Medical Devices

Public Workshop - Robotically-Assisted Surgical Devices: Challenges and Opportunities, July 27-28, 2015

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: "Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities."

The purpose of this workshop was to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS technologies. The participants of this workshop discussed current challenges and opportunities related to RAS devices and address clinical, technical and training questions related to the safe and effective use of these devices.


Date, Time and Location

This meeting was held July 27-28, 2015, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Agenda

July 27, 2015 - Day 1

TimeEventSpeaker/Panelist
7:30 AM – 8:00 AMRegistration
8:00 AM – 8:10 AMWelcomeBinita Ashar, M.D., M.B.A.
Center for Devices and Radiological Health (CDRH), FDA
8:10 AM – 8:30 AMU.S. Food and Drug Administration (FDA) VisionWilliam H. Maisel, M.D., M.P.H.
CDRH, FDA

CHALLENGES AND OPPORTUNITIES I
What are the key fundamental technological and performance characteristics for a new RASD platform? What are the key fundamental technological and performance characteristics for iterative changes to marketed RASD platforms?

CHALLENGES AND OPPORTUNITIES II
How should interoperability among RASD platforms and and other medical devices intended for use with those platforms (including those from different manufacturers) be assessed?  What sort of evidence, if any, should be provided? Should interoperability be promoted?
Moderators: Binita Ashar, M.D., M.B.A. & Dwight Yen, M.S.

8:30 AM – 8:45 AMRASD: An FDA PerspectiveJoshua Nipper, M.E.
CDRH, FDA
8:45AM  – 9:05 AMEssential Performance Characteristics of RASDRussell Taylor, Ph.D.
Johns Hopkins University
9:05 AM – 9:15 AMInteroperabilityPeter Kazanzides, Ph.D.
Johns Hopkins University
9:15 AM – 9:40 AMPanel Discussion:
Bench Testing
Pre-clinical Testing
Peter Kazanzides, Ph.D.
Johns Hopkins University
Jacob Rosen, Ph.D.
University of California, Los Angeles
Russell Taylor, Ph.D.
Johns Hopkins University
Joshua Nipper, M.E.
CDRH, FDA
Howie Choset, Ph.D.
Carnegie Mellon University
9:40 AM – 9:55 AMAudience Q&A
9:55 AM – 10:15 AMPanel Discussion:
New Innovation & Interoperability
10:15 AM – 10:30 AMAudience Q&A
10:30 AM – 10:45 AMBreak
CHALLENGES AND OPPORTUNITIES III
What are the considerations when distinguishing between “general” use indications and “specific” indications for RASD?
Moderators: Binita Ashar, M.D., M.B.A. & Steven Nagel, M.D.
10:45 AM – 11:00 AMBackground and Clinical Utility of RASD Marketed with General ClaimsMyriam Curet, M.D.
Intuitive Surgical Inc.
11:00 AM – 11:15 AMLevel of Evidence Used to Justify General IndicationsDaniel Herron, M.D.
Mount Sinai Hospital
11:15 AM – 12:00 PMPanel Discussion:
Define General Surgery
Types of Procedures
Scope and Limitations
Other General Indications
Myriam Curet, M.D.
Intuitive Surgical Inc.
David Earle, M.D.
Tufts University Medical School
Warren Grundfest, M.D.
University of California, Los Angeles
Daniel Herron, M.D.
Mount Sinai Hospital
Steven Schwaitzberg, M.D.
University of Buffalo School of Medicine
12:00 PM – 12:15 PMAudience Q&A
12:15 PM – 1:00 PMLunch
CHALLENGES AND OPPORTUNITIES  IV
Under what circumstance are additional data needed to support indications for specific surgical procedures, when a RASD is already cleared for general use? 
Moderators: Binita Ashar, M.D., M.B.A. & Steven Nagel, M.D.
1:00 PM – 1:15 PMGeneral SurgerySteven Schwaitzberg, M.D.
University of Buffalo School of Medicine
1:15 PM – 1:30 PMUrologyVipul Patel, M.D.
Florida Hospital Global Robotics Institute
1:30 PM –  1:45 PMGynecologyArnold Advincula, M.D.
Columbia University Medical Center
1:45 PM – 2:00 PMColorectalVincent Obias, M.D.
George Washington University
2:00 PM – 3:00 PMPanel Discussion
Evaluation of Specific Procedures
Benefit / Risk Assessments
Safety and Effectiveness Endpoints
Arnold Advincula, M.D.
Columbia University Medical Center
Vincent Obias, M.D.
George Washington University
Vipul Patel, M.D.
Florida Hospital Global Robotics Institute
Steven Schwaitzberg, M.D.
University of Buffalo School of Medicine
3:00 PM – 3:15 PMAudience Q&A
3:15 PM – 3:30 PMBreak
CHALLENGES AND OPPORTUNITIES  IV
Under what circumstance are additional data needed to support indications for specific surgical procedures, when a RASD is already cleared for general use?
Moderators: Binita Ashar, M.D., M.B.A. & Steven Nagel, M.D.
3:30 PM – 3:45 PMEar, Nose & Throat (ENT)Gregory Weinstein, M.D.
University of Pennsylvania
3:45 PM – 4:00 PMCardiothoracicRandolph Chitwood, M.D.
East Carolina University Brody School of Medicine
4:00 PM – 4:15 PMNewly Enabled SurgeriesDana Portenier, M.D.
Duke Univesity Medical Center
4:15 PM – 5:05 PMPanel Discussion
Evaluation of Specific Procedures
Benefit / Risk Assessments
Safety and Effectiveness Endpoints
Randolph Chitwood, M.D.
East Carolina University Brody School of Medicine
Myriam Curet, M.D.
Intuitive Surgical Inc.
Dana Portenier, M.D.
Duke Univesity Medical Center
Gregory Weinstein, M.D.
University of Pennsylvania
5:05 PM – 5:20 PMAudience Q&A
5:20 PM – 5:30 PMAdjournJoshua Nipper, M.E.
CDRH, FDA

