EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

K251366 · Nihon Kohden Corporation · OLT · Oct 9, 2025 · Neurology

Device Facts

• Record ID: K251366
• Device Name: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
• Applicant: Nihon Kohden Corporation
• Product Code: OLT · Neurology
• Decision Date: Oct 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

EEG-1260A: The EEG-1260A Electroencephalographs record electroencephalogram and related vital signals and displays the electroencephalogram and vital signals as waveforms. JE-940A: The JE-940A amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. JE-944A is intended to relay EEG and other vital signals to the JE-940A. LS-940A: LS-940A is intended to evoke response photic stimulator.

Device Story

The EEG-1260A Neurofax System is a clinical electroencephalograph for recording/displaying EEG and polysomnography (PSG) signals. The system utilizes the JE-940A EEG Amplifier to acquire biological signals—including EEG, ECG, EMG, respiration, EOG, snoring, body position, SpO2, and pulse waveforms—from patients. The LS-940A Photic Stimulator provides visual stimuli to assess EEG responsiveness and visual evoked potentials. The system is operated by qualified medical personnel in clinical or home settings. Data is transmitted to the EEG-1260A for display and analysis. Optional software (QP-160AK) provides seizure detection and burst-suppression pattern identification. The system aids clinicians in diagnosing neurological and sleep disorders by providing objective waveform data and automated analysis, facilitating clinical decision-making and patient management.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through non-clinical bench testing, including software/firmware validation, cybersecurity assessment, electromagnetic compatibility (EMC), electrical safety, mechanical/thermal safety, and usability engineering per ISO 62366-1. Compliance with international standards (IEC 60601-1, IEC 80601-2-26, ISO 80601-2-61) was demonstrated.

Technological Characteristics

System includes EEG-1260A workstation, JE-940A amplifier (24-bit A/D, 63 inputs, 4000Hz max sampling), and LED-based LS-940A photic stimulator. Connectivity via USB/LAN with AES-256 encryption. JE-940A supports battery (AA/NiMH) or AC power. Software includes seizure detection and burst-suppression analysis. Complies with IEC 60601-1, IEC 62304, and ISO 14971.

Indications for Use

Indicated for recording, measuring, and displaying cerebral and extracerebral activity for EEG and Sleep Studies in patients of any age. Used by clinicians as an aid in diagnosing sleep disorders, epilepsies, and related disorders. Used by medical personnel in medical facilities, laboratories, clinics, nursing homes, or outside facilities under direct professional supervision.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• EEG-1200A Series Neurofax (K080546)
• JE-921A Electrode Junction Box (K080546)
• Lifelines Photic Stimulator (K101691)

Reference Devices

• JE-120A (K113117)
• WEE-1200 (K171124)
• AE-120A (K183529)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 9, 2025

Nihon Kohden Corporation
% Charlemagne Chua
Senior Manager, Regulatory Affairs
Nihon Kohden America, LLC
15353 Barranca Parkway
Irvine, California 92618

Re: K251366
Trade/Device Name: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
Regulation Number: 21 CFR 882.1400
Regulation Name: Electroencephalograph
Regulatory Class: Class II
Product Code: OLT, GWQ, OLV, GWE
Dated: September 12, 2025
Received: September 12, 2025

Dear Charlemagne Chua:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251366 - Charlemagne Chua
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251366 - Charlemagne Chua
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for

Jay Gupta

Assistant Director

DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices

OHT5: Office of Neurological and Physical Medicine Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251366 | |
| Device Name EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | |
| Indications for Use (Describe) EEG-1260A Neurfax System The EEG-1260A series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional. | |
| JE-940A EEG Amplifier Unit The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders. The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel. The device is available for use on any patient as determined by qualified medical personnel. | |
| LS-940A Photic Light The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials. The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel. The device is available for use on any patient as determined by qualified medical personnel. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

