Product Classification

• Device: disinfectant, subsystem, water purification
• Regulation Description: Water purification system for hemodialysis.
• Definition: Disinfectant intended for reprocessing water purification systems for hemodialysis.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General Hospital
• Product Code: NIH
• Submission Type: 510(k)
• Regulation Number: 876.5665
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI
• ISO 13959 Second edition 2009-04-15 Water for haemodialysis and related therapies
• ISO 23500 First edition 2011-05-15 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
• ISO 11663 First edition 2009-04-15 Quality of dialysis fluid for haemodialysis and related therapies
• AAMI/ANSI/ISO 13959:2009 Water for hemodialysis and related therapies
• AAMI/ANSI/ISO 23500:2011 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
• AAMI/ANSI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies

Guidance Documents

• Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
• Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems

Third Party Review

Not Third Party Eligible