(45 days)
K914571A, K851300
Not Found
No
The summary describes standard signal processing and display of EEG and EP waveforms, along with basic calculations and alarm triggering based on user-defined limits. There is no mention of AI, ML, or any learning algorithms.
No
The device is described as a monitor and measuring device for brain and nervous system activity, designed to observe changes and evaluate nervous system function. It does not state that it provides treatment or therapy.
Yes
Explanation: The device is used to record and measure brain activity (EEG) and evoked potentials (EP's) to evaluate nervous system function and observe changes, which are diagnostic activities. It monitors, processes, and stores data for interpretation by healthcare professionals.
No
The device description explicitly states that the product is sold as "configured with hardware and software" and lists several hardware components including amplifiers, a processor unit, an evoked potential stimulator, a display, a connecting box (headbox), personality cards, electrode leadwires, auditory headphones or tubephones, electrodes for electrical stimulation, a keyboard, and a mouse. It also mentions accessories like a computer cart, audio-output, manual switch box, external storage device, and a printer. This clearly indicates it is not a software-only device.
Based on the provided information, the Neurotrac II-EP is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Neurotrac II-EP Function: The Neurotrac II-EP directly monitors electrical activity within the patient's body (EEG and EP's) using electrodes placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it records and monitors electrical signals from the patient over extended periods, primarily during surgery and intensive care.
- Device Description: The description details the hardware and software used to acquire and process these electrical signals directly from the patient.
Therefore, the Neurotrac II-EP falls under the category of a patient monitoring device that measures physiological signals directly from the body, rather than an IVD device that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The intended use for the Neurotrac II-EP is: To record the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order for trained health care professionals to observe changes.
The intended use of the Neurotrac II-EP is to monitor the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order to observe changes. The Neurotrac II-EP acts as a patient monitor as it displays EEG waveforms, performs calculations on the data and triggers alarms when user-defined limits are exceeded. In addition, the Neurotrac II-EP is an evoked potential measuring device designed to record and measure the brain stem and the somatosensory pathways in order to evaluate nervous system function. It stores monitored waveforms for retrospective on-screen review or for hard copy interpretation. The Neurotrac II-EP is designed for use on the same clinical patient populations as the predicate devices, the Nicolet Viking IV, the Cadwell Excel, and the Nihon Kohdon Neuropack 8. The Neurotrac II-EP is not life supporting nor life sustaining and is used alongside conventional patient monitoring such as ECG and blood pressure.
Use of the Neurotrac II-EP is indicated when electroencephalographic (EEG) and/or evoked potential (EP) monitoring is required during surgery or intensive care over extended periods of time. It is necessary for the Neurotrac II-EP to perform a wide variety of EEG techniques and EP modalities for use in these settings. The Neurotrac II-EP is designed as a bedside continuous EEG/EP monitor.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Neurotrac II-EP provides continuous monitoring of brain electrical activity (EEG) and monitoring of evoked electrical activity from the central and peripheral nervous system (EP). The system provides for recording of any combination of EEG/EP and displays the results. The system not only displays the raw EEG waveform but processes the EEG in ways which make it easier to detect changes in the amplitude and frequency of the signal. The umplitude and frequency of the signal are the two main characteristics of the EEG: In addition to displaying the EEG, the raw input of the EP waveform as well as it's average are displayed. The system processes the EP waveform which makes it easier to detect changes in the amplitude and latency of the signal. The amplitude and latency of the signal are the two main characteristics of the EP. The Neurotrac II-EP also provides clinicians the capability of reviewing collected data. All raw EEG and EP waveforms and computer processed information may be stored on an internal hard drive or a removable cartridge hard drive for retrieval at a later time. All data can be printed for immediate hard copy interpretation.
The Neurotrac II-EP is an enhanced version of the original Neurotrac II. The Neurotrac II-EP monitors brain function via the electroencephalogram (EEG) and via evoked potentials (EP).
The product will be sold as Neurotrac II-EP configured with hardware and software for both continuous EEG, auditory and somatosensory evoked potential monitoring. The amplifiers, processor unit and evoked potential stimulator of the Neurotrac II-EP system will be manufactured by Moberg Medical. These components are connected to the M1094 Display, manufactured by Hewlett-Packard (HP), to complete the basic Neurotrac II-EP system. The amplifiers are housed in a connecting box (headbox) which accepts one of several patented "Personality Cards (PCARD)". The electrode leadwires connect into the PCARD which shows the user where to connect the patient electrodes on the head and configures user defined monitoring procedures for different clinical applications. The PCARD only accepts electrodes with DIN 42 802 standard touch proof connectors. The evoked potential stimulator includes both auditory and electrical outputs. These are delivered to the patient by industry standard auditory headphones or tubephones and FDA approved electrodes for electrical stimulation. The electrical stimulator provides for six standard current level outputs and two low current level outputs. The low current level outputs are designed to be used with custom electrodes, provided with the Neurotrac II-EP. These custom electrodes provide for additional patient safety by prohibiting their use in standard higher current level outputs. A keyboard and mouse are provided for entry of alpha numeric information and changes with pull-down menus for parameters. Accessories to the product are a computer cart for portability, an audio-output for listening to electrical impulses from selected nerves or muscles, a manual switch box to select electrical outputs, a safety agency approved external storage device (i.e. hard drive, optical) and a PCL5 compatible printer for hard copy printouts.