# 510(k) SUMMARY

## Administrative Information

**Sponsor:**
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560
FDA Est. Registration: 9611252

**Submitter:**
Nihon Kohden America, LLC
15353 Barranca Parkway
Irvine, CA 92618
FDA Est. Registration: 2080783

**Primary Correspondent /U.S. Agent:**
Charlemagne Chua
Senior Manager, Regulatory Affairs
15353 Barranca Parkway
Irvine, CA 92618
Office Phone: [phone]
Email: [e-mail]

## Subject Device Information

**Submission Type:** Traditional 510(k)

**Common Device Name:** Non-Normalizing Quantitative Electroencephalograph Software

**Regulation Medical Specialty:** Neurology

**Classification Panel:** Neurology

**Product Codes:** OLT, GWQ, OLV, GWE

**Premarket Review:** Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)

**Regulation Number:** 882.1400

**Classification:** Class II

**Decision Type:** 510(k)

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

Proprietary Name: EEG-1260A Neurofax
Reason for 510(k) Submission: Modification to an Existing Device and Introduction of New Accessories
Original 510(k) / Predicate: EEG-1200A Series Neurofax (K080546)
Predicate Manufacturer: Nihon Kohden Corporation
Submission Date: October 3, 2025

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

# 1. PRODUCT DESCRIPTION

The EEG-1260A Neurofax is an electroencephalograph system specifically designed for use in healthcare facilities. This device is designed to measure and display the patient's electroencephalogram (EEG) and polysomnography (PSG) signals, providing information and analysis of brain electrical activity.

The JE-940A EEG amplifier unit is a new amplifier unit and is an input unit of the EEG-1260A. The JE-940A Amplifier unit acquires and measures EEG and other polysomnography signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, and pulse waveforms) associated with EEG/PSG testing, and transmits the acquired data to the EEG-1260A Neurofax. The JE-940A operates on AC power or on battery power for mobile EEG measurements. The JE-940A offers an option to connect with the JE-944A Mini electrode junction box, which enhances the operational efficiency and mobility in EEG measurements.

The LS-940A Photic stimulator is a device which provides visual stimuli in the form of flashing light and is used to assess a patient's EEG responses to light stimulation. The parameters for flashing the light signal are controlled by the EEG-1260A Neurofax.

# 2. INDICATION FOR USE / INTENDED USE

## EEG-1260A

**Intended Use**: The EEG-1260A Electroencephalographs record electroencephalogram and related vital signals and displays the electroencephalogram and vital signals as waveforms.

**Indication for Use**: The EEG-1260A Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional.

## JE-940A

**Intended Use**: The JE-940A amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph.

**Indication for Use**: The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders.

The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

K251366-S003: 510(k) Summary
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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

The device is available for use on any patient as determined by qualified medical personnel.

# LS-940A

Intended Use: LS-940A is intended to evoke response photic stimulator.

Indication for Use: The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials.

The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

The device is available for use on any patient as determined by qualified medical personnel.

# 3. SUBMISSION SCOPE

Nihon Kohden (NK) is requesting market clearance for a modified Nihon Kohden device, the EEG-1260A Neurofax and newly introduced accessories. The new accessories of the EEG-1260A Neurofax include the JE-940A EEG Amplifier Unit and LS-940A Photic Stimulator.

# 4. COMPARISON WITH THE PREDICATE DEVICES

## 4.1 Subject Device Information

Table 1 provides the regulation and classification for the subject device and accessories.

Table 1 Regulatory Information on EEG-1260A, JE-940A, and LS-940A

| Device | Regulation | Product Code | Device Classification | Classification |
| --- | --- | --- | --- | --- |
| EEG-1260A | §882.1400 | OLT, GWQ, OLV, GWE | Non-Normalizing Quantitative Electroencephalograph Software | Class II |
| JE-940A | §882.1400 | GWQ, OLV, OLT | Full-Montage Standard Electroencephalograph | Class II |
| LS-940A | §882.1890 | GWE | Stimulator, Photic, Evoked Response | Class II |

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

## 4.2 Predicate Device Information

Table 2 lists the basic information about the predicate devices including 510(k) number, device name, 510(k) holder, and clearance date. Regulatory information used for comparison is provided in Table 3

