(287 days)
No
The description focuses on data acquisition, storage, and viewing, with no mention of algorithms for analysis or interpretation of the EEG data. The "Intelligent" in the name appears to refer to the device's capabilities for data handling and wireless communication, not AI/ML processing.
No.
The device's intended use is to acquire and store electrical activity of the brain for review by a medical professional to monitor the brain, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended to acquire and store electrical activity of the brain for review by a medical professional to monitor the brain, which is a diagnostic purpose.
No
The device description explicitly states that the iEEG device consists of an "iEEG transmitter module," a "medical grade AC charging adapter/charging cable," and "iEEG viewer/recorder software." The transmitter module is described as a physical component with electrode connections, indicators, and a push button switch, powered by an internal rechargeable source. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The iEEG device acquires and stores electrical activity of the brain. It does not analyze biological specimens from the body.
- Intended Use: The intended use is to acquire and store electrical activity of the brain for review by a medical professional to monitor the brain. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the iEEG device falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healtheare professional. The device is intended for use on all patient populations including pediatric.
Product codes (comma separated list FDA assigned to the subject device)
OMC
Device Description
The Intelligent Electroencephalogram (iEEG) device acquires and stores electrical activity of the brain and patient data. The iEEG can be used with other FDA cleared devices such as the BraiNet Kit (K043009) and Ives EEG electrode (K062880). The BraiNet Kit consists of the BraiNet Template (electrode cap), and Sub-dermal EEG Needle Electrodes and Cutaneous EEG Electrodes.
The iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software.
The wireless iEEG transmitter module provides an EEG electrode connection, electrode impedance (connection) status indicator(s), a single-user multi-function push button switch that provides power on/off, electrode impedance check. The wireless module is powered by an internal rechargeable energy source.
The AC charger module provides a convenient means to recharge the wireless module's internal energy source when not in use. The device is not intended to be charged when attached to the patient.
The iEEG viewer/recorder software provides, with the aid of host computer hardware and operating system, the ability to collect EEG electrode data from the wireless iEEG transmitter module, view EEG data, and record data to digital file. The iEEG viewer/recorder provides eight signal graphic display of selectable EEG montages (lead/electrode combinations). It also enables subject data entry (Name, DOB, ID number etc.) and control of EEG data recording to digital file.
The Intelligent Electroencephalogram (iEEG) is designed to be capable of usage and storage in hospital, clinic, and emergency room environments. The iEEG transmitter modules communicate with the computer by using Bluetooth wireless technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
Brain
Indicated Patient Age Range
all patient populations including pediatric
Intended User / Care Setting
medical professional, in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested to IEC 60601-1-1 for safety and IEC 60601-2 Electromagnetic Compatibility. The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications. The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements. All applicable tests according to the specified standards were completed and passed. Bench testing was performed and confirms that the device meets design requirements and 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.
BrainScope Zoom-100 (K082886 cleared on 8/10/2009)
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.
Lifelines Trackit Recorder (K010460 cleared on 05/14/2001)
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
4. 510(k) Summary
દાદ્ગાવવાય APR 1 0 2014
Summary Date: November 4, 2013
Submitter Data: Jordan NeuroScience, Inc. 1660 Plum Lane Redlands, CA 92374 909-881-2694
Primary Contact: Anne Perry aperry@jordaneuro.com
Device Name: iEEG (Intelligent Electroencephalograph)
Common Name: electroencephalograph
Device Classification Name: Electroencephalograph
Regulation: 882.1400 - Electroencephalograph
Requlatory Class: Class II
Primary Product Code(s):
OMC - Reduced- Montage Standard Electroencephalograph
Predicate Information
BrainScope Zoom-100 (K082886 cleared on 8/10/2009) Lifelines Trackit Recorder (K010460 cleared on 05/14/2001).
