(37 days)
The microTargeting™ Guideline 4000 5.0 System is intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments.
The microTargeting™ Guideline 4000™ 5.0 System is an electrophysiological recording and stimulation system designed primarily for functional neurosurgery procedures. The system provides high quality and research-grade recordings on both microelectrodes and macroelectrodes, including low-frequency signals on externalized DBS leads, improved signal quality, decreased noise susceptibility, improved user experience with redesigned software, new intraoperative data analysis options, and an updated user interface to support touch screens and multiple high-resolution monitors. Additionally, it provides simultaneous constant-current and constant-voltage stimulation capabilities that include multiple weighted sources and return paths as well as complex and arbitrary stimulation waveforms. The software provides an intuitive patient management system, as well as advanced visualization and analysis methods for both single-unit recording and low-frequency signals (LFP, SEEG etc.). A fully configured system consists of a Core Module, a notebook PC, an 8-channel UE interface unit, a remote, an optional second 8-channel LF interface and an optional synchronization unit.
The provided document is a 510(k) Premarket Notification for the "microTargeting™ Guideline 4000 5.0 System." This document focuses on demonstrating substantial equivalence to a predicate device, as required for certain medical devices by the FDA. It does not include the information typically found in a study proving a device meets acceptance criteria for an AI/ML-driven diagnostic or assistive device (e.g., performance metrics like sensitivity, specificity, AUC, human-in-the-loop studies, ground truth establishment, or sample sizes for deep learning models).
The document is for an electrophysiological recording and stimulation system for neurosurgical procedures, not an AI/ML-driven device or an imaging diagnostic device. Therefore, the details requested (e.g., acceptance criteria for AI diagnostic performance, sample size for test sets, number of experts for ground truth, MRMC studies) are not applicable to the content of this specific submission.
The "acceptance criteria" discussed in the document are related to electrical safety, mechanical integrity, macro/micro stimulation accuracy, and software regression testing for an electrophysiological device, comparing its performance to that of a previous version of the device (the predicate device).
However, I will extract and present the information available that is conceptually similar to what your questions are asking for, but with the understanding that it pertains to a different type of device and different evaluation methodology than what your questions imply.
Here's an attempt to answer your questions based on the provided text, while making it clear where the information is not relevant or not present due to the nature of the device and submission:
Device: microTargeting™ Guideline 4000™ 5.0 System
Intended Use: To record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments during functional neurosurgical procedures.
1. A table of acceptance criteria and the reported device performance:
The document describes nonclinical performance data for the device, and the "acceptance criteria" are implied by the "Results" section for each test, indicating that the device "met the acceptance criteria."
| Test | Test Method Summary | Acceptance Criteria (Implied by Results) & Reported Device Performance |
|---|---|---|
| Electrical Safety | Electrical Safety consistent with IEC 60601 (Class 1 ME Equipment). Internal Testing based on IEC 60601 protocols. 60601-1 Electrical Safety Testing Performed Externally by 3rd Party entity. | Acceptance Criteria: Passing the acceptance criteria necessary for establishing basic safety per IEC 60601. Reported Performance: Both internally and externally performed electrical safety testing passed the acceptance criteria. Substantive equivalence to predicate established. |
| Mechanical Integrity | Mechanical Strength and Integrity testing consistent with standard IEC 60601. Internal Testing based on IEC 60601 protocols. 60601-1 Mechanical Strength Testing Performed Externally by 3rd Party entity. | Acceptance Criteria: Passing the acceptance criteria necessary for establishing basic safety per IEC 60601. Reported Performance: Both internally and externally performed mechanical strength testing passed the acceptance criteria. Substantive equivalence to predicate established. |
| Macro Stimulation | Internally generated protocol assessing three key parameters: accurate output frequency, accurate pulse duration, and accurate stimulus amplitude. Measured using a NIST traceable oscilloscope with precision resistive loads as microelectrode analogs. Each parameter adjusted via software user interface. | Acceptance Criteria: Accuracy of stimulator outputs to within ±10% of the User Interface set point for frequency, pulse duration, and amplitude. Reported Performance: The subject devices met the acceptance criteria. Substantive equivalence to predicate established. |
| Micro Stimulation | Same test protocol as Macro Stimulation, but for lower stimulus amplitude range. | Acceptance Criteria: Accuracy of stimulator outputs to within ±10% of the User Interface set point for frequency, pulse duration, and amplitude. Reported Performance: The subject devices met the acceptance criteria. Substantive equivalence to predicate established. |
| Software Regression Testing | Internally created protocol based on workflow established in the Usability specification of the predicate device. Performed iteratively at each software release per IEC 62304. All major and minor software functions tested. Bugs fixed since previous round assessed for effectiveness and risk. | Acceptance Criteria: All major areas of software functionality confirmed, and no remaining bugs with a risk level greater than "Acceptable" as defined by risk management plan. Reported Performance: All major areas of software functionality were confirmed for the subject device. No remaining bugs had a risk level of greater than Acceptable. Substantive equivalence to predicate established. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of "test set" samples (e.g., patient cases) as this is not a diagnostic AI/ML device. The tests described are device-level verification and validation (e.g., electrical safety, mechanical, stimulation accuracy) conducted on the physical device and its software. The number of units tested is not stated but standard V&V would involve a representative sample of manufactured units.
