VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500

K091733 · Maquet Cardiovascular, LLC · GEI · Aug 28, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091733
• Device Name: VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
• Applicant: Maquet Cardiovascular, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VASOVIEW 6 PRO 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. The VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.

Device Story

The VasoView 6 Pro is an endoscopic vessel harvesting system used in minimally invasive surgery. The system includes a harvesting cannula with four lumens housing a 7mm endoscope, C-Ring wire, endoscope washer tube, and a Bipolar BiSector for tissue ligation and division. Accessories include an extended-length endoscope, dissection tip for blunt tissue isolation, and a shortport blunt tip trocar for instrument access. The system also includes the VasoShield pressure-controlling syringe, which features a pressure relief valve and setting ring to manage irrigation pressure for bypass grafts. Operated by surgeons in an OR setting, the device enables visualization and mechanical/electrosurgical dissection of vessels. The output is the harvested vessel, prepared for use as a bypass graft. The device benefits patients by facilitating minimally invasive access, potentially reducing surgical trauma compared to open harvesting techniques.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and verification results demonstrating performance equivalent to predicate devices.

Technological Characteristics

Electrosurgical cutting and coagulation system. Components: 7mm endoscope, C-Ring wire, Bipolar BiSector, blunt tip trocar, and pressure-controlled syringe. Connectivity: None. Energy source: Electrosurgical (bipolar). Sterilization: Not specified. Materials: Not specified.

Indications for Use

Indicated for patients undergoing minimally invasive endoscopic surgery for arterial bypass, including coronary artery bypass grafting (CABG) and peripheral artery bypass. Used for blunt dissection of blood vessels (saphenous vein, radial artery), ducts, and structures in the extraperitoneal, subcutaneous extremity, and thoracic spaces. Also indicated for cutting tissue and coagulation. VASOSHIELD syringe indicated for pressure-controlled preparation/irrigation of bypass grafts.

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

• VV6 (K041981)
• VASOSHIELD Pressure Controlling Syringe (K082725)

Submission Summary (Full Text)

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K091733

Maquet Cardiovascular LLC

VasoView 6 Pro Endoscopic Vessel Harvesting System
System
Special 510(k)

AUG 2 8 2009

## APPENDIX A: 510(K) SUMMARY

| Submitter | MAQUET Cardiovascular LLC |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's<br>Address | 40 Barbour Pond Drive<br>Wayne, NJ 07470 |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Person | Artie Kaushik |
| Date Prepared | June 10, 2009 |
| Device Trade<br>Name | VASOVIEW 6 PRO 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>VASOVIEW 6 PRO Endoscopic Vessel Harvesting System are substantially<br>equivalent with regard to those features in the predicate device: the VV6<br>(K041981, August 20, 2004) and VASOSHIELD Pressure Controlling Syringe<br>(K082725, December 17, 2008) |
| Device<br>description | The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System consists of the<br>VASOVIEW 6 PRO Harvesting Cannula which is designed for use in<br>conjunction with the 7mm Endoscope. The Harvesting Cannula has four lumens<br>which house the Endoscope, C-Ring wire, endoscope washer tube and Bipolar<br>BiSector for ligation and division of vessel branched. The system includes the<br>following accessories- (1) The 7mm Extended Length Endoscope and Dissection<br>Tip for blunt dissection of tissue and isolation of structures in the cavity. (2)<br>Shortport Blunt Tip Trocar (BTT) to provide a port for insertion of endoscoic<br>instruments into an incision site. (3) VASOSHIELD Pressure Controlling<br>Syringe is a fully assembled 60 mL syringe with a pressure relief valve that is<br>controlled by a pressure setting ring. |

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The VASOVIEW 6 PRO System is indicated for use in minimally invasive Indications for surgery allowing access for vessel harvesting, and is primarily indicated for Use 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. The VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft. The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System incorporates the Technological same fundamental scientific technology as the predicate devices. characteristics The results of the verification testing demonstrate that the VASOVIEW 6 PRO Performance meet the established acceptance criteria and performs in a manner equivalent to data the predicate device. No new safety or effectiveness issues were raised during the testing program. The results of the verification testing for the VASOSHIELD Pressure Controlling Syringe also demonstrate that the syringe meets established acceptance criteria and performs in a manner equivalent to its predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Maquet Cardiovascular, LLC % Ms. Artie Kaushik Associate, Regulatory Affairs 170 Baytech Drive San Jose, California 95134

## AUG 2 8 2009

Re: K091733

Trade/Device Name: VASOVIEW 6 PRO Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GBX Dated: July 31, 2009 Received: August 4, 2009

Dear Ms. Kaushik:

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. Isting 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 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

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Page 2 - Ms. Artie Kaushik

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) number (if known) The 510(k) number has not been issued yet.

Device name

VASOVIEW 6 PRO Endoscopic Vessel Harvesting System

Indications for Use

The VASOVIEW 6 PRO 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.

The VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use ﮐﮯ OR Prescription Use (Per 21 CFR 801.109)

K091733

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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