VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

K092789 · Terumo Cardiovascular Systems Corp. · GCJ · May 12, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092789
• Device Name: VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 blood 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.

Device Story

System consists of disposable trocar, dissector, and harvester; used in minimally invasive surgery. Trocar provides access port; dissector rod performs blunt dissection of saphenous vein and surrounding branches; harvester rod cauterizes and cuts branches for vessel harvesting. Clinician uses external video monitor to view images transmitted from reusable endoscope inserted through dissector/harvester. Device enables vessel harvesting for arterial bypass procedures; minimizes surgical trauma compared to open techniques.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design.

Technological Characteristics

Electrosurgical cutting and coagulation device. System includes disposable trocar, dissector, and harvester. Utilizes electrosurgical energy for tissue cutting and coagulation. Compatible with reusable endoscopes for visualization. Design and materials are equivalent to predicate devices.

Indications for Use

Indicated for patients undergoing minimally invasive endoscopic surgery for arterial bypass, specifically requiring blunt tissue dissection and vessel harvesting (e.g., saphenous vein) for coronary or peripheral artery bypass grafting.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• VirtuoSaph™ Endoscopic Vein Harvesting System (K083194)
• Guidant VasoView 6 Harvesting Cannula (K041981)

Submission Summary (Full Text)

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K09278S

Terumo Cardiovascular Systems Corp. VirtuoSaph™ Plus Endoscopic Vessel Harvesting Systems Corp.
VirtuoSaph™ Plus Endoscopic Vessel Harvesting System

## 5. 510(k) Summary

| | MAY 12 2010 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) Submission: | Traditional |
| Device's Classification Name: | Electrosurgical Cutting and Coagulation Device |
| 510(k) Submitter: | Terumo Cardiovascular Systems Corporation<br>6200 Jackson Road,<br>Ann Arbor, MI 48103 |
| Primary Contact Name: | Christina Thomas, Regulatory Affairs Manager<br>Tel: [phone] |
| Secondary Contact Name: | Steven Arick, Regulatory Affairs Director<br>Tel: [phone] |
| Date Prepared: | September 4, 2009 |
| Device Trade name: | VirtuoSaph™ Plus Endoscopic Vessel Harvesting<br>System |
| Device Common Name: | Electrosurgical cutting and coagulation device and<br>accessories |
| Establishment Registration Number: | 1828100 |
| Classification: | Class II |
| Product Code: | GCJ |
| Panel: | 79, General and Plastic Surgery Devices |
| Indication for Use: | The VirtuoSaph™ Plus Endoscopic Vessel Harvesting<br>System is indicated for use in minimally invasive<br>surgery allowing access for vessel harvesting, and is<br>primarily indicated for patients undergoing endoscopic<br>surgery for arterial bypass. It is indicated for cutting<br>tissue and controlling bleeding through coagulation, and<br>for patients requiring blunt dissection of tissue including<br>dissection of blood vessels and dissection of blood<br>vessels of the extremities. Extremity procedures include<br>tissue dissection and/or vessel harvesting along the<br>saphenous vein for coronary artery bypass grafting and<br>peripheral artery bypass grafting. |

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Description of the Device: The system consists of a disposable trocar, dissector, and harvester. The trocar is inserted into the leg incision and stays in place with the clip securely placed on the skin allowing fast conversion between procedural steps. The dissector or harvester rod accesses the saphenous vein by entering the trocar through the port. A reusable endoscope (which is not in the scope of this submission) enters the body through dissector or harvester, and has optical components that send an image from inside of the body to a video monitor for the clinician to view. Dissector rod dissects the saphenous vein and surrounding branches. Harvester cauterizes and cuts the branches of the saphenous vein allowing for the harvesting of it. Predicate Device: VirtuoSaph™ Endoscopic Vein Harvesting System (K083194) Guidant VasoView 6 Harvesting Cannula (K041981) Technological Characteristics: The VirtuoSaph™ Plus Endoscopic Vessel Harvesting System incorporates the same fundamental scientific technology as both the predicate device # 1, VirtuoSaph™ Endoscopic Vein Harvesting System and predicate device # 2, Guidant VasoView 6 Harvesting Cannula (K041981). Summary of substantial equivalence: The VirtuoSaph™ Plus Endoscopic Vessel Harvesting System is substantially equivalent to both predicate devices in terms of intended use, principles of operation, technology, design, materials, and performance. Any noted differences between the devices are minor and do not raise new issues of safety and effectiveness.

Page 16 of 306

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

Terumo Cardiovascular Systems Corporation % Ms. Christina Thomas 6200 Jackson Road Ann Arbor, Michigan 48103

MAY 1 2 2010

Re: K092789

_Trade/Device.Name:_VirtuoSaph________________________________________________________________________________________________________________________________________________ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 10, 2010 Received: May 11, 2010

Dear Ms. Thomas:

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 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.

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Page 2 - Ms. Christina Thomas

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 A. Milliken.

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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## 4. Indication for Use Statement

## Indications for Use

510(k) Number (if known): K092789

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 primarily indicated for patients undergoing endoscopic surgery for arterial bypass. lt is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood 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 grafing.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

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(Division Sign Off)

(Division S 12-13 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092759