Device Description
The Intelligent Electroencephalogram (iEEG) device acquires and stores electrical activity of the brain and patient data. The iEEG can be used with other FDA cleared devices such as the BraiNet Kit (K043009) and Ives EEG electrode (K062880). The BraiNet Kit consists of the BraiNet Template (electrode cap), and Sub-dermal EEG Needle Electrodes and Cutaneous EEG Electrodes.
The iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software.
The wireless iEEG transmitter module provides an EEG electrode connection, electrode impedance (connection) status indicator(s), a single-user multi-function push button switch that provides power on/off, electrode impedance check. The wireless module is powered by an internal rechargeable energy source.
1
The AC charger module provides a convenient means to recharge the wireless module's internal energy source when not in use. The device is not intended to be charged when attached to the patient.
The iEEG viewer/recorder software provides, with the aid of host computer hardware and operating system, the ability to collect EEG electrode data from the wireless iEEG transmitter module, view EEG data, and record data to digital file. The iEEG viewer/recorder provides eight signal graphic display of selectable EEG montages (lead/electrode combinations). It also enables subject data entry (Name, DOB, ID number etc.) and control of EEG data recording to digital file.
The Intelligent Electroencephalogram (iEEG) is designed to be capable of usage and storage in hospital, clinic, and emergency room environments. The iEEG transmitter modules communicate with the computer by using Bluetooth wireless technology.
Intended Use
The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a legally marketed digital EEG system to assist in the diagnosis of neurological disorders. The device is intended for use by medical personnel in any location within a medical facility. physician's office, laboratory, and clinic or outside of a medical facility under the supervision of a medical professional. The device is intended for use on all patient populations including pediatric.
Technological Characteristics
The proposed iEEG and both predicate devices are batterv operated reusable electro-medical devices used to acquire and store electrical activity of the brain within a medical facility. The proposed iEEG and the predicate devices are also used outside of a medical facility under the supervision of a medical professional. The proposed iEEG and the predicate devices have the added capability to export data via wireless Bluetooth technology. The different technological characteristics are included in the risk assessment and testing (see section 16, 17, and 18). No new questions of safety and effectiveness were introduced. Refer to the following Table of Technological Characteristics for a summary.
Performance Data
The device was tested to IEC 60601-1-1 for safety and IEC 60601-2 Electromagnetic Compatibility. The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications. The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements. All applicable tests according to the specified standards were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications.
2
Substantial Equivalence
The proposed iEEG device is substantially equivalent in both function and use to the predicate device, BrainScope Zoom-100 (K082886 cleared on 8/10/2009). The iEEG device is substantially equivalent in EEG function and use of the reference device, Lifelines Trackit Recorder (K010460 cleared on 05/14/2001). The iEEG device is not used for a polysomnographs (sleep studies). Therefore the product code OLV of the device (Lifelines Trackit Recorder) does not apply.
Trackit, Zoom-100 and Insight are Class II legally marketed devices.
BrainScope Zoom-100 (K082886 cleared on 8/10/2009) is the predicate. The proposed device has equivalent intended use and has equivalent technology to the BrainScope Zoom-100 as indicated in the table below. Lifelines Trackit Recorder (K010460 cleared on 05/14/2001) is included as a reference device for the added technology of the Bluetooth wireless transmission of recorded data and for the additional application environment of outside of a medical facility under the supervision of a medical professional.
3
| | | Device | iEEG
(Subject) | BrainScope Z-100
(Predicate) | Trackit EEG
(Predicate)
The information
is based on use
of the device with
Persyst software
K010460 | Persyst
Insight | Explanation of
Variation |
|------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k)# | | K882886 | K082886 | K010460 | K011397 | N/A |
| | Class | | Class II | Class II | Class II | Class II | Same |
| | Product
code | | OMC | OMC | GWQ | GWQ/OMB | The two
product codes
OMC and GWQ
have exactly
the same
definition
except GWQ
has 16
channels and
above, OMC
has less than
16. The number
of channels
does not affect
the
fundamental
scientific
technology of
the device.
