Predicate Devices for Medical Stent Essay Example for Free

Predicate Devices for Medical Stent EssayOstial professional Stent Positioning SystemPREDICATE DEVICES Cordis Corporation, ATWTM Marker Wire steerable Guidewire, K994358 Lake Region Manufacturing, Inc., Coronary, Peripheral and Renal Steerable Hydrophilic Guidewire, K042338 EV3 Inc., Nitrex Guidewire, K031864 BioSphere Medical, Inc., Sequitor TM Steerable Guidewire, K061171PORGES silicone polymer double draw in ureteral stentPREDICATE DEVICES PORGES ureteral stentfrom BIVONA VORTEK and BIOSOFT ureteral double hand-build stentsDescription of DeviceThe Ostial Pro Stent Positioning System is a medical grade, spendable guidewire remains.The overlap will be use of goods and servicesd in coronary and nephritic stenting procedures. The product is provided sterile and intended for single use.This finished product will be compatible with 6, 7 and 8 French catheters.The PORGES Silicone double grommet ureteral stents are supplied in kits containing the following1. A double loop ureteral stent and an obturator2. A guide-wire, where applicablePredicate Devices 33. A pusher (where applicable supplied with a clamp)The ureteral stent kits are supplied sterile and for single use only.Functional ComponentsMedical grade, disposable guidewire system. The product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.A double loop ureteral stent and an obturatorA guide-wire, where applicable and,A pusher (where applicable supplied with a clamp)Principle of OperationThe Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures.This is a double loop ureteral stent for use in the drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour cicatrisation stent management of ureteral stenoses partitionial enlargement of the diameter localized steno ses connected with ureteropelvic junction and,total enlargement of the diameter stenoses over all or part of the ureter.Predicate Devices 4Properties of Device Relevant to Diagnosis/Treatment/Prevention/Cure/Mitigation of ConditionThe device is a medical grade, disposable guidewire system This finished product will be compatible with 6, 7 and 8 French catheters. The product will be used in coronary and renal stenting procedures.The catheter is manufactured entirely from silicone polymer elastomer. The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent. They are steerable or non-steerable, and radiopaque. Renal and vesical loops may be either closed or open. The straight surgical incision may be totally or partially reinforced.The eye are lateral and staggered and are situated every 2 cm along the entire length of the stent (exceptfor the no eye on the straight section version). The ureteral stents have either a fixed core guide-wire , a movable core guide-wire or no guide-wire,depending upon the method of use. The steerable ureteral stents have connectable pushers, and non-steerable stents have aboveboard pushers. All these properties are relevant for its intended use as specified below.Definition of Intended UseThe Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within thecoronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning Systemis intended to facilitate the alignment of interventional devices and give out as an alignment tool.Predicate Devices 5The PORGES Silicone double loop ureteral stent is intended for the exact same use as the currentPORGES ureteral stent (K881744) and VORTEK and BIOSOFT ureteral double loop stents (K981591).The PORGES Silicone double loop ureteral stent is used forA. Standard versions1. Drainage of the upper urinary tract over fistulas or urete ral obstructions (e.g. periureteral tumour2. Cicatrisation stentB. Reinforced versions1. Management of ureteral stenoses2. overtone enlargement of the diameter localized stenoses connected with ureteropelvic junction3. Total enlargement of the diameter stenoses over all or part of the ureter.Comparison to Substantially tantamount(predicate) DeviceThe indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Ostial Pro Stent Positioning System. Thetechnological characteristics for the Ostial Pro Stent Positioning System are in any case substantially equivalent to the predicate devices. each differences in the technologicalcharacteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Ostial Pro Stent Positioning System is substantially equivalent to the predicate devices.Predicate Devices 6Predicate Devices 6The PORGES Silicone double loop ureteral stent has similar technological and c ognitive process characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicatedevices. The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent. They are steerable or non-steerable, and radiopaque.Safety and Effectiveness SummaryThe safety of the Ostial Pro Stent Positioning System was evaluated through design verification testing, biocompatibility testing and presymptomatic animal testing. Thecollective results have demonstrated that the Ostial Pro Stent Positioning System is safe and is substantially equivalent to the respective predicate devices with regard to safety and efficacy. Any differences in technological characteristics between the Ostial ProStent Positioning System and the predicate devices do not raise any new issues of safety or efficacy.The PORGES Silicone double loop ureteral stent is held to the same design, manufacture, and performance specifications as t he predicate devices. Substantial equivalence of the devices with the VORTEK and BIOSOFT ureteral double loop stents (K981591) with respect to functional performance has been demonstrated in conformity with the FDA Guidance for the content of premarket notifications for ureteral stents dated February 10th, 1993. Where accessible, standard specifications are usedPredicate Devices 7to establish test methods. Tests are conducted in conditions similar to virtually unfavorable conditions of Predicate Devices 7medical/surgical practice.The following tests have been performed 1. Flow rate through the stent2. Elongation and tensile strength of the stent after a 18 month soaking period in different buffer solutions3. Loop strengthThe PORGES Silicone double loop ureteral stent passes biocompatibilityt esting per IS0 10993-1. The data currently available for the silicone stents enables them to be validated for an implantation period of up to 12Predicate Devices 8months. The decision to leave the withdrawal wire in function on the stent must be taken in relation to the planned implantation period. Periodic examinations via radiographic and/or cystoscopic means are recommended to evaluate stent aptitude and to observe for possible complications. The stent must be replaced if encrustation hampers drainage, if there is indication of infection in the area of the stentor in case of migration or rupture.Predicate Devices 9References510(k) Summary. 510(k) Notification K062192. 510(k) Premarket Notification. (2007). Retrieved March 23, 2008, from Ostial Solutions, LLC. http//www.fda.gov/cdrh/pdf6/K062192.pdfSection J 51O(k) Summary. PORGES Silicone double loop ureteral stent 510(k) submission. (2002). Retrieved March 23, 2008. http//69.20.19.211/cdrh/pdf/k013921.pdf