Table 2 Predicate Device General Information

| Device | Predicate/Reference Device General Information | | | |
| --- | --- | --- | --- | --- |
| | 510(k) Number | Device Name | 510(k) Holder | Clearance Date |
| EEG-1260A | K080546 | EEG-1200A Series Neurofax | Nihon Kohden Corp. | August 29, 2008 |
| JE-940A | K080546 | JE-921A Electrode Junction Box | Nihon Kohden Corp. | August 29, 2008 |
| LS-940A | K101691 | Lifelines Photic Stimulator | Lifelines Ltd. | August 10, 2010 |

Table 3 Predicate Device Regulatory Information

| Device | Regulation | Product Code | Device Classification | Classification |
| --- | --- | --- | --- | --- |
| EEG-1200A | §882.1400 | OLT, GWQ, OLV | Non-Normalizing Quantitative Electroencephalograph Software | Class II |
| JE-921A | §882.1400 | GWQ, OLV | Full-Montage Standard Electroencephalograph | Class II |
| Lifelines Photic Stimulator | §882.1890 | GWE | Stimulator, Photic, Evoked Response | Clas II |

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

# 4.3 Comparison Table

Table 4 Comparison Table of the EEG-1260A Neurofax and its Predicate

| Description | EEG-1260A
Subject Device | EEG-1200A (K080546)
Predicate Device | Comment |
| --- | --- | --- | --- |
| General | | | |
| Manufacturer (Applicant) | Nihon Kohden Corporation | Nihon Kohden Corporation | No change |
| Classification panel | Neurology | Neurology | No change |
| Device class | Class II | Class II | No change |
| Regulatory number | 21 CFR Part 882.1400 | 21 CFR Part 882.1400 | No change |
| Product code | OLT, GWQ, OLV | OLT, GWQ, OLV | No change |
| Indications for use | The EEG-1260A series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional. | The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional. | No change*
*Note: after K080546 was FDA cleared, EEG-1200A was renamed as EEG-1260A. |
| Intended use | The EEG-1260A Electroencephalographs record electroencephalogram and related vital signals and displays the electroencephalogram and vital signals as waveforms. | Not Specified | No change |
| Intended Population | Patient age not specified | Patient age not specified | No change |
| Cybersecurity | | | |
| Cybersecurity | Comply with FDA guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2023) | Not embedded | Change |

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

| Description | EEG-1260A
Subject Device | EEG-1200A (K080546)
Predicate Device | Comment |
| --- | --- | --- | --- |
| Cybersecurity -
Protection data | Encryption function
complies with FIPS 140-2
Level.1 | Not embedded | Change |
| **Compatible Input Unit** | | | |
| EEG amplifier | JE-940A (New) | JE-921A
JE-120A (K113117)
WEE-1200 (K171124)
AE-120A (K183529) | Change
The predicate device is available with the *same optional compatible amplifier(s)* as with the subject device through the 510(k) clearance K113117, K171124, K183529. |
| **Function (Software)** | | | |
| PE-210AK,
Switch Box Program | Available | Not Available at the time
of K080546 clearance. | Change |
| Identification and characterization of areas of burst-suppression pattern in the EEG. | Available
(Optional Software QP-160AK) | Not available at the time
of K080546 clearance. | Change |
| Seizure detection | Available
(Optional Software QP-160AK) | Not available at the time
of K080546 clearance. | Change |
| Digital video software | Available
(Optional Software QP-110AK) | Available
(Optional Software QP-110AK) | No Change |

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510(K) Summary

Table 5 Comparison Table of the JE-940A EEG Amplifier Unit and its Predicate

| Description | JE-940A
Subject Accessory Device | JE-921A (K080546)
Predicate Device | Comments |
| --- | --- | --- | --- |
| General | | | |
| Manufacturer | Nihon Kohden Corporation | Nihon Kohden Corporation | No Change |
| Product code | GWQ, OLV | GWQ, OLV | No Change |
| Indications for use | The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders.
The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.
The device is available for use on any patient as determined by qualified medical personnel. | Not clearly defined at the time of K080546 clearance. | Change |
| Intended use | The JE-940A amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph.
JE-944A is intended to relay EEG and other vital signals to the JE-940A. | Not clearly defined at the time of K080546 clearance. | Change |

