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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 045 Date of Recognition 09/21/2016 
FR Recognition Number 5-109
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.
Scope/Abstract
ISO 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;

- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;

- 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
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.
Transition Period
FDA recognition of ISO 80369-3 First Edition 2016-07-01 [Rec# 5-109] will be superseded by recognition of ISO 80369-3 First Edition 2016-07-01 [Including AMENDMENT 1 (2019)]. [Rec# 5-123]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 5-109] until July 26, 2020. After this transition period, declarations of conformity to [Rec # 5-109] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§876.5980 Enteral Specific Transition Connectors Class 2 PIO
§876.5980 Enteral Syringes With Enteral Specific Connectors Class 2 PNR
§876.5980 Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§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 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
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) Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors
http://www.fda.gov/medicaldevices/safety/alertsandnotices/tubingandluermisconnections/ucm313322.htm
FDA Technical Contact
 Joshua Silverstein
  FDA/OMPT/CDRH/ODE/
  301-796-5155
  joshua.silverstein@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
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