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510(k) Data Aggregation
K Number
K043500Device Name
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
Manufacturer
INNOSPINE, INC.
Date Cleared
2005-04-15
(116 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
INNOSPINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Functional Anaesthetic Discography (FAD) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopague contrast, local anaesthetics, and/or saline solution to the intradiscal space. The FAD Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the FAD Catheter and Guidewire into the intradiscal space.
Device Description
The Functional Anaesthetic Discography (FAD) System consists of the FAD Catheter Kit and The FAD Introducer Needle. The FAD Catheter Kit includes one FAD Catheter, one Guidewire, one FAD Introducer Needle, and other purchased accessories, including one Guidewire, one FAD Introducer Needle, two 1 cc syringes and two Touhy-Borst adapters.
The FAD Catheter is a micro-catheter with a flexible polymer shaft. There is a polymer anchor near the distal tip of the catheter, which is expanded once the catheter is in place for the purpose of manually controlling catheter placement during the delivery of fluids to the intradiscal space and prior to removal of the catheter. Two lumens run the length of the polymer shaft of the catheter, one for the purpose of expanding the anchor, the other for the purpose of tracking over the guidewire and injecting the desired fluid. There are two radiopaque markers, one proximal to the anchor and one distal to the anchor for radiographic positioning of the anchor. There is also a guidewire over which the catheter is tracked to the desired location.
The FAD Introducer Needle is provided in the FAD Catheter Kit and will also be sold separately. The FAD Introducer Needle is stainless steel and has a stainless steel stylet. The FAD Introducer Needle provides access to the intradiscal space. The Guidewire and Catheter are delivered through the FAD Introducer Needle.
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