(308 days)
Not Found
Yes
The description explicitly mentions "archived clinical data from multiple sites was used to train and validate the internal parameters involved in seizure detection," which is characteristic of training a machine learning model. The performance study also evaluates an "event detection algorithm" which is likely the trained model.
No
Explanation: The Intended Use section clearly states that the device is a "clinical decision support system for medical data" that assists in "visualization and analysis of EEG data" and is "NOT designed to provide definitive diagnoses of diseases or treatments of ailments." This indicates it is for informational support, not direct therapy.
Yes.
The device is intended to assist healthcare professionals in the visualization and analysis of EEG data, specifically for marking sections that may correspond to electrographic seizures, directly supporting diagnostic assessment. The text also states that it provides "analytics data derived from a patient's input EEG data" and "detects seizure events for review by qualified medical professionals," which are key characteristics of a diagnostic device. While it explicitly states it is "NOT designed to provide definitive diagnoses," its function is to provide critical information that aids in the diagnostic process.
Yes
The device description and intended use clearly define CliniscanSM EEG as a software system for visualizing and analyzing previously acquired EEG data. There is no mention of any hardware components being part of the device itself; it processes input data and provides outputs through a user interface.
Based on the provided information, CliniscanSM EEG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body.
- CliniscanSM EEG's Function: CliniscanSM EEG analyzes previously acquired EEG recordings. EEG recordings are electrical signals measured from the scalp, representing brain activity. While this data is derived from a patient, the device is analyzing the recording itself, not a biological specimen taken from the body.
- Intended Use: The intended use clearly states that the device assists healthcare professionals in the visualization and analysis of EEG data. It is a clinical decision support system for medical data.
- Device Description: The device description reinforces that it analyzes and displays information from EEG recordings.
In summary, CliniscanSM EEG processes and analyzes electrical signals recorded from the body, which falls under the category of medical devices that analyze physiological data, rather than IVD devices that analyze biological specimens.
No
The input text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device, nor does it reference "Control Plan Authorized (PCCP)" or section 515C(b)(1).
Intended Use / Indications for Use
- CliniscanSM EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data.
- The Seizure Detection component of CliniscanSM EEG 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.
- CliniscanSM EEG is intended for use on EEG recordings acquired using full scalp montage according to the standard 10/20 system.
- The user may annotate the data, and the annotations are stored with the EEG recording in the cloud.
- CliniscanSM EEG displays standard qEGG features to the user including FFT Power Spectrum, Coherence Mapping (EEG Activity Mapping), Density Spectral Array, EEG Localization Maps, and Wavelet Subband Decomposition (Delta, Theta, Alpha, Beta, and Gamma).
- CliniscanSM EEG detects seizure events for review by qualified medical professionals.
- CliniscanSM EEG is designed to provide analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
Product codes (comma separated list FDA assigned to the subject device)
OMB, OLT
Device Description
Cliniscan®M EEG, a Picofemto product, is a clinical decision support system for medical data, designed to assist healthcare professionals in the visualization and analysis of EEG data. The device provides seizure event detection and calculates many qEEG (quantitative EEG) parameters for display to the user. All analysis (seizure detection and qEEG) are displayed in conjunction with the original EEG recording for review by experts and are designed to be reviewed in the context of the original data.
The Cliniscan®% EEG visualizer provides a user-friendly environment for displaying the available qEEG parameters along with the original EEG recording (see below). The EEG recording display window, time bar, and User Annotations frames remained fixed within the visualizer; however, the bottom portion of the screen contains tabs for the user to navigate the qEEG features. The user may access the FFT Power Spectrum, Coherence Maps, and EEG Topography Maps under the "Combo" tab; Wavelet Subband Decomposition and the FFT Power Spectrum (again) are located under the "Power" tab; the "DSA" tab contains only the Density Spectral Array display.
After uploaded an EEG in EDF format, the user may view the following qEEG Parameters:
- FFT Power Spectrum The user can select any two channels to view an FFT Power Spectrum of Power vs. Frequency between the two channels.
