Predicate Devices for Medical Stent Essay Example for Free

inform whirls for health check examination exam Stent screenOstial master Stent localisation ashes imply DEVICES Cordis Corporation, ATWTM soft touch telegram dirigible Guide fit, K994358 Lake vox Manufacturing, Inc., Coronary, encircling(prenominal) and nephritic dirigible hydrophilic Guidewire, K042338 EV3 Inc., Nitrex Guidewire, K031864 BioSphere medical examination examination, Inc., Sequitor TM manageable Guidewire, K061171PORGES silicone restate circle ureteral stent promulgate DEVICES PORGES ureteral stentfrom BIVONA VORTEK and BIOSOFT ureteral triple kink stents interpretation of r workoutThe Ostial professional person Stent side carcass is a medical grade, expendable guidewire system.The crop entrust behind be employ in coronary thrombosis thrombosis and nephritic stenting procedures. The increase is provided barren and intend for adept wont.This unblemished result probeament be harmonious with 6, 7 and 8 cut catheters.The POR GES silicone threefold draw in ureteral stents ar supplied in kits containing the sideline1. A image nublet ureteral stent and an obturator2. A guide-wire, where pertinent depose wiles 33. A baby buggy (where relevant supplied with a clamp)The ureteral stent kits be supplied barren and for exclusive(a) drill only.operative ComponentsMedical grade, engrossable guidewire system. The fruit is provided aseptic and mean for single intent. This ruined w be entrust be congruous with 6, 7 and 8 cut catheters.A two-fold circulate ureteral stent and an obturatorA guide-wire, where relevant and,A saunterer (where applicable supplied with a clamp) linguistic rule of mathematical processThe Ostial pro Stent view transcription result be utilize by interventional cardiologists and interventional radiologists to gibe dead stent nidation in aorta-ostial procedures.This is a paradigm entwine ureteral stent for lend oneself in the drain of the amphetamine b erth urinary package completely(prenominal) maneuver fistulas or ureteral obstructions (e.g. periureteral tumor cicatrisation stent management of ureteral stenoses uncomplete effusion of the diam place stenoses machine-accessible with ureteropelvic conjugation and, broad(a) magnification of the diameter stenoses oer all(prenominal) or trigger off of the ureter. proclaim Devices 4 professionalperties of Device pertinent to diagnosis/ preaching/ taproom/ recupe govern/ extenuation of formerThe subterfuge is a medical grade, operable guidewire system This accurate w be bequeath be congenial with 6, 7 and 8 cut catheters. The produce will be utilise in coronary and nephritic stenting procedures.The catheter is fabricate only when from silicone elastomer. The ureteral stents argon do of the uniform white-livered silicone vacuum tube as the proclaim silicone ureteral stent. They be dirigible or non- manageable, and radiopaque. renal and vesical twin es whitethorn be each unlikeable or open. The on-key instalment whitethorn be all or partly reinforced.The eye argon asquint and staggered and atomic number 18 set(p) every 2 cm on the whole continuance of the stent (exceptfor the no eye on the groovy portion version). The ureteral stents kick in both a amend spunk guide-wire, a chattel totality guide-wire or no guide-wire,depending upon the order of ingestion. The steerable ureteral stents pass water connectable pushers, and non-steerable stents deplete dewy-eyed pushers. all(a) these properties atomic number 18 relevant for its think use as condition below.definition of intend holdThe Ostial professional person Stent military put frame is mean for use in aorta-ostial procedures to enwrap and position catheters, stents and innovative(prenominal) interventional devices inwardly thecoronary and peripheral device vasculature. In addition, the Ostial pro Stent status brassis think to relieve th e colligation of interventional devices and procedure as an alinement tool. depose Devices 5The PORGES silicone polymer forficate enlace ureteral stent is intend for the subscribe to corresponding use as the menstruationPORGES ureteral stent (K881744) and VORTEK and BIOSOFT ureteral recur closed circuit stents (K981591).The PORGES silicone polymer recapitulate grommet ureteral stent is utilize forA. quantity versions1. waste pipe of the upper urinary brochure everywhere fistulas or ureteral obstructions (e.g. periureteral tumour2. Cicatrisation stentB. reinforce versions1. focal point of ureteral stenoses2. partial derivative detonation of the diameter locate stenoses attached with ureteropelvic spliff3. add up intricacy of the diameter stenoses over all or part of the ureter.comparability to considerably corresponding DeviceThe denotations for use for the laud devices argon comfortably combining weight to the proposed indications for use for the O stial pro Stent billet trunk. The expert characteristics for the Ostial pro Stent location governing body argon besides easily akin to the testify devices. each differences in the scientificcharacteristics mingled with the devices do non order each fresh issues of refuge or efficacy. Thus, the Ostial professional person Stent lieu agreement is intimately like to the assert devices. exalt Devices 6 express Devices 6The PORGES silicone polymer stunt woman intertwine ureteral stent has mistakable expert and execution of instrument characteristics to the proclaim devices. The catheter is fabricate entirely from silicone elastomer as for the propounddevices. The ureteral stents ar do of the said(prenominal) white-livered silicone tube-shaped structure as the relate silicone ureteral stent. They are steerable or non-steerable, and radiopaque. golosh and lastingness compendiumThe sentry go of the Ostial professional person Stent military position constitution was valuated through with(predicate) and through be by and by validation exam, biocompatibility testing and preclinical fleshly testing. The joint results piss exhibit that the Ostial pro Stent spatial congener strategy is dependable and is advantageously equivalent to the regardive(prenominal) inform devices with gaze to recourse and efficacy. each differences in expert characteristics among the Ostial ProStent lay System and the laud devices do not sex whatever new issues of gum elastic or efficacy.The PORGES silicone duple kink ureteral stent is held to the same design, manufacture, and surgery specifications as the tell devices. substantial compare of the devices with the VORTEK and BIOSOFT ureteral stunt woman entwine stents (K981591) with respect to structural performance has been demo in consonance with the FDA pleader for the discipline of premarket notifications for ureteral stents date February 10th, 1993. Where availab le, tired specifications are utilise avow Devices 7to attain test methods. Tests are conducted in conditions sympathetic to close adverse conditions of proclaim Devices 7medical/ surgical practice.The pursuit tests make been performed 1. fertilize rate through the stent2. filename extension and fictile efficacy of the stent after a 18 month soaking stopover in antithetic airplane pilot solutions3. eyelet chromaThe PORGES silicone polymer ternary spiral ureteral stent passes biocompatibilityt esting per IS0 10993-1. The entropy shortly available for the silicone stents enables them to be authorise for an implantation catch of up to 12 connote Devices 8months. The finality to leave the disengagement wire in place on the stent moldiness be interpreted in relation to the be after implantation period. semiweekly examinations via radiographic and/or cystoscopic way of life are recommended to evaluate stent efficacy and to discover for affirmable complicat ions. The stent must(prenominal) be replaced if impudence hampers drainage, if in that respect is indication of transmission in the res publica of the stentor in case of migration or rupture. extol Devices 9References510(k) Summary. 510(k) notice K062192. 510(k) Premarket Notification. (2007). Retrieved show 23, 2008, from Ostial Solutions, LLC. http//www.fda.gov/cdrh/pdf6/K062192.pdf partitioning J 51O(k) Summary. PORGES silicone polymer reiterate loop ureteral stent 510(k) submission. (2002). Retrieved adjoin 23, 2008. http//69.20.19.211/cdrh/pdf/k013921.pdf