VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
Device Facts
| Record ID | K083194 |
|---|---|
| Device Name | VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 |
| Applicant | Terumo Cardiovascular Systems Corp. |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Jan 16, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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
Device Story
The VirtuoSaph™ Endoscopic Vein Harvesting Disposable System is a surgical tool used in minimally invasive procedures. It consists of a disposable trocar, a dissector rod, and a harvester rod. The trocar is inserted into a leg incision and secured to the skin, providing a port for the other instruments. A reusable endoscope (not included) is inserted through the dissector or harvester to provide visualization on a video monitor. The dissector rod is used to dissect the saphenous vein and surrounding branches, while the harvester rod cauterizes and cuts the branches to facilitate vein removal. The device is operated by a clinician in a surgical setting. By enabling endoscopic access, the system allows for smaller incisions compared to traditional open harvesting, potentially reducing patient trauma and recovery time.
Clinical Evidence
No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.
Technological Characteristics
The system is a disposable, manually operated surgical instrument set. It includes a trocar, dissector rod, and harvester rod. It utilizes electrosurgical energy for cauterization and cutting. The device is designed for use with a separate, reusable endoscope for visualization.
Indications for Use
Indicated for patients undergoing minimally invasive surgery requiring endoscopic saphenous vein harvesting for peripheral and coronary 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 Disposable System (K031891)
Related Devices
- K031891 — VIRTUOSAPH · Terumo Cardiovascular Systems Corp. · Jul 29, 2003
- K092789 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM · Terumo Cardiovascular Systems Corp. · May 12, 2010
- K963184 — OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM · Olympus America, Inc. · Dec 31, 1996
- K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING · Karl Storz Endoskop GmbH · Nov 7, 1997
- K012724 — SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 · Smith & Nephew, Inc. · Nov 8, 2001
