• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 13-81
Standard
IEEE Std 11073-10419:2015
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
Scope/Abstract
This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices. In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.5725 Pump, Infusion, Insulin Class 2 LZG
§880.5725 Pump, Infusion, Insulin Bolus Class 2 OPP
Unclassified Automated Insulin Dosing , Threshold Suspend Class 3 OZO
Unclassified Automated Insulin Dosing Device System, Single Hormonal Control Class 3 OZP
Unclassified Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor Class 3 OYC
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems, 11/09/2012

Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps, 03/01/1993

Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff, 12/02/2014
FDA Technical Contacts
 Lening Shen
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-6291
  lening.shen@fda.hhs.gov
 Joshua Balsam
  FDA/OMPT/CDRH/OIR/DCTD/DDDB/
  240-402-6521
  joshua.balsam@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
-
-