(205 days)
Not Found
Yes
The device description explicitly mentions the "HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation." This functionality, particularly the "accurately detects" and "recommendation" aspects based on real-time data analysis, strongly suggests the use of AI/ML algorithms for pattern recognition and predictive analysis. The performance study also validates the accuracy of this software's detection capabilities against expert judgment.
Yes
The device is intended for therapeutic purposes, including aiding in functional neurosurgery procedures, providing stimulation for functional brain mapping during treatment of seizure disorders, and assisting in the placement of depth electrodes for movement disorder treatment.
No
Explanation: While the device can "aid the clinician in the diagnosis of neuromuscular disease (EMG)" and record various bioelectric signals, its primary intended uses outlined involve assisting neurosurgeons during functional neurosurgery, aiding in the placement of depth electrodes, monitoring and displaying signals, and providing stimulation, which are often interventional or monitoring functions rather than solely diagnostic. The "diagnosis" aspect mentioned is an aid to the clinician and not a primary output of a diagnosis itself.
No
The device description explicitly states that the "Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit". This indicates the device includes hardware components (the Drive HeadStage unit) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Function: The Neuro Omega System, as described, is used for:
- Recording and stimulating brain neurons.
- Aiding in the placement of depth electrodes.
- Monitoring and recording bioelectric signals from muscles and nerves (EMG).
- Measuring and recording brain electrical activity (EEG and ECOG).
- Providing stimulation for functional brain mapping.
- Assisting in the localization of the Sub Thalamic Nucleus (STN) using real-time software analysis of electrical signals.
- Lack of Specimen Analysis: The device directly interacts with the patient's body (brain, muscles, nerves) to record and stimulate electrical activity. It does not analyze specimens taken from the body in a laboratory setting.
The device is clearly intended for in vivo use, meaning it is used within the living body, rather than in vitro (in glass, referring to laboratory analysis of specimens).
No
The input text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating no mention of FDA review, approval, or clearance of a PCCP for this device.
Intended Use / Indications for Use
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System incorporated the installed HaGuide software is also intended:
-To monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular disease (EMG).
-To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).
-To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
-To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
Product codes
GZL, GWF, IKN, GWQ, GYC
Device Description
The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG).
The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The subject device, the Neuro Omega System incorporated the installed HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.
The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary. The tool presents real time graphs of power spectrum density and RMS of each region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Deep brain, cranial surface, intracranial cortex and body limbs.
Indicated Patient Age Range
Adults and children
Intended User / Care Setting
Intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
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
Test Method Summary: A Retrospective, Multi-centre, Clinical Validation of HaGuide Software module accuracy in mapping sub-thalamic nucleus (STN) boundaries in Parkinson's disease patients who underwent Deep Brain Stimulation (DBS) procedure.
Location of Study: Both in United States and Outside United States.
Sample Size: 81 patients were enrolled, in total 105 surgeries, as 213 electrodes were evaluated.
Annotation Protocol: The reference against which the accuracy of HaGuide mapping was compared is the gold standard being the qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Single-arm study with Objective Performance Criteria
Sample Size: 81 patients, 105 surgeries, 213 electrodes.
Key Results: Percent agreement between Haguide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %). Correlation between the HaGuide measurements expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site was found very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91). Bland-Altman analysis of average against the difference between Haguide and expert measurements for the location of STN entry was 0.18 mm (95% CI, -0.9, 1.2 mm) and exit points was -0.15 mm (95% CI, -1.25, 1 mm). No adverse events and complications observed in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent agreement between Haguide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
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December 22, 2017
Alpha Omega Engineering Ltd, Maysana Mousa QA/RA Manager Nazareth Industrial Park, Mount Precipice, St.2015 Nazareth, 1612102 IL
Re: K171581
Trade/Device Name: Neuro Omega System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL, GWF, IKN, GWQ, GYC Dated: November 13, 2017 Received: November 20, 2017
Dear Ms. Mousa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2017.12.22 14:03:23 -05'00'
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) K171581
Device Name Neuro Omega System
Indications for Use (Describe)
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System incorporated the installed HaGuide software is also intended:
-To monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular disease (EMG).