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Traditional 510(k) – EEG-1260A Neurofax System
510(K) Summary

| Description | JE-940A
Subject Accessory Device | JE-921A (K080546)
Predicate Device | Comments |
| --- | --- | --- | --- |
| Prescription / Over-the-counter use | Prescription | Prescription | No Change |
| Intended population | Patient age not specified | Patient age not specified | No Change |
| **System Configuration** | | | |
| Compatible Junction Box | JE-922A Mini Electrode Junction Box
JE-944A Mini Electrode Junction Box | JE-922A Mini Electrode Junction Box | Change |
| Connection method (Data transfer) | Wired communication: USB or LAN (Wired LAN: 100 BASE-TX) | Wired communication: USB or LAN | No Change |
| Connection security | Encryption method: AES-256 Encryption key: 256 bit (32 bytes) | Not embedded | Change |
| **Acquisition Features**
Parameters | EEG, ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform | EEG, ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform, CO2 | Change |
| Total number of inputs | 63 | 49 | Change |
| - EEG input jacks | 25 | 25 | |
| - Multi-purpose input jacks | 16 | 4 | |
| - Bipolar input jacks | 16 (8 pairs)
(*All bipolar input jacks can also be used as multi-purpose jacks*) | 14 (7 pairs)
(8 jacks (4 pairs) of bipolar input jacks can also be used as multi-purpose jacks) | |
| - DC input jacks | 4 | 4 | |
| - Body position channel | 1 | Not available | |
| - SpO2 connector | 1 | 1 | |
| - CO2 connector | Not available | 1 | |
| Sampling frequency | Select from the following: 4000 Hz, 2000 Hz, 1000 Hz, 500 Hz, 200 Hz | Select from the following: 1000 Hz, 500 Hz, 200 Hz, 100Hz | |
| Input impedance | 200 MΩ | 100 MΩ | |
| Internal noise level | Less than 1.5 μVp-p (0.5Hz to 60Hz) | Less than 1.5 μVp-p (0.5Hz to 60Hz) | |
| CMRR | 120 dB or greater (EEG input, multi-purpose input)
100 dB or greater (bipolar input) | 105 dB or greater (EEG input/extra input, 60Hz)
100 dB or greater (bipolar input, 60 Hz) | |
| Offset tolerance | ±1000 mV or greater | ±600 mV | |
| Input range | ±1.6 mV, ±3.2 mV, or ±12.8 mV (selectable) | ±3.2 mV | |
| A/D conversion | 24 bits | 16 bits | |
| Anti-aliasing filter | Select from the following: | | |

