KILOWIN by CADWELL LABORATORIES, INC.

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:

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

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cadwell Laboratories, Inc c/o Mr. Carlton Cadwell President and CEO 909 North Kellogg Street Kennewick, Washington 99336

APR - 9 2012

Re: K971214 Trade/Device Name: Kilowin Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWQ, IKN, JXE, OLV, GWF, GWE, GWJ Dated (Date on orig SE Itr): February 19, 1998 Received (Date on orig SE ltr): March 13, 1998

Dear Mr. Cadwell:

This letter corrects our substantially equivalent letter of June 11, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Image /page/1/Picture/7 description: The image shows a handwritten word "for" in cursive script. The letter 'f' has a large, sweeping loop that extends below the baseline, and the letters 'o' and 'r' are connected in a fluid, continuous stroke. The writing style appears elegant and somewhat stylized.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510K Supplement 1- Indications for Use

April 16, 1997 Date:

510(K) Number: K971214

Device Name: Kilowin

Indications for Use:

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__v (Per 21 CFR 801.109 OR

Over the Counter Use

Ploolts

(Divisit n Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev 510(k) Number

Regulation Number and Section

§ 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).