-To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).
-To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
-To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
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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3
Image /page/3/Picture/0 description: The image is a logo for Alpha Omega. The logo features a stylized letter "A" in maroon, with a gray omega symbol underneath. The words "ALPHA" in maroon and "omega" in gray are to the right of the symbols. The tagline "Defining Neuroscience Technology" is in maroon below the logo.
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92
Submitter Information
Alpha Omega Engineering Ltd. Mount Precipice 2015 P.O. Box 2268 Nazareth 1612102, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075
Submission contact person:
Mrs. Maysana Mousa Tel:+972-4-6563-327 Fax:+972-4-6574-075 Mobile: +972-54-9043303
Device Classification
| Proprietary Device Name:
Common name: | Neuro Omega System
Intraoperative neurophysiological recording and
stimulating device | | |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------|--------------------------------------|
| Product Code: | GZL | | |
| Subsequent Product Code: | GWF, IKN, GWQ, GYC | | |
| Classification Name: | Depth Electrode | | |
| Subsequent Classification names: | Electroencephalograph,
electrical,
electromyograph,
electrode | evoked
diagnostic, | stimulator,
response,
cortical |
| Classification Regulation:
Regulatory Class: | 21 CFR §882.1330
II | | |
| Identification of Legally Marketed Predicate Devices | | | |
| Neuro Omega System -
For cortical recording and stimulation | | K123796 | |
| Nicolet Cortical Stimulator - | | K072964 | |
Page 1 of 18
4
1. Device Description
The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG).
The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The subject device, the Neuro Omega System incorporated the installed HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.
The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary. The tool presents real time graphs of power spectrum density and RMS of each region.
2. Intended Use of Device
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.
The subject device, the Neuro Omega System incorporated the installed HaGuide software is also intended:
To monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG).
To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).
To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
5
3. Safety & Effectiveness
The Neuro Omega System has been compared to the New Omega System (K123796), in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features.
| # | Compariso
n parameter | Subject device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device for
cortical recording and
stimulation:
Nicolet Cortical
Stimulator | SE comparison
discussion |
|---|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Legally
distribution clearance
No. | Subject device | K123796 | K072964 | |
| 2 | Owner | Alpha Omega Engineering
Ltd. | Alpha Omega Engineering
Ltd. | Cardinal Health, Inc | |
| 3 | Intended use
and
indications
for use. | The subject device, the Neuro
Omega System incorporated
the installed HaGuide software,
including the Drive HeadStage
unit, is intended to assist
neurosurgeons in the operating
room during functional
neurosurgery and to record
from and stimulate brain motor
and sensory neurons and to aid
in the placement of depth
electrodes.
The subject device, the Neuro
Omega System incorporated | The Neuro Omega System,
including the NeuroDrive unit,
is intended to assist
neurosurgeons in the operating
room during functional
neurosurgery and to record
from and stimulate brain motor
and sensory neurons and to aid
in the placement of depth
electrodes.
The Neuro Omega System is
also intended to monitor,
record and display the
bioelectric signals produced by | The Cortical Stimulator is
intended for use in
functional brain mapping
procedures during
treatment of patients with
seizure disorder, providing
stimulation via electrode
pairs or a hand held
bipolar probe | Similarity
The intended use and
indications of the modified
Neuro Omega is identical to
the intended use and
indications of the legally
marketed Neuro Omega and
the Nicolet Cortical
Stimulator predicate
Devices.
Differences
The intended use and
indications of the modified |
| # | Comparison parameter | Subject device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device for cortical recording and stimulation:
Nicolet Cortical Stimulator | SE comparison discussion |
| | | the installed HaGuide software
is also intended:
To monitor, record and display
the bioelectric signals produced
by muscles, to stimulate
peripheral nerves, and to
monitor, record and display the
electrical activity produced by
nerves to aid the clinician in
the diagnosis and prognosis of
neuromuscular disease (EMG).
