(46 days)
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.
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).
This is a 510(k) premarket notification for a medical device called the VirtuoSaph™ Endoscopic Vein Harvesting Disposable System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.
Therefore, the provided document does not contain the information requested in points 1-9 regarding acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods for demonstrating device performance against specific metrics.
This document is a regulatory approval notification, and it focuses on:
- Device Identification: Proprietary Name, Common Name, Classification, Product Code.
- Predicate Device: Vaso-View™ Dissection / Vessel Harvesting System and Olympus Endoscopic System for Vessel Harvesting.
- Intended Use/Indications for Use: The device is for minimally invasive endoscopic saphenous vein harvesting (EVH), including tissue dissection and vessel harvesting along the saphenous vein for use in coronary artery bypass grafting.
- Device Description: Composed of a Trocar, a Dissector Rod, and a Harvesting Rod.
- Summary of Comparative Technological Characteristics with Predicate Device: Mentions intended use, system components, target patient population, two-rod system, CO2 delivery, and sterilization method. The document states to "See Section 9.0" for details, but this section is not included in the provided text.
- FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
In summary, the provided document does not contain a study report or data on acceptance criteria and device performance as typically expected from a clinical trial or a more rigorous performance study. The FDA clearance is based on substantial equivalence, not a direct demonstration of meeting predefined acceptance criteria for performance metrics via a detailed study as outlined in your request.
§ 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.