(170 days)
No
The summary describes a hardware switch box and software for managing electrode stimulation sites during EEG recording and cortical stimulation. It mentions image processing for arranging electrodes on a brain map but does not mention any AI or ML capabilities for data analysis, interpretation, or decision support. The performance studies focus on hardware and software functionality and safety, not on the performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity).
No
The device is used to record, measure, and display cerebral activity for diagnosis, and for cortical stimulation to support diagnostic and surgical epilepsy procedures, which are diagnostic or procedural aid functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the data generated by the device "may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis," and the accessory supports "functional brain mapping to support diagnostic and surgical epilepsy procedures."
No
The device description explicitly states that the PE-210AK is a hardware switch box with electronic switches and cable connections, making it a hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EEG-1200A Series Neurofax and its accessory, the PE-210AK Switch Box, are used to record, measure, and display electrical activity of the brain (EEG) and for sleep studies. The switch box facilitates switching between EEG recording and cortical stimulation.
- Sample Type: The device works directly with the patient's body (cerebral and extracerebral activity) and does not analyze samples taken from the body.
Therefore, the device falls under the category of in vivo diagnostic devices as it interacts directly with the living body to gather diagnostic information.
N/A
Intended Use / Indications for Use
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 PE-210AK Switch Box is an optional accessory for the EEG-1200A device. It is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures.
The device is intended for use within a hospital or medical facility under direct supervision of a medical professional
Product codes
GWQ, GYC
Device Description
The PE-210A Switch Box is an optional accessory for the EEG-1200A device cleared under 510k # K080546. The PE-210AK Hardware is made up of electronic switches inside a box enclosure and cable connections on the outside of the box enclosure. The PE210AK Hardware switch box does not have any controls or adjustment for the operator. All settings, controls, and adjustments are made using the PE-210AK software installed on the EEG's (off the shelf) PC. Utilizing the EEG's CPU. Data storage, keyboard, mouse, and display, the PE-210AK switch box software allows the user switch electrode stimulation sites between the EEG recording and the cortical stimulator. The PE-210AK software allows the user to query the data recorded on the EEG's PC and create a report of the stimulation sites, including duration and intensity settings.
The PE-210AK Software Program contains the following capabilities:
(1) Acquisition
- Electrodes can be arranged on the brain map image.
- Image files (JPEG/BMP/TIF) can be used for the brain map image.
- STIM SITE (+) and STIM REF (-) electrodes switched for stimulation can be selected.
- Identification when the stimulation electrodes are selected:
- STIM SITE (+) -> Red
- STIM REF (-) -> Blue
Names of the selected electrodes are displayed outside the brain map image.
- Zoom display of electrode frames and electrode names
- Current value (intensity) of stimulation of the electric stimulator can be set for the stimulation event.
- Duration time for switching electrodes for stimulation (train duration, max 300sec) can be set.
- Switching electrodes for stimulation can be started or stopped with the mouse or the space key.
- State of being stimulating can be easily recognized by the START button highlighted in fluorescent color.
- Comments can be entered and stimulation events can be registered.
- The table of stimulation events including names of the selected stimulation electrodes and current values can be displayed.
- Trigger signal (stimulation rate/trigger pulse width/train) can be set.
- Equipped with the symbols for the functional map and the functional mapping report can be created simultaneously.
- Symbols can be added arbitrarily by a user.
- The functional mapping report and the table of stimulation events can be saved in a file.
- Equipped with the automatic file backup function
- The functional mapping report and the table of stimulation events can be printed.
(2) Review
- The functional mapping report can be edited.
- Comments can be entered and stimulation events can be reviewed and edited.
- The table of stimulation events including names of the selected stimulation electrodes and current values can be displayed.
- The functional mapping report and the table of stimulation events can be printed.
(3) Others
- Operation method is based on Windows (GUI/mouse/keyboard).
- Files can be read and written on the network.
- Equipped with the check-up program for the switch/trigger signals
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain/Cerebral and extracerebral
Indicated Patient Age Range
Any patient population (including adults and children) as determined by Trained professionals.
Intended User / Care Setting
medical professional / hospital or medical facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications. The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(K) SUMMARY
, ...
ﻧﮯ
JUL 2 9 2011
Name and Address of Applicant .