To measure, record and display
the electrical activity of the
patient's brain obtained from
two or more electrodes on the
head (EEG).
To measure, display and record
the electrical activity of the
patient's brain obtained from
ECOG strip and grid
electrodes.
To provide stimulation via
electrode pairs or a hand held
bipolar probe for use in
functional brain mapping
procedures during treatment of
patients with seizure disorder.
The device is intended for | muscles, to stimulate
peripheral nerves, and to
monitor, record and display the
electrical activity produced by
nerves to aid the clinician in
the diagnosis and prognosis of
neuromuscular disease (EMG).
The device may also be used
to measure and record the
electrical activity of the
patient's brain obtained by
placing two or more electrodes
on the head (EEG).
The device is intended for use
by medical personnel within a
hospital, laboratory, clinic or
nursing home setting or
outside of a medical facility
under direct supervision of a
medical professional. The
device may also be placed in
the intensive care unit or
operating room for continuous
recording. | | Neuro Omega combines the
intended use and indications
of the predicate and
reference devices. |
| # | Comparison parameter | Subject device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device for cortical recording and stimulation:
Nicolet Cortical Stimulator | SE comparison discussion |
| | | intraoperative use by medical
personnel. Within hospitals,
laboratory, clinic or nursing
home setting or outside of a
medical facility under direct
supervision of a medical
professional. The device may
also be placed in the intensive
care unit or operating room for
continuous recording.
The device is intended for
intraoperative use by medical
personnel. Within hospitals,
laboratory, clinic or nursing
home setting or outside of a
medical facility under direct
supervision of a medical
professional. The device may
also be placed in the intensive
care unit or operating room for
continuous recording. | | | |
| 4 | Device code and
regulation | Product Code: GZL
Regulation #: 21CFR882.1330
Subsequent Product Code:
GWF, IKN, GWQ, GYC
Subsequent Regulation #:
21CFR882.1870, 21CFR | Product Code: GZL
Regulation #:
21CFR882.1330
Subsequent Product Code:
GWF, IKN, GWQ
Subsequent Regulation #:
21CFR882.1870, 21CFR | Product Code: GYC
Regulation #:
21CFR882.1310 | Similarity
The device code and
regulation number of the
modified Neuro Omega are
identical to the intended use
and indications of the
legally marketed Neuro |
| # | Compariso
n
parameter | Subject device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device for
cortical recording and
stimulation:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| | | 890.1375, 21CFR882.1400,
21CFR882.1310 | 890.1375, 21CFR882.1400 | | Omega and the Nicolet
Cortical Stimulator
Predicate Devices.
Differences
The device code and
regulation number of the
modified Neuro Omega
combines the device code
and regulation number of
the predicate and reference
devices. Additionally, the
modified Neuro Omega does
not include the ETN device
code |
• Intended Use Comparison
6
7
8
• Performance Comparison
| # | Comparison
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
|-----|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Legally
distribution
clearance No. | Subject device | K123796 | K072964 | |
| 2 | Owner | Alpha Omega Engineering
Ltd. | Alpha Omega Engineering
Ltd. | Cardinal Health, Inc | |
| 3 | Body Areas | Deep brain, cranial surface,
intracranial cortex and body | Deep brain, cranial surface and
body limbs | Intracranial brain cortex | Similarity
Identical for Neuro Omega |
| # | Comparison
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| | | limbs | | | modified and unmodified
devices
Differences
In addition to deep brain, cranial surface and body
limbs, the modified Neuro Omega may be used
mapping the brain by stimulation of the cortical
surface, which is equivalent to both predicate and
reference devices. |
| 4 | Target
population | Adults and children | Adults and children | Adults and children | Similarity
Identical.
