Friday, January 31, 2020
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
Wednesday, January 22, 2020
Empiricism and Behaviorism Essay -- essays research papers
the turn of the twentieth century, the field of Psychology found itself in a war between two contending theoretical perspectives: Gestalt psychology versus Behaviorism. With its roots within the United States, behaviorists in America were developing a theory that believed psychology should not be concerned with the mind or with human consciousness. Instead, behavior and the actions of humans would be the foremost concern of psychologists. Across the Atlantic, Gestalt psychology emerged by placing its criticism upon the methodology of introspection, especially by ways of disparaging behaviorism. Although the two theories originated on separate continents, their opposing ideas were brought together after World War II and continued to battle each other for almost half a century.      An American psychologist, by the name of John B. Watson, is historically known for â€Å"selling†the idea of Behaviorism to other American psychologists during the 1900s. Watson insisted that â€Å"psychology had failed to become an undisputed natural science because it was concerned with conscious processes that were invisible, subjective, and incapable of precise definition†(Hunt, page256). Watson’s position on human behavior was that it could be explained entirely in terms of reflexes, stimulus-response associations, and the effects of multiple reinforcements upon a person--entirely excluding any mental processes. Watson’s work was based on the experiments of Ivan Pavlov, who had studied animals’ responses to conditioning. In Pavlov’s most well-known experiment, he rang a bell each time he presented the dogs with food. Every time the dogs would hear the bell, their initial response would be to salivate because they be lieved that food was going to be offered. Pavlov then rang the bell without bringing food, yet the dogs continued to salivate. In essence, the dogs had been â€Å"conditioned†to salivate at the sound of the bell. From this research, Pavlov concluded that humans also react to stimuli in the same way--a finding that Watson would later emphasize.      In modern psychology, behaviorism is most closely associated with B.F. Skinner, a man who molded his reputation by testing Watson’s theories in the laboratory. Skinner’s studies led him to believe that people operate on the environment to produce certain consequences, along with sim... ...alist thought and empiricism primarily embodies the question of how humans gain knowledge. In rationalism, pure reason is used in determining the fundamental natures of things and it is through human intuition and deductive reasoning that humans can obtain knowledge. Rationalists assert that there is an already existing innate knowledge, which is independent of experience, which God has bestowed upon every human individual. Descartes believed that, without innate ideas, no other information could be known. Furthermore, our innate knowledge is not learned through experience but is known intuitively through reason. Empiricists criticized the rationalists at this point, arguing that the matters of the innate ideas were in fact learned through one’s previous experiences. They emphasized that large amounts of knowledge were gained through interaction with societyâ€â€which occurs in early childhood and therefore cannot be considered intrinsic. Moreover, empiricists accentuate the notion that knowledge stem from internal mental experiences (such as emotion and self-reflection). For empiricists, facts precede theories and it is plausible for one to be a fair, unbiased observer of â€Å"facts†.
Tuesday, January 14, 2020
Carnival Event Essay
To conclude this magical event full of happiness, dances, music, costumes and charisma produce in every single person each year a colorful spirit of carnival. To conclude this magical event full of happiness, dances, music, costumes and charisma produce in every single person each year a colorful spirit of carnival. The lovely kids that every body was waiting for arrived to the carnival event. Preschool beautiful princesses were already dancing through all the marathon gym so every single person could see the great dancers they were. We could say that this show was a triumph just because of the presentation of preschool with all the little kids that had happy faces during all the presentation so they keep us motivated and gave us energy to bravely keep shouting and applauding to them. After this amazing carnival event of the British international college finally finished, some interviews to certain teachers were made. Mrs. Sarah, primary teacher and queen of the event, told us â€Å"even though I’ve never been in a carnival event before I can say that this â€Å"lectura del bando†was totally Very exiting for me. Very serious Mr. Nelson, high school teacher, told us â€Å"well I could honestly admit that this year dew to the fact that there were no high school queen it was a very organized and colorful event and Finally with a big smile in his face , Mr. Guy , headmaster of the school