Product Classification

• Device: pump, infusion, insulin bolus
• Regulation Description: Infusion pump.
• Definition: The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
• Physical State: The device is worn directly on the body. It is constructed of a variety of polymeric materials. Stainless steel is used in springs.
• Technical Method: The device contains the insulin in a reservoir attached to a pumping mechanism. The pump delivers a discrete bolus volume to the patient on demand. There are no means of providing continuous infusion.
• Target Area: Subcutaneous tissue. The device is generally targeted for use on the abdomen, buttocks, or other location acceptable for insulin delivery and device placement.
• Regulation Medical Specialty: General Hospital
• Review Panel: Clinical Chemistry
• Product Code: OPP
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 880.5725
• 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

• 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
• 6-422 AAMI TIR38:2019
  Medical device safety assurance case guidance
• 6-482 AAMI TIR101:2021
  Fluid delivery performance testing for infusion pumps
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods
• 13-81 IEEE Std 11073-10419:2015
  Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
• 13-145 IEEE Std 11073-10419:2023
  Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump

Guidance Document

• Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible