(323 days)
Not Found
No
The document describes standard EEG processing and trending features (aEEG, FFT, burst suppression) without mentioning any AI or ML algorithms. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as software that records, calculates, and displays EEG data to help monitor and analyze the state of the brain. It does not provide any diagnostic conclusions or indicate any treatment function.
No
The text explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user." It is intended to help users monitor, analyze, and identify patterns in EEG data.
No
The device is described as a software program installed on an existing electroencephalograph (EEG) system (EEG-1200A Series). While the QP-160AK itself is software, its function is entirely dependent on and integrated with the hardware of the EEG system to acquire and process the data. Therefore, it is not a standalone software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes electrical signals from the brain (EEG data) obtained directly from the patient via electrodes.
- The intended use is to monitor and analyze EEG data to help qualified medical practitioners assess the state of the brain. While this information is used in a clinical context, it's not about analyzing a biological sample in vitro (outside the body).
- The device description focuses on processing and displaying EEG waveforms and trends. This aligns with the function of an electroencephalograph accessory, not an IVD.
Therefore, the QP-160AK Trend program is a software accessory for an electroencephalograph, not an IVD.
N/A
Intended Use / Indications for Use
The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.
The intended use for each of the software's outputs 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 burstsuppression pattern in the EEG.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Product codes (comma separated list FDA assigned to the subject device)
OMA, OLT, ORT
Device Description
Physical Description
The QP-160AK EEG Trend program is a software program stored on electronic media such as CD Rom.
Principles of Operation
The EEG-1200A OP-160AK Trend program is a device which is installed on the electroencephalograph EEG-1200A Series and records the EEG waveforms and identifies trends in the EEG data over extended periods of time in order for trained health care professionals to observe changes over time.
Design Features
The QP-160AK design features are as follows:
- Trend display of aEEG and Burst suppression ratio .
- Display of EEG waveform maximum of 64 channels
- DC Trend display including analog inputs .
- Operations of functions by control buttons adapted to touch panels .
- Data management by NeuroWorkbench .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical practitioners, trained in Electroencephalography / Any location within a medical facility, physician's office, laboratory, clinic or nursing home.
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)
The QP-160AK EEG Trend Program was subjected to safety and performance testing procedures. The QP-160AK EEG Trend Program has undergone validation and verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of the burst suppression ratio and aEEG. These tests verified that the device performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021185, K081551, K092039, K080217
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 - Nihon Kohden QP-160AK EEG Trend Program
JUL -- 9 2010
Name and Address of Applicant Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610
Contact: Steve Geerdes Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550
Summary revised on 7/8/2010
Trade/Device Name:
Nihon Kohden QP-160AK EEG Trend Program
Common or usual Name:
Electroencephalograph (EEG)
Legally Marketed Predicate:
Nervus Monitor (K021185) commercial distribution certification dated July 12, 2002.
Grass Technologies TWin Neurotrac-III (K081551) commercial distribution certification dated December 241" 2008.
Natus Neuroworks (K092039) commercial distribution certification dated Febuary 2200 2009.
Day One Medical CNS Monitor (K080217) commercial distribution certification dated November 5th 2008.
Intended Use:
The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.
The intended use for each of the software's outputs 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 burstsuppression pattern in the EEG.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
1
Device Description
Physical Description
The QP-160AK EEG Trend program is a software program stored on electronic media such as CD Rom.
Principles of Operation
The EEG-1200A OP-160AK Trend program is a device which is installed on the electroencephalograph EEG-1200A Series and records the EEG waveforms and identifies trends in the EEG data over extended periods of time in order for trained health care professionals to observe changes over time.
Design Features
The QP-160AK design features are as follows:
- Trend display of aEEG and Burst suppression ratio .
- Display of EEG waveform maximum of 64 channels
- DC Trend display including analog inputs .
- Operations of functions by control buttons adapted to touch panels .
- Data management by NeuroWorkbench .
A summary of the technological characteristics of the device compared to the predicate device:
The main difference between the new QP-160AK EEG Trend program and the predicate the Nervus Monitor is a different time interval of trends.
The main difference between the new QP-160AK EEG Trend program and the predicate device " Grass Technologies Neurotrac III is a different time interval of trends
The main difference between the new QP-160AK EEG Trend program and the predicate device "Natus Neuroworks is the Natus only provides aEEG elements of the OP-160AK
The main difference between the new OP-160AK EEG Trend program and the predicate device "Day One Medical CNS Monitor is a stand alone product.
COMPARATIVE INFORMATION
A. Intended Use
| Nihon Kohden | Carefusion | Grass | Natus | Day One Medical |
|---|---|---|---|---|
| QP -160 Trends | Nervus Monitor | NeuroTrac III | Neuroworks | CNS Monitor |
| 510k Pending | K-021185 | K-081551 | K-090019 | K-080217 |
| (07-12-02) | (12-24-08) | (02-22-10) . | (11-05-08) | |
| aEEG | Yes (aEEG) | Yes (aEEG) | Yes (aEEG) | Yes (aEEG) |
| Burst Suppression | ||||
| Ratio | Yes (Burst | |||
| Suppression Ratio) | Yes (Burst | |||
| Suppression | ||||
| Index) | No | Yes (percent | ||
| Suppression) |
2
| Inter-burst Interval | Yes (Burst Suppression) | Yes (Inter-Burst Interval) | No | Yes (Inter Burst Interval) |
|---|---|---|---|---|
| Burst per minute | Yes (Burst Suppression) | No | No | Unknown |
| FFT Power | Yes (Abs band power/Tower power) | Yes (FFT bands trends) | No | Yes (Total Power) |
| FFT Power Ratio | ||||
| (Alpha /Delta) | Yes (Alpha to Delta) | Yes (FFT bands trends) | No | Yes (EEG Band Power Percentages) |
| DC Trend including | ||||
| analog input | Yes (Generic trend) | Yes (DC | ||
| Channel Display) | No | Yes (Serial input) |
Physical Characteristics B.
| Nihon Kohden | Carefusion, | Grass | Natus | Day One Medical |
|---|---|---|---|---|
| QP -160 Trends | Nervus Monitor | NeuroTrac III | Neuroworks | CNS Monitor |
| CD ROM or electronic | ||||
| media | Incorporate in the | |||
| Monitor | CD ROM or | |||
| electronic | ||||
| media | CD ROM or | |||
| electronic | ||||
| media | Incorporate in the | |||
| Monitor |
C. Target Population
| Nihon Kohden
OP-160 Trends | Carefusion
Nervus
Monitor | Grass
NeuroTrac
III | Natus
Neuroworks | Day One
Medical
CNS Monitor |
|----------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------|---------------------|-----------------------------------|
| 1. Any location within a medical
facility, physician's office,
laboratory, clinic or nursing home. | Same | Same | Same | Same |
Performance Testing
- To date no special controls or performance standards are known or established for this . device as required by sections 513(b) and 514 of the Food, Drug and Cosmetic Act as implemented by 21 CFR Part 861.
- The device is not sterile. .
- . The device does not directly contact patients. Therefore, good laboratory practice studies were not required per 21 CFR Part 58.
- . The QP-160AK EEG Trend Program was subjected to safety and performance testing procedures. The QP-160AK EEG Trend Program has undergone validation and
3
verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of the burst suppression ratio and aEEG. These tests verified that the device performed within specifications.
Conclusion of Substantial Equivalence:
- The comparison of technological characteristics and performance testing of the QP-. 160AK EEG Trend Program demonstrate that its safety, effectiveness, and performance are equivalent to the specified predicate devices. Therefore, Nihon Kohden believes that the device is substantially equivalent to the Nervus Monitor, Grass Neurotrac III, Natus Neuroworks, and the Day One Medical CNS Monitor predicate devices as stated.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and two curved lines representing its feet. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nihon Kohden America, Inc. c/o Mr. Steve Geerdes Director, Regulatory Affairs 90 Icon Street Foothill Ranch, CA 9261 0
APA - 5 2012
K092573 Re:
Trade/Device Name: Nihon Kohden QP-160AK EEG Trend Program for the Nihon Kohden EEG-1200A Series Neurofax Electroencephalograph Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OLT, ORT Dated (Date on orig SE ltr): June 30, 2010 Received (Date on orig SE Itr): July 1, 2010
Dear Mr. Geerdes:
This letter corrects our substantially equivalent letter of July 9, 2010.
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.
5
Page 2 - Mr. 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 (21 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 (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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Image /page/5/Picture/8 description: The image shows the handwritten word "for" in cursive script. The letters are connected, with the "f" having a prominent loop extending both above and below the baseline. The "o" and "r" are smaller and connected smoothly to the "f", creating a flowing and elegant appearance.
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
6
Indications for Use Form
510(k) Number (if known): _ K092573
Device Name: _Nihon Kohden QP-160AK EEG Trend Program
Indications for Use:
The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.
The intended use for each of the software's outputs 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 burstsuppression pattern in the EEG.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Prescription Use × (Part 21 CFR 801 Subpart.D) AND/OR
Over-The-Counter Use (21 GFR 801 Subpart C).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.C.
ion Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092573