| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
060
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Date of Entry 05/29/2023
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|
FR Recognition Number
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6-495
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| Standard | |
ISO 20698 First Edition 2018-07
Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
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Scope/AbstractISO 20698 specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications.
This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements.
Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to deliver wound infiltration analgesia and to other regional analgesia procedures or to monitor or remove fluids from neuraxial sites for therapeutic or diagnostic purposes.
... |
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| Extent of Recognition
|
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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5120 |
Catheter, Percutaneous, Intraspinal, Short Term
|
Class 2
|
MAJ
|
| §880.5440 |
Administrations Sets With Neuraxial Connectors
|
Class 2
|
PWH
|
| §880.5440 |
Neuraxial Administration Set - Intrathecal Delivery
|
Class 2
|
PYR
|
| §880.5860 |
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
|
Class 2
|
QEH
|
| N/A |
Pump, Infusion, Implanted, Programmable
|
Class 3
|
LKK
|
| N/A |
Catheter, Percutaneous, Long Term, Intraspinal
|
Class 3
|
LNY
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