- Coherence Maps Coherence maps are displayed to the user, allowing the user to define cut-off values ranging from 0-1 and the frequency of interest (composite, delta, theta, alpha, beta, or gamma). As the user-defined parameters are adjusted, the six maps display the corresponding coherence. The user may also select to view Lateral, Sagittal, or both types of coherence.
- EEG Topographical Maps EEG Topographical Maps maps and a corresponding Power vs. Frequency graph are displayed to the user. The maps are calculated using independent component analysis, and the top four components along with the scaled average are displayed to the user. The relative powers of the independent components are displayed in which the higher power corresponds to the top (red) part of the spectrum. The absolute power of these components is not necessary, and, therefore, is not displayed to the user.
- Wavelet Subband Decomposition –The user may select a channel of interest to view the different frequencies of said channel broken down into the five main frequency bands of interest: Delta, Theta, Alpha, Beta, and Gamma. The original channel is displayed at the top of the graph, with the corresponding frequency ranges displayed in the same time frame beneath the channel.
- Density Spectral Array (DSA) – The DSA display updates for each user-selected time-window. Additionally, the user may select which channels to include in the DSA calculation.
- User Annotations The user may add annotations including the time of the event, the subject name, and any important details. These annotations are saved with the recording in the cloud.
- Seizure Event Detection The visualizer automatically displays the results of the seizure event detection algorithm for the user to review. The event is indicated by a small red block marked on the overall time bar, followed by a larger red block marked on the user-selected time-bar. Within the channel display, the onset and offset of the detected seizure are indicated using red dashed lines, and the inclusive time window is highlighted a tan color to differentiate from the non-seizure windows.
- Info Under the "Info" tab, additional details are available to the user as selectable text (may be copied and pasted). This information includes Analysis Details, Incidents (seizure events with onset and offset time), and Channels.
Cliniscan®ª EEG is designed to provide industry standard analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
Cliniscan§™ EEG detects and marks possible seizure events on previously acquired EEG recordings for review by qualified medical professionals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG recordings
Anatomical Site
Scalp (Brain)
Indicated Patient Age Range
Adult (greater than or equal to 18 years)
Intended User / Care Setting
Healthcare professionals / qualified clinical practitioners / qualified medical professionals. Clinical Decision Support System.
Description of the training set, sample size, data source, and annotation protocol
Archived clinical data from multiple sites was used to train and validate the internal parameters involved in seizure detection.
Description of the test set, sample size, data source, and annotation protocol
Cliniscan® EEG was evaluated using 144 subjects for seizure determination acquired from the Epilepsy Monitoring Unit (EMU). Recordings are attained as archived clinical data from subjects 18 years of age and greater. Each recording lasts approximately 2 hours for a total of about 293 hours of EEG recordings. Roughly 20% of the recordings are "normal", coming from subjects with no history of seizures; each recording contains no more than 4 seizures to reduce bias and heavily weighted results. After ground truth determination, 134 seizures were identified in the clinical study collection. All recordings were previously acquired using a standard 10-20 montage scalp EEG and saved down in .edf format.
Each of the 144 recordings were manually marked for seizure onset and offset by three independent and blinded EEG experts. Each expert was provided with a basic EEG visualizer loaded onto a remote machine along with the previously acquired EEG recordings. The end point for the clinical study was for each EEG expert to manually mark any seizure events located in the collection of EEG recordings. Due to the expected inter-rater variability, a two-thirds majority rule was used to determine the ground truth for seizure presence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study, Non-Clinical Performance Data
Non-Clinical Performance Data:
Testing was performed at the unit, integration, and functional/system levels and included verification testing of algorithms and risk control measures. Synthetic data was used to test ICA, Coherence, FFT, and Seizure Detection.
Clinical Study:
A clinical study was conducted to demonstrate substantial safety and effectiveness when Cliniscan5M EEG's event detection algorithm is compared to ground truth (two-thirds majority rule of manual markings by EEG experts). These claims are supported by evaluating the Positive Percent Agreement (PPA) and False Positives per hour (Fp/H) of Cliniscan®M EEG verses ground truth, each EEG expert verses the compiled ground truth, and comparison to previous results from predicate Persyst Reveal.
