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K Number
K112435
Device Name
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
Manufacturer
RHYTHMLINK INTERNATIONAL, LLC
Date Cleared
2011-09-22

(29 days)

Product Code
ETN
Regulation Number
874.1820
Type
Special
Panel
EN
Reference & Predicate Devices
K072736
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only

Device Description

Monopolar Stimulating Instrument

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a Monopolar Stimulating Instrument. It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

However, it does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. Therefore, I am unable to fulfill your request based on the provided input.

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.