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K Number
K971214
Device Name
KILOWIN
Manufacturer
CADWELL LABORATORIES, INC.
Date Cleared
1998-06-11

(435 days)

Product Code
GWE,GWF,GWJ,GWQ,IKN,JXE,OLT,OLV
Regulation Number
882.1890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Kilowin is an electroneurodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle and central nervous system. It will acquire the data necessary for electroencephalography (EEG), system. It will dequiry (ENG), electrocardiography (ECG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation and sleep assessment.

The Kilowin instrument is designed for use during the duration of the procedure only.

Use of the proposed device is to be administered under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in an operating room or clinic.

The Kilowin device(s) are intended for use during electroencephalography (EEG), electronystagmography (ENG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (brainstem, visual, somatosensory), repetitive nerve stimulation testing and sleep assessment.

Device Description

Kilowin is an electroneurodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle and central nervous system.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Cadwell Laboratories, Inc. for their device, Kilowin. It confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

The document includes:

  • Device Name: Kilowin
  • Indications for Use: Kilowin is an electroneurodiagnostic device designed to measure and display electrical signals generated by peripheral nerve, muscle, and central nervous system for electroencephalography (EEG), electronystagmography (ENG), electrocardiography (ECG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation, and sleep assessment. It is for use during the procedure only, under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in an operating room or clinic.

However, the letter does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
  6. Information about standalone algorithm performance studies.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. Sample sizes for the training set.
  9. How ground truth for the training set was established.

§ 882.1890 Evoked response photic stimulator.

(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).