Subject Population and Test Data Set:
Cliniscan® EEG was evaluated using 144 subjects for seizure determination acquired from the Epilepsy Monitoring Unit (EMU). Recordings are attained as archived clinical data from subjects 18 years of age and greater. Each recording lasts approximately 2 hours for a total of about 293 hours of EEG recordings. Roughly 20% of the recordings are "normal", coming from subjects with no history of seizures; each recording contains no more than 4 seizures to reduce bias and heavily weighted results. After ground truth determination, 134 seizures were identified in the clinical study collection. All recordings were previously acquired using a standard 10-20 montage scalp EEG and saved down in .edf format.
Reference Standard (Ground Truth):
Each of the 144 recordings were manually marked for seizure onset and offset by three independent and blinded EEG experts. Each expert was provided with a basic EEG visualizer loaded onto a remote machine along with the previously acquired EEG recordings. The end point for the clinical study was for each EEG expert to manually mark any seizure events located in the collection of EEG recordings. Due to the expected inter-rater variability, a two-thirds majority rule was used to determine the ground truth for seizure presence.
Statistical Analysis:
- Inter-rater Performance for Seizure Detection: Each rater is compared to every other rater to find their relative PPA and Fp/H. The PPAs ranged from 0.77-0.90 and the Fp/H ranged from 0.13-0.20. These ranges are typical for acceptable predicate devices; therefore, the inter-rater agreement is sufficient for compiling a 2/3 majority ground truth.
- Algorithm Seizure Detection Analysis: The same recordings marked by all three EEG experts were ran through the Cliniscan5M EEG event detection algorithm. The algorithm results are compared to the compiled ground truth using PPA and Fp/H. A bootstrap method is compiled to create a 95% confidence interval to compare the algorithm to ground truth.
Results:
Cliniscan§™ results are obtained from the clinical study designed specifically for testing Cliniscan5M. The Cliniscan5M EEG's seizure detection algorithm was compared to the ground truth to determine PPA and Fp/H.
PPA (95% C.I.): [0.687, 0.857]; Original Mean: 0.7835; Bias-corrected Mean: 0.7846; Standard Error: 0.042
Fp/H (95% C.I.): [0.325, 0.540]; Original Mean: 0.4164; Bias-corrected Mean: 0.4162; Standard Error: 0.054
Conclusion:
Based on the non-clinical testing, it is believed that Clinican™ EEG provides automatic EEG seizure event detection which introduces no new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), False Positives per hour (Fp/H)
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.
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The overall design is simple and professional, reflecting the organization's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Picofemto LLC Srikant Krishna Founder and CEO 228 East 45th St., 2nd Floor New York, NY 10001
Re: K141883
Trade/Device Name: CliniScan5M EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT Dated: April 13, 2015 Received: April 14, 2015
Dear Mr. Krishna:
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. Isting 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 (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.
1
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/Resourcesfor You/Industry/default.htm. 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 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 yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for 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) K141883
Device Name CliniScanSM EEG
Indications for Use (Describe)
-
CliniscanSM EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data.
-
The Seizure Detection component of CliniscanSM EEG 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.
-
CliniscanSM EEG is intended for use on EEG recordings acquired using full scalp montage according to the standard 10/20 system.
-
The user may annotate the data, and the annotations are stored with the EEG recording in the cloud.
-
CliniscanSM EEG displays standard qEGG features to the user including FFT Power Spectrum. Coherence Mapping (EEG Activity Mapping), Density Spectral Array, EEG Localization Maps, and Wavelet Subband Decomposition (Delta, Theta, Alpha, Beta, and Gamma).
-
CliniscanSM EEG detects seizure events for review by qualified medical professionals.
