(198 days)
The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.)
The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles
Galileo NT Line is a software package running on a Personal Computer under Windows Operative System. This package is devoted to the complete management of various exams in the Neurodiagnostic field of application, as electroencephalography, electromyography, Evoked Potentials etc.
The product is essentially a suite of applications dedicated to the comprehensive management of neurological diagnostics in a Department of Neurophysiology, etc. ... starting from the patient's acceptance, the execution of specific tests, and finally to the production of the exam reports. The package is substantially made by a common "platform" and by various independent modules, each of which is devoted to a particular application (EEG, Video EEG, EMG, EP, ICU, etc.). All the parts of the package together with the related User Documentation are residing on the same distribution media (a DVD).
As illustrated by figure 1 below, GALILEO NT Line (simply Galileo NT in other documents of this submission) is a "software only device" that can control and acquire data from a series of (FDA cleared) Amplifier platforms developed by EBNeuro for the Neurodiagnostic field and specifically :
For each of the above devices, Galileo NT provides the appropriate "software interface" module in order to allow the control of the Amplifier (and of all the accessories eventually provided with it, as, for example, the Evoked Potential stimulators embedded in the Nemus 1 and 2 hardware) and in order to collect the acquired data. The data, once acquired from the amplifier, are "passed" to the specialized module for successive handling as display, measure, printing, trending, archiving and so on.
The provided text is a 510(k) premarket notification for the EB Neuro Galileo NT Line software. This document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format specified (a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for testing/training).
Specifically:
- 1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the software's features and intended use to predicate devices, not on quantitative performance metrics with associated acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not applicable, as a performance study of this nature is not described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a software package for recording and displaying physiological data, not an AI-powered diagnostic tool that assists human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a software suite for managing neurodiagnostic exams, not an algorithm with standalone diagnostic performance.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable, as no algorithm training is described for diagnostic performance.
- 9. How the ground truth for the training set was established: Not applicable.
The document explicitly states under "Summary of Clinical Tests": "No clinical tests were performed." This further confirms that no performance study as described in your request was conducted for this 510(k) submission. The FDA clearance was based on substantial equivalence to existing devices and compliance with relevant industry standards (ISO 14971, IEC 62304, IEC 62366) for design and development, rather than a clinical performance study.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
EB Neuro, SpA c/o Allison Scott Senior Regulatory Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268
Re: K142064 Trade/Device Name: Galileo NT Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Codes: OLT, GWF, GWQ, GWE, GWJ, IKN, OLV, JXE Dated: February 9, 2015 Received: February 10, 2015
Dear Allison Scott:
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.
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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.
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,
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Galileo NT
Indications for Use (Describe)
The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.)
The device is intended to be used in the clinical and hospital room, emergency room, emergency room, intensive care unit, neuro-intensive care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles
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)
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Traditional 510(k) Summary
807.92(a)(1)
Submitter Information
EB Neuro, S.p.A. Via Pietro Fanfani 97/a Florence, Italy 50127
Contact Person:
Allison Scott 317.228.8719 Allison.Scott@Navigant.com
Date:
February 12, 2015
807.92(a)(2)
Devices
| Common Name: | Electroencephalograph Software |
|---|---|
| Trade Name: | Galileo NT Line |
| Classification Name(s): | Electroencephalograph; Evoked Potential; Electromyograph;Polisomnograph; Nerve Conduction Velocity Measurement |
| Classification Number: | 21 CFR 882.1400 (Product Code: OLT); 21 CFR 882.1870 (Product Code:GWF); 21 CFR 882.1400 (Product Code: GWQ); 21 CFR 882.1890(Product Code: GWE); 21 CFR 882.1900 (Product Code: GWJ); 21 CFR882.1375 (Product Code: IKN); 21 CFR 882.1940 (Product Code: OLV); 21CFR 882.1550 (Product Code: JXE) |
| Regulatory Class: | Class II |
807.92(a)(3)
Predicate Device(s)
| Device | Owner | 510(k) |
|---|---|---|
| BRAVO Multimodality System | Nicolet Biomedical, Inc | K991054 |
| Nemus 1 System | EBNeuro SpA | K073415 |
| Twin Plus Software | Astromed-Med, Inc. | K012976 |
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807.92(a)(4)
Device Description
Galileo NT Line is a software package running on a Personal Computer under Windows Operative System. This package is devoted to the complete management of various exams in the Neurodiagnostic field of application, as electroencephalography, electromyography, Evoked Potentials etc.