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510(K) Summary

| Description | JE-940A
Subject Accessory Device | JE-921A (K080546)
Predicate Device | Comments |
| --- | --- | --- | --- |
| | 1,200 Hz, 600 Hz, 300 Hz, 120 Hz, 70 Hz, 60 Hz | 300 Hz | |
| Time constant | 2 seconds (0.08 Hz) or 10 seconds (0.016 Hz) (selectable) | 2 seconds | |
| EEG | Comply with IEC 80601-2-26:2019 | Comply with IEC 60601-2-26:2002 | Change |
| Polysomnography Signals (Measurement Parameters other than EEG) | | | |
| ECG | Linearity and dynamic range
Amplitude of displayed waveform within 10 % of 50 μV of the input signal (Input signal of triangular wave with amplitudes of 0.5 mV, 1 mV, 2 mV, and 6 mV p-v, 6.25Hz)
Input impedance
10 MΩ or greater (5 mV sinusoidal signal with offset voltages of 300 mV and -300 mV, 10Hz)
Common mode rejection
At least 60 dB at the supply mains frequency (Sine wave, 50/60 Hz)
At least 45 dB at twice the supply mains frequency (Sine wave, 100/120 Hz)
System noise
Not exceed 50 μV p-v over any 10-second period | Linearity and dynamic range
Amplitude of displayed waveform within 10 % of 50 μV of the input signal (Input signal of triangular wave with amplitudes of 0.5 mV, 1 mV, 2 mV, and 6 mV p-v, 6.25Hz)
Input impedance
10 MΩ or greater (5 mV sinusoidal signal with offset voltages of 300 mV and -300 mV, 10Hz)
Common mode rejection
At least 60 dB at the supply mains frequency (Sine wave, 50/60 Hz)
At least 45 dB at twice the supply mains frequency (Sine wave and 100/120 Hz)
System noise
- Not exceed 50 μV p-v over any 10-second period | No change |
| EMG | Amplitude of the displayed waveform is between 45μVp-p and 55μVp-p when a voltage of 10Hz and 50μVp-p is applied. | Amplitude of the displayed waveform is between 45μVp-p and 55μVp-p when a voltage of 10Hz and 50μVp-p is applied. | No change |
| Respiration (air flow) | Available (waveform) | Available (waveform) | No change |
| EOG | Amplitude of the displayed waveform is between 45μVp-p and 55μVp-p when a voltage of 10Hz and 50μVp-p is applied. | Amplitude of the displayed waveform is between 45μVp-p and 55μVp-p when a voltage of 10Hz and 50μVp-p is applied. | No change |
| Snoring | Available (waveform) | Available (waveform) | No change |
| Body position | Available | Available | No change |
| SpO2 declared range and pulse rate (PR) | SpO2 Declared range - 70 to 100%SpO2 | SpO2 Declared range - 70 to 100%SpO2 | Change |

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| Description | JE-940A
Subject Accessory Device | JE-921A (K080546)
Predicate Device | Comments |
| --- | --- | --- | --- |
| | Pulse Rate Display Range
- 30 to 300 beats/min
Alarm
- None
Comply with ISO 80601-2-61:2017 | Alarm
- None | Compliance to ISO 80601-2-61: 2017 |
| Pulse waveform | Available | Available | No Change |
| CO2 | Not Available | Optional | Change |
| Operating Mode | | | |
| Recording | The operation to start or stop data recording is available on both the device panel and from the electroencephalograph screen. | The operation to start or stop data recording is available only from the electroencephalograph screen. | Change |
| Data backup | Available | Not available | Change |
| Battery operation | Available
Use of four AA batteries (alkaline primary batteries or NiMH secondary batteries). | Not available | Change |
| Lead check | Available | Not available | Change |
| Calibration data, log information (ISO 15189) | Available | Not available | Change |
| Environmental | | | |
| Operation conditions | Temperature 10 to 35°C (50 to 95°F)
Humidity 30 to 85% (noncondensing)
Atmospheric pressure 70 to 106 kPa | Temperature 10 to 35°C (50 to 95°F)
Humidity 30 to 80% (noncondensing)
Atmospheric pressure 70 to 106 kPa | Change |
| Storage conditions | Temperature -20 to +65°C (-4 to +140°F)
Humidity 10 to 95%
Atmospheric pressure 70 to 106 kPa | Temperature -20 to +60°C (-4 to +140°F)
Humidity 10 to 80%
Atmospheric pressure 70 to 106 kPa | No Change |

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Table 6 Comparison Table of the LS-940A Photic Stimulator and its Predicate

