| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
041
|
Date of Entry 04/04/2016
|
|
FR Recognition Number
|
9-113
|
| Standard | |
CEN EN 1618:1997
Catheters other than intravascular catheters - Test methods for common properties |
|
Scope/Abstract| Specifies test methods for corrosion resistance, tensile properties, leakage of fluids and air, water flow rate and security of connectors. |
|
| Extent of Recognition
|
Transition Period
FDA recognition of CEN EN 1615:2000 [Rec# 9-95] and CEN EN 1618:1997 [Rec# 9-113] will be superseded by recognition of ISO 20695 First edition 2020-03 [Rec# 9-138]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-95] and [Rec# 9-113] until July 7, 2024. After this transition period, declarations of conformity to [Rec# 9-95] and [Rec# 9-113] will not be accepted.
|
|
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
|
|
Relevant FDA Guidance and/or Supportive Publications*
Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications; Guidance for Industry and Food and Drug Administration Staff, Issued February 2015.
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)
| ObGyn/Gastroenterology/Urology |
|
| *These are provided as examples and others may be applicable. |
