(147 days)
Not Found
Unknown
While the device performs seizure detection, a task often accomplished with AI/ML, the summary does not explicitly mention the use of AI, DNN, or ML algorithms in the "Mentions AI, DNN, or ML" section or the "Device Description". The performance study description also doesn't provide details about the underlying algorithm that would confirm or deny the use of AI/ML.
No.
This device is for monitoring, analysis, and identification of EEG data, including potential seizure events, but it does not provide any treatment or therapy. It is an analytical tool for medical practitioners.
No
The "Intended Use / Indications for Use" section explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user."
Yes
The device description explicitly states "The QP-160AK EEG Trend Program is a software-only device." and describes its function as calculating and displaying data obtained from a separate host device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The QP-160AK EEG Trend Program analyzes electrical signals from the brain (EEG data) obtained from a host device connected to the patient. It does not analyze biological specimens like blood, urine, or tissue.
- The intended use is focused on monitoring and analysis of physiological signals. The device is intended to help users monitor the state of the brain, analyze EEG waveforms, identify burst-suppression patterns, and aid in the identification of potential electrographic seizures. These are all related to the analysis of a physiological signal, not an in vitro specimen.
- The device description confirms it processes EEG data. The description explicitly states it "calculates and displays EEG data obtained from the neurology product's system."
Therefore, the QP-160AK EEG Trend Program falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows:
· The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
· The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
• The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.
• The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
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.
Product codes
OMB, OMA, OLT, ORT
Device Description
The QP-160AK EEG Trend Program is a software-only device. When installed in Nihon Kohden neurology products with EEG measurement function, the device calculates and displays EEG data obtained from the neurology product's system. In addition, the QP-160AK EEG Trend Program identifies trends in the EEG data over extended periods of time in order for trained healthcare professionals to observe changes over time. Below is an illustration of how the device interacts with the Medical Personnel and Patient.
The program's existing main features are listed below:
- Calculate and display aEEG, DSA, FFT and burst suppression ratio trend .
- Display up to 64 channel EEG ●
- . Display SpO2 and ETCO2 trends
- Operation by touch panel buttons
- . Data management with Neuro Workbench software
The modification is to add:
- Seizure detection and notification .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
Brain (from EEG waveforms)
Indicated Patient Age Range
adult (greater than or equal to 18 years)
Intended User / Care Setting
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.
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
The testing was performed using archived EEG recordings obtained from 139 patients of 18 years and older admitted to an Epilepsy Monitoring Unit. All EEG data were recorded with full scalp montage using the standard 10/20 system. Each recording lasts approximately 4 hours for a total of 556 hours of EEG recording. All 139 recordings were manually annotated by three independent EEG experts and the clinical reference standard (ground truth) was determined by using a two-third majority rule.
Summary of Performance Studies
Study Type: Seizure detection performance testing
Sample Size: 139 patients, 556 hours of EEG recording
Standalone Performance: Not specified as standalone, comparison to ground truth of expert annotation listed.
Key Results:
- Positive Percent Agreement (PPA) between QP-160AK EEG Trend Program's seizure detection and ground truth: Mean 77.2%, 95% CI 69.0 - 83.5
- False Detection Rate (FDR) of QP-160AK EEG Trend Program: Mean 0.451, 95% CI 0.320 - 0.669
Key Metrics
Positive Percent Agreement (PPA) = (True Positives) / (True Positives + False Negatives)
False Detection Rate (FDR) = (False Positives) / (hour of EEG Recording)
Predicate Device(s)
Nihon Kohden QP-160AK EEG Trend Program (K120485), Persyst 12 EEG Review and Analysis Software (K133793)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Nihon Kohden Corporation % Tom Bento Sr. Vice President, Quality and Regulatory Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618
Re: K163644
Trade/Device Name: Nihon Kohden QP-160AK EEG Trend Program Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT, ORT Dated: April 21, 2017 Received: April 21, 2017
Dear Mr. Bento:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163644
Device Name
Nihon Kohden QP-160AK EEG Trend Program
Indications for Use (Describe)
The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows:
· The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
· The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
• The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.
• The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
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.
| 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.