-
CliniscanSM EEG is designed to provide analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
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) |
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Image /page/3/Picture/0 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and orange circles on the left, followed by the text "PICOFEMTO" in a large, bold, blue font. Below "PICOFEMTO" is the text "BIOMEDICAL ANALYTICS" in a smaller, lighter blue font. The overall design is clean and modern, suggesting a focus on precision and innovation in the biomedical field.
228 E. 45th St., 2nd Floor, NY 10017 ● (P) 212-502-3770 ● (F) 212-502-0818 ● contact@picofemto.com
510(k) Summary
A summary of safety and effectiveness information in accordance with 21 CFR 807.92
- Submitter: Picofemto LLC
- Address: 228 East 45th St., 2nd Floor
New York, New York 10017
- Contact Person: Srikant Krishna
- Phone Number: (212) 502-3770
- Fax Number: (212) 502-0818
- Date Prepared: 04/13/2015
- Trade Name: CliniscanSM EEG
- Common Name: Electroencephalogram (EEG) signal spectrum and source analyzer
- Classification (OMB) Automatic event detection software for full-montage electroencephalograph and (OLT) qEEG Name:
- Regulation 21 CFR 882.1400
Number:
- Predicate The Cliniscan560 EEG is substantially equivalent to the Persyst ® Reveal [FDA 510(k) Devices: number K011397] and Neurosoft Curry 7 [FDA 510(k) number K001781].
Image /page/3/Picture/16 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and light blue circles with one orange circle, arranged in a circular pattern on the left. To the right of the circles, the text "PICOFEMTO" is written in a combination of black and blue, with "BIOMEDICAL ANALYTICS" in smaller, light blue letters underneath.
4
Device Cliniscan®M EEG, a Picofemto product, is a clinical decision support system for medical Description data, designed to assist healthcare professionals in the visualization and analysis of EEG data. The device provides seizure event detection and calculates many qEEG (quantitative EEG) parameters for display to the user. All analysis (seizure detection and qEEG) are displayed in conjunction with the original EEG recording for review by experts and are designed to be reviewed in the context of the original data.
The Cliniscan®% EEG visualizer provides a user-friendly environment for displaying the available qEEG parameters along with the original EEG recording (see below). The EEG recording display window, time bar, and User Annotations frames remained fixed within the visualizer; however, the bottom portion of the screen contains tabs for the user to navigate the qEEG features. The user may access the FFT Power Spectrum, Coherence Maps, and EEG Topography Maps under the "Combo" tab; Wavelet Subband Decomposition and the FFT Power Spectrum (again) are located under the "Power" tab; the "DSA" tab contains only the Density Spectral Array display.
Image /page/4/Figure/2 description: The image shows an EEG analysis interface. The interface displays EEG waveforms over time, with timestamps indicating the duration of the recording. Below the waveforms, there are several plots including FFT power spectrum, coherence maps, EEG localization, and scaled average plots. The FFT power spectrum shows the power of different frequency bands, while the coherence maps display the connectivity between different brain regions.
After uploaded an EEG in EDF format, the user may view the following qEEG Parameters:
-
- FFT Power Spectrum The user can select any two channels to view an FFT Power Spectrum of Power vs. Frequency between the two channels.
Image /page/4/Picture/5 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and orange circles on the left, followed by the text "PICOFEMTO" in black and blue. Below "PICOFEMTO" is the text "BIOMEDICAL ANALYTICS" in a smaller, lighter blue font. The logo is clean and modern, with a focus on the company's name and area of expertise.
- FFT Power Spectrum The user can select any two channels to view an FFT Power Spectrum of Power vs. Frequency between the two channels.
5
Image /page/5/Figure/0 description: The image shows a graph of an FFT Power Spectrum from +00:00:00.000 to +00:00:10.000. The y-axis is labeled "Power (10*log_10(µV^2/Hz)" and ranges from -10 to 15. The x-axis is labeled "Frequency (hz)" and ranges from 0 to 35. There are two lines on the graph, one green and one purple, representing the channel selections F7-T3 and T3-T5, respectively.
