VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

{0}------------------------------------------------ Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, abstract style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 31, 2014 Terumo Cardiovascular Systems Corporation Mr. Garry Courtney, MBA, RAC Director, Regulatory Affairs 125 Blue Ball Road Elkton, Maryland 21921 Re: K140008 Trade/Device Name: VirtuoSaph® Plus Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 29, 2014 Received: September 30, 2014 Dear Mr. Courtney: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in large, bold letters. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in smaller letters. # SECTION 4 - INDICATION FOR USE VirtuoSaph® Plus Endoscopic Vessel Harvesting System 510(k) Number (if known): Unknown at time of submission K140008 Device Name: VirtuoSaph® Plus Endoscopic Vessel Harvesting System # Indications for Use: The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primearily indicated for priments undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring dissue and controlling dissection of blood vessels and dissection of blood vessels of the extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) or Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" are the words "Cardiovascular Systems" in a smaller, sans-serif font. The logo is a teal color. ## SECTION 5 – 510(K) SUMMARY VirtuoSaph® Plus Endoscopic Vessel Harvesting System | Date Prepared: | December 20, 2013 | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor Information:<br>Owner/Applicant/Submitter: | Terumo Cardiovascular Systems Corporation<br>125 Blue Ball Road<br>Elkton, MD 21921<br>Phone: 1-800-262-3304, Ext. 7486<br>Fax: 410-398-6079<br>Registration No. 1124841 | | Contact Person: | Garry A. Courtney, MBA, RAC<br>Director, Regulatory Affairs<br>Phone: 1-800-262-3304, Ext. 7486<br>Fax: 410-398-6079<br>Email: garry.courtney@terumomedical.com | | Device Names/Classifications:<br>Device Trade Name: | VirtuoSaph® Plus Endoscopic Vessel Harvesting System | | Device Common Name: | Electrosurgical Cutting and Coagulation Device | | Classification Name: | Electrosurgical Cutting and Coagulation Device | | Regulation Number: | 21 C.F.R. 878.4400 | | Classification: | Class II | | Product Code: | GEI | #### Predicate Devices: - · Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System Cleared by FDA under K092789 on May 12, 2010. - · Guidant VasoView 6 Endoscopic Vessel Harvesting System Cleared by FDA under K041981 on August 20, 2004 #### Purpose of Submission: Terumo Cardiovascular Systems Corporation is submitting this Premarket Notification because of its intent to expand the product's current usage indications. The expanded indication will allow for the device to be used in harvesting the radial artery for coronary artery bypass grafting procedures. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Terumo Cardiovascular Systems. The logo consists of a circle with a stylized "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below "TERUMO" are the words "Cardiovascular Systems" in a smaller, lighter font. The logo is in a teal color. # Summary of Comparisons Between Subject and Predicate Devices: This 510k Summary is intended to provide a brief presentation of the similarities and differences between the proposed VirtuoSaph® Plus device and the predicate VasoView 6 device. This summary will include a review of product indications, technology, design materials and product performance. #### Intended Use/Indications for Use: The subject VirtuoSaph® device shares common indications with the predicate VasoView® 6 device: ## Proposed VirtuoSaph® Plus Indications: The VirtuoSaph® Plus is currently indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and contralling bleeding through coagulation, and for patients requiring blunt dissection of itssue including dissection of blood vessels and dissection of blood vessels of the extentises, The extremity procedures include tissue dissection and/or vessel havesting anoming the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting. #### Predicate VasoView 6 Indications: The VasoView® 6 device is FDA-cleared for use in minimally invasive surgery allowing for access to vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is also indicated for putting times and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including the dissection of blood vessels and blood vessels of the externities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. These extremity procedures include tissue dissention end vein harvesting along the saphenous vein (for use in coronary and peripheral artery bypass procedures), as well as harvesting of the radial artery for use in coronary artery bypass grafting. Additionally, thoroscopic procedures include exposure and dissettin of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall. A primary difference between these two product indications is that the predicate VasoView® 6 device is cleared for the harvesting of the radial artery for use in coronary artery bypass grifting. It is Terumo Cardiovascular System's intent to expand indications to include harvesting of the radial artery for use in coronary artery bypass grafting. No additional product indications are being pursued with this submission. