| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
052
|
Date of Entry 07/15/2019
|
|
FR Recognition Number
|
5-123
|
| Standard | |
ISO 80369-3 First Edition 2016-07-01
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]. |
|
Scope/AbstractISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.
NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.
It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
It does not specify requirements for small-bore connectors that are used for the following:
- gastric suction-only medical devices;
- oral-only medical devices;
EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.
- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;
- gastrointestinal endoscopy equipment;
- skin level gastrostomy medical devices.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. |
|
| 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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5980 |
Tube, Nasogastric
|
Class 2
|
BSS
|
| §876.5980 |
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
|
Class 2
|
FEF
|
| §876.5980 |
String And Tubes, Gastrointestinal, To Locate Internal Bleeding
|
Class 2
|
FFW
|
| §876.5980 |
Set, Gavage, Infant, Sterile
|
Class 2
|
FHT
|
| §876.5980 |
Tube, Feeding
|
Class 2
|
FPD
|
| §876.5980 |
Tube, Gastro-Enterostomy
|
Class 2
|
KGC
|
| §876.5980 |
Tubes, Gastrointestinal (And Accessories)
|
Class 2
|
KNT
|
| §876.5980 |
Gastrointestinal Tubes With Enteral Specific Connectors
|
Class 2
|
PIF
|
| §876.5980 |
Enteral Specific Transition Connectors
|
Class 2
|
PIO
|
| §876.5980 |
Enteral Syringes With Enteral Specific Connectors
|
Class 2
|
PNR
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, Issued on February 11, 2015
(Website) Medical Device Connectors: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-connectors
Reducing Risks through Standards Development for Medical Device Connectors:
https://www.fda.gov/medical-devices/medical-device-connectors/reducing-risks-through-standards-development-medical-device-connectors
ENFit low dose tip (LDT) syringes labeling change request letter. October, 2021.
https://www.fda.gov/media/152862/download
Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets. February, 2022.
https://www.fda.gov/medical-devices/safety-communications/potential-risk-strangulation-children-who-use-enteral-feeding-delivery-sets
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 Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
