GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000

K052274 · Guidant Corporation · GEI · Sep 21, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052274
• Device Name: GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
• Applicant: Guidant Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for patients undergoing minimally invasive endoscopic surgery for arterial bypass, including saphenous vein or radial artery harvesting for coronary or peripheral artery bypass grafting. Also indicated for blunt dissection of blood vessels, ducts, and other structures in extraperitoneal, subcutaneous extremity, and thoracic spaces (including chest wall structures external to the parietal pleura).

Regulatory Classification

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)
• VV6 (K041981)

Submission Summary (Full Text)

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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<br>Address | 3200 Lakeside Drive<br>Santa Clara, CA 95054 |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Person | M. Laurie Wong |
| Date Prepared | August 19, 2005 |
| Device Trade<br>Name | Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System |
| Device<br>Common Name | Electrosurgical cutting and coagulation device and accessories |
| Device<br>Classification<br>Name | Electrosurgical cutting and coagulation device and accessories |
| Device<br>Classification | Class II |
| Summary of<br>substantial<br>equivalence | The design, materials, method of delivery, and intended use features of the<br>Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System are<br>substantially equivalent with regard to those features in the predicate devices:<br>the VV4 (K030512, May 14, 2003), and the VV6 (K041981, August 20, 2004). |
| Device<br>description | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System is<br>designed for use in conjunction with the 7 mm Endoscope. The Harvesting<br>Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer<br>tube and VasoView® HemoPro™ Harvesting Tool for cutting and sealing of<br>vessel branches. The C-Ring/distal lens washer is independently controlled by a<br>C-Ring Slider on the handle of the device that retracts the vessel and washes the<br>distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from<br>the main cannula by inserting it into the Tool Adapter Port, and rotated<br>independently. The Harvesting Tool has two curved Jaws. One Jaw contains the<br>heating elements for branch cutting and sealing; the second Jaw is longer and has<br>a serrated inner edge. Cutting and sealing of vessel branches is achieved in two<br>steps: (1) capture of the branch between the Jaws of the Harvesting Tool and<br>then (2) simultaneous coagulation and ligation of the branch with the Jaws using<br>direct current. Both steps are achieved by mechanical application of the<br>Activation Toggle. Positioning of the device, cutting, and sealing are performed<br>under endoscopic visualization. This device is intended for specific use with the |
| Indications for<br>Use | The VasoView® HemoPro™ System is indicated for use in minimally invasive<br>surgery allowing access for vessel harvesting, and is primarily indicated for<br>patients undergoing endoscopic surgery for arterial bypass. It is indicated for<br>cutting tissue and controlling bleeding through coagulation, and for patients<br>requiring blunt dissection of tissue including dissection of blood vessels,<br>dissection of blood vessels of the extremities, dissection of ducts and other<br>structures in the extraperitoneal or subcutaneous extremity and thoracic space.<br>Extremity procedures include tissue dissection/vessel harvesting along the<br>saphenous vein for use in coronary artery bypass grafting and peripheral artery<br>bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic<br>procedures include exposure and dissection of structures external to the parietal<br>pleura, including nerves, blood vessels and other tissues of the chest wall. |
| Technological<br>characteristics | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System<br>incorporates the same fundamental scientific technology as the predicate devices. |
| Performance<br>data | The results of the verification testing demonstrate that the Guidant VasoView®<br>HemoPro™ Endoscopic Vessel Harvesting System meet the established<br>acceptance criteria and performs in a manner equivalent to the predicate devices.<br>No new safety or effectiveness issues were raised during the testing program. |

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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.

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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 [phone] 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

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## 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

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510(k) Number K052274