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, Ca 92610
Telephone: (949) 580-1555 Ext. 3325 Fax: (949) 580-1550 Attn: Steve Geerdes, Director of Regulatory Affairs
Date: July 20th , 2011
- Name/Trade Name of the Device: Nihon Kohden PE-210AK Switch Box for EEG-. 1200A
- The common or usual Name: Electroencephalograph (EEG) .
- The Classification: The device has been classified as Class II by the Neurology Device . Classification Panel under 21 CFR Part 882.1400 Electroencephalograph per GWO.
- . The legally marketed equivalence: The predicate device is the Excel Tech EMU 128s Switch Matrix commercial distribution March 12, 2004 cleared under 510k # K040360
- A description of the device: .
The PE-210A Switch Box is an optional accessory for the EEG-1200A device cleared under 510k # K080546. The PE-210AK Hardware is made up of electronic switches inside a box enclosure and cable connections on the outside of the box enclosure. The PE210AK Hardware switch box does not have any controls or adjustment for the operator. All settings, controls, and adjustments are made using the PE-210AK software installed on the EEG's (off the shelf) PC. Utilizing the EEG's CPU. Data storage, keyboard, mouse, and display, the PE-210AK switch box software allows the user switch electrode stimulation sites between the EEG recording and the cortical stimulator. The PE-210AK software allows the user to query the data recorded on the EEG's PC and create a report of the stimulation sites, including duration and intensity settings.
The PE-210AK Software Program contains the following capabilities:
(1) Acquisition
- Electrodes can be arranged on the brain map image.
- Image files (JPEG/BMP/TIF) can be used for the brain map image.
- STIM SITE (+) and STIM REF (-) electrodes switched for stimulation can be selected.
- Identification when the stimulation electrodes are selected:
- STIM SITE (+) -> Red
- STIM REF (-) -> Blue
Names of the selected electrodes are displayed outside the brain map image.
- Zoom display of electrode frames and electrode names
- Current value (intensity) of stimulation of the electric stimulator can be set for the stimulation event.
1
-
Duration time for switching electrodes for stimulation (train duration, max 300sec) can be set.
-
Switching electrodes for stimulation can be started or stopped with the mouse or the space key.
-
State of being stimulating can be easily recognized by the START button highlighted in fluorescent color.
-
Comments can be entered and stimulation events can be registered.
-
The table of stimulation events including names of the selected stimulation electrodes and current values can be displayed.
-
Trigger signal (stimulation rate/trigger pulse width/train) can be set.
-
Equipped with the symbols for the functional map and the functional mapping report can be created simultaneously.
-
Symbols can be added arbitrarily by a user.
-
The functional mapping report and the table of stimulation events can be saved in a file.
-
Equipped with the automatic file backup function
-
The functional mapping report and the table of stimulation events can be printed.
(2) Review
-
The functional mapping report can be edited.
-
Comments can be entered and stimulation events can be reviewed and edited.
-
The table of stimulation events including names of the selected stimulation electrodes and current values can be displayed.
-
The functional mapping report and the table of stimulation events can be printed.
(3) Others
-
Operation method is based on Windows (GUI/mouse/keyboard).
-
Files can be read and written on the network.
-
Equipped with the check-up program for the switch/trigger signals
Intended Use .
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 PE-210AK Switch Box is an optional accessory for the EEG-1200A device. It is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures.
The device is intended for use within a hospital or medical facility under direct supervision of a medical professional
A summary of the technological characteristics of the device compared to the . predicate device:
2
The new PE-210AK Switch Box is connected between the multi-channel electrode junction box (JE-0011/0012/0013 and switches the connection destination of signal lines of electrodes between the electroencephalograph and the external stimulation unit (only one pair of electrodes can be switch at a time). The switch box is controlled by the switch box software which is installed on the electroencephalograph (EEG). Both the EMU128s and the PE-210AK have a hardware switch box and software controls that allow electrodes to be switched between the stimulation unit and the EEG device.