Differences
None |
| 5 | Users | Neurosurgeon, Neurosurgery
staff and professional medical
personnel. | Neurosurgeon, Neurosurgery
staff and professional medical
personnel. | Qualified medical
personnel | Similarity
Identical for Neuro Omega modified and unmodified
devices
Differences
Subject device is equivalent to primary predicate device,
Nicolet Cortical Stimulator can be used by qualified
medical personnel |
| 6 | Use | Within hospitals, laboratory, | Within hospitals, laboratory, | Within a hospital or | Similarity |
| # | Comparison
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| | environment | clinic or nursing home setting
or outside of a medical facility
under direct supervision of a
medical professional. The
device may also be placed in
the intensive care unit or
operating room for continuous
recording | clinic or nursing home setting
or outside of a medical facility
under direct supervision of a
medical professional. The
device may also be placed in
the intensive care unit or
operating room for continuous
recording | clinical environment. | Identical.
Differences
Subject device is equivalent
to primary predicate device,
Nicolet Cortical Stimulator
can be used within a hospital
or clinical environment. |
| 7 | Usability and
Human Factors | ISO 62366, IEC 60601-1-6 and
FDA draft guidance
UCM259760 June 2011 | ISO 62366, IEC 60601-1-6
and
FDA draft guidance
UCM259760 June 2011 | Unknown | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| 8 | AC Power
Supply | 100-120 V AC,220-240V AC
50/ 60 Hz | 100-120 V AC,220-240V AC
50/ 60 Hz | 100-120 V AC,220-240V
AC
50/ 60 Hz | Similarity
Identical.
Differences
None |
| 9 | Software
applications | GUI, Monitoring, display,
Audio, signal processing,
Recording, Stimulation control,
identify number of channels
connected. | GUI, Monitoring, display,
Audio, signal processing,
Recording, Stimulation
control, identify number of
channels connected. | GUI, display, signal
processing and Stimulation
control | Similarity
Identical.
Differences
None |
| 10. | Electrical Safety | IEC 60601-1 3rd ED +
Risk analysis (ISO 14971) | IEC 60601-1 +
Risk analysis (ISO 14971) | IEC 60601-1 | Similarity
Tested for same or more
resent safety standards
Differences |
| # | Comparison
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| 11 | Particular safety | IEC 60601-2-10,
IEC 60601-2-26,
IEC 60601-2-40 +
Risk analysis (ISO 14971) | IEC 60601-2-10,
IEC 60601-2-26,
IEC 60601-2-40 +
Risk analysis (ISO 14971) | IEC 60601-1,
IEC 60601-2-26 | None
Similarity
Identical.
Differences
None |
| 12 | Electromagnetic
Compatibility | IEC 60601-1-2 +
Risk analysis (ISO 14971) | IEC 60601-1-2 +
Risk analysis (ISO 14971) | IEC 60601-1-2 | Similarity
Identical.
Differences
None |
| 13 | Sterility and
Sterility
standards | Sterility of the reusable
components is performed by
the hospital clinical staff and
was validated to comply with
the following standards: ISO
17665-1, ST81 and STERRAD | Sterility of the reusable
components is performed by
the hospital clinical staff and
was validated to comply with
the following standards: ISO
11135, ISO 10993-7, ST77,
ST81, ST67 | Not relevant for the ECoG. | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
For the modified Neuro
Omega system only
STERRAD sterilization is
allowed for HeadStage
electronic components,
while in the legally cleared
device ETO and STERRAD
were allowed. |
| 14 | Software
development
standard | ISO 62304 | ISO 62304 | Not relevant for the ECoG. | Similarity
Identical for Neuro Omega
modified and unmodified |
| # | Comparison
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| | | | | | devices
Differences
None |
| 15 | Electrical Class | I | I | Not relevant for the ECoG. | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| 16 | Protective Type | BF | BF | BF | Similarity
Identical
Differences
None |
| # | Compariso
n
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| 1 | Legally
distributio
n clearance
No. | Subject device | K123796 | K072964 | |
| 2 | Owner | Alpha Omega Engineering
Ltd. | Alpha Omega Engineering
Ltd. | Cardinal Health, Inc | |
| 3 | Device
Components | Main Unit including: Mobile
Rack, Power Supply, Isolation
Transformer, PC, Monitor,
keyboard, mouse, Speakers,
I/O analog/ Digital unit and
Front End unit.