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3
510(k) Summary for Nihon Kohden EEG Trend Program QP-160AK
| Submitter: | Nihon Kohden Corporation | |
|---|---|---|
| Address: | 1-31-4 Nishiochiai, 1-Chome, Shinjuku-Ku | |
| Tokyo, Japan 161-8560 | ||
| Phone number: | 81-2-59968020 | |
| Contact person: | Tom Bento | |
| Phone number: | (949) 680-9048 | |
| Fax number: | (913) 273-0732 | |
| Date prepared: | December 21, 2016 | |
| Device name: | Nihon Kohden QP-160AK EEG Trend Program | |
| Common name: | Electroencephalograph (EEG) | |
| Primary product codes: | OMB, OLT, ORT, OMA | |
| Regulation numbers: | 21 CFR 882.1400 | |
| Substantial equivalence claimed to: | Nihon Kohden QP-160AK EEG Trend Program (K120485 | |
| Persyst 12 EEG Review and Analysis Software (K133793) |
Description:
The QP-160AK EEG Trend Program is a software-only device. When installed in Nihon Kohden neurology products with EEG measurement function, the device calculates and displays EEG data obtained from the neurology product's system. In addition, the QP-160AK EEG Trend Program identifies trends in the EEG data over extended periods of time in order for trained healthcare professionals to observe changes over time. Below is an illustration of how the device interacts with the Medical Personnel and Patient.
The program's existing main features are listed below:
- Calculate and display aEEG, DSA, FFT and burst suppression ratio trend .
- Display up to 64 channel EEG ●
- . Display SpO2 and ETCO2 trends
- Operation by touch panel buttons
- . Data management with Neuro Workbench software
The modification is to add:
- Seizure detection and notification .
4
Indications for Use:
The QP-160AK EEG Trend program is a software-only device intended to calculate, and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.
The intended use is as follows:
- . The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
- . The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
- . The burst suppression parameters of this software (interburst interval and bursts per minute) are intended to aid in the identification and characterization of areas of burstsuppression pattern in the EEG.
- . The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
The device is intended for use by medical personnel within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
Technological Characteristics - Substantial Equivalence Discussion
The Nihon Kohden QP-160AK EEG Trend Program is substantially equivalent to the predicate device of the same name (K120485) with the additional features of seizure detection and notification. For the seizure detection and notification, QP-160AK is substantially equivalent to the other listed predicate devices, Persyst 12 EEG Review and Analysis Software (K133793). Differences between the devices are minor and do not raise questions regarding safety or efficacy.
These differences include:
-
- The QP-160AK EEG Trend Program is the same as the previous submission of QP-160AK cleared under K120485, but has two additional functions: seizure detection and notification of seizure detection.
-
- For these new functions, we refer to Persyst 12 EEG Review and Analysis Software
5
(K133793) as the predicate.
| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG (Predicate device K133793) |
|---|---|---|
| Indications for Use | The QP-160AK EEG Trend program is a software-only device intended to calculate, and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. | |
| The intended use is as follows: The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. The burst suppression parameters of this software (interburst interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. The seizure detection component of QP-160AK is intended to mark EEG waveforms of adult (greater than or equal to 18 years) | 1. Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. |
-
The Seizure Detection and Seizure Probability component of Persyst 12 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system.
-
The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike |
| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG
(Predicate device
K133793) |
| | electrographic seizures in
order to aid in identification of
seizure events and help
review and annotation of EEG
traces by user. EEG should
be recorded with full scalp
montage at the standard
10/20 system. The
notifications for seizure
detection are provided. | Detection performance has not been
assessed for intracranial recordings. |
| | This device does not provide any
diagnostic conclusion about the
patient's condition to the user. | 4. Persyst 12 includes the calculation
and display of a set of quantitative
measures intended to monitor and
analyze the EEG waveform. These
include FFT, Automatic event marking
is not applicable to the quantitative
measures. These quantitative EEG
measures should always be
interpreted in conjunction with review
of the original EEG waveforms. |
| | The device is intended for use by
medical personnel within a medical
facility, laboratory, clinic or nursing
home or outside of a medical facility
under direct supervision of a medical
professional. | 5. The aEEG functionality included in
the Persyst 12 is intended to monitor
the state of the brain. The automated
event marking function of Persyst 12
is not applicable to aEEG. |
| | | 6. Persyst 12 provides notifications for
seizure detection, quantitative EEG
