Product Classification

• Device: set, administration, intravascular
• Regulation Description: Intravascular administration set.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FPA
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5440
• 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?: No

Recognized Consensus Standards

• 5-108 ISO 80369-6 First Edition 2016-03-15
  Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
• 6-122 ISO 8536-5 Second edition 2004-02-01
  Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-359 ISO 8536-9 Second Edition 2015-06-15
  Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
• 6-360 ISO 8536-10 Second Edition 2015-06-15
  Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
• 6-361 ISO 8536-11 Second Edition 2015-06-15
  Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
• 6-447 ISO 8536-4 Sixth edition 2019-09
  Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
• 6-481 AAMI ANSI CN27:2021
  General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

Guidance Documents

• Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA

• Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]

• Intravascular Administration Sets Premarket Notification Submissions [510(k)] - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc