Enteral Specific Transition Connectors

Device Code: 2101

Product Code(s): PIO

Definition: Facilitates Enteral Specific Connections Between AAMI/CN3(PS):2014 Compliant Connectors And Non ISO 80369-1 Compliant Legacy Enteral Connectors.

Device Classification Information

• Device Type ID: 2101
• Device Name: Enteral Specific Transition Connectors
• Physical State: Plastic Connector
• Technical Method: A Plastic Connector That Allows For AAMI/CN3(PS):2014 Compliant Connectors To Connect To Non ISO 80369-1 Compliant Legacy Enteral Connectors.
• Target Area: GI
• Regulation Description: Gastrointestinal Tube And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Gastroenterology Devices Branch (GEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5980 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: PIO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 5-109 ISO 80369-3 First Edition 2016-07-01
  Small-bore Connectors For Liquids And Gases In Healthcare Applications - Part 3: Connectors For Enteral Applications.
• 5-119 ISO 18250-3 First Edition 2018-06
  Medical Devices - Connectors For Reservoir Delivery Systems For Healthcare Applications - Part 3: Enteral Application
• 9-113 CEN EN 1618:1997
  Catheters Other Than Intravascular Catheters - Test Methods For Common Properties

Total Product Life Cycle

• Device Type ID: 2101
• Device: Enteral Specific Transition Connectors
• Product Code: PIO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Gastrointestinal Tube And Accessories.
• CFR Regulation Number: 876.5980 [🔎]

Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
CEDIC S.R.L.
	SUBSTANTIALLY EQUIVALENT	3
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYGON
	SUBSTANTIALLY EQUIVALENT	1
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak / Splash	301
Failure To Infuse	9
Failure To Sense	9
Failure To Deliver	7
Connection Problem	2
Infusion Or Flow Problem	1
Material Disintegration	1
Material Integrity Problem	1
Partial Blockage	1
Protective Measures Problem	1
Disconnection	1
Free Or Unrestricted Flow	1
Adapter (Adaptor)	1
Improper Flow Or Infusion	1
Total Device Problems	337

TPLC Last Update: 2019-04-02 20:06:03