told us â€Å"that he was very proud of all the work done in this fantastic event were teachers and student gave all their effort . The lovely kids that every body was waiting for arrived to the carnival event. Preschool beautiful princesses were already dancing through all the marathon gym so every single person could see the great dancers they were. We could say that this show was a triumph just because of the presentation of preschool with all the little kids that had happy faces during all the presentation so they keep us motivated and gave us energy to bravely keep shouting and applauding to them. After this amazing carnival event of the British international college finally finished, some interviews to certain teachers were made. Mrs. Sarah, primary teacher and queen of the event, told us â€Å"even though I’ve never been in a carnival event before I can say that this â€Å"lectura del bando†was totally Very exiting for me. Very serious Mr. Nelson, high school teacher, told us â€Å"well I could honestly admit that this year dew to the fact that there were no high school queen it was a very organized and colorful event and Finally with a big smile in his face , Mr. Guy , headmaster of the school told us â€Å"that he was very proud of all the work done in this fantastic event were teachers and student gave all their effort .  This surprising and colorful event started at 7:00 a.m. and took place in the marathon gym. Everyone was very exited, there were beautiful dresses every were, blue, yellow, red, black, all colors you can imagine. People were amazed o f such gracefully dances with the folkloric music. The main event of this fascinated carnival opening started with the entrance of the princesses and â€Å"rey momos†of primary. they all had spectacular carnivals costumes which in a way they â€Å"illuminated†the marathon gym with they dances and the charisma they had. This surprising and colorful event started at 7:00 a.m. and took place in the marathon gym. Everyone was very exited, there were beautiful dresses every were, blue, yellow, red, black, all colors you can imagine. People were amazed of such gracefully dances with the folkloric music. The main event of this fascinated carnival opening started with the entrance of the princesses and â€Å"rey momos†of primary. they all had spectacular carnivals costumes which in a way they â€Å"illuminated†the marathon gym with they dances and the charisma they had. Yesterday morning in the British international school we had one of the most expected event of the year â€Å"lectura del bando†one of the happiest celebration of the carnivals. Yesterday morning in the British international school we had one of the most expected event of the year â€Å"lectura del bando†one of the happiest celebration of the carnivals.
Monday, January 6, 2020
Examining the Article Managers’ Business School Education...
Recently, the public take notice of corporate lawbreaking because of scandals on Wall Street in past years (Jaboub, 1995) and headline of prosecution to global organizations on the media, for instance, Exxon, Nippon, IBM and Samsung (Corporate Crime Reporter). These corporate criminal activities not only raised remarkable economic losses for stockholders (William et al., 2000) but also eliminated benefits of the public (Jaboub, 1995). Therefore, the researches of corporate crime are argued for many decades in different fields, such as criminology and sociology (McKendall and Wagner, 1997). What this essay attempts to illustrate is to briefly summarize the article stated by William et al. (2000) and examine the main argument within the†¦show more content†¦Similar correlation in military experience is that the more managerial staff with prior military service among TMT, the more corporate criminal act are committed in large firms. On the other hand, there is negative corr elation between return on assets (ROA) and citations. The result also commended a surprising finding that TMT tenure has a significant influence certainly on corporate misbehavior while some researchers suggest that managers with short tenure would commonly more involve in corporate wrongdoing. Further study focused on TMT tenure is carried out in research of William et al. (2005). Within this essay, the statistics design and main arguments of this article would be evaluated. To begin with, the sample quantity of firm is 184 (TMT data is reachable) Fortune 500 companies which is fewer compared with prior researches which were related to firm size (Lane, 1953: 275 firms; Cochran and Nigh, 1987: 485 firms; Dalton and Kesner, 1988: 384 firms). Only 202 (In fact, 184) of 500 companies which remain in Fortune 500 during period of year 1991 to 1994 as shown in this study probably promoted the increasing competitive environment at that time. In such a challengeable situation, corporation performance which is taken away from this study as a factor may by and large affectShow MoreRelatedSocial Media6807 Words  | 28 PagesAvailability, Confidentiality and Integrity Musa Ramadhani Davenport University IAAS 667 - Legal and Ethical Security Topics Deanne Cranford-Wesley Table of Contents Abstract3 