VIRTUOSAPH

K031891 · Terumo Cardiovascular Systems Corp. · GCJ · Jul 29, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031891
• Device Name: VIRTUOSAPH
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The TCVS VirtuoSaph™ Endoscopic Vein Harvesting Disposable System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting (commonly known as EVH) including tissue dissection and vessel harvesting along the saphenous vein for use in coronary artery bypass grafting.

Device Story

VirtuoSaph is a minimally invasive endoscopic saphenous vein harvesting (EVH) system. It consists of a trocar and two specialized rods: a dissector rod for tissue and tributary dissection, and a harvesting rod for transecting and cauterizing branches to facilitate vein removal. Used by surgeons in an operating room setting for coronary artery bypass grafting procedures. The device provides mechanical access and electrosurgical capability to harvest the saphenous vein through small incisions, reducing surgical trauma compared to open harvesting techniques.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparative technological characteristics.

Technological Characteristics

System includes a trocar, dissector rod, and harvesting rod. Features CO2 delivery for endoscopic visualization/workspace maintenance. Utilizes electrosurgical cutting and coagulation. Sterilization method is not specified in the provided text. Device is a disposable system.

Indications for Use

Indicated for patients undergoing coronary artery bypass grafting requiring saphenous vein harvesting via minimally invasive endoscopic surgery.

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

• Vaso-View™ Dissection / Vessel Harvesting System (K98170)
• Olympus Endoscopic System for Vessel Harvesting (K963184)

Submission Summary (Full Text)

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JUL 2 9 2003

K031891
1 OF 2

:

| 10.0 | 510(k) SUMMARY | JUL 2 9 2003 | | K031017<br>1 OF 2 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|-------------------|
| Date of Application: | 05 May 03 | | | |
| Applicant's Name and Address: | Terumo Cardiovascular Systems Corporation<br>6200 Jackson Road<br>Ann Arbor, MI 48103 | | | |
| Name of Contact Person: | Kim E. Aves<br>Sr. Regulatory Affairs Specialist | | | |
| Telephone and Fax Numbers: | Telephone: [phone]<br>Fax: [phone] | | | |
| Proprietary Name: | VirtuoSaph | | | |
| Common Name: | Minimally Invasive Saphenous Vein Harvesting System | | | |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories. | | | |
| Classification Number: | 878.4400 | | | |
| Class: | II | | | |
| Classification Panel: | 79, General and Plastic Surgery | | | |
| Product Code: | GEI | | | |
| Predicate Device: | Vaso-View™ Dissection / Vessel Harvesting System #K98170<br>Olympus Endoscopic System for Vessel Harvesting<br>(endoscope only) #K963184 | | | |
| Applicability of Performance Standards: Terumo has determined that no mandatory performance<br>standards have been established for these devices under<br>Section 514 of the Medical Device Amendments to Federa<br>Food, drug, and Cosmetic Act or by any subsequent<br>regulatory action. | | | | |

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K031891
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## Device Intended Use:

The TCVS VirtuoSaph™ Endoscopic Vein Harvesting Disposable System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting (commonly known as EVH) including tissue dissection and vessel harvesting along the saphenous vein for use in coronary artery bypass grafting,

#### Device Description:

The VirtuoSaph System is composed of a Trocar, two rods: the Dissector Rod (to dissect the saphenous yein (SV) and tributaries), and the Harvesting Rod (to transect and cauterize the branches and allow harvesting of the SV).

#### Summary of Comparative Technological Characteristics with Predicate Device:

- D Intended use
- . System Components
- Target patient population .
- . Two-Rod system
- . CO2 delivery
- Sterilization method .

See Section 9.0.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The logo is printed in black and white.

JUL 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Cardiovascular Systems Corporation c/o Mr. Heinz Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road Newtown, Connecticut 06470

Re: K031891

Trade/Device Name: VirtuoSaph™ Endoscopic Vein Harvesting Disposable System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 11, 2003 Received: July 14, 2003

Dear Mr. Steneberg:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Mr. Heinz Joerg Steneberg

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Adalie N Milburn

Celia M. Witten, Ph.D., M.D. 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 FORM

Page 1 of 1

K 031891

510(k) Number (if known): Unknown

Device Name: VirtuoSaph™ Endoscopic Vein Harvesting DIsposable System

Indications for Use:

The TCVS VirtuoSaph™ Endoscopic Vein Harvesting Disposable System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting (commonly known as EVH) including tissue dissection and vessel harvesting along the saphenous vein for use in coronary artery bypass grafting.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

L. Mark A. Milkerson

Division Sign-( Division of General, Restorative and Neurological Devices

K03189
510(k) Number

Over-The-Counter (Optional Format 1-2-96)