Friday, September 6, 2019
Predicate Devices for Medical Stent Essay Example for Free
Predicate Devices for Medical Stent Essay Ostial Pro Stent Positioning System PREDICATE DEVICES:  ·Ã‚        Cordis ® Corporation, ATWTM Marker Wire Steerable Guidewire, K994358  ·Ã‚        Lake Region Manufacturing, Inc., Coronary, Peripheral and Renal Steerable Hydrophilic Guidewire, K042338  ·Ã‚        EV3 ® Inc., Nitrex ® Guidewire, K031864  ·Ã‚        BioSphere Medical, Inc., Sequitor TM Steerable Guidewire, K061171 PORGESâ„ ¢ Silicone double loop ureteral stent PREDICATE DEVICES:  ·Ã‚        PORGES ureteral stent from BIVONA  ·Ã‚        VORTEKâ„ ¢ and BIOSOFTâ„ ¢ ureteral double loop stents Description of Device The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The product will be used in coronary and renal 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 PORGESâ„ ¢ Silicone double loop ureteral stents are supplied in kits containing the following: 1. A double loop ureteral stent and an obturator; 2. A guide-wire, where applicable; Predicate Devices    3 3. A pusher (where applicable supplied with a clamp) The ureteral stent kits are supplied sterile and for single use only. Functional Components Medical 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 obturator; A guide-wire, where applicable; and, A pusher (where applicable supplied with a clamp) Principle of Operation The 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; partial enlargement of the diameter: localized stenoses connected with ureteropelvic junction; and, total enlargement of the diameter: stenoses over all or part of the ureter. Predicate Devices    4 Properties of Device Relevant to Diagnosis/Treatment/ Prevention/ Cure/ Mitigation of Condition The 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 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 section may be totally or partially reinforced. The eyes are lateral and staggered and are situated every 2 cm along the entire length of the stent (except for 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 simple pushers. All these properties are relevant for its intended use as specified below. Definition of Intended Use The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool. Predicate Devices    5 The PORGESâ„ ¢ Silicone double loop ureteral stent is intended for the exact same use as the current PORGES ureteral stent (K881744) and VORTEKâ„ ¢ and BIOSOFTâ„ ¢ ureteral double loop stents (K981591). The PORGESâ„ ¢ Silicone double loop ureteral stent is used for: A. Standard versions: 1. Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour 2. Cicatrisation stent B. Reinforced versions: 1. Management of ureteral stenoses 2. Partial enlargement of the diameter: localized stenoses connected with ureteropelvic junction 3. Total enlargement of the diameter; stenoses over all or part of the ureter. Comparison to â€Å"Substantially Equivalent†Device The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Ostial Pro Stent Positioning System. The technological characteristics for the Ostial Pro Stent Positioning System are also substantially equivalent to the predicate devices. Any differences in the technological characteristics 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    6 Predicate Devices    6 The PORGESâ„ ¢ Silicone double loop ureteral stent has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicate devices. 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 Summary The safety of the Ostial Pro Stent Positioning System was evaluated through design verification testing, biocompatibility testing and preclinical animal testing. The collective 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 Pro Stent Positioning System and the predicate devices do not raise any new issues of safety or efficacy. The PORGESâ„ ¢ Silicone double loop ureteral stent is held to the same design, manufacture, and performance specifications as the predicate devices. Substantial equivalence of the devices with the VORTEKâ„ ¢ and BIOSOFTâ„ ¢ 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 available, standard specifications are used Predicate Devices    7 to establish test methods. Tests are conducted in conditions similar to most unfavorable conditions of       Predicate Devices    7 medical/surgical practice. The following tests have been performed : 1. Flow rate through the stent; 2. Elongation and tensile strength of the stent after a 18 month soaking period in different buffer solutions; 3. Loop strength The PORGESâ„ ¢ 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 12 Predicate Devices    8 months. The decision to leave the withdrawal wire in place 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 efficiency 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    9 References 510(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.pdf Section J: 51O(k) Summary. PORGESâ„ ¢ Silicone double loop ureteral stent 510(k)       submission. (2002). Retrieved March 23, 2008.            http://69.20.19.211/cdrh/pdf/k013921.pdf
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