PSG-1100 SLEEP DIAGNOSTIC SYSTEM
Device Facts
| Record ID | K120888 |
|---|---|
| Device Name | PSG-1100 SLEEP DIAGNOSTIC SYSTEM |
| Applicant | Nihon Kohden Corp. |
| Product Code | GWQ · Neurology |
| Decision Date | Nov 9, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
Indications for Use
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 Story
PSG-1100 Sleep Diagnostic System is a digital PSG amplifier; records EEG and other bio-potential signals; includes head box and main interface unit. Inputs: bio-potential signals from electrodes, SpO2 via probe, ETCO2 via optional modules, and airflow via pressure transducer. Operation: sensors attach to patient; junction box digitizes analog signals; DSP and software reproduce waveforms. Used in medical facilities or supervised settings by medical personnel. Output: physiological waveform data for clinician review as diagnostic aid. Benefits: facilitates diagnosis of sleep disorders and epilepsy.
Clinical Evidence
Bench testing only. Verification and validation testing performed in compliance with Design Control requirements confirmed the device meets specifications and is equivalent to predicate devices in safety and effectiveness.
Technological Characteristics
Digital PSG amplifier; 16-bit A-D conversion; 100 M ohm input impedance; 105 dB CMRR; frequency response 0.08-300 Hz. Includes SpO2 module, optional ETCO2 module (TG-970P/TG-920P), and internal pressure transducer for airflow. Connectivity via Ethernet. Electrical safety per IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-26.
Indications for Use
Indicated for patients requiring EEG and polysomnography (PSG) for the diagnosis of sleep disorders, epilepsy, and other related conditions. Intended for use by medical personnel in clinical or supervised non-clinical settings.
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
- Nihon Kohden JE-912A PSG Input Box (K022121)
- Nihon Kohden EEG-1200A Series Neurofax (K080546)
- Nihon Kohden JE-921A junction Box (K050833)
- Neurotronics Polysmith (K062943)
Submission Summary (Full Text)
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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 with<br>Electroencephalograph | 882.1400 | OLV |
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## Predicate Device
| • Nihon Kohden JE-912A PSG Input Box | KO22121 |
|--------------------------------------|---------|
|--------------------------------------|---------|
## 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 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.
#### Intended Use of Device 2.0
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.
#### 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 of<br>Channels(*) | 42 | 32 | 34 |
| Input Impedance | 100 M ohm | 100 M ohm | 100 M ohm |
| Calibration Check | Step square<br>50 uV (1 step) | Step square or Sine<br>wave<br>2 to 1000 uV (9 steps) | Step square or Sine<br>wave<br>2 to 1000 uV (9 steps) |
| Impedance Check | All inputs with Screen<br>and Input box<br>readout | All inputs with Screen<br>and Input box<br>readout | All inputs with Screen<br>and Input box<br>readout |
| Common-Mode<br>Rejection Ratio<br>(CMRR) | 105 dB or more | 105 dB or more | 105 dB or more |
| Noise Level | < 1.5 uV p-p (0.53 to<br>60 Hz) | < 1.5 uV p-p (0.53 to<br>60 Hz) | < 1.5 uV p-p (0.53 to<br>60 Hz) |
| Frequency Response | 0.08 to 300 Hz | 0.08 to 300 Hz | 0.08 to 120 Hz |
| High-pass Filter (Low-<br>cut) | 0.08 to 53 Hz<br>DC standard | 0.016 to 159 Hz<br>DC standard | 0.016 to 159 Hz<br>DC standard |
| Low-pass Filter (High-<br>cut) | 15 to 300 Hz | 15 to 300 Hz | 15 to 120 Hz |
| AC Filter | 50 or 60 Hz (rejection<br>ratio > 1/25) | 50 or 60 Hz (rejection<br>ratio > 1/25) | 50 or 60 Hz (rejection<br>ratio > 1/25) |
| Sensitivity | OFF, 0.1 to 200<br>uV/mm (20 steps)<br>DC: OFF, 10 to 200<br>mV/mm (10 steps) | OFF, 1 to 200 uV/mm<br>(15 steps)<br>DC: OFF, 10 to 200<br>mV/mm (10 steps) | OFF, 1 to 200 uV/mm<br>(15 steps)<br>DC: OFF, 10 to 200<br>mV/mm (10 steps) |