The HP Display, Model M1094 provides the electrical power for the MMI processor. amplifiers, evoked potential stimulator and audio speaker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
brain electrical activity (EEG) and evoked electrical activity from the central and peripheral nervous system (EP)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals; surgery and intensive care stays; medical professionals who have been trained in patient monitoring procedures; bedside continuous EEG/EP monitor.
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
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.
K914571A, K851300
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
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
0170
510(k) Summary
- Moberg Medical, In‹ . Submitter's Information: . 124 S. Maple Way Ambler, PA 19002 Phone: 215 283-0860) Fax: 215 283-0859
- Contact: Larry Engle .
- . Date: 1-15-96
- Trade name: Neurotrac 11-EP .
- Common name: Neurotrac II-EP .
- Classification name: Electroencephalograph (EEG) . EEG Signal Spectrum Analyzer Evoked Response Electrical Stimulator Evoked Response Auditory Stimulator
. *
Substantially Equivalent Predicate Devices: .
| Product | Manufacturer | 510(k) No. | Comments |
|---|---|---|---|
| Neurotrac II | Moberg Medical, Inc. | ||
| 124 S. Maple Way | |||
| Ambler, PA 19002 | K914571A | Basic foundation for | |
| Neurotrac II-EP | |||
| Viking IV | Nicolet Biomedical Inc. | ||
| 5225 Verona Rd. | |||
| Madison, WI 53711 | ** | Configured with Intra-Operative | |
| Monitoring Software Package-IOM | |||
| Excel | Cadwell Laboratories, Inc. | ||
| 909 N. Kellogg St. | |||
| Kennewick, WA 99336 | ** | One of many Models for EP/EEG carried | |
| by Cadwell. | |||
| Neuropack 8 | Nihon Kohden America Inc. | ||
| 2601 Campus Dr. | |||
| Irvine, CA 92715 | K851300 | 8-channel version of Neuropack product | |
| line which includes Neuropack 2, | |||
| Neuropack 4 Mini |
** 510(k)'s not available from 1-01. Equivalence based on labeling (See appendix B) and information available from ECRI Healthcare Product Comparison System, #217982:424-008, March 1995. Plymouth Meeting, PA 19462-1298.
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1
510(k) Summary
. Device Description:
The Neurotrac II-EP provides continuous monitoring of brain electrical activity (EEG) and monitoring of evoked electrical activity from the central and peripheral nervous system (EP). The system provides for recording of any combination of EEG/EP and displays the results. The system not only displays the raw EEG waveform but processes the EEG in ways which make it easier to detect changes in the amplitude and frequency of the signal. The umplitude and frequency of the signal are the two main characteristics of the EEG: In addition to displaying the EEG, the raw input of the EP waveform as well as it's average are displayed. The system processes the EP waveform which makes it easier to detect changes in the amplitude and latency of the signal. The amplitude and latency of the signal are the two main characteristics of the EP. The Neurotrac II-EP also provides clinicians the capability of reviewing collected data. All raw EEG and EP waveforms and computer processed information may be stored on an internal hard drive or a removable cartridge hard drive for retrieval at a later time. All data can be printed for immediate hard copy interpretation.
The Neurotrac II-EP
Moberg Medical. Inc. (MMI) designs and manufactures the Neurotrac II monitor (510k# K914571A). The Neurotrac II monitors brain function via the electroencephalogram (EEG). The new Neurotrac II-EP is an enhanced version of the original Neurotrac II. The Neurotrac II-EP monitors brain function via the electroencephalogram (EEG) and via evoked potentials (EP). Although, the Neurotrac II-EP will expand the features and functions of the Neurotrac II platform the intended uses are the same as the predicate devices. The Neurotrac II-EP is designed and manufactured by MMI. No changes in the product enhancement are being made which will adversely affect patient safety.
