Department of Labor and Industries Office of the Medical Director MEDICAL DEVICE 7273 Linderson Way SW REVIEW REQUEST PO Box 44321 Olympia WA 98504-4321 Information provided will be used in evaluating the medical device. Your Name Company Name Mailing Address Date City State ZIP + 4 FAX Number Telephone Number E-Mail Address Name of Device Manufacturer of Device Please provide answers on a separate sheet. Number answers to correspond to numbered questions. 1. a. Why do you believe this device merits consideron atiand review by the Office of the Medical Director? b. What is the device intended to do? 2. a. What published, peer-reviewed literature documents the efficacy of this device or the science that underlies it? Please enclose articles or a bibliography. b. Specify which, if any, of the enclosed articles look atc thlinie cal effectiveness of the device and its impact on retur wn toork of the injured workers. c. Are there any sources that would provide useful information? Please enclose or provide a bibliography. 3. FDA approval: a. Does the device have FDA approval? b. When was the device approved? c. For what indications has the FDA approved the device? d. What approval process was employed (e.g., 510(k), PMA, IDE)? If approved under the 510(k) process, towhat device is it substantially equivalent? Please include approval letter and other relevant supporting documents to or from the FDA. 4. How is this device (1) different fromand (2) mor e efficacious than devices that currently address the mdice al conditions for which this device has been approved? 5. How is this device (1) different from and (2) moreffeic acious than current medical treatment procedures or diagnostic alternatives for this type of injury? 6. Total cost for the device: a. What is the total cost for thde evice for which the Department of Labor and Industries will be charged? b. What are the on-going costs associated with the device during the patients use? c. How does this cost compare with othermedical treatment proced ures or diagnostic alternatives for this type of injury? 7. How would this device increase the quality of e thcare Washington State workers would receive? 8. How would this device return Washington State workers to work more quickly than existing devices and medical treatment procedures currently do? 9. Which State workers compensation programs reimburse for use of this device? Please provide contact names and phone numbers. 10. Which private insurers reimburse for use of this device? Please provide contact names and phone numbers. 11. Have any relevant medical organizations (e.g., AMA) expressed an opinion on this device? If so, please provide verification documents and contact names and numbers if possible. 12. What safety and efficacy issues does use of this device raise? Date Received: OMD Personnel For Office Use Action Submitter Advised/Date: Comments: F252-013-000 med device review request 4-97