Nihon Kohden's model number MEE-1000 is intended for medical purposes to measure, monitor, record and display the bioelectric signals produced by muscles (EMG), to stimulate peripheral nerves and to monitor, record and display the electrical activities produced by nerves to aid clinicians in the diagnosis and prognosis of neuromuscular disease. The device monitors electric/auditory/visual evoked potential, EEG and EMG. The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient thru commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation. The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved in a large capacity storage media.

Device Description

The Neuromaster, MEE-1000A, Neural Function Measuring System model measures and displays electric/auditory/visual evoked potential, and EMG for surgical and diagnostic procedures. For evoked potential, continuous and periodic measurements are available. The acquired waveforms and data can be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved in a large capacity storage media and printed via any commercially available printer.

AI/ML Overview

The provided text describes a 510(k) notification for the NIHON KOHDEN AMERICA, INC. MEE-1000A Neuromaster. This filing is for substantial equivalence to a predicate device, not for a de novo marketing authorization. Therefore, it does not include typical detailed performance data from a clinical study with acceptance criteria.

The acceptance criteria and performance data for substantial equivalence filings are often demonstrated through conformance to recognized standards, functional testing, and comparison of technical specifications to the predicate device, rather than patient outcome studies with specific numerical performance metrics like sensitivity and specificity.

Based on the provided text, the following information can be extracted/inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" primarily relate to meeting safety and performance standards and being demonstrably similar to the predicate device. The "reported device performance" refers to the device's adherence to these standards and functional capabilities.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Safety & Performance Standards	IEC 60601-1: 1988-12	Device complies.
	IEC 60601-1 Amendment 1: 1991-11	Device complies.
	IEC 60601-1 Amendment 2: 1995-03	Device complies.
	IEC 60601-1-1 Second edition: 2000-12	Device complies.
	IEC 60601-2-10: 1987-12	Device complies.
	IEC 60601-2-40: 1998-02	Device complies.
	IEC-60601-1-2 Second edition: 2001-09	Device complies.
	21 CFR Part 898 (Performance Standard for Electrode Lead Wires and Patient Cables)	Device complies with IEC 60601-1 sub-clause 56.3 as implemented by this CFR part.
Functional/Design Validation	Operation of software and hardware according to design specifications	Design validation confirmed proper operation.
Device Operation	Proper operation during electromagnetic, environmental, safety, and performance testing	Tests verified proper operation.
Equivalence to Predicate	Functional and technical characteristics comparable to the predicate device (Nihon Kohden MEB-2200A Neuropack)	The new device allows monitoring EMG, EEG and evoked potential responses in similar settings, has more channels (16/32 vs. predicate), and allows saving data on various media, similar to the predicate.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a Design Validation process, which included various testing procedures.

"Design validation confirmed the operation of the software and hardware of the device according to the design specifications."

"The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the proper operation of the device."

This indicates a set of engineering and functional tests were performed to ensure the device performs as intended and meets the regulatory safety standards. However, details of specific test plans, protocols, or quantitative results are not included in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in the context of a typical clinical study with a "test set" of patient data. The "test set" here refers to the device itself being tested for functionality and safety. The document does not specify the number of devices or components tested, but implies that the device (or representative units) underwent the described validation and testing.
Data Provenance: Not applicable for device functional and safety testing as described. This is internal company testing for design validation and compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is not a study assessing the diagnostic accuracy of an AI or imaging device where expert ground truth is established for patient cases. The "ground truth" for this device's validation is adherence to technical specifications, safety standards, and functional performance, which is typically assessed by engineers and regulatory experts.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of patient data, which is not the nature of this validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is a clinical study comparing human reader performance, often with and without AI assistance. This document describes a 510(k) for a neural function measuring system, not an AI-powered diagnostic imaging tool, and no clinical comparative effectiveness study involving human readers is mentioned.

6. If a Standalone Study Was Done:

Yes, in a sense. The described "design validation," "electromagnetic, environmental, safety and performance testing procedures" are assessments of the device's standalone functionality and compliance with standards. There is no mention of a "human-in-the-loop" component in these tests. The device is evaluated on its own functional merits against its specifications and applicable standards.

7. The Type of Ground Truth Used:

The "ground truth" for this device's validation is its design specifications, international and national safety and performance standards (e.g., IEC 60601 series, 21 CFR Part 898), and the functional equivalence to its predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a "training set" of data in the common sense for model development. The device's design and engineering are based on established principles of neural function measurement, not on learning from a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned for this type of device.

Summary

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K05 1178

NIHON KOHDEN AMERICA, INC.

