BERKELEY  DAVIS  IRVINE  LOS ANGELES  RIVERSIDE  SAN DIEGO  SAN FRANCISCO
SANTA BARBARA  SANTA CRUZ
UNIVERSITY OF CALIFORNIA, DAVIS
SCHOOL OF MEDICINE
OFFICE OF THE DEAN
Clinical and Translational Science Center (CTSC)
Telephone: (916) 703-9120
FAX: (916) 703-9124
UC DAVIS MEDICAL CENTER
2921 Stockton Boulevard, Suite 1400
Sacramento, CA 95817
May 15, 2010
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Division of Ophthalmic, Neurological and ENT Devices
Document Mail Center WO66-G609
10903 New Hampshire Avenue
Silver Springs Maryland 20993-0002
RE: Original Investigational Device Exemption Application
Serial 0000
Please find enclosed three copies of this initial IDE application for the clinical feasibility
study entitled “Safety and Efficacy of the Device X for improvement of swallowing in
patients with life-threatening aspiration secondary to feeding tube-dependent
oropharyngeal dysphagia”, sponsored by the University of California, Davis. No
additional copies were requested by the Ear, Nose and Throat devices Branch.
Device Information:
Device name: Device X
Intended Use: Device X will be indicated for improvement of swallowing in patients
with life-threatening aspiration secondary to feeding tube dependent oropharyngeal
dysphagia.
Device X structure and function [describe briefly].
Sponsor Contact Information:
The initial study protocol for use under this IDE is sponsored by the University of
California, Davis.
The Sponsor/Principle Investigator:
Peter Belafsky, MD, M.D., M.P.H., Ph.D.
Associate Professor, Director
Center for Voice and Swallowing
Department of Otolaryngology/Head and Neck Surgery
University of California, Davis
2521 Stockton Blvd., Suite 7200
Sacramento, CA 95817
Phone: 916-734-7470
Fax: 916-703-5011
E-mail: peter.belafsky@ucdmc.ucdavis.edu
Regulatory contact:
Kate Marusina, Ph.D., MBA
Clinical and translational Sciences Center
UC Davis School of Medicine
2921 Stockton Blvd
Sacramento, CA 95817
Phone: 916-703-9177
Fax: 916-703-9124
Email: kate.marusina@ucdmc.ucdavis.edu
Contract Manufacturer Information:
John Doe
Kluge Design, Inc.
14150 Northdale Blvd.
Rogers, MN 5374
Phone: 763-428-5140
Fax: 763-428-5146
E-mail: johndoe@klugedesign.net
Applicant Information:
Peter Belafsky, MD, M.D., M.P.H., Ph.D.
Associate Professor, Director
Center for Voice and Swallowing
Department of Otolaryngology/Head and Neck Surgery
University of California, Davis
2521 Stockton Blvd., Suite 7200
Sacramento, CA 95817
Phone: 916-734-7470
Fax: 916-703-5011
E-mail: peter.belafsky@ucdmc.ucdavis.edu
Prior Meetings:
There were no prior pre-IDE meetings with the reviewing division. We reaffirm that this
study will not proceed until this IDE is effective and IRB approval is received from the
University of California, Davis. The information in this IDE is confidential to University
of California, Davis.
If there are any questions regarding this submission, please contact myself or Dr.
Belafsky at 916-734-7470 or at peter.belafsky@ucdmc.ucdavis.edu. Dr. Belafsky could
act on my behalf on any issues regarding this IDE.
Sincerely
Kate Marusina, Ph.D., MBA
Clinical and translational Sciences Center
UC Davis School of Medicine
2921 Stockton Blvd
Sacramento CA 95817
Phone: 916-703-9177
E-mail: kate.marusina@ucdmc.ucdavis.edu