The product is essentially a suite of applications dedicated to the comprehensive management of neurological diagnostics in a Department of Neurophysiology, etc. ... starting from the patient's acceptance, the execution of specific tests, and finally to the production of the exam reports. The package is substantially made by a common "platform" and by various independent modules, each of which is devoted to a particular application (EEG, Video EEG, EMG, EP, ICU, etc.). All the parts of the package together with the related User Documentation are residing on the same distribution media (a DVD).
As illustrated by figure 1 below, GALILEO NT Line (simply Galileo NT in other documents of this submission) is a "software only device" that can control and acquire data from a series of (FDA cleared) Amplifier platforms developed by EBNeuro for the Neurodiagnostic field and specifically :
For each of the above devices, Galileo NT provides the appropriate "software interface" module in order to allow the control of the Amplifier (and of all the accessories eventually provided with it, as, for example, the Evoked Potential stimulators embedded in the Nemus 1 and 2 hardware) and in order to collect the acquired data. The data, once acquired from the amplifier, are "passed" to the specialized module for successive handling as display, measure, printing, trending, archiving and so on.
807.92(a)(5)
Intended Use
The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.)
The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles
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807.92(a)(6)
Technological Characteristics
Both the Bravo Multimodality System and the Nemus 1 System are devices that include both a "software device" and a "hardware device" (the Amplifier/Stimulators). In this context comparison will be made among the Galileo NT Line software and the software part of the predicate devices
The "software device" of the Nemus 1 is simply "a part" of the whole Galileo NT Line package. The Nemus 1 software is actually made by the Galileo NT PMS module (the "main" module) and the Galileo NT Line EMG/EP module. This two modules, described in the other parts of this submission, where already evaluated together the other parts of Nemus 1 system (hardware + software) with K073415.
The substantial difference between the two devices is that while Nemus System software is capable to handle only EMG and EP data, the Galileo NT Line package is capable to handle EMG, EP, and EEG and VIDEO EEG data as detailed in other part of this submission. In other words the Galileo NT Line package includes, in addition to the PMS and EMG/EP modules, the EEG and ICU modules.
The two products are similar in their "multimodal" concept: a common platform that using specialized hardware(s) is capable to acquire, display and record data of different clinical application (EEG, EMG, EP) so acting as an electroencephalograph, an electromyography or an evoked potential device.
Both devices include a patient database on which store patients data and exams reports.
A substantial difference between the two devices is that the Bravo System can handle also TCD data other than EEG/EMG/EP data, while Galileo NT Line does not handle TCD data.
The Twin Plus Software and Galileo NT are indicated for EEG and PSG. Both packages use the output of an appropriate capture hardware on the PC to digitize and store patient image data. Provision is included to playback video data synchronized with the EEG waveform display. This technique is referred as VIDEO-EEG. Both devices perform real time collection, real time display, data collection and recording to disk of real time video and audio data, usually an image of the patient being monitored. Both device performs review and analysis of previously recorded data including the ability to look back the old data while real time recording of ongoing data is in progress. Both devices work with a number of different amplifier system with various digital interface models (EBNeuro BE Plus LTM, BE micro, Nemus 2 for Galileo NT, Grass Telefactor BEEHIVE, BEEHIVE USB, TS for Twin Plus) Each of these hardware device have their own separate 510(k) marketing authority. Both device allow specific section of data to be easily selected for further analysis including frequency and amplitude measurement, potential mapping, spectral analysis, and frequency band mapping. Both device handle a patient/recording data base.
A substantial difference between the devices is that the Twin Plus software has a Seizure Analysis module and performs a semiautomatic sleep data scoring, where the Galileo NT does not have this module or scoring. Galileo NT allows EP and EMG recording, Twin Plus does not handle EP or EMG data recording.
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807.92(b)(1)
Summary of Non-Clinical Tests
The Galileo NT has been designed and developed according to the following medical device industry standards.
- . ISO 14971 Second Edition 2007
- . IEC 62304 First Edition 2006
- . IEC 62366 Edition 1.0 2007
807.92(b)(2)
Summary of Clinical Tests
No clinical tests were performed.
807.92(b)(3)
Conclusion
The Galileo NT Line is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
§ 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).