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K Number
K050633
Device Name
TRIAL CABLE RETENTION CLIP
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2005-04-21

(41 days)

Product Code
GZB
Regulation Number
882.5880
Type
Special
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the THE ANS Frour of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Trial Cable Retention Clip is intended to be used with the ANS trial cable.

Device Description

Trial Cable Retention Clip

AI/ML Overview

I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a "Trial Cable Retention Clip" and primarily discusses regulatory approval, not device performance studies or acceptance criteria. It refers to the device being "substantially equivalent" to predicate devices, but does not detail specific performance metrics, study designs, or ground truth establishment.

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).