Changes
|08/01/2008 08:00:55 PST
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==Ureteral stents regulatory issues==
The FDA classifies a ureteric stent as follows:
* TITLE 21 - FOOD AND DRUGS
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
* SUBCHAPTER H - MEDICAL DEVICES
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
* Subpart E - Surgical Devices
* Sec. 876.4620 - Ureteral stent.
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]
===Pre-Market Notification===
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers.
A 510(k) is required when:
* Introducing a device into commercial distribution (marketing) for the first time.
* Proposed different intended use for a device already in commercial distribution.
* Change or modification of a legally marketed device.
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)
{| border="2" cellspacing="0" cellpadding="4" width="100%"
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center>
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center>
| style="background-color:#ccffff;padding:0.079cm;"| Silicone
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center>
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center>
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center>
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center>
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center>
| style="padding:0.079cm;"| <center>Mar 2003</center>
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating
| style="padding:0.079cm;"| Bladder loop design
| style="padding:0.079cm;"| <center>365</center>
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center>
| style="background-color:#ccffff;padding:0.079cm;"| Metal
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center>
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]
|-
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center>
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center>
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center>
| style="padding:0.079cm;"| <center>Aug 2002</center>
| style="padding:0.079cm;" rowspan="2"| Polyurethane
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent
| style="padding:0.079cm;" rowspan="2"| <center>13</center>
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]
|-
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center>
| style="padding:0.079cm;"| <center>Sep 2005</center>
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center>
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center>
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]
|}
===Timeline Sheet===
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]
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