The Trackit
EEG device
allows for both
full and
reduced
channel
configurations. |
| | Regulation
number | | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Same |
| Regulatory Information | Indications
for Use | | The iEEG device is
intended to acquire
and store electrical
activity of the brain
and patient data for
review by a medical
professional using a
digital EEG system to
monitor the state of
the brain. | The ZOOM-100DC
is used to measure
and record the
electrical activity of
a patient's brain.
The ZOOM-100DC
is intended to
monitor the state of
the brain by
acquisition and
display of EEG
signals and by the
calculation of
standard
quantitative EEG
parameters. | The Lifelines
Trackit is a 10 to
36 channel
ambulatory
electroencephalo
-graph that is
designed for use
in a variety of
monitoring
applications to
record
physiological
data for EEG and
Sleep Studies. | Persyt Insight
(Reveal)
software is
universal
EEG
software for
display of
EEG data to
be
interpreted by
a medical
professional. | Equivalent. The
Zoom-100 and
Trackit devices are
used to acquire and
store electrical
activity of the brain.
Persyst only
displays acquired
data. |
| | Clinical
Application
environment | The device is
intended for use in a
healthcare facility,
clinical research
environment, or in the
home under the
supervision of a
qualified healthcare
professional | Hospitals and
clinics | For use in any
location within a
medical facility or
outside of a
medical facility
under the
supervision of a
medical
professional | The software
is intended
for use by a
trained EEG
technologist
or physician | Equivalent. All
devices are usable
within a medical
facility. The iEEG
and Trackit have
the similar
application in
environment
outside of a
medical facility
under the
supervision of a
medical
professional. | |
| | Modalities | EEG | EEG | EEG/PSG | EEG | Equivalent for EEG.
The iEEG does not
have the modality
option of PSG. The
PGS is used for
monitoring sleep
studies. | |
| | | | | | | The product code
OLV does not apply
as IEEG is not used
for a
polysomnographs
(PSG). | |
| | EEG
Channels | 8 | 8 | 10 to 32 | 4 to 64 | Equivalent.
Reduced montage
is the same for
iEEG and Zoom-
100. The Trackit
EEG reference
device allows for
both full and
reduced montage.
The number of | |
| | | | | | | electrodes does not
affect the
fundamental
scientific
technology of the
device. | |
| | Montage | 10/20 system | 10/20 system | 10/20 system | 10/20 system | Same | |
| | Sample
Rate | 250 Hz | 200 Hz | 256 Hz | NA | Equivalent,
sampling rate
defines the number
of samples per
second taken to
create a digital
representation of
the EEG | |
| specifications | | | | | | waveforms. All
devices provide a
sampling rate well
above the upper
frequency content | |
4
:
.
.
.
5
| | | | | | of the EEG
waveforms to
provide comparable
and high fidelity
representation of
the EEG
waveforms. | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| ADC
Resolution | 16 bit | 16 bit | 16 bit | NA | Same | |
| ADC CMRR | > 115dB | >100dB | >100dB | NA | Equivalent,
Common Mode
Rejection Ratio
(CMRR) is the
measure of a
system's ability to
ignore or reject
common
background
electrical noise
from the EEG
signals to be
recorded (60 Hz
line power noise for
example) The
greater the CMRR
value the better the
rejection of
common noise
sources. The iEEG
device is slightly
better than the
predicate or
reference device
and would provide
comparable
performance | |
| Input
Impedance | 10MOhm | 10MOhm | 1 MOhm | NA | Equivalent, Same
as The primary
predicate (Zoom
100) (Trackit EEG)
is lower in
impedance, subject
to a loss in EEG
signal level. | |
| Electrode
Impedance | Yes | Yes | Yes | NA | Same | |
| Wireless
Output | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Class 1 Bluetooth
Connection | NA | Same | |
| Data Format | edf | Unknown | edf | NA | Equivalent to
Trackit device. | |
| Electrode
Material | Standard off shelf
electrodes | Standard off shelf
electrodes | Standard off shelf
electrodes | NA | Same | |
| Battery | Rechargeable
Lithium-Polymer | Rechargeable
Lithium Ion | Disposable
Batteries or
Rechargeable
Lithium Ion | NA | Equivalent, Lithium
Polymer and
Lithium Ion use the
same chemistries. | |
| | Charger | Yes | Yes | Yes | NA | utilizes a micro
pore polymer
material as the
battery plate
separator.
