← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K052274 # GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (K052274) _Guidant Corporation · GEI · Sep 21, 2005 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K052274 ## Device Facts - **Applicant:** Guidant Corporation - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Sep 21, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The VasoView® HemoPro™ 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 blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall. ## Device Story VasoView® HemoPro™ is an endoscopic vessel harvesting system used in minimally invasive surgery. The device features a harvesting cannula with four lumens housing an endoscope, C-ring, distal lens washer, and a harvesting tool. The harvesting tool, equipped with two curved jaws (one with heating elements, one serrated), performs vessel branch cutting and sealing. Operation involves capturing a branch between the jaws and applying direct current via a mechanical activation toggle to simultaneously coagulate and ligate the tissue. Positioning, cutting, and sealing are performed under endoscopic visualization. The device is operated by surgeons in an OR setting to harvest vessels for bypass grafting or perform blunt dissection. It benefits patients by enabling minimally invasive access, reducing the trauma associated with traditional open vessel harvesting procedures. ## Clinical Evidence Bench testing only. Verification testing demonstrated that the device meets established acceptance criteria and performs in a manner equivalent to the predicate devices. ## Technological Characteristics Electrosurgical cutting and coagulation device. Features a 4-lumen harvesting cannula, 7 mm endoscope compatibility, and a harvesting tool with integrated heating elements for bipolar-like coagulation/ligation. Mechanical activation toggle. Operates via direct current. No software or electronic processing described. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - VV4 ([K030512](/device/K030512.md)) - VV6 ([K041981](/device/K041981.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Guidant Corporation Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System Special 510(k) K052274 ## APPENDIX A: 510(K) SUMMARY | Submitter | Guidant Corporation, Cardiac Surgery | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's
Address | 3200 Lakeside Drive
Santa Clara, CA 95054 | | Telephone | (408) 845-2014 | | Fax | (408) 845-2077 | | Contact Person | M. Laurie Wong | | Date Prepared | August 19, 2005 | | Device Trade
Name | Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System | | Device
Common Name | Electrosurgical cutting and coagulation device and accessories | | Device
Classification
Name | Electrosurgical cutting and coagulation device and accessories | | Device
Classification | Class II | | Summary of
substantial
equivalence | The design, materials, method of delivery, and intended use features of the
Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System are
substantially equivalent with regard to those features in the predicate devices:
the VV4 (K030512, May 14, 2003), and the VV6 (K041981, August 20, 2004). | | Device
description | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System is
designed for use in conjunction with the 7 mm Endoscope. The Harvesting
Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer
tube and VasoView® HemoPro™ Harvesting Tool for cutting and sealing of
vessel branches. The C-Ring/distal lens washer is independently controlled by a
C-Ring Slider on the handle of the device that retracts the vessel and washes the
distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from
the main cannula by inserting it into the Tool Adapter Port, and rotated
independently. The Harvesting Tool has two curved Jaws. One Jaw contains the
heating elements for branch cutting and sealing; the second Jaw is longer and has
a serrated inner edge. Cutting and sealing of vessel branches is achieved in two
steps: (1) capture of the branch between the Jaws of the Harvesting Tool and
then (2) simultaneous coagulation and ligation of the branch with the Jaws using
direct current. Both steps are achieved by mechanical application of the
Activation Toggle. Positioning of the device, cutting, and sealing are performed
under endoscopic visualization. This device is intended for specific use with the | | Indications for
Use | The VasoView® HemoPro™ 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 blood vessels,
dissection of blood vessels of the extremities, dissection of ducts and other
structures in the extraperitoneal or subcutaneous extremity and thoracic space.
Extremity procedures include tissue dissection/vessel harvesting along the
saphenous vein for use in coronary artery bypass grafting and peripheral artery
bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic
procedures include exposure and dissection of structures external to the parietal
pleura, including nerves, blood vessels and other tissues of the chest wall. | | Technological
characteristics | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System
incorporates the same fundamental scientific technology as the predicate devices. | | Performance
data | The results of the verification testing demonstrate that the Guidant VasoView®
HemoPro™ Endoscopic Vessel Harvesting System meet the established
acceptance criteria and performs in a manner equivalent to the predicate devices.
No new safety or effectiveness issues were raised during the testing program. | {1}------------------------------------------------ : ______________________________________________________________________________________________________________________________________________________________________________ {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending from the head. ## SEP 2 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. M. Laurie Wong Principal Regulatory Affairs Associate Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, California 95054 Re: K052274 K052274 Trade/Device Name: Guidant Vaso View® HemoPro™ Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: 21 CFR 078. 1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 19, 2005 Received: August 22, 2005 Dear Ms. Wong: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > ro(t) prematics is substantially equivalent (for the indications referenced above and nave ucterimined the acted predicate devices marketed in interstate for use stated in the encrosule for regally manatise for the Medical Device American so to commerce prior to May 20, 1970, the enaounter with the provisions of the Federal Food, Drug. devices that have been reclassified in accordance with the provisions of the Unit devices that have been reclassified in acceraanse was a proval approval application (PMA). and Cosment Act (Act) that do not require approvile controls provisions of the Act. The You may, merelore, market the devices, belyer to the see of the sensual registration, listing of general controls provisions of the free morely of the more of the manage of the branding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the entires and regulations affecting your device can may be subject to such additional controls. Existing major regulations FDA may may be subject to such additional controller 21, Parts 800 to 898. In addition, FDA may be found in the Oode of I cases in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuation of a basesian and other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of any I edical statutes and regalations and limited to: registration and listing (21 Comply with an the Act 5 requirements, as a sood manufacturing practice requirements as set CITY art 6077, adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2- Ms. M. Laurie Wong This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manxoning of substantial equivalence of your device to a legally premarket notification. The PDA maing of saostalian organ 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 If you desire specific advice for your ac not 10-75-0115. Also, please note the regulation entitled, contact the Office of Complance at (210) 275 - 17 877 Part 807.97). You may obtain "Misoranding by relective to premarker notificas in the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Barbara BuecheD for Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ____K052274 Device Name:_VasoView® HemoPro™ Endoscopic Vessel Harvesting System Indications For Use: Indications For Use: The VasoView® HemoPro™ System is indicated for use in minimally invasive surgery The VasoView" HemoPro " System is indicated for patients undergoing allowing access for vesser narvesting, and is primating tissue and controlling endoscopic surgery for arterial bypass. It is indicated for cutting the sue endoscopic surgery for antenal bypass. It is manufact blunt dissues of tissues bleeding through coagulation, and for patients routing analysis of the extremities, including dissection of blood vessels, dissection of blood vessels of the extremity including dissection of blood vessels, and other straperitoneal or subcultaneous dissection of ducts and other structures in the extraperity of the elissection/vi dissection of ducts and other stucctures in the extrapentonealise in the endissection/vessel extremity and thoracic space. Extremity procedures include thisses graffing and extremity and thoracle space. Extremity prosediate and artery bypass grafting and harvesting along the Saphellous vein to use in coronary artery bypass grafting. peripheral artery bypass or radial artery for use in coronary arternal peripheral artery bypass of faulal and in one in other unformation of estimal to the Thoracoscopic procedures include exposure and dissection of the chest wall Thoracoscopic procedures include exposure and other tissues of the chest wall. parietal pleura, including nerves, blood vessels and other tissues of the chest wall. Prescription Use __ x_ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Soubane buchud formen Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number K052274 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K052274](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K052274) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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