| Description | LS-940A
Subject Accessory Device | Lifelines Photic Stimulator
(K101691)
Predicate Accessory Device | Comparison |
| --- | --- | --- | --- |
| Regulatory Information | | | |
| Manufacturer | Nihon Kohden Corporation | LifeLines Ltd | Change |
| Product code | GWE | GWE | No Change |
| Indication for use | The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials.
The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.
The device is available for use on any patient as determined by qualified medical personnel. | The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials. | Change |
| Intended use | LS-940A is intended to evoke response photic stimulator. | Not Specified | No change |
| Intended Population | Patient age not specified | Patient age not specified | No change |
| Specification | | | |
| Light source | LED | LED | No change |
| Illuminance Flash rate | - Typ. 26,000 lx / Single Manual flash (0.5 Hz, 1 to 33 Hz)
- Typ. 26,000 lx (flash rate) 0.5 Hz, 1 to 33 Hz)
- Typ. 13,800 lx (flash rate 40, 50, 60 Hz)
(30 cm away from the light-emitting surface) | - 700 lm typical, 900 lm max
- 13,000 lux at one 1 foot
1 to 60 Hz or single manual flash | Change |
| Frequency | - NORMAL
0.5, 1 – 33 (1Hz step),
40, 50, 60Hz
- RANDOM
0.5, 1 – 33 (1Hz step) | The frequency is constant. | |

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# 5. PERFORMANCE

## 5.1 Summary of Non-Clinical Performance Testing

Nihon Kohden conducted non-clinical bench performance testing as part of the design verification and validation activities. The EEG-1260A, JE-940A, and LS-940A were evaluated for reprocessing & shelf-life, biocompatibility, software & firmware, cybersecurity & interoperability, electromagnetic compatibility & electrical, mechanical, wireless & thermal safety, system connection, and usability performance. The same test methods and specifications were used as for the predicate device, establishing equivalency with the predicate devices. The testing was conducted using EEG-1260A, JE-940A, and LS-940A as a system. These tests were performed according to the international and FDA-recognized consensus standards listed in Table 7.

Table 7 Applied Standards and Guidance List for the EEG-1260A, JE-940A, and LS-940A

| Recognition Number | Description |
| --- | --- |
| 5-125 | ISO 14971:2019
Medical devices - Application of risk management to medical devices |
| 13-79 | IEC 62304:2006+A1:2015
Medical device software -Software life cycle processes |
| 13-122 | IEC 81001-5-1: 2021
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle |
| 19-4 | IEC 60601-1:2005+A1:2012+A2:2020
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 19-36 | IEC 60601-1-2:2014+A1:2020
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 19-50 | IEC TS 60601-4-2:2024
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical system |
| 5-129 | IEC 62366-1:2015+A1:2020
Medical devices - Part 1: Application of usability engineering to medical devices |
| Not Recognized | IEC 80601-2-26:2019
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| 1-139 | ISO 80601-2-61:2017
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| 2-258 | ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| 10-130 | ANSI Z80.36:2021
Ophthalmic - Light Hazard Protection for Ophthalmic Instruments |

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| Recognition Number | Description |
| --- | --- |
| Not recognized | ISO 15004-2:2007
Ophthalmic instruments - Fundamental requirements and test methods Part 2: Light hazard protection |
| 12-249 | IEC 62471:2006
Photobiological safety of lamps and lamp systems |
| Guidance | |
| | “General Principles of Software Validation” Document issued on: January 11, 2002 |
| | “Content of Premarket Submissions for Device Software Functions” Document Issued on June 14, 2023. |
| | “Multiple Function Device Products: Policy and Considerations”, Document issued on June 14, 2023. |
| | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Document Issued on September 27, 2023. |
| | “Postmarket Management of Cybersecurity in Medical Devices” Document Issued on December 28, 2016 |
| | “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” Document issued on September 6, 2017 |
| | “Off-The-Shelf Software Use in Medical Devices” Document Issued on September 27, 2023. |
| | “Electromagnetic Compatibility (EMC) of Medical Devices” Document issued on June 6, 2022. |
| | “Applying Human Factors and Usability Engineering to Medical Devices” Document issued on: February 3, 2016 |
| | Draft guidance “Content of Human Factors Information in Medical Device Marketing Submissions” December, 2022. |

## 6. SUBSTANTIAL EQUIVALENCE DISCUSSION

The comparison of the EEG-1260A Neurofax to its predicate device (EEG-1200A Series Neurofax K080546), the JE-940A EEG Amplifier unit to its predicate device (JE-921A Electrode Junction Box K080546), and the LS-940A Photic Stimulator to its predicate device (Lifelines Photic Stimulator K101691) and the discussion of the key aspects are presented in the following sections.