-
- Coherence Maps Coherence maps are displayed to the user, allowing the user to define cut-off values ranging from 0-1 and the frequency of interest (composite, delta, theta, alpha, beta, or gamma). As the user-defined parameters are adjusted, the six maps display the corresponding coherence. The user may also select to view Lateral, Sagittal, or both types of coherence.
Image /page/5/Figure/2 description: The image shows a series of coherence maps, displaying brain activity over time. The time frame is from +00:00:00.000 to +00:00:10.000. The maps are arranged in a grid, with labels such as c_s1_e4, c_s4_e8, c_s8_e15, c_s15_e30, and c_s30_e60. The frequency is set to composite, and both lateral and sagittal views are selected.
- Coherence Maps Coherence maps are displayed to the user, allowing the user to define cut-off values ranging from 0-1 and the frequency of interest (composite, delta, theta, alpha, beta, or gamma). As the user-defined parameters are adjusted, the six maps display the corresponding coherence. The user may also select to view Lateral, Sagittal, or both types of coherence.
Image /page/5/Picture/3 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and light blue circles with one orange circle, followed by the text "PICOFEMTO" in a dark blue sans-serif font. Below "PICOFEMTO" is the text "BIOMEDICAL ANALYTICS" in a smaller, lighter blue sans-serif font.
6
-
- EEG Topographical Maps EEG Topographical Maps maps and a corresponding Power vs. Frequency graph are displayed to the user. The maps are calculated using independent component analysis, and the top four components along with the scaled average are displayed to the user. The relative powers of the independent components are displayed in which the higher power corresponds to the top (red) part of the spectrum. The absolute power of these components is not necessary, and, therefore, is not displayed to the user.
Image /page/6/Figure/1 description: The image shows an EEG localization analysis. On the left, there is a graph of power spectral density versus frequency, with multiple lines representing different EEG channels. The x-axis is labeled "Frequency (Hz)" ranging from 0 to 35, and the y-axis is labeled "Power (10*log_10(µV^2/Hz)". On the right, there are topographical maps showing the spatial distribution of EEG activity for different components, labeled as "Scaled Average", "Component 0", "Component 1", "Component 2", "Component 3", and "Component 4".
- EEG Topographical Maps EEG Topographical Maps maps and a corresponding Power vs. Frequency graph are displayed to the user. The maps are calculated using independent component analysis, and the top four components along with the scaled average are displayed to the user. The relative powers of the independent components are displayed in which the higher power corresponds to the top (red) part of the spectrum. The absolute power of these components is not necessary, and, therefore, is not displayed to the user.
-
Wavelet Subband Decomposition –The user may select a channel of interest to 4) view the different frequencies of said channel broken down into the five main frequency bands of interest: Delta, Theta, Alpha, Beta, and Gamma. The original channel is displayed at the top of the graph, with the corresponding frequency ranges displayed in the same time frame beneath the channel.
Image /page/6/Figure/3 description: The image shows a graph of wavelet subbands over time. The graph displays the frequency bands F7-T3, Delta, Theta, Alpha, and Beta. The x-axis represents time, ranging from +00:00:00.000 to +00:00:10.0. The y-axis represents the amplitude of the wavelet subbands. -
- Density Spectral Array (DSA) – The DSA display updates for each user-selected time-window. Additionally, the user may select which channels to include in
Image /page/6/Picture/5 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and light blue circles with one orange circle, followed by the text "PICOFEMTO" in a dark gray sans-serif font. Below the text is the phrase "BIOMEDICAL ANALYTICS" in a smaller, lighter blue sans-serif font.
- Density Spectral Array (DSA) – The DSA display updates for each user-selected time-window. Additionally, the user may select which channels to include in
7
the DSA calculation.
Image /page/7/Figure/1 description: The image shows a density spectral array with a color gradient from blue to red. The y-axis represents frequency in Hz, ranging from 5 to 55. The x-axis represents time, with labels such as '+00:13:20.000' and '+00:40:00.000'. The color intensity indicates the density or intensity of the spectral data at each frequency and time point.
