Shunt, Central Nervous System And Components

Device Code: 3731

Product Code(s): JXG

Device Classification Information

Device Type ID	3731
Device Name	Shunt, Central Nervous System And Components
Regulation Description	Central Nervous System Fluid Shunt And Components.
Regulation Medical Specialty	Neurology
Review Panel	Neurology
Premarket Review	Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB)
Submission Type	510(k)
CFR Regulation Number	882.5550 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	JXG
GMP Exempt	No
Summary MR	Ineligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

5-108 ISO 80369-6 First Edition 2016-03-15
Small Bore Connectors For Liquids And Gases In Healthcare Applications - Part 6: Connectors For Neuraxial Applications.
17-4 ASTM F647-94 (Reapproved 2014)
Standard Practice For Evaluating And Specifying Implantable Shunt Assemblies For Neurosurgical Application
17-12 ISO 7197 Third Edition 2006-06-01
Neurosurgical Implants - Sterile, Single-use Hydrocephalus Shunts And Components [Including: Technical Corrigendum 1 (2007)]

Total Product Life Cycle

Device Type ID	3731
Device	Shunt, Central Nervous System And Components
Product Code	JXG
FDA Device Classification	Class 2 Medical Device
Regulation Description	Central Nervous System Fluid Shunt And Components.
CFR Regulation Number	882.5550 [🔎]

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	2
AQUEDUCT CRITICAL CARE, INC.
	SUBSTANTIALLY EQUIVALENT	3
ARKIS BIOSCIENCES INC.
	SUBSTANTIALLY EQUIVALENT	1
BTG INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	3
INTEGRA
	SUBSTANTIALLY EQUIVALENT	6
INTEGRA LIFESCIENCES CORP.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
JOHNSON & JOHNSON PROFESSIONALS, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
MOLLER MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SOPHYSA SA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Operates Differently Than Expected	403
Adverse Event Without Identified Device Or Use Problem	369
Occlusion Within Device	360
Appropriate Term/Code Not Available	355
Obstruction Of Flow	307
Break	303
Insufficient Information	290
Programming Issue	253
Leak / Splash	195
Partial Blockage	109
No Flow	108
Device Operational Issue	97
Device Dislodged Or Dislocated	96
Fluid Leak	90
Mechanical Problem	88
Excess Flow Or Over-Infusion	80
Inaccurate Flow Rate	80
Valve, Flow	78
Use Of Device Problem	77
Device Difficult To Program Or Calibrate	68
Pressure Problem	68
Disconnection	65
Mechanics Altered	62
Mechanical Jam	57
Insufficient Flow Or Under Infusion	54
Improper Flow Or Infusion	54
Migration Or Expulsion Of Device	53
Fracture	48
Crack	42
Material Separation	37
Infusion Or Flow Problem	37
Blocked Connection	27
Device Issue	26
Detachment Of Device Or Device Component	15
Complete Blockage	14
Overcorrection	14
Migration	13
Material Fragmentation	13
Overheating Of Device	13
Product Quality Problem	11
Connection Problem	11
Failure To Prime	10
Defective Device	10
Torn Material	10
Hole In Material	10
Restricted Flow Rate	9
Material Integrity Problem	9
Kinked	8
Valve, Pressure Limit	8
Device Contamination With Chemical Or Other Material	7
Separation Problem	7
Device Or Device Fragments Location Unknown	7
Misassembled	7
Material Split, Cut Or Torn	6
Flushing Problem	6
Material Rupture	6
Free Or Unrestricted Flow	6
Detachment Of Device Component	6
Sticking	6
Air Leak	6
Decrease In Pressure	5
Device Contaminated During Manufacture Or Shipping	5
Catheter	5
Material Puncture / Hole	5
Label	5
Device Displays Incorrect Message	5
Defective Component	5
Device Inoperable	4
Improper Or Incorrect Procedure Or Method	4
Material Discolored	4
Improper Device Output	4
Physical Resistance	4
Material Twisted / Bent	4
Device Component Or Accessory	4
Failure To Auto Stop	4
Separation Failure	4
Cut In Material	4
Split	4
Packaging Problem	4
Incorrect, Inadequate Or Imprecise Result Or Readings	3
Display Or Visual Feedback Problem	3
Filling Problem	3
Malposition Of Device	3
Device Damaged Prior To Use	3
Activation, Positioning Or Separation Problem	3
Difficult To Flush	3
Incorrect Measurement	3
Missing Information	3
Display Difficult To Read	2
Valve	2
Corroded	2
Difficult To Remove	2
Retraction Problem	2
Unknown (for Use When The Device Problem Is Not Known)	2
Component Missing	2
Output Above Specifications	2
Material Frayed	2
Difficult To Advance	2
Loose Or Intermittent Connection	2
Positioning Problem	2
Total Device Problems	4818

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Mar-01-2018
2	Aesculap, Inc.	II	Jan-26-2015
3	Aesculap, Inc.	III	Dec-16-2014
4	Aesculap, Inc.	II	Dec-03-2014
5	Aesculap, Inc.	II	Jun-02-2014
6	Aesculap, Inc.	II	Feb-19-2014
7	Codman & Shurtleff, Inc.	II	Oct-20-2014
8	Codman & Shurtleff, Inc.	II	Aug-12-2014
9	Codman & Shurtleff, Inc.	II	Apr-17-2014
10	Codman & Shurtleff, Inc.	II	Jan-29-2014
11	Integra LifeSciences Corp.	II	Sep-30-2016
12	Integra LifeSciences Corp.	II	Jan-03-2014
13	Medtronic Neurosurgery	I	Apr-07-2017
14	Medtronic Neurosurgery	II	Feb-02-2017
15	Medtronic Neurosurgery	I	Jun-27-2014

TPLC Last Update: 2019-04-02 20:35:38