Request. product overview. Value Analysis Brief. Clinical Information. Cross- Reference. 510(k) Cool Zone. Suction Coagulator.

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1 Request Letter product overview Value Analysis Brief Clinical Information Cross- Reference 510(k) Cool Zone Valleylab TM Suction Coagulator

2 I am requesting the new Valleylab TM suction coagulator be stocked in our facility so that I have consistent access to this device for my cases. The new Valleylab TM suction coagulator offers several advantages over existing suction coagulators. Cooler Additional shaft insulation, compared to the existing Valleylab TM suction coagulator, which lowers the shaft temperature and may reduce the potential for oral burns Safety Features Shaft temperature lower than other competitive devices evaluated 1 The new Valleylab TM suction coagulator is currently the only product on the market with additional thermal reduction features Versatile Hand switch and foot switch activated Available in 10 Fr and 12 Fr for varied patient anatomy Clinical studies have shown: Inadvertent thermal injuries during otolaryngology procedures can result from inadequate device insulation 2 Oral burns have physical and emotional costs to patients 3 I am confident using this technology and believe it may help reduce the potential for oral burns during otolaryngology procedures. Thank you for reviewing this information. Please feel free to contact me if you have any questions. Sincerely, Additional Comments: 1. Internal testing of Valleylab TM suction coagulator, Megadyne and ConMed devices. Data on file at Covidien, Boulder, Colo. 2. Richter GT, Willging JP. Int J Pediatr Otorhinolaryngol. 2008:72(7); Nuara MJ, Park AH, Alder SC, Smith ME, Kelly S. Muntz H. Arch Otolaryngol Head Neck Surg. 2008;134(1):10-15.

3 Product Overview Valleylab TM Suction Coagulator Overview The new Valleylab TM suction coagulator provides fluid suction for ENT procedures. It features additional shaft insulation, compared to our existing Valleylab TM suction coagulator, which lowers the shaft temperature and may reduce the potential for oral burns. Currently, this is the only suction coagulator available with additional thermal reduction features. The device can be hand switch and foot switch activated, and is available in 10 Fr and 12 Fr for a variety of patient anatomies. Specialties Tonsillectomy Adenoidectomy Order Information Ordering code: E3310 (10 Fr), E3305 (12 Fr) Order quantity: 25 units/case Cool Zone Specifications Sterile, single use Shaft length: 15 cm Shaft diameter: 10 Fr (E3310), 12 Fr (E3305) Cord length: 3 m Handswitch and footswitch activated

4 Clinical Information Inadvertent thermal injuries during routine otolaryngology procedures can result from inadequate device insulation. 1 The new Valleylab TM suction coagulator may reduce the potential for oral burns. The cool zone lowers the shaft temperature as compared to existing Valleylab TM suction coagulators and may reduce the potential for oral burns. The shaft temperature of the new Valleylab TM suction coagulator is lower than that of competitive devices evaluated (see chart below) 2. Average Device Temperature at 5 cm from Tip Temperature (Celsius) Time (s) = Megadyne 10fr footswitching = Megadyne 10fr handswitching = ConMed 10fr footswitching = ConMed 12fr handswitching = Valleylab suction coagulator (E3305) = Weck 11 fr footswitching References 1. Richter GT, Willging JP. Int J Pediatr Otorhinolaryngol. 2008:72(7); Internal testing of Valleylab suction coagulator, Megadyne and ConMed devices. Data on file at Covidien, Boulder, Colo. Internal testing of Valleylab suction coagulator, Megadyne, ConMed, and Weck devices. Data on file at Covidien, Boulder, Colo.

5 Cross-REference Vendor Catalog # Description Size (French) Covidien Covidien E3305 E3310 New Valleylab TM Hand and Foot Switch Suction Coagulator New Valleylab TM Hand and Foot Switch Suction Coagulator Thermal Reduction Feature 12 Fr Yes 10 Fr Yes The new Valleylab TM Suction Coagulator can potentially replace the following devices: Covidien Covidien E E , E2610-6, E Valleylab TM Hand or Foot Switch Suction Coagulator Valleylab TM Hand Switch Suction Coagulator 10 Fr No 12 Fr No Megadyne TM * Hand Control 8 Fr No Megadyne TM * Foot Control 10 Fr No Megadyne TM * Hand Control 10 Fr No Megadyne TM * Hand Control 12 Fr No ConMed TM * ConMed TM * ConMed TM * ConMed TM * UltraClean * Handswitch 8 Fr No UltraClean * Footswitch 10 Fr No UltraClean * Handswitch 10 Fr No UltraClean * Handswitch 12 Fr No

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8 COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Megadyne TM* is a trademark of MEGADYNE Medical Products, Inc. and UltraClean * and ConMed TM* are trademarks of CONMED Corporation. Weck * is a trademark of Teleflex Medical. Other brands are trademarks of a Covidien company Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]