- Data Provenance: Not applicable in the context of patient data sets. The testing is based on internal protocols, external third-party testing (for electrical safety and mechanical strength), and comparison to a legally marketed predicate device (FHC, Inc.'s microTargeting™ Guideline 4000).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a device that relies on expert interpretation of data (e.g., images, waveforms) to establish a "ground truth" for diagnostic accuracy in the way an AI/ML-driven device would. The "ground truth" for this device's performance is objectively measured against established engineering and safety standards (e.g., IEC 60601) and specifications for electrical outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human interpretations of patient data involved in establishing "ground truth" for the tests described, no adjudication method is relevant.
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:
- No. This device is an electrophysiological recording and stimulation system, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers are not applicable to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Interpreted Differently. While the device itself operates "stand-alone" in its core functions (e.g., generating stimuli, recording signals), there is no 'algorithm-only' performance test in the diagnostic sense. The software functions were tested through "Software regression testing," which assesses the functionality and correctness of the software components. The device is intended for use by a neurosurgeon, neurologist, or clinical neurophysiologist, meaning there is always a human-in-the-loop controlling its operation and interpreting its outputs in a clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for evaluating this device's performance would be the expected engineering specifications and international safety standards. For example:
- For electrical safety: Compliance with IEC 60601-1.
- For mechanical integrity: Compliance with IEC 60601-1.
- For stimulation accuracy: Output frequency, pulse duration, and amplitude within ±10% of the user interface set point, as measured by calibrated equipment (NIST traceable oscilloscope).
- For software: Functionality confirmed against use-case specifications and risk assessment ensuring no unacceptable risks.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set" of data for learning.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2018
FHC. Inc. Kelly Moeykens Quality Systems Officer 1201 Main Street Bowdoin, Maine 04287
Re: K183123
Trade/Device Name: microTargeting Guideline 4000 5.0 System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: November 6, 2018 Received: November 13, 2018
Dear Kelly Moeykens:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-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,
Jay R. Gupta -S
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
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Indications for Use
510(k) Number (if known) K183123
Device Name
microTargeting™ Guideline 4000 5.0 System
Indications for Use (Describe)
The microTargeting™ Guideline 4000 5.0 System is intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo features a stylized image of a neuron on the left, followed by the letters "FHC" in a bold, sans-serif font. Below the letters, the tagline "Neural microTargeting™ Worldwide" is written in a smaller font.
SPECIAL 510(k) SUMMARY
-
- Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
FHC, Inc. 1201 Main Street Bowdoin, ME-04287
- Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
Tel: 207-666-5651 Fax: 207-666-8292
Contact: Kelly Moeykens Date:11/01/18
2. Name(s) of the Device:
| Proprietary/Trade Name: | microtargeting™ Guideline 4000™ 5.0 System |
|---|---|
| Common Name: | Guideline 5 or GL5 or Guideline 4000™ 5.0TM or MT-LPPor Intraoperative neurophysiological recording andstimulating device |
| Classification Name: | Depth Electrode |
| Regulation # | 21 CFR 882.1330 |
| Regulatory Class: | II |
| Product Code: | GZL |
3. Legally Marked Predicate Device to which the submitter claims substantial equivalence:
The microtargeting™ Guideline 4000™ 5.0 System is substantially equivalent to FHC, Inc.'s microTargeting" Guideline 4000 (K071364); decision date: July 25th 2007, product code: GZL.
