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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.
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83194 Terumo Cardıovascular Systems Gorio VirtuoSaph™ Endoscopic Vein Harvesting Disposable System
5. 510(k) Summary
દ્વા
ﺮ ﺩﺭ ﺍ
JAN 1 6 2009
् र
| 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 | |
| K083194 and Page 2 of 2 Terumo Cardiovascular Systems Corp VirtuoSaph™ Endoscopic Vein Harvesting Disposable System | |
| 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Terumo Cardiovascular Systems % Junko Kurosawa Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103
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 regustration. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon
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
3
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 Brometric'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 Wilkerson
- Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
083194
4 Indication for Use Statement
Indications for Use
K083194 510(k) Number (if known)
Device Name
VırtuoSaph™ Endoscopic Vein Harvesting Dısposable 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)
Danl Krone for wxyxl 1/16/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
ત્ત્વ જૂન્તર
510(k) Number K083194