Introduction4 Problem Statement7 Literature Review8 Findings11 Military Families12 Identifying your social media users16 Common myths about Social Media17 Data leakage and non-disclosure17 Social Media Squatting18 A new generation of hackers18 The high cost of inaction19 Harm to brand reputation19 Lost productivity19 Read MoreContemporary Issues in Management Accounting211377 Words  | 846 PagesManagement Accounting Edited by ALNOOR BHIMANI 1 Great Clarendon Street, Oxford ox2 6dp Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide in Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi New Delhi Shanghai Taipei Toronto With oYces in Argentina Austria Brazil Chile Czech Republic France GreeceRead MoreArticle: Performance Appraisal and Performance Management35812 Words  | 144 PagesIOSR Journal of Business and Management (IOSRJBM) ISSN: 2278-487X Volume 3, Issue 5 (Sep,-Oct. 2012), PP 01-06 www.iosrjournals.org From Performance Appraisal to Performance Management 1 Ms. Leena Toppo, 2Dr. (Mrs.) Twinkle Prusty 1,2 (Faculty of Commerce, Banaras Hindu University, INDIA) ABSTRACT: Performance appraisal and performance management were one of the emerging issues since last decade. Many organizations have shifted from employee’s performance appraisal system to employee’sRead MoreHbr When Your Core Business Is Dying74686 Words  | 299 PagesTOP-TEAM POLITICS†¦page 90 WHEN YOUR CORE BUSINESS IS DYING†¦page 66 Y GE SE PA IN DS CK R M WA A 53 www.hbr.org April 2007 58 What Your Leader Expects of You Larry Bossidy 66 Finding Your Next Core Business Chris Zook 78 Promise-Based Management: The Essence of Execution Donald N. Sull and Charles Spinosa 90 The Leadership Team: Complementary Strengths or Conï ¬â€šicting Agendas? Stephen A. Miles and Michael D. Watkins 100 Avoiding Integrity Land Mines BenRead MoreSales and Marketing for Financial Institutions80443 Words  | 322 Pages6 TOPIC 7 TOPIC 8 TOPIC 9 INTRODUCTION DISCLAIMER These materials are issued by Kaplan Higher Education on the understanding that: 1. Kaplan Higher Education and individual contributors are not responsible for the results of any action taken on the basis of information in these materials, nor for any errors or omissions; and 2. Kaplan Higher Education and individual contributors expressly disclaim all and any liability to any person in respect of anything and of the consequencesRead MoreSources of Ethics20199 Words  | 81 PagesETHICS: 6 1- Religion: 6 2- Genetic Inheritance: 8 3- Philosophical Systems: 8 4- Cultural Experience: 8 5- The Legal System: 9 6- Codes of Conduct: 9 2.0- EXPLANATION OF THE SOURCES OF ETHICS: 10 2.1- RELIGION: 10 Teaching business ethics 12 2.11- Impact Of Religiosity: 13 2.12- Ethics Of Islam: 14 Nature of Islamic Ethics 17 The Human-Environment Relationship: 20 The Sustainable Care of Nature: 22 The Practice of Islamic Environmental Ethics: 22 2.14-Read MoreManagement Course: Mba−10 General Management215330 Words  | 862 PagesManagement Course: MBA−10 General Management California College for Health Sciences MBA Program McGraw-Hill/Irwin abc McGraw−Hill Primis ISBN: 0−390−58539−4 Text: Effective Behavior in Organizations, Seventh Edition Cohen Harvard Business Review Finance Articles The Power of Management Capital Feigenbaum−Feigenbaum International Management, Sixth Edition Hodgetts−Luthans−Doh Contemporary Management, Fourth Edition Jones−George Driving Shareholder Value Morin−Jarrell Leadership, Fifth EditionRead MoreAbstract: Strategic Contingency Planning23625 Words  | 95 PagesPLANNING By Karen Scott-Martinet Fall 2006 The objective of this study was to develop a strategic contingency planning model to be used to fully incorporate emergency management and business continuity into organization structures. (For the purpose of this study, Emergency Management and Business Continuity were collectively referred to as â€Å"contingency planning.†) Presently, contingency planning is mainly done on an operational or tactical level. Current thinking suggests that contingencyRead MoreAccounting Information System Chapter 1137115 Words  | 549 PagesYou came up with a great idea for a new mobile phone application that you think will make lots of money. Your business plan won second place in a local competition, and you are using the $10,000 prize to support yourselves as you start your company. a. Identify the key decisions you need to make to be successful entrepreneurs, the information you need to make them, and the business processes you will need to engage in. b. Your company will need to exchange information with various externalRead MoreLibrary Management204752 Words  | 820 Pagesto Distributed Information Access Solutions Thomas R. Kochtanek and Joseph R. Matthews The Complete Guide to Acquisitions Management Frances C. Wilkinson and Linda K. Lewis Organization of Information, Second Edition Arlene G. Taylor The School Library Media Manager, Third Edition Blanche Woolls Basic Research Methods for Librarians Ronald R. Powell and Lynn Silipigni Connoway Library of Congress Subject Headings: Principles and Application, Fourth Edition Lois Mai Chan Developing Library and Information
Subscribe to:
Posts (Atom)