Product Classification

• Device: pump, infusion, insulin, to be used with invasive glucose sensor
• Definition: The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
• Physical State: Must include product code MDS, sensor, invasive test system, or product code PQF, sensor, glucose, invasive, non-adjunctive.
• Technical Method: The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor
• Target Area: see indications for use
• Review Panel: Clinical Chemistry
• Product Code: OYC
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: PMA
• Device Class: 3
• 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

• 7-307 CLSI POCT05 2nd Edition
  Performance Metrics for Continuous Interstitial Glucose Monitoring
• 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

Third Party Review

Not Third Party Eligible