- User Annotations The user may add annotations including the time of the ର) event, the subject name, and any important details. These annotations are saved with the recording in the cloud.
User Annotations
New Annotation
| Time | +00: 00:05 .000 |
|---|---|
| Subject | |
| Details |
Create
Notes
-
- Seizure Event Detection The visualizer automatically displays the results of the seizure event detection algorithm for the user to review. The event is indicated by a small red block marked on the overall time bar, followed by a larger red block marked on the user-selected time-bar. Within the channel display, the onset and offset of the detected seizure are indicated using red dashed lines, and the inclusive time window is highlighted a tan color to differentiate from the non-seizure windows.
Image /page/7/Picture/5 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue circles of varying sizes on the left, with one orange circle among them. To the right of the circles is the text "PICOFEMTO" in a sans-serif font, with "BIOMEDICAL ANALYTICS" in a smaller font below it. The text is also in blue, matching the color of the circles.
- Seizure Event Detection The visualizer automatically displays the results of the seizure event detection algorithm for the user to review. The event is indicated by a small red block marked on the overall time bar, followed by a larger red block marked on the user-selected time-bar. Within the channel display, the onset and offset of the detected seizure are indicated using red dashed lines, and the inclusive time window is highlighted a tan color to differentiate from the non-seizure windows.
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| こことなってきてきてきてきてきましたときてきてきてきてきてきてきてきていましたときてくるときてくるときてく | |||||||||||
| いていますときてくるとことできるとしてきましたときてくるときてくるときてくるとしてきてくってくって | |||||||||||
| -00 2806.000 | -00 28:10 :000 | +00, 28:15 ,000 | |||||||||
| Sortes By Recommended Gan 5 | Range Frèe Form |
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- Info Under the "Info" tab, additional details are available to the user as selectable text (may be copied and pasted). This information includes Analysis Details, Incidents (seizure events with onset and offset time), and Channels.
Cliniscan®ª EEG is designed to provide industry standard analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
- Info Under the "Info" tab, additional details are available to the user as selectable text (may be copied and pasted). This information includes Analysis Details, Incidents (seizure events with onset and offset time), and Channels.
Cliniscan§™ EEG detects and marks possible seizure events on previously acquired EEG Technology Description recordings for review by qualified medical professionals.
Image /page/8/Picture/4 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and orange circles on the left, followed by the text "PICOFEMTO" in a bold, sans-serif font. Below "PICOFEMTO" is the text "BIOMEDICAL ANALYTICS" in a smaller, lighter font. The overall design is clean and modern, suggesting a focus on precision and innovation in the biomedical field.
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Intended Use/Indications for Use:
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- Cliniscan®ª EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data.
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- The Seizure Detection component of Cliniscan500 EEG 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.
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- Cliniscan®ª EEG is intended for use on EEG recordings acquired using full scalp montage according to the standard 10/20 system.
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- The user may annotate the data, and the annotations are stored with the EEG recording in the cloud.
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- Cliniscan3M EEG displays standard qEEG features to the user including FFT Power Spectrum, Coherence Mapping (EEG Activity Mapping), Density Spectral Array, EEG Topography Maps, and Wavelet Subband Decomposition (Delta, Theta, Alpha, Beta, and Gamma).
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- Cliniscan5M EEG detects seizure events for review by qualified medical professionals.
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- Cliniscan5M EEG is designed to provide analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
Image /page/9/Picture/8 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and light blue circles with one orange circle, followed by the text "PICOFEMTO" in black and blue. Below "PICOFEMTO" is the text "BIOMEDICAL ANALYTICS" in a smaller, lighter blue font.