Head Stage components: Head
Box, Connection Box. Drive
HeadStage System, Remote
control handpiece, Head stage
cables, and single use
electrodes cable. | Main Unit including: Mobile
Trolley, Power Supply,
Isolation Transformer, Panel
PC, Monitor, keyboard,
mouse, Speakers and Front
End unit.
Head Stage components: Head
Box module, NeuroDrive
System, Remote control
handpiece, Head stage
recording cable, Head stage
cables and single use
electrodes cable. | Hand-held unit including;
display, power supply and
control knob | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| 4 | Operating
System | Windows 7, 64bit | Same | Not relevant for the ECoG
HeadBox. | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| 5 | Computer | Touch screen PC | Industrial PC | Not relevant for the ECoG | Similarity |
| # | Comparison
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| 6 | Trolley
Connectors | 4 USB ports | 4 USB ports | Not relevant | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| 7 | Main Unit
system
connectors | •Ethernet ports
•1 Remote port
•2 Audio out | Same | Not relevant | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| 8 | Communicati
on | Ethernet protocol | Same | Not relevant | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
| # | Compariso
n
parameter | Proposed device:
Neuro Omega | Primary Predicate device:
Neuro Omega | Reference device:
Nicolet Cortical
Stimulator | SE comparison
discussion |
| 9 | Peripherals | Microsoft Wireless keyboard
and mouse | Wired keyboard and mouse | Not relevant | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
Wireless KB and Mouse is
more comfortable than
wired ones |
| 10 | Number of
Channels | •Up to 10 MER channels
•Up to 112 EEG/EMG/ECOG
channels. | Same | Not Applicable | Similarity
Identical for Neuro Omega
modified and unmodified
devices
Differences
None |
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• Technology Comparison
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Image /page/16/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" in a stylized font, with the "A" in red and the rest of the letters in gray. Below the letters is the phrase "Defining Neuroscience Technology" in a smaller font. The logo is likely used to represent a company or organization that specializes in neuroscience technology.
Based on the performance results provided in this submission (including test results and clinical evaluation) and the analysis of similarities and differences presented above, Alpha Omega Technologies Ltd. believes that the proposed device is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.
Rational for Substantial Equivalency
Similarities:
- The Neuro Omega System and the predicate legally cleared Neuro Omega System 1. (K123796) share the same device code and have the same intended use and indications for use for Depth Electrode Recording and Stimulation, EEG and EMG. Both devices are intended for the same body target organs (Human Brain), same population, same users, same operation environment (operation room) and tested for compliance to the same development control, safety standards and use same technologies i.e. main unit base of standard PC with application software.
For cortical recording and stimulation, the legally cleared predicate device, Nicolet Cortical Stimulator (K072964) has the same device code and have the same intended use and indications for use.
The device code and regulation number of the subject device, the modified Neuro Omega, combines the device code and regulation number of the two predicate devices.
Sterileable components (head stage, Drive HeadStage) that are located inside the sterile operation area are intended for re-sterilization by the hospital staff. Sterileable components where validated for cleaning and sterilization procedures described in the manual.
Differences:
-
- In addition to deep brain, cranial surface and body limbs, the modified Neuro Omega may be used mapping the brain by stimulation of the cortical surface, which is equivalent to the predicate device Nicolet Cortical Stimulator (K072964).
-
- For the modified Neuro Omega system only STERRAD sterilization is allowed for HeadStage electronic components, while in the legally cleared device ETO and STERRAD were allowed.
