GU Advisory Panel Meeting

1
GU Advisory Panel Meeting

• Nocturnal Home Hemodialysis
• Draft
• Carolyn Y. Neuland, Ph.D.
• Chief, Gastroenterology and Renal Devices Branch
• Division of Reproductive, Abdominal and
  Radiological Devices
• Office of Device Evaluation
• Center for Devices and Radiological Health
• June 8, 2005

2
Overview

• Introduction
• Panel Update
• Regulation of Hemodialysis Devices
• Guidance Documents for Hemodialysis
• Definition of Nocturnal Home Hemodialysis
• Meeting Objectives

3
Linda Carr Consumer Safety
Technician Jeffrey Cooper, D.V.M.
Veterinarian / Panel Exec. Sec. Linda Dart, M.S.
Biochemist Gema Gonzalez , M.S.
Biomedical Engineer Irada Isayeva,
Ph.D. Polymer Chemist Kristina Lauritsen,
Ph.D. Tumor Biologist Barbara McCool, M.S.R.N.
Nurse Consultant Joshua Nipper , M.E.
Biomedical Engineer Kathleen Olvey
Biologist Claudia Ruiz-Zacharek, M.D.
Nephrologist Rebecca Stephenson Chemical
Engineer Kellie Straughn Clerk Typist Richard
Williams Mechanical Engineer
4
Panel Update
5
P020006 - Enteryx Procedure KitBoston Scientific
Corporation

• Description/Indication solution injected into
  the LES for the
• treatment of GERD
  in patients who are not
• responsive to
  pharmacologic therapy
• Panel Meeting Date January 17, 2003
• GU Panel Recommendation Approval with
  Conditions
• Modified physician labeling
• Modified patient labeling
• Post market study with 36 months follow-up from
  the last injection
• Current Status PMA approved April 22, 2003
• Post-approval Study
• 3 year post-implantation follow-up

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Nocturnal Home Hemodialysis
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Regulation of Hemodialysis Devices

• Class II Medical Devices
• Risk Based classification
• Class II - Moderate level of risk
• Requirement for General controls and Special
  controls to ensure safety and effectiveness
• 510(k) - Premarket Notification
• There are currently no devices cleared by FDA for
  Nocturnal Home Hemodialysis

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Premarket Notification 510(k)

• Establishes substantial equivalence (SE) to a
  legally marketed predicate device
• Same intended use and technological
  characteristics, or
• Same intended use and different technological
  characteristics, but the submission shows that
• No new types of questions of safety or
  effectiveness are raised
• As safe and as effective as predicate device

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Premarket Notification 510(k)

• Performance testing (bench) is usually
  recommended and may be sufficient to demonstrate
  safety and effectiveness.
• Clinical data may be requested depending on
  differences from the predicate device.
• 5-10 of 510(k)s contain / require clinical
  data.
• If found SE Substantially equivalent (i.e., as
  safe and as effective) to the predicate, the
  device is cleared, not approved.
• If not SE to another device, it is
  automatically placed into the Class III, PMA
  category.

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Safety

• There is reasonable assurance that a device is
  safe when it can be determined, based on valid
  scientific evidence, that the probable benefits
  to health from use of the device for its intended
  uses and conditions of use, when accompanied by
  adequate directions and warnings against unsafe
  use, outweigh the probable risks.
• - 21 CFR 860.7

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Effectiveness

• There is reasonable assurance that a device is
  effective when it can be determined, based upon
  valid scientific evidence, that in a significant
  portion of the target population, the use of the
  device for its intended uses and conditions of
  use, when accompanied by adequate directions for
  use and warnings against unsafe use, will provide
  clinically significant results.
• 
  - 21 CFR 860.7

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Dialysis Devices

• Most are Regulated as Class II devices
• Primary Classification Regulations used
• 876.5820 Hemodialysis systems and accessories
• Conventional Dialyzers
• Reuse of Conventional Dialyzers
• Dialysis delivery systems and tubing sets
• Hemodialysates
• 876.5860 High Permeability Hemodialysis
  systems
• High Flux Dialyzers
• Reuse of High flux Dialyzers
• Dialysis systems with Ultrafiltration controller

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Dialysis Devices (contd)

• 876. 5600 - Sorbent regenerated dialysate
  delivery system for
  hemodialysis
• 876. 5665 - Water purification system for
• hemodialysis
• 876. 5540 - Blood access device and accessories
• Class III for implanted catheters
• 876.5630 - Peritoneal dialysis system and
  accessories

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Guidance Documents for Hemodialysis Devices

• Guidance for the Content of Premarket
  Notifications for Conventional and High
  Permeability Hemodialyzers 1998
• Guidance for the Content of Premarket
  Notifications for Hemodialysis Delivery Systems
  1998
• Guidance for Hemodialyzer Reuse Labeling 1995
• Guidance for the Content of Premarket
  Notifications for Water Purification Components
  and Systems for Hemodialysis 1997
• Guidance documents are documents prepared
  for FDA staff, applicants/sponsors, and the
  public that describe the agencys interpretation
  of or policy on a regulatory issue 21 CFR
  10.115

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Definition of Nocturnal Home Hemodialysis

• Nocturnal Home Hemodialysis is a type of
  hemodialysis performed in the home, while the
  patient is asleep (typically at night), over a
  6-10 hour period, using slow blood and dialysate
  flow rates, and a treatment frequency of 5 to 7
  days per week.

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Nocturnal Home HemodialysisObjectives of Meeting

• Panel discussion and recommendations on the
  clinical and scientific issues associated with
  hemodialysis equipment to be labeled for
  Nocturnal Home Hemodialysis
• To obtain scientific feedback which can be used
  to help in device evaluation decisions and may
  lead to the future development of a Guidance
  document for NHD

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Nocturnal Home Hemodialysis

• Overview of Conventional
• Hemodialysis System
• Joshua Nipper Biomedical Engineer
• Gastroenterology and Renal Devices Branch