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Device Comparison to Predicate Device:
| Features | Persyst Reveal
EEG Review and
Analysis Software
K011397 | Curry 7
Multimodal
Neurolmaging
Software
K001781 | CliniscanSM EEG
Electroencephalogram
(EEG) signal spectrum
and source analyzer
K141883 |
|-----------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 1. Product Code | OMB/OLT | OLX | OMB/OLT |
| 2. Product Class | II | II | II |
| 3. EEG Modality Compatible | Yes | Yes | Yes |
| 4. Identifies seizures | Yes | No | Yes |
| 5. Intended Use Age Range | Pediatric and Adult | Pediatric and Adult | Adult (18+) |
| 6. Montage/Channel Array | Scalp 10/20 Array | Custom and Scalp
10/20 Array | Scalp 10/20 Array |
| 7. Type of EEG analysis | Post-hoc | Real-time and post hoc | Post-hoc |
| 8. Data storage | Yes | Yes | Yes |
| 9. Artifact Reduction | Yes | Yes | Yes |
| 10. Wavelet sub band
decomposition | Yes | Yes | Yes |
| 11. Density spectral maps | Yes | No | Yes |
| 12. FFT Power Spectrum | Yes | Yes | Yes |
| 13. EEG Topographical Maps | Yes | Yes | Yes |
| 14. Coherence Maps (EEG
Brain Mapping) | No | Yes | Yes |
| 15. User-defined parameters
for display purposes | Yes | Yes | Yes |
| 16. Cloud based | No | No, but includes an
online signal processing
package | Yes |
| 17. Operating Systems | Unknown | Unknown | Windows and MacOS |
| 18. Applicable Web Browsers | N/A | Unknown | Firefox ESR Version
24
Chrome Version 35 |
| 19. Computer hardware
needed but not provided. | unknown | Unknown | Yes |
We have found that Cliniscan® EEG is substantially equivalent to Persyst Reveal for all of the features (1-19) with the exception of Coherence Mapping; however, Cliniscan®º EEG is substantially equivalent to Curry 7 regarding the Coherence Mapping feature (See Explanation 14. Coherence Mapping below).
Image /page/10/Picture/3 description: The image shows the logo for PicoFemto Biomedical Analytics. The logo consists of a cluster of blue and light blue circles with one orange circle, followed by the text "PICOFEMTO" in a combination of black and blue. Below "PICOFEMTO" is the text "BIOMEDICAL ANALYTICS" in a smaller font size.
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- Product Code: Persyst Reveal and Picofemto's Cliniscan® EEG both fall under product code OMB with a secondary product code OLT. Both devices mark events in previously acquired EEG recordings with supplemental quantitative EEG analysis.
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- Product Class: Both devices are a product class II due to the possibility of a medical professional relying on device output to determine patient diagnosis. Neither device attempts to diagnose a disease or ailment of any kind, and results must always be reviewed by qualified medical professionals.
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- EEG Modality Compatible: Both devices are intended to take previously acquired EEG recordings and analytically process the data.
- Identifies Seizures: Both devices detect seizure activity. Cliniscan® EEG detects seizures by 4. highlighting the window of the suggested event location. Persyst Reveal provides an equivalent single bar with the seizure event indicated.
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- Intended Use Age Range: Both devices are intended for use in adults; however, Persyst Reveal includes pediatric use for seizure detection.
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- Montage/Channel Array: Both devices are compatible with a standard 21-channel 10/20 monopolar montage using scalp electrodes.
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- Type of EEG Analysis: Both devices are intended for use in post-hoc analysis of EEG recordings. Neither device is meant to detect events in real-time analysis or to administer any medication based on detected events.
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- Data Storage: Both devices offer data storage so the user only needs to upload the EEG recording one-time. In Cliniscan® EEG, data is stored safely on the cloud for the user to access from any compatible device.
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- Artifact Reduction: Both products offer artifact reduction using overlapping epochs to remove artifacts resulting from muscle twitches, eye movement, electrical, heartbeat, tongue and chewing. Persyst Reveal offers artifact reduction based on a user selection using blind source separation algorithms. Cliniscan500 uses measures of Kurtosis in back-end processing to automatically remove artifacts.
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- Wavelet Sub-band Decomposition: Both devices decompose brain waves into alpha (8-12 Hz), beta (13-30 Hz), delta (