Same |
| | Data format | iEEG
edf | Zoom-100
unknown | Trackit
edf | edf | edf is a universal
data format for
EEG |
| | Data Review | Persyst Insight, or
JNS Viewer or legally
marketed edf reader | unknown | Persyst Insight or
legally marketed
edf reader | edf and
various
proprietary
data formats | Same |
| | Display
Channels | 8 to 24 | unknown | NA | 4 to 64 | |
| | Hi Filter
Settings | off
10 Hz
13 Hz
15 Hz
20 Hz
25 Hz
35 Hz
50 Hz
70 Hz | NA | NA | off
1 Hz
5 Hz
10 Hz
15 Hz
20 Hz
25 Hz
35 Hz
40 Hz
80 Hz | Same or clinically
insignificant
differences |
| Waveform Review | Low filter
settings | off
0.3 Hz
0.5 Hz
1 Hz
2 Hz
3 Hz
10 Hz
15 Hz
20 Hz | NA | NA | off
0.3 Hz
0.5 Hz
1 Hz
2 Hz
3 Hz
10 Hz
15 Hz
20 Hz | Same |
| | 60 Hz filter | yes | NA | NA | yes | Same |
| | Gain | 1 uv/mm
1.5 uv/mm
3 uv/mm
5 uv/mm
7 uv/mm
10 uv/mm
15 uv/mm
20 uv/mm
25 uv/mm
35 uv/mm
50 uv/mm
125 uv/mm
250 uv/mm | NA | NA | 1 uv/mm
1.5 uv/mm
3 uv/mm
5 uv/mm
7 uv/mm
10 uv/mm
15 uv/mm
20 uv/mm
30 uv/mm
35 uv/mm
50 uv/mm
125 uv/mm
250 uv/mm
500 uv/mm | Same or clinically
insignificant
differences |
| | Time Base | 1 Sec
2 Sec
5 Sec
10 Sec | NA | NA | 1 Sec
2 Sec
5 Sec
10 Sec
15 Sec | Same or clinically
insignificant
differences |
| | 30 Sec
60 Sec
120 Sec | | | 20 Sec
30 Sec
60 Sec
120 Sec
240 Sec | | |
| Display
Montage | User selectable
Transverse-AP
Hatband Plus
Hatband
Double diamond
Common Ave Ref
Referential
D-Banana | NA | NA | User
selectable
User
definable
Transverse
Transverse-
AP
Common Ave
Referential
Referential
Laplacian
Double
Banana
BiPolar
Double
Diamond | Same or clinically
insignificant
differences | |
·
:
,
·
·
·
:
6
:
.
:
.
.
7
:
. . . . . .
8
Image /page/8/Picture/0 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized design featuring three overlapping shapes that resemble waves or ribbons. The overall design is simple and professional, reflecting the department's role in public health and welfare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2014
Jordan Neuroscience Inc. Ms. Anne Perry VP Finance and Administration 1660 Plum Lane Redlands, CA 92374
Re: K131944
Trade/Device Name: iEEG Regulation Number: 21 CFR 882.1400 Regulation Name: Reduced- montage Standard Electroencephalograph Regulatory Class: Class II Product Code: OMC Dated: March 12, 2014 Received: March 13, 2014
Dear Ms. Perry:
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 that I Dr Haral 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
9
Page 2 - Ms. Anne Perry
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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
10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131944
Device Name IEEG
Indications for Use (Describe)
The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healtheare professional. The device is intended for use on all patient populations including pediatric.
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)
Please do not write below this line – continue on a separate page if needed.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
ം Date: 2014.04.10
2017:46:16 -04'00'
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
11
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