 

July 28, 2015 - Day 2

TimeEventSpeaker/Panelist
7:30 AM – 8:00 AMRegistration
8:00 AM – 8:05 AMWelcome – Recap of Day 1Binita Ashar, M.D., M.B.A.
CDRH, FDA
CHALLENGES AND OPPORTUNITIES V        
What is the role of training and simulation during premarket evaluation in ensuring device usability and mitigating risk?  How should they be assessed?
Moderators: Binita Ashar, M.D., M.B.A. & Steven Nagel, M.D.
8:05 AM – 8:20 AMTraining and Credentialing in New TechnologiesAjit Sachdeva, M.D.
American College of Surgeons
8:20 AM – 8:35 AMImplementation of a RASD Training ProgramRichard Satava, M.D.
University of Washington Medical Center
8:35 AM – 8:50 AMValidation of Surgical Simulators for RASDRoger Smith, Ph.D.
Florida Hospital Nicholson Center
8:50 AM – 9:05 AMRobotic Training NetworkIsabel Green, M.D.
Johns Hopkins School of Medicine
9:05 AM – 10:15 AMPanel Discussion:
Manufacturer Responsibilities
Role of Professional Societies
Credentialing
Role of Simulators
Isabel Green, M.D.
Johns Hopkins School of Medicine
Dennis Fowler, M.D.
Titan Medical Inc.
Dmitry Oleynikov, M.D.
University of Nebraska Medical Center
Adrian Park, M.D.
Anne Arundel Medical Center
Vipul Patel, M.D.
Florida Hospital Global Robotics Institute
Ajit Sachdeva, M.D.
American College of Surgeons
Richard Satava, M.D.
University of Washington Medical Center
Roger Smith, Ph.D.
Florida Hospital Nicholson Center
10:15 AM – 10:30AMAudience Q&A
10:30 AM – 10:45 AMBreak
CHALLENGES AND OPPORTUNITIES VI
How can collaboration among all stakeholders be promoted to improve and create data sources that can be efficiently leveraged for multiple purposes?
Moderators: Binita Ashar, M.D., M.B.A. & Steven Nagel, M.D.
10:45 AM – 11:00 AMMedical Device Epidemiology Network Initiative (MDEpiNet)Benjamin C Eloff, PhD
Senior Scientific Program Manager
Division of Epidemiology
11:00 AM –  11:15 AMIdea, Development, Exploration, Assessment, Long-term follow up (IDEAL) FrameworkArt Sedrakyan, M.D.
Weill Cornell Medical College
11:15 AM – 12:10 PMPanel Discussion:
Use of Published Literature and other Data Sources
Myriam Curet, M.D.
Intuitive Surgical Inc.
David Earle, M.D.
Tufts University Medical School
Dmitry Oleynikov, M.D.
University of Nebraska Medical Center
Ajit Sachdeva, M.D.
American College of Surgeons
Art Sedrakyan, M.D.
Weill Cornell Medical College
12:10 PM – 12:25 PMAudience Q&A
12:25 PM – 12:45 PMPublic Comment
12:45 PM – 1:00 PMClosing: Workshop SummaryBinita Ashar, M.D., M.B.A.
CDRH, FDA

Webcast

July 27

July 28

Transcript

Contact Us

For questions regarding workshop content please contact

  • Mark Trumbore, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, Phone: 301-796-5436, Mark.Trumbore@fda.hhs.gov.
  • Germarie Sanchez-Pomales, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, Phone: 301-796-4573, Email: Germarie.Sanchez-Pomales@fda.hhs.gov

 

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