FHC Corporate & Manufacturing 1201 Main Street Bowdoin, ME 04287-7302 USA www.fh-co.com
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281 Sector 2 Romania
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Image /page/4/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo features a stylized blue neuron graphic on the left, followed by the large, blue letters "FHC". Below the letters is the text "Neural microTargeting™ Worldwide" in a smaller font. The overall design is clean and professional, conveying a sense of scientific expertise and global reach.
4. Description of device:
The microtargeting™ Guideline 4000™ 5.0 System is an electrophysiological recording and stimulation system designed primarily for functional neurosurgery procedures.
The microtargeting™ Guideline 4000™ 5.0 System provides:
- . High quality and research-grade recordings on both microelectrodes and macroelectrodes, including low-frequency signals on externalized DBS leads
- . Improved signal quality
- Decreased Noise susceptibility
- Improved user experience with redesigned software
- . New intraoperative data analysis options
- Updated user interface to support touch screens and multiple high-resolution monitors
Additionally, Guideline 5 interface provides unprecedented simultaneous constant-current and constant-voltage stimulation capabilities that include multiple weighted sources and return paths as well as complex and arbitrary stimulation waveforms. Together, these capabilities result in the output of advanced stimulation protocols, including current steering. The software provides an intuitive patient management system, as well as advanced visualization and analysis methods for both single-unit recording and low-frequency signals (LFP, SEEG etc.).
The Guideline 5 offers neurosurgical teams a powerful microelectrode recording/stimulating system in a compact, streamlined package. It offers fully integrated stimulation and impedance check capabilities on all channels, in addition to one-click recall of user preferences and side-byside review of all recorded snapshots.
As shown below, a fully configured system consists of a Core Module, a notebook PC, an 8channel UE interface unit, a remote, an optional second 8-channel LF interface and an optional synchronization unit.
FHC Corporate & Manufacturing 1201 Main Street Bowdoin. ME 04287-7302 USA www.fh-co.com
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281 Sector 2 Romania
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| FHC | |
|---|---|
| UE Interface | |
| Optional LF Interface | |
| Optional Sync Unit | |
| Bif Burdoch | |
| IntraOp | |
| Guideline 5 | |
| Core module and Notebook PC & external speaker | |
| remote |
Figure 1 : A fully configured Guideline 5 system.
Individual components which comprise the Guideline 5 system are listed in the table below:
| Component Name | CatalogNumber | Description | Classification |
|---|---|---|---|
| Main Processing Unit | C0215 | Guideline 5 Main Unit | Core Component |
| Guideline PC | C0216 | Guideline 5 Notebook | Core Component |
| Ethernet Cable | C0234 | Ethernet Cable | Core Component |
| UE Interface | C0219 | Microelectrode head-stage | Core Component |
| LF Interface | C0220 | Low Frequency Signal head-stage | Accessory |
| Software | C0217 | Guideline 5 Software Application | Core Component |
| Secondary InterfaceProcessing Card | C0218 | Interface Processing Card (factory or field installed) | Variant (internal) |
| Interface Digital Cable | C0221 | 3m Interface Cable | Core Component |
| Motor | C0235 | microTargeting Power Assist Unit(existing medical device, not withinthe scope of these design inputs) | Accessory |
| Table 1: List of components of Guideline 5 system | |||
|---|---|---|---|
| -- | -- | --------------------------------------------------- | -- |
FHC Corporate & Manufacturing
1201 Main Street Bowdoin, ME 04287-7302 USA www.fh-co.com
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281 Sector 2 Romania
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Image /page/6/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo features a stylized blue neuron graphic on the left, followed by the letters "FHC" in a bold, sans-serif font. Below the letters, the tagline "Neural microTargeting™ Worldwide" is written in a smaller font.
| mT Controller Card | C0223 | Integrated microTargetingController | Variant (internal) |
|---|---|---|---|
| Remote Control | C0222 | Guideline 5 Remote Control | Core Component |
| Breakout Box | C0224 | