The PSG-1100 Sleep Diagnostic System is intended to record the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.

Device Description

The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies. The device consists of an amplifier box (head box) and main interface unit. The head box operates with commercially available sensors and interfaces with a main unit which connects to and communicates with computer hardware/ software via Ethernet connection.

AI/ML Overview

The Nihon Kohden PSG-1100 Sleep Diagnostic System is a polysomnograph intended to record electrical activity of the brain (EEG) and other biopotential signals as an aid in diagnosing sleep disorders, epilepsies, and other disorders.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant industry standards. The acceptance criteria are implicitly defined by matching or exceeding the specifications of the predicate devices and adhering to safety and performance standards for medical electrical equipment.

Acceptance Criteria Category	Specific Criteria (from Predicate/Standards)	Reported Device Performance (Nihon Kohden PSG-1100A)
Functional/Technical	Number of Channels: 32 (JE-912A)	34
	Input Impedance: 100 M ohm	100 M ohm
	Calibration Check: Step square or Sine wave, 2 to 1000 uV (9 steps)	Step square, 50 uV (1 step)
	Impedance Check: All inputs with Screen and Input box readout	All inputs with Screen and Input box readout
	Common-Mode Rejection Ratio (CMRR): 105 dB or more	105 dB or more
	Noise Level: < 1.5 uV p-p (0.53 to 60 Hz)	< 1.5 uV p-p (0.53 to 60 Hz)
	Frequency Response: 0.08 to 120 Hz	0.08 to 300 Hz
	High-pass Filter (Low-cut): 0.016 to 159 Hz, DC standard	0.08 to 53 Hz, DC standard
	Low-pass Filter (High-cut): 15 to 120 Hz	15 to 300 Hz
	AC Filter: 50 or 60 Hz (rejection ratio > 1/25)	50 or 60 Hz (rejection ratio > 1/25)
	Sensitivity: OFF, 1 to 200 uV/mm (15 steps) DC: OFF, 10 to 200 mV/mm (10 steps)	OFF, 0.1 to 200 uV/mm (20 steps) DC: OFF, 10 to 200 mV/mm (10 steps)
	A-D Conversion: 16 bits	16 bits
	Sampling: All channels, 100, 200, 500 Hz	All channels, 200, 250, 500, 1000, 2000 Hz
	Display Resolution: N/A, 1600 x 1200	1600 x 1200
	Power: 120 V +/- 10%, 50/60 Hz, 750 VA (incl PC and display)	100-240 V +/- 10%, 50/60 Hz, 42 VA (Main unit only)
Environmental	Operating Temperature: 10 to 35 C	10 to 35 degree C
	Operating Humidity: 30 to 80 %	30 to 80 %
Safety and Effectiveness	Equivalent in safety and effectiveness to predicate devices; no new questions of safety or effectiveness.	Confirmed by verification/validation testing in compliance with Design Control requirements and risk analysis.
Standards Compliance	IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-26, CAN/CSA-C22.2 No. 601.1-M90 and related amendments	Confirmed by compliance testing with all listed standards.
Labeling	Equivalent to predicate devices	Confirmed by verification/validation testing.

Study Proving Acceptance Criteria:

The study described is a design control and verification/validation testing process rather than a traditional clinical study with human subjects to evaluate diagnostic accuracy. The primary method used to prove the device meets acceptance criteria is a demonstration of substantial equivalence to legally marketed predicate devices.

Study Type: Design Control and Verification/Validation Testing for Substantial Equivalence.
Methodology: Comparative analysis of technical characteristics, performance specifications, and compliance with recognized consensus standards.

2. Sample Size for the Test Set and Data Provenance

This submission does not involve a "test set" in the sense of a clinical dataset of patient recordings for diagnostic accuracy evaluation. Instead, the "test set" refers to the device itself and its components undergoing engineering and performance testing.

Sample Size for Test Set: Not applicable in the context of diagnostic accuracy, as this is a device performance and safety evaluation. The "sample" would be the manufactured device units undergoing verification/validation.
Data Provenance: The data arises from internal company testing (Nihon Kohden Corporation) and compliance with international and national safety and performance standards. No specific country of origin for clinical retrospect/prospective data is mentioned because it's not a clinical diagnostic performance study.

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

Number of Experts: Not applicable. Ground truth for this type of submission is established by engineering specifications, performance standards, and regulatory requirements, not by expert interpretation of patient data for diagnostic accuracy.
Qualifications of Experts: The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists at Nihon Kohden, along with the standard bodies and regulatory agencies (like the FDA) whose criteria the device must meet.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for a traditional diagnostic accuracy adjudication. The "adjudication" in this context is the process of verifying that the device's technical specifications and performance meet the established design requirements, predicate device specifications, and relevant standards. This is typically done through documented testing procedures, review by quality assurance, and compliance checks against standards by certified bodies or internal personnel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence, not on the improvement of human reader performance with or without AI assistance. This device is an amplifier and diagnostic system, not an AI-driven image analysis or interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This device is a measurement and recording system; it does not contain a standalone algorithm for diagnosis that would operate without human interaction. Its function is to acquire and present physiological data to a clinician.