| A-D Conversion | 16 bits | 16 bits | 16 bits |
| Sampling | All channels | All channels | All channels |
| | 200, 250, 500, 1000,<br>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%<br>50 / 60 Hz<br>42 VA (Main unit only) | 120 V +/- 10%<br>50 / 60 Hz<br>750 VA (including PC and display) | N/A |
| Operating<br>Environment | Temperature: 10 to<br>35 degree C<br>Humidity: 30 to 80 % | Temperature: 10 to<br>35 degree C<br>Humidity: 30 to 80 % | Temperature: 10 to<br>35 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 /<br>Intended use/Functional | Confirmed by verification/validation testing in<br>compliance with the Design Control<br>requirements. User need and intended use<br>was shown to be equivalent in safety and<br>effectiveness to the predicate devices. The<br>modifications do not alter the fundamental<br>scientific technology of the device |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| Chassis | Confirmed by verification/validation testing in<br>compliance with the Design Control<br>requirements. The Chassis was shown to be<br>equivalent to the predicate devices |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling | Confirmed by verification/validation testing in<br>compliance with the Design Control<br>requirements. Labeling was shown to be<br>equivalent to the predicate devices |
| Operating environment<br>[temperature and humidity,<br>EMC and EMI] | Confirmed by verification/validation testing in<br>compliance with the Design Control<br>requirements. The Operating environment<br>was shown to be equivalent to the predicate<br>devices |
| Storage environment | Confirmed by verification/validation testing in<br>compliance with the Design Control<br>requirements. Storage environment was<br>shown to be equivalent to the predicate<br>devices |
| Condition for transport | Confirmed by verification/validation testing in<br>compliance with the Design Control<br>requirements. Codition of transport was<br>shown to be equivalent in safety and<br>effectiveness to the predicate devices |
| Risk analysis | Based on risk analysis the new device was<br>shown to be equivalent in safety and<br>effectiveness to the predicate devices no new<br>questions were raised. |
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## 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.<br>Safety requirements for medical electrical systems, 2000-12 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 2nd edition | Part 1-2: General requirements for safety - Collateral<br>standard. Electromagnetic compatibility, 2001-09 |
| IEC 60601-1-2 2nd edition,<br>Amendment 1 | Part 1-2: General requirements for safety - Collateral<br>standard. Electromagnetic compatibility. Amendment 1, 2004 |
| IEC 60601-2-26 | Part 2-26: Particular Requirements for the safety of<br>electroencephalographs, 2002-11 |
| CAN/CSA-C22.2 No. 601.1-M90 | Medical electrical equipment, Part 1: General requirements for<br>safety. |
| CAN/CSA-C22.2 No. 601.1S1-94 | Supplement No. 1-94 to CAN/CSA-C22.2 No. 601-1-M90 Medical<br>Equipment- 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 Medical<br>equipment Part 1: General requirements for safety: 2002 |
| CAN/CSA-C22.2 No. 60601-1-1-02 | Medical electrical equipment, Part 1-1: General requirements<br>for safety- Collateral: Safety requirements for medical electrical<br>systems, 2006 |
| CAN/CSA-C22.2 No.60601-1-2-03 | Medical Electrical Equipment . Part 1-2: General Requirements<br>for Safety . Collateral Standard: Electromagnetic Compatibility .<br>Requirements and Tests (Adopted IEC 60601-1-2:2001, second<br>edition, 2001-09) |
| CAN/CSA C22.2 60601-2-26-04 | Medical Electrical Equipment part 2-26: Particular<br>requirements for the safety of Electroencephalographs,<br>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:
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.
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