and aEEG that can be used when
processing a record during
acquisition. These include an on
screen display and the optional
sending of an email message. Delays
of up t several minutes can occur
between the beginning of a seizure
and when the Persyst 12 notifications
will be shown to a user. Persyst 12
notifications cannot be used as a
substitute for real time monitoring of
the underlying EEG by a trained
expert. |
| | | 7. Persyst AR (Artifact Reduction) is
intended to reduce EMG, eye
movement, and electrode artifacts in
a standard 10-20 EEG recording. AR
does not remove the entire artifact
signal, and is not effective for other
types of artifacts. AR may modify
portions of waveforms representing
cerebral activity. Waveforms must still
be read by a qualified medical |
| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG
(Predicate device
K133793)
practitioner trained in recognizing
artifact, and any interpretation or
diagnosis must be made with
reference to the original waveforms. -
This device does not provide any
diagnostic conclusion about the
patient's condition to the user. |
| Identify Seizures | Yes | Yes |
| Provides Seizure
Notifications | Yes | Yes |
| Identify Spikes | No | Yes |
| Montage/Channel
Array | Scalp 10/20 Array | Scalp 10/20 Array |
| Number of EEG
Channels | Up to 32/64 EEG channels
(dependent on amplifier) | Up to 32/64 EEG channels
(dependent on amplifier) |
| Number of DC
Channels | Up to 8 channels (dependent on
amplifier) | Up to 8 channels (dependent on
amplifier) |
| Density Spectral
Array (DSA) Trend | Yes | Yes |
| Density Spectral
Array (DSA)
Asymmetry Trend | Yes | Yes |
| Spectral Edge
Frequency Trend
Amplitude | Yes | Yes |
| Integrated EEG
(aEEG) Trend | Yes | Yes |
| Burst Suppression
Ratio (BSR) Trend | Yes | Yes |
| Inter-Burst Interval
(IBI) Trend | Yes | No |
| Burst Per Minute
(BPM) Trend | Yes | No |
| FFT Power Trend | Yes | Yes |
| FFT Power
Asymmetry Trend | Yes | Yes |
| FFT Power ratio
(e.g. Alpha/Delta,
Alpha/Beta) Trend | Yes | Yes |
| External Input (DC
Input) Display | Yes | Yes |
| Number of Trends | More than 16 | More than 16 |
| User Selectable
Trend Group
(Panel) | Yes | Yes |
| Time Interval of
Trends | 1 minute/page to 24 hours/page,
1cm/hour to 300cm/hour | 1 minute/page to 24 hours/page,
1cm/hour to 60cm/hour |
| User Selectable
Trends Time Scale | Yes | No |
| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG
(Predicate device
K133793) |
| Annotation List | Yes | Yes |
| Raw EEG data
display look-back
while recording
synchronized video | Yes | Yes |
Device Comparison
6
7
8
Test Summary:
Performance testing for the QP-160AK includes software verification tests, system validation tests, and seizure detection performance tests. Traceability has been documented between all system specifications to validation test protocols.
Verification and validation testing includes:
-
- Code inspections
-
- Unit level testing
-
- Integration level testing
-
- System level testing
-
- Seizure detection performance testing: The testing was performed using archived EEG recordings obtained from 139 patients of 18 years and older admitted to an Epilepsy Monitoring Unit. All EEG data were recorded with full scalp montage using the standard 10/20 system. Each recording lasts approximately 4 hours for a total of 556 hours of EEG recording. All 139 recordings were manually annotated by three independent EEG experts and the clinical reference standard (ground truth) was determined by using a two-third majority rule. Total 145 seizures were identified. The same EEG recordings were used for seizure detection by the QP-160AK EEG Trend Program and the results were compared against the ground truth by calculating Positive Percent Agreement (PPA) and False Detection Rate (FDR) as below:
$$\text{PPA} = \frac{True \text{ Positives}}{True \text{ Positives} + False \text{ Negatives}}$$
$$\text{FDR} = \frac{\text{False Positives}}{hour \text{ of } EEG \text{ Recording}}$$
The following mean and 95% Confidence Intervals using bootstrap method were obtained:
| Performance Statistics | Mean | 95% CI |
|---|---|---|
| Positive Percent Agreement (%) | 77.2 | 69.0 - 83.5 |
| False Detection Rate (FDR) | 0.451 | 0.320 - 0.669 |
9
Image /page/9/Figure/0 description: The image is a graph titled "PPA and 95% Confidence Interval for Seizure Detection". The x-axis is labeled "PPA (%)" and ranges from 40 to 100. The y-axis lists different devices: QP-160AK, Persyst12, Cliniscan, Cadwell, IdentEvent, and Persyst Reveal. Each device has a horizontal line representing its 95% confidence interval for seizure detection, with markers indicating the lower and upper bounds.
Comparison of Positive Percent Agreement and 95% Confidence Interval
Comparison of False Detection Rate and 95% Confidence Interval
Image /page/9/Figure/3 description: The image is a plot titled "FDR and 95% Confidence Interval for Seizure Detection". The x-axis is labeled "FDR (Fp/h)" and ranges from 0 to 1. There are six different devices plotted on the graph: Cadwell, IdentEvent, Persyst Reveal, Persyst12, Cliniscan, and QP-160AK. Each device has a different symbol and color associated with it.
Conclusion:
The performance of the Nihon Kohden QP-160AK EEG Trend Program is substantially equivalent to the predicate devices, the Nihon Kohden QP-160AK EEG Trend Program (K120485) and Persyst 12 EEG Review and Analysis Software (K133793), and raises no safety or effectiveness issues.