## Discussion for Intended Use

In comparing the Intended Use between the EEG-1260A Neurofax and its predicate device, the Intended Use are the same.

In comparing the Intended Use between the JE-940A EEG Amplifier Unit and its predicate device, the Intended Use are the same.

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In comparing the Intended Use between the LS-940A Photic Stimulator and its predicate device, the Intended Use for the predicate device and LS-940A Photic Stimulator are used as a light source for photic stimulation,

## 6.1 Indications for Use

In comparing the Indications for Use between the EEG-1260A Neurofax and its predicate device, there were no changes in the Indications for Use.

In comparing the Indications for Use between the JE-940A EEG Amplifier Unit and its predicate device, the Indications for Use are the same.

In comparing the Indications for Use between the LS-940A Photic Stimulator and its predicate device, the Indications for Use were modified to include more details to better support the intended use of the LS-940A as a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials. Based on the Intended Use, the predicate device and LS-940A Photic Stimulator are regulated under the same regulation number and FDA product code.

## 6.2 Discussion for Technological Characteristics

The EEG-1260A Neurofax and its predicate device have the same technological characteristics.

The JE-940A EEG Amplifier Unit and its predicate device have the same technological characteristics.

The LS-940A Photic Stimulator and its predicate device have the same technological characteristics.

## 6.3 Discussion for Design Characteristics

There are slight differences between the EEG-1260A Neurofax System and the predicate as referenced. The differences are based on design changes to accommodate new design improvement and to ensure compliance with current applicable standards. The changes have been evaluated to ensure there is no impact on the safety and effectiveness of the EEG-1260A Neurofax System.

There are slight differences between the JE-940A EEG Amplifier Unit and its predicate device. The differences are based on design changes to accommodate new design features and to ensure compliance with current applicable standards. The changes have been evaluated to ensure there is no impact on the safety and effectiveness of the JE-940A EEG Amplifier Unit.

There are slight differences between LS-940A Photic Stimulator and the predicate accessory device. The differences are based on design changes to accommodate the subject device's intended use and to ensure compliance with current applicable standards. The changes have been evaluated to ensure there is no impact on the safety and effectiveness of the LS-940A Photic Stimulator.

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## 6.4 Discussion for Compatible Devices

The EEG-1260A Neurofax System and predicate device require the device to be connected to Nihon Kohden amplifiers. The subject device is available with the same amplifiers as with the predicate device. Currently, there are more Nihon Kohden amplifiers that have received 510(k) clearance since the predicate device has cleared by FDA, the differences do not impact the safety and effectiveness of the EEG-1260A Neurofax System when compared to the predicate device.

When compared to the predicate, the JE-940A EEG Amplifier Unit may require the use of a Mini Electrode Junction box (JE-944A). The predicate may require the Mini Electrode Junction box (JE-922A) to relay the signal. Both JE-922A and JE-944A connect to electrode leads attached to patients and relays EEG and other vital signals to EEG Amplifier Unit. Both JE-922A and JE-944A are compatible with EEG-1260A Neurofax System.

## 6.5 Discussion for Performance Specifications

The EEG-1260A Neurofax System has been compared and evaluated using the same performance methods and testing criteria as the predicate.

The JE-940A EEG Amplifier Unit has been compared and evaluated using the same performance methods and testing criteria as the predicate accessory device.

When compared to the predicate accessory device, the LS-940A Photic Stimulator has been evaluated to the most current versions of the Applicable Standards. Any new standard has been considered to ensure safety and efficacy of the subject device.

## 7. CONCLUSION

The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety, and electromagnetic compatibility, software verification, and validation demonstrate that the EEG-1260A Neurofax, JE-940A EEG Amplifier Unit, and LS-940A Photic Stimulator do not raise concerns regarding their safety and effectiveness compared to their predicate device and operates in accordance with claimed indications for use. EEG-1260A Neurofax, JE-940A EEG Amplifier Unit, and LS-940A Photic Stimulator are substantially equivalent to the predicate devices.

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