Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

041

Date of Entry 04/04/2016

FR Recognition Number

3-125

Standard

ISO 5841-3 Third edition 2013-04-15
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers

Scope/Abstract

ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods.

ISO 5841-3:2013 is applicable only to the form and fit of the connector assembly.

ISO 5841-3:2013 supplements ISO 14708‑2 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§870.3680	Permanent Pacemaker Electrode	Class 3	DTB
§870.3680	Electrode, Pacemaker, Temporary	Class 2	LDF
§870.3680	Electrode, Pacing And Cardioversion, Temporary, Epicardial	Class 2	NHW
N/A	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Class 3	NVN
N/A	Permanent Defibrillator Electrodes	Class 3	NVY

Relevant FDA Guidance and/or Supportive Publications*

Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions, Issued November 2000.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Robert T. Kazmierski

FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/

301-796-5447

Robert.Kazmierski@fda.hhs.gov

Andrew Smith

CDRH/OPEQ/OHTII/DHTIIA/

Andrew.Smith@fda.hhs.gov

Luke Ralston

FDA/CDRH/OPEQ/OHTII/

301-796-6362

Luke.Ralston@fda.hhs.gov