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4. Performance Tests For non-clinical performance tests:
| Test | Test Method Summary | Results |
|---|---|---|
| Software | ||
| Verification | This verification performed on full | |
| system, the subject device (SW & | ||
| HW) including accessories, and | ||
| checked that the design output | ||
| meets the SW design input. | Neuro Omega SW has been tested | |
| under a complete SW verification plan | ||
| traceable to Neuro Omega SRS. | ||
| All samples passed the acceptance | ||
| criteria which determines the | ||
| effectiveness of Neuro Omega System, | ||
| the subject device, with HaGuide | ||
| software. | ||
| System Verification | This verification performed on full | |
| system, the subject device (SW & | ||
| HW), and checked that the design | ||
| output meets the system (HW & | ||
| MECH) design input | Neuro Omega system has been | |
| verified under a complete system | ||
| verification plan traceable to Neuro | ||
| Omega system design input. All | ||
| samples passed the acceptance criteria | ||
| which determines the effectiveness of | ||
| Neuro Omega System, the subject | ||
| device, with HaGuide software. | ||
| Steam Sterilization | ||
| Validation | Mechanical accessories of the | |
| subject device | Each test article was evaluated to a | |
| sterility assurance level (SAL) of ≤ 10-6 | ||
| using the biological indicator (BI) | ||
| overkill method. Geobacillus | ||
| stearothermophilus, ATCC #7953, was | ||
| the indicator organism. All test method | ||
| acceptance criteria were met. | ||
| In addition to the SAL validation, dry | ||
| times were validated using full cycle | ||
| parameters. | ||
| STERRAD NX | ||
| sterilization | ||
| validation | Electrical accessories of the | |
| subject device | Each test article was evaluated to a | |
| sterility assurance level (SAL) of ≤ 10-6 | ||
| using the biological indicator (BI) | ||
| overkill method. Geobacillus | ||
| stearothermophilus, ATCC #7953, was | ||
| the indicator organism. | ||
| Results validate the individual test | ||
| articles for the STERRAD® NX | ||
| standard cycle. | ||
| STERRAD 100NX | ||
| sterilization | ||
| validation | Electrical accessories of the subject | |
| device | Results from testing validate that the | |
| Alpha Omega Engineering, Ltd. Neuro | ||
| Omega Tray is able to achieve a 10-6 | ||
| SAL in a STERRAD® 100NX | ||
| Standard sterilization process |
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For clinical performance test:
HaGuide Clinical Study:
. Test Method Summary:
A Retrospective, Multi-centre, Clinical Validation of HaGuide Software module accuracy in mapping sub-thalamic nucleus (STN) boundaries in Parkinson's disease patients who underwent Deep Brain Stimulation (DBS) procedure
Level of evidence: ●
Single-arm study with Objective Performance Criteria
. Location of Study:
Both in United States and Outside Unitest States
● Primary Effectivness Endpoint:
Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements, for STN entry point vs. exit point depth (in mm).
| Stage | Investigational Device
Arm total | Control Arm
Total | Total |
|-------------------------------------------|-------------------------------------|----------------------|-------|
| Enrollment | 81 | - | 81 |
| Treatment | 81 | - | 81 |
| Primary Effectivness
Endpoint Analysis | 81 | - | 81 |
. Patient Accountability:
. The study met the primary endpoint:
The reference against which the accuracy of HaGuide mapping was compared is the gold standard being the qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns.
● Results:
In total 81 patients were enrolled. In total 105 surgeries, as 213 electrodes were evaluated for percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements about the location of the entry and exit points of the sub-thalamic nucleus (STN).
Percent agreement between Haguide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %)
Correlation between be the HaGuide measurements expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site and was found very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91).
Bland-Altman analysis of average against the difference between Haguide and expert measurements for the location of STN entry was 0.18 mm (95% CI, -0.9, 1.2 mm) and exit points was -0.15 mm (95% CI, -1.25, 1 mm).
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- No adverse events and complications observed in the study ●
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5. Substantial Equivalence Statement
Based on the above, it is Alpha Omega's opinion that the proposed modified Neuro Omega System is substantially equivalent in terms of design principles, performance features and of safety & effectiveness to the predicate legally cleared devices referred to in section 3 of this document.