7. Type of Ground Truth Used

Ground Truth: The "ground truth" for this device's acceptance is based on:
- Engineering Specifications: The design parameters and performance targets set by Nihon Kohden.
- Predicate Device Performance: The established specifications and performance of the legally marketed predicate devices (JE-912A PSG Input Box, JE-921A junction Box, EEG-1200A Series Neurofax).
- Consensus Standards: Compliance with international and national standards for medical electrical equipment (e.g., IEC 60601 series, CAN/CSA-C22.2 series).

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware system for signal acquisition and display, not a machine learning or AI algorithm that requires a "training set" of data.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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K120888

510(k) Summary

NOV 9 2012

Company Name:	Nihon Kohden Corporation
	90 Icon Street
	Foothill Ranch, CA 92610
Device Name:	Nihon Kohden PSG-1100 Sleep Diagnostic System
510(k) Sponsor, Contact:	Nihon Kohden America, Inc.
	90 Icon Street
	Foothill Ranch, CA 92610
	Steve Geerdes
	Director Quality Assurance and Regulatory Affairs
	Phone: (949) 580-1555 Ext. 3325
	Fax: (949) 580-1550
Summary Date:	Revised 11/7/2012
Common Name:	Electroencephalograph amplifier (EEG Amplifier)

Classification Names:

Electroencephalograph	882.1400	GWQ
Standard Polysomnograph withElectroencephalograph	882.1400	OLV

Predicate Device

• Nihon Kohden JE-912A PSG Input Box	KO22121
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Additional predicates

Nihon Kohden EEG-1200A Series Neurofax	K080546
Nihon Kohden JE-921A junction Box	K050833
Neurotronics Polysmith	K062943

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Description of Device 1.0

The device consists of an amplifier box (head box) and main interface unit. The head box operates with commercially available sensors and interfaces with a main unit which connects to and communicates with computer hardware/ software via Ethernet connection.

Intended Use of Device 2.0

3.0 Technical Characteristics

The PSG-1100 head box provides the SpO₂ capability of monitoring through SpO₂ probe, internal module is a standard feature. ETCO₂ is an optional feature and can be added via TG-970P or TG-920P ETCO2 module. Airflow monitoring can be measured through the internal pressure transducer by connecting commercially available filtered airflow cannulas via the built in luer lock connector. As with the existing device, the operator performs an impedance check and runs the calibration program. Electrodes and/or sensors are attached to the patient and connect to the corresponding jacks on the junction box, which is optically isolated via the main unit to ensure electrical safety. Skin-electrode impedance check is performed to verify surface electrode connection and impedance levels. The operator then begins recording waveform data.

The analog bio-potential signals applied to the electrode junction box are digitized. The DSP (digital signal processor) in combination with the device software reproduces the waveforms.

Technical comparison

New PSG-1100A	JE-921A	PSG Input Box
	Junction Box	JE-912A

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	K050833/080546	K022121
Number ofChannels(*)	42	32	34
Input Impedance	100 M ohm	100 M ohm	100 M ohm
Calibration Check	Step square50 uV (1 step)	Step square or Sinewave2 to 1000 uV (9 steps)	Step square or Sinewave2 to 1000 uV (9 steps)
Impedance Check	All inputs with Screenand Input boxreadout	All inputs with Screenand Input boxreadout	All inputs with Screenand Input boxreadout
Common-ModeRejection Ratio(CMRR)	105 dB or more	105 dB or more	105 dB or more
Noise Level	< 1.5 uV p-p (0.53 to60 Hz)	< 1.5 uV p-p (0.53 to60 Hz)	< 1.5 uV p-p (0.53 to60 Hz)
Frequency Response	0.08 to 300 Hz	0.08 to 300 Hz	0.08 to 120 Hz
High-pass Filter (Low-cut)	0.08 to 53 HzDC standard	0.016 to 159 HzDC standard	0.016 to 159 HzDC standard
Low-pass Filter (High-cut)	15 to 300 Hz	15 to 300 Hz	15 to 120 Hz
AC Filter	50 or 60 Hz (rejectionratio > 1/25)	50 or 60 Hz (rejectionratio > 1/25)	50 or 60 Hz (rejectionratio > 1/25)
Sensitivity	OFF, 0.1 to 200uV/mm (20 steps)DC: OFF, 10 to 200mV/mm (10 steps)	OFF, 1 to 200 uV/mm(15 steps)DC: OFF, 10 to 200mV/mm (10 steps)	OFF, 1 to 200 uV/mm(15 steps)DC: OFF, 10 to 200mV/mm (10 steps)
A-D Conversion	16 bits	16 bits	16 bits
Sampling	All channels	All channels	All channels
	200, 250, 500, 1000,2000 Hz	100, 200, 500, 1000 Hz	100, 200, 500 Hz
Display			N/A
Resolution	1600 x 1200	1600 x 1200	N/A
Channels	32	64 + Mark Channel	N/A
Power	100-240 V +/- 10%50 / 60 Hz42 VA (Main unit only)	120 V +/- 10%50 / 60 Hz750 VA (including PC and display)	N/A
OperatingEnvironment	Temperature: 10 to35 degree CHumidity: 30 to 80 %	Temperature: 10 to35 degree CHumidity: 30 to 80 %	Temperature: 10 to35 degree C