COMPARATIVE INFORMATION
| New Device | Predicate | |
|---|---|---|
| PE-210AK Switch Box | Excel Tech's EMU 128S | |
| Switch Matrix | ||
| Switch output from a Stimulation Unit to EEG | ||
| electrodes connected to the patient and the EEG | ||
| instrument | Same | |
| Stimulated site manually selected by user | Same | |
| Data may be used by the clinician to aid in diagnosis. | Same | |
| For use by medical personnel. | Same | |
| For use functional mapping | ||
| Measurement. | Same | |
| Electrodes can be arranged on the brain map image | Same | |
| Image files (JPEG/BMP/TIF) can be used for the brain | ||
| map image | Same | |
| STIM SITE (+) and STIM REF (-) electrodes | ||
| switched for stimulation can be selected | Same | |
| Identification when the stimulation electrodes are | ||
| selected: | ||
| STIM SITE (+) -> Red | ||
| STIM REF (-) -> Blue | Same | |
| Names of the selected electrodes are displayed outside | ||
| the brain map image. | Same | |
| Zoom display of electrode frames and electrode | ||
| names | No | This is just a zoom in |
| feature. There is no impact | ||
| on patient safety or | ||
| effectiveness of device. | ||
| Switching electrodes for stimulation can be started or | ||
| stopped with the mouse or the space key. | Same | |
| State of being stimulating can be easily recognized by | ||
| the START button highlighted in fluorescent color. | Same | |
| Comments can be entered and stimulation events can | ||
| be registered. | Same | |
| The table of stimulation events including names of the | ||
| selected stimulation electrodes and current values can | ||
| be displayed. | No Current Values just | |
| electrode Names | All values are registered | |
| including Electrode names, | ||
| Intensity and Duration | ||
| The functional mapping report and the table of | ||
| stimulation events can be saved in a file. | Same | Only when entered as |
| comment | ||
| Equipped with the automatic file backup function | Same | |
| The functional mapping report and the table of | ||
| stimulation events can be printed. | Same | Only when entered as |
| comment | ||
| The functional mapping report can be edited in | ||
| Review Mode. | Same | Only when entered as |
| comment | ||
| Comments can be entered and stimulation events can | ||
| be reviewed and edited. | Same | |
| The table of stimulation events including names of the | ||
| selected stimulation electrodes and current values can | ||
| be displayed | Same | Only when entered as |
| comment | ||
| The functional mapping report and the table of | ||
| stimulation events can be printed. | Same | Only when entered as |
| comment | ||
| Operation method is based on Windows | ||
| (GUI/mouse/keyboard). | Same | |
| Files can be read and written on the network. | Same | Only comments |
| Equipped with the check-up program for the | ||
| switch/trigger signals | No | This feature has No impact |
| on effectiveness of device. | ||
| Tool to assure proper | ||
| operation. |
Software Capabilities/ Characteristics
3
ﺘﻪ ﻫ
い
Physical (Hardware) Characteristics
| PE-210AK Switch Box | EMU 128S Switch Matrix | Comments |
|---|---|---|
| Electronic Switch | Same | Controlled by software |
| Trigger out for external Stimulator is available. | Same |
4
| Switch output from a Stimulation Unit to EEG
electrodes connected to the patient and the EEG
| instrument. | ||
|---|---|---|
| Same | ||
| Creates report for functional | ||
| mapping. (Use a EEG PC Unit) | ||
| Same | ||
| Prints report for functional | ||
| mapping. (Printed by Printer with EEG's PC) | ||
| Same |
Target Population
| PE-210AK Switch Box | EMU 128S Switch Matrix | Comments |
|---|---|---|
| 1. Any location within a medical | ||
| facility, physician's office, | ||
| Laboratory or clinic. | Same | |
| 2. May be used in the intensive care | ||
| unit or operating room for | ||
| Monitoring or recording. | Same | |
| 3. Any patient population (including | ||
| adults and children) as determined by | ||
| Trained professionals. | Same |
The device is not sterile.
The device is not contacting patients. Therefore, no good laboratory practice studies were required per 21 CFR 58.
Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.
The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device. Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.
Therefore based on the above, Nihon Kohden believes that the PE-210AK is substantially equivalent to the Excel Tech EMU 128s Switch Matrix cleared under 510k # K040360.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nihon Kohden Corporation c/o Steve Geerdes Director of Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610
JUL 2 9 2011
Re: K110376
Trade/Device Name: Nihon Kohden PE-210AK Switch Box for EEG 1200A Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ and GYC Dated: November 30, 2010 Received: February 09, 2011
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.
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 of medical device-related
6
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,
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known):
Device Name: PE-210AK Switch Box
Indications for Use:
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 PE-210AK Switch Box is an optional accessory for the EEG-1200A device. It is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures.
The device is intended for use within a hospital or medical facility under direct supervision of a medical professional
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_
Division Sign-Off Office of Device Evaluation
510(k)________________________________________________________________________________________________________________________________________________________________________
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