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller font. The logo is likely used to represent the company and its focus on cardiovascular products and services. The proposed product indications for the VirtuoSaph® Plus Endoscopic Vessel Harvesting System are: The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation and for patients requiring blunt dissection of tissue including dissection of hylood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting. #### Product Technology: The primary functions of most vessel harvesting systems include tissue cauterization and tissue dissection functions. This is also true for the VirtuoSaph® Plus device and the predicate VasoView 6 device. The subject VirtuoSaph® Plus device and the predicate VasoView 6 device each rely upon bipolar radio frequency (RF) energy to cauterize vessels that are to be harvested. For each of these two devices, the RF current is transmitted a cross two electrodes in order to effect the necessary cauterization/sealing of the tissue is oppropriated is positioned between the two electrodes. With respect to cutting of the tissue, the VirtuoSaph® Plus device relies upon bipolar RF energy to effect separation, whereas the cutting process with the predicate Vaso View® 6 is achieved by a mechanical blade which slices through the tissue to effect separation. While this difference is recognized, Terumo Cardiovascular Systems conducted performance assessments to deremonstrate equivalence to the identified predicate device. #### Design: The design of the VirtuoSaph® Plus device and the VasoView® 6 device are similar. Both devices are designed to harvest vessels from the human body that are deemed appropriate for subsequent use (i.e., bypass grafting). Both devices are designed to be used with pp epdoscope and both products are packaged without endoscope - as the endoscopes are commercially available separate from the vessel harvesting systems. The VasoView® 6 device presents with a dissector tip that can be affixed to endoscope for tunnel dissection whereas the VirtuoSaph® Plus device presents a separate full-length dissector ror tonice (with integrated conical tip) which "houses" the endoscope during tunnel dissection. The difference being that the conical shaped tip is an attachment component with the VasonView 6 device verses a fully assembled device with the subject VirtuoSaph® Plus device. There is no clinical relevance to this difference in tunnel dissection as either method safely and effectively accomplishes tunnel dissection. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter T inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, lighter font. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials. Both devices utilize upon bipolar RF energy to coagulate vessels/branches during the harvesting of the vessel. Additionally, both devices are presented with the necessary bipolar connector/cord that will interface with the bipolar outlets of compatible generators. The VirtuoSaph® Plus device and the VasoView® 6 device each provide CO2 insufflation to assist in the tunneling and harvesting of target vessels. Insufflation with the VirtuoSaph® device is accomplished from the distal position of the system tools for both dissection and harvesting procedures, whereas the VasoView® 6 device provides insufflation from the proximal handle position for the dissection procedure – and from the distal position of the harvester rod during the harvesting procedure. This difference is clinically insugnificant as insufflig the sufficiently accomplished with either device without adversely impacting clinical ontounnal. #### Materials: The materials that are used in the construction of the VirtuoSaph® Plus device and the Vaso View 6 device vary from component to component. While there are differences annong the materials of construction, these differences are not clinically relevant. Both devices have already been cleared by FDA with their respective materials of construction, and because the devices are being used in the manner for which they were cleared, there would be no issues of the safety or effectiveness with respect to materials. Furthermore, the would be in issues on the construction of the VirtuoSaph® Plus have satisfied all applicable biocompatibility requirements. It is concluded that while difference in materials do exist, these differences are not clinically relevant. #### Performance Evaluations: Terumo Cardiovascular Systems conducted performance studies with the VirtuoSaph® Plus Endoscopic Vessel Harvesting System (with expanded radial harvest indication) - where a comparison was made to the predicate VasoView® 6 device. The studies were comparative in nature with the intent to demonstrate performance equivaleoce between the devices. The studies were also designed and conducted to ensure that the subject ViruoSaph® devices satisfies appropriate device performance specifications and to ensure that it satisfies customer needs. There are no appreciable differences between the subject devices and the predicate devices with respect to product performance - including harvesting of the radial artery. Clinical studies involving patients are not necessary to demonstrate the safety and effectiveness of the subject devices. Performance assessments for safety and effectiveness were accomplished through animal studies, cadaver studies and bench evaluations. These studies assessed the following: - Radial Artery Dissection and Harvesting . - Insufflation . - Cauterization 0 - o Radial Artery Encapsulation (V-Keeper) - Burst Pressure . - Spot Cauterization o - Sealing / Bleeding 0 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller font. The logo is likely used to represent the company and its products or services related to cardiovascular health. ### Additional Areas of Comparison: The information presented in this section depicts other areas of focus for examining the similarities and differences between the VirtuoSaph® Plus Endoscopic Vessel Harvestinming System and the predicate device. #### . Duration of Use: The VirtuoSaph® Plus Endoscopic Vessel Harvesting System and the predicate VasoView® 6 can each be used in procedures lasting up to 6 hours in duration. #### ರ್ಥ Comparison of Labeling: The labeling that will be used for the VirtuoSaph® Plus Endoscopic Vessel Harvesting System (with radial artery harvest indication) is nearly identical to the labeling of the same device (VirtuoSaph® Plus) without the expanded product indication. Additionally, the labeling for the subject device is comparable to the labeling associated with the predicate Vaso View 6 device in that both labeling schemes satisfy the required with for medical device labeling - including adequate directions for use product including instructions, warnings/cautions, and contact information. #### Conclusion: The information and data included in the 510(k) notice demonstrate the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System is substantially equivalent to the prodicate Vaso View 6 Endoscopic Vessel Harvesting System with respect to harvesting of the prodial artery for use in bypass grafting.