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Data Summary 4.0

Testing of the Nihon Kohden the PSG-1100A was performed in compliance with Nihon Kohden resting of the Mirror Control process. The testing showed PSG-1100A met equivalent acceptance Corporation abolgh our reveal and was shown to be equivalent in safety and effectiveness to the predicate devices

Testing included:

User needs /Intended use/Functional	Confirmed by verification/validation testing incompliance with the Design Controlrequirements. User need and intended usewas shown to be equivalent in safety andeffectiveness to the predicate devices. Themodifications do not alter the fundamentalscientific technology of the device
-----------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Chassis	Confirmed by verification/validation testing incompliance with the Design Controlrequirements. The Chassis was shown to beequivalent to the predicate devices
Labeling	Confirmed by verification/validation testing incompliance with the Design Controlrequirements. Labeling was shown to beequivalent to the predicate devices
Operating environment[temperature and humidity,EMC and EMI]	Confirmed by verification/validation testing incompliance with the Design Controlrequirements. The Operating environmentwas shown to be equivalent to the predicatedevices
Storage environment	Confirmed by verification/validation testing incompliance with the Design Controlrequirements. Storage environment wasshown to be equivalent to the predicatedevices
Condition for transport	Confirmed by verification/validation testing incompliance with the Design Controlrequirements. Codition of transport wasshown to be equivalent in safety andeffectiveness to the predicate devices
Risk analysis	Based on risk analysis the new device wasshown to be equivalent in safety andeffectiveness to the predicate devices no newquestions were raised.

Medical Electrical Equipment

IEC 60601-1	Part1: General requirements for safety 1998-12
IEC 60601-1, Amendment 1	Part 1: General Requirements for safety, Amendment 1, 1991-11
IEC 60601-1, Amendment 2	Part 1: General Requirements for safety, Amendment 2, 1995-03

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IEC 60601-1-1 2nd edition	Part 1-1: General requirements for safety - Collateral standard.Safety requirements for medical electrical systems, 2000-12
IEC 60601-1-2 2nd edition	Part 1-2: General requirements for safety - Collateralstandard. Electromagnetic compatibility, 2001-09
IEC 60601-1-2 2nd edition,Amendment 1	Part 1-2: General requirements for safety - Collateralstandard. Electromagnetic compatibility. Amendment 1, 2004
IEC 60601-2-26	Part 2-26: Particular Requirements for the safety ofelectroencephalographs, 2002-11
CAN/CSA-C22.2 No. 601.1-M90	Medical electrical equipment, Part 1: General requirements forsafety.
CAN/CSA-C22.2 No. 601.1S1-94	Supplement No. 1-94 to CAN/CSA-C22.2 No. 601-1-M90 MedicalEquipment- Part 1:General requirements for safety.
CAN/CSA-C22.2 No. 601.1B-90	Amendment 2 to CAN/CSA-C22.2 No. 601.1-M90 Medicalequipment Part 1: General requirements for safety: 2002
CAN/CSA-C22.2 No. 60601-1-1-02	Medical electrical equipment, Part 1-1: General requirementsfor safety- Collateral: Safety requirements for medical electricalsystems, 2006
CAN/CSA-C22.2 No.60601-1-2-03	Medical Electrical Equipment . Part 1-2: General Requirementsfor Safety . Collateral Standard: Electromagnetic Compatibility .Requirements and Tests (Adopted IEC 60601-1-2:2001, secondedition, 2001-09)
CAN/CSA C22.2 60601-2-26-04	Medical Electrical Equipment part 2-26: Particularrequirements for the safety of Electroencephalographs,adopted IEC 60601-2-26 Ed.2 (02).

5.0 Conclusions

Based on the comparison information in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements. The intended use and fundamental scientific technology of the device (Nihon Kohden PSG-1100 Sleep Diagnostic System) was shown to be equivalent in safety.and effectiveness to the predicate devices, JE-912A PSG Input Box K022121 and the JE-921A Junction Box K050833/K080546, No new questions of safety or effectiveness are raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Nihon Kohden America, Inc. c/o Mr. Steve Geerdes 90 Icon Street Foothill Ranch, CA 92610

NOV

Re: K120888

Trade/Device Name: PSG-1100 Sleep Diagnostic System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLV Dated: September 6, 2012 Received: September 7, 2012

Dear Mr. Geerdes:

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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Page 2 - Mr. Steve Geerdes

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 (2) 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 (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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Joyce M. Whanq

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine · Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _k120888

Device Name: PSG-1100 Sleep Diagnostic System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

KRISTEN ROWSHER

(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurological and Ear, Division St. Throat Devices

510(k) Number K120888

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).