Product Classification

• Device: ultrafiltration-controlled nocturnal dialysate delivery system
• Regulation Description: High permeability hemodialysis system.
• Definition: Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.
• Physical State: Device is an electronic, software-controlled system with a user interface. Device can include extracorporeal tubing sets, but not necessarily.
• Technical Method: Device consists of a system of pumps, valves, sensors, monitors and other components that direct blood through a dialyzer so that hemodialysis may be performed.
• Target Area: Device is an extracorporeal device treating patients' blood.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: ODN
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.5860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Guidance Document

• Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible