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

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

4. Panel Update

5. P020006 - Enteryx Procedure Kit Boston Scientific Corporation n Description/Indication – solution injected into the LES for the treatment of GERD in patients who are not treatment of GERD in patients who are not responsive to pharmacologic therapy responsive to pharmacologic therapy n Panel Meeting Date – January 17, 2003 n GU Panel Recommendation – Approval with Conditions –Modified physician labeling –Modified patient labeling –Post market study with 36 months follow-up from the last injection n Current Status – PMA approved April 22, 2003 n Post-approval Study –3 year post-implantation follow-up –Medical Device Reporting (MDR)

6. Nocturnal Home Hemodialysis

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

8. Premarket Notification [510(k)] n 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

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

10. SafetySafety “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

11. EffectivenessEffectiveness “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 - 21 CFR 860.7

12. Dialysis Devices n Most are Regulated as Class II devices n 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

13. Dialysis Devices (cont’d) –§876. 5600 - Sorbent regenerated dialysate delivery system for hemodialysis –§876. 5665 - Water purification system for hemodialysis hemodialysis –§876. 5540 - Blood access device and accessories < Class III for implanted catheters –§876.5630 - Peritoneal dialysis system and accessories

14. Guidance Documents for Hemodialysis Devices n Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers – 1998 n Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems – 1998 n Guidance for Hemodialyzer Reuse Labeling – 1995 n 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 agency’s interpretation of or policy on a regulatory issue” 21 CFR §10.115 “Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue” 21 CFR §10.115

15. Definition of Nocturnal Home Hemodialysis n 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.

16. Nocturnal Home Hemodialysis Objectives of Meeting n Panel discussion and recommendations on the clinical and scientific issues associated with hemodialysis equipment to be labeled for Nocturnal Home Hemodialysis n 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

17. Nocturnal Home Hemodialysis Overview of Conventional Overview of Conventional Hemodialysis System Joshua Nipper – Biomedical Engineer Gastroenterology and Renal Devices Branch