The Neurotrac II-EP System
The product will be sold as Neurotrac II-EP configured with hardware and software for both continuous EEG, auditory and somatosensory evoked potential monitoring. The amplifiers, processor unit and evoked potential stimulator of the Neurotrac II-EP system will be manufactured by Moberg Medical. These components are connected to the M1094 Display, manufactured by Hewlett-Packard (HP), to complete the basic Neurotrac II-EP system. The amplifiers are housed in a connecting box (headbox) which accepts one of several patented "Personality Cards (PCARD)". The electrode leadwires connect into the PCARD which shows the user where to connect the patient electrodes on the head and configures user defined monitoring procedures for different clinical applications. The PCARD only accepts electrodes with DIN 42 802 standard touch proof connectors. The evoked potential stimulator includes both auditory and electrical outputs. These are delivered to the patient by industry standard auditory headphones or tubephones and FDA approved electrodes for electrical stimulation. The electrical stimulator provides for six standard current level outputs and two low current level outputs. The low current level outputs are designed to be used with custom electrodes, provided with the Neurotrac II-EP. These custom electrodes provide for additional patient safety by prohibiting their use in standard higher current level outputs. A keyboard and mouse are provided for entry of alpha numeric information and changes with pull-down menus for parameters. Accessories to the product are a computer cart for portability, an audio-output for listening to electrical impulses from selected nerves or muscles, a manual switch box to select electrical outputs, a safety agency approved external storage device (i.e. hard drive, optical) and a PCL5 compatible printer for hard copy printouts
2
510(k) Summary
The HP Display, Model M1094 provides the electrical power for the MMI processor. amplifiers, evoked potential stimulator and audio speaker.
The Neurotrac II-EP system will be sold by MMI.
. Intended Use:
The intended use for the Neurotrac II-EP is:
To record the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order for trained health care professionals to observe changes.
The intended use of the Neurotrac II-EP is to monitor the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order to observe changes. The Neurotrac II-EP acts as a patient monitor as it displays EEG waveforms, performs calculations on the data and triggers alarms when user-defined limits are exceeded. In addition, the Neurotrac II-EP is an evoked potential measuring device designed to record and measure the brain stem and the somatosensory pathways in order to evaluate nervous system function. It stores monitored waveforms for retrospective on-screen review or for hard copy interpretation. The Neurotrac II-EP is designed for use on the same clinical patient populations as the predicate devices, the Nicolet Viking IV, the Cadwell Excel, and the Nihon Kohdon Neuropack 8. The Neurotrac II-EP is not life supporting nor life sustaining and is used alongside conventional patient monitoring such as ECG and blood pressure.
. Summary of technological characteristics compared to predicate device:
In general, the Neurotrac II-I:P and the predicate devices are similar in features and technical characteristics. There are no major differences that would alter intended use or jeopardize patient safety. The specifications for diagnostic EMG have not been included here given that the Neurotrac II-EP makes no claim to be a diagnostic EMG product
The indications for use of the Moberg Medical Neurotrac II-EP are the same as those of the predicate devices.
Use of the Neurotrac II-EP is indicated when electroencephalographic (EEG) and/or evoked potential (EP) monitoring is required during surgery or intensive care over extended periods of time. It is necessary for the Neurotrac II-EP to perform a wide variety of EEG techniques and EP modalities for use in these settings. The Neurotrac II-EP is designed as a bedside continuous EEG/EP monitor. The users of the Neurotrac II-EP will be medical professionals who have been trained in patient monitoring procedures.
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3
510(k) Summarv
It is necessary for the Neurotrac II-EP, along with the predicate devices, the Neurotrac II, the Viking IV, the Excel and the Neuropack 8 to perform a wide variety of EEG techniques and/or EP modalities. These techniques and modalities differ for ICU and OR neuromonitoring, as compared to the requirements generally found on EEG or EP products in the diagnostic laboratory setting. The EEG functionality of the Neurotrac II-EP is identical to the predicate device the Neurotrac II. The other predicate devices do not have the features and capabilities as the Neurotrac II-EP for recording EEG and do not claim product classification #84GWO They therefore, could not function in a diagnostic setting to record an EEG based on the minimal EEG recording standards as set forth by the American EEG Society. Similarly, the predicate devices claim product classification #891KM, electromyograph, diagnostic. The Neurotrac II-EP is not being marketed for diagnostic EMG recordings. Two of the most common modalities of evoked potentials for OR and ICU work are the brain stem auditory and the short latency somatosensory evoked potential. The Neurotrac II-EP as well as the EP predicate devices the Viking IV, the Excel and the Neuropack 8 allow for a full range of features to perform these modalities. The Neurotrac II-EP as well as the EP predicate devices supports external triggers for pattern reversal stimulation and LED goggle stimulation for recording visual evoked potentials.