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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.

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.

The provided 510(k) submission for the InnoSpine, Inc. Functional Anaesthetic Discography (FAD) System does not contain a study that establishes acceptance criteria and proves the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. This type of submission relies on showing that the new device has the same intended use and similar technological characteristics to legally marketed devices, and that any differences do not raise new questions of safety or efficacy. Therefore, the information requested regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details are not present in this document because a formal clinical or performance study with defined acceptance criteria was not conducted for this 510(k) submission.

The document explicitly states:

"Any differences in technological characteristics between the FAD System and the predicate Any differences in technological characteristics occircuit. The safety of the FAD System was devices do not false ally new issues of sales, or sales, or docompatibility testing, evaluated through design vermeation the FAD Catheter Kit and the FAD introducer I he collective results have demonstation that the respective predicate devices with regard to safety."

This indicates that safety was evaluated through "design verification" and "biocompatibility testing," which are typically internal engineering and laboratory tests, not a clinical study designed to meet specific performance acceptance criteria as usually seen for AI/ML devices or devices requiring clinical proof of efficacy.

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