Rese 1 of 2

510(k) NOTIFICATION MEE-1000A Neuromaster

SECTION 2 - 510(K) SUMMARY

AUG 1 7 2005

Name and Address of Applicant . Nihon Kohden America, Inc. 90 Icon St. Foothill Ranch, Ca 92610
Phone: (949) 580-1555 Ext. 4401 Fax: (949) 580-1550 Attn: Serrah Namini, Regulatory Affairs Assoc. Dir.

Date: 05/3/05

Name of the device: Neural Function Measuring System .
Trade or proprietary name: MEE 1000A Neuromaster .
The common or usual name: Common names for the device include Evoked Response, . Evoked Potential (EP) and Electromyograph (EMG)
The classification name: The device has been classified as Class II under 21 CFR Part . 890.1375 "Diagnostic Electromyograph" per IKN; 21 CFR part 874.1820 "Surgical 090.1375 Diagnosuo 22.000.01.30 Part 882.1400 "Electroencephalograph" per GWQ; 21 CFR Part 882.1550 "Nerve Conduction Velocity Measurement Device" per JXE; 21 CFR 882.1540 "Galvanic Skin Response Measurement Device" PER GZO; 21 CFR 882.1870 "Evoked Response Electrical Stimulator" per GWF; 21 CFR 882.1890 21 CFR 882.1070 " DVG Stimulator" per GWE; and 21 CFR 882.1900 "Bvoked Response Auditory Stimulator" per GWJ.
The legally marketed equivalence: The predicate marketed device is the Nihon Kolden . I he legally markets ogarraised (1) #K991899, commercial distribution certification dated 9/1/1999.
A description of the device: The Neuromaster, MEE-1000A, Neural Function . A description of the devices and displays electric/auditory/visual evoked potential, and Measuring Bystom modeles and eas surgical and diagnostic procedures. For evoked provides first and 2011 continuous and periodic measurements are available. The potchired waveforms and data can be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved annotations (events). In inted via any commercially available printer.
A summary of the technological characteristics of the device compared to the . A summal y of the teather to the predicate device, the new device allows monitoring EMG, EEG and evoked potential responses of patients in the same settings as well as under Intensive Care Units. The data is displayed to continuously monitor the patient's under meensFX Care Only allows examinations, managing and storing measurement conditions. The product is available with more channels; 16/32 channel amp unit acquires waveforms from 16 or 32 channel amplifiers with the 2 or 3 breakout boxes (electrode waveloniis from 10 or 52 circe is available with more compact junction boxes. Measured Julietion 002). The new be saved on various types of durable media, such as a CD or a

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K05 1178

NIHON KOHDEN AMERICA, INC.

510(k) NOTIFICATION MEE-1000A Neuromaster

hard drive, similar to the predicate. Saved waveforms and data can be either printed or reviewed on the screen, similar to the predicate.

The device is intended for use by medical personnel within a hospital, clinic or nursing The device to member of a medical facility under direct supervision of a medical nome somily. The device may also be placed in the intensive care unit or operating room for continuous recording. Similar to the predicate, the device is available for use on adults and children as determined by the medical professional.

The device complies with IEC 60601-1 sub-clause 56.3 as implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. The device is in compliance with the following voluntary industrial standards: IEC 60601-1: 1988-12; IEC 60601-1 Amendment 1: 1991-11, IEC 60601-1 Amendment 2: 1995-03, IEC 60601-1-1 Second edition: 2000-12, IEC 60601-2-10: 1987-12, IEC 60601-2-40: 1998-02, and IEC-60601-1-2 Second edition: 2001-09

The device is not sterile. Design validation confirmed the operation of the software and hardware of the device according to the design specifications.

The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the proper operation of the device.

Therefore based on the above, Nihon Kohden believes that the MEE-1000A Neuromaster, Neural Function Measuring System, is substantially equivalent to the predicate device, MEB-2200A Neuropack.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." are arranged in a circular pattern around the eagle.

AUG 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Serrah Namini Regulatory Affairs, Associate Director Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, California 92610

Re: K051178

Trade/Device Name: Neuromaster: MEE-100A series Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: July 21, 2005 Received: July 22, 2005

Dear Ms. Namini:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter witification. The FDA finding of substantial equivalence of your device to a legally premated noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Barbara Brehus
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NIHON KOHDEN AMERICA, INC.

G. Indications for Use Statement

510(k) Number (if known):

Device Name: ____ Neuromaster : MEE-1000A series

Indications for Use: Nihon Kohden's model number MEE-1000 is intended for medical purposes to measure, monitor, record and display the bioelectric signals produced by muscles (EMG), to stimulate peripheral nerves and to monitor, record and display the electrical activities produced by nerves to aid clinicians in the diagnosis and prognosis of neuromuscular disease. The device monitors electric/auditory/visual evoked potential, EEG and EMG. The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Barbare fructus for melkerson

Division Sign-Off)	Page 8 of 21
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Division of General. Restorative.

K051178

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).