staples) or suturing. The LTC VAD System can be used on vessels up to 7mm in diameter, on ducts up to 2mm in diameter, and tissue bundles as large as will fit in the jaw electrodes of the instrument. The LTC VAD system has not yet been tested for use in tubal sterilization or tubal coagulation for sterilization procedures; therefore, the company does not recommend the use of the LTC VAD system for such procedures. In addition, LTC recommends against the use of the VAD System for male circumcisions. Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark H. Millerson (Division Sign.Off Division of General, Restorative, and Neurological Devices 510(k) Number. K071754