(79 days)
VirtuoSaph™ Endoscopic Vein Harvesting System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting including tissue dissection for use in peripheral and coronary artery bypass grafting.
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 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.
N/A
VirtuoSaph™ Endoscopic Vein Harvesting Disposable System
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5. 510(k) Summary
JAN 16 2009
Type of 510(k) Submission: Traditional
Device's Classification Name: Electrosurgical Cutting and Coagulation Device
510(k) Submitter: Terumo Cardiovascular Systems Corporation
6200 Jackson Road,
Ann Arbor, MI 48103
Primary Contact Name: Junko Kurosawa, Senior Associate, Regulatory Affairs
Tel 1(800)262-3304, Extension 6563
Secondary Contact Name: Christina Thomas, Manager, Regulatory Affairs
Tel 1(800)262-3304, Extension 6278
Date Prepared: October 28, 2008
Device Trade name: VirtuoSaph™ Endoscopic Vein Harvesting Disposable System
Establishment Registration Number: 1828100
Classification: Class II
Product Code: GCJ
Panel: 79, General and Plastic Surgery Devices
Indication for Use: VirtuoSaph™ Endoscopic Vein Harvesting System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting including tissue dissection for use in peripheral and coronary artery bypass grafting
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CONFIDENTIAL AND PROPRIETRY
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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 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 Disposable System (K031891)
Purpose of the Submission: Modification of the indication for use statement to include the word "peripheral" as a method of use
Technological Characteristics and Comparison to Predicate Device:
The difference between the modified and (unmodified) predicate device is only in the intended use statement. It the addition of the word "peripheral" to the indications statement that relates only to a method of use, not to the effect of which harvesting is achieved.
Conclusion: In summary, the VirtuoSaph™ Endoscopic Vein Harvesting System with the modified indications for use statement is substantially equivalent in intended use, principles of operation, technology, design, materials, and performance to the predicate VirtuoSaph™ Endoscopic Vein Harvesting System. Any noted differences between the devices do not raise new issues of safety and effectiveness.
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CONFIDENTIAL AND PROPRIETRY
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Terumo Cardiovascular Systems
℅ Junko Kurosawa
Regulatory Affairs
6200 Jackson Road
Ann Arbor, Michigan 48103
JAN 16 2009
Re: K083194
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: January 5, 2009
Received: January 7, 2009
Dear Junko Kurosawa:
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 - Junko Kurosawa
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological 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): K083194
Device Name: VirtuoSaph™ Endoscopic Vein Harvesting Disposable System
Indications for Use:
VirtuoSaph™ Endoscopic Vein Harvesting System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting including tissue dissection for use in peripheral and coronary artery bypass grafting.
Prescription Use X AND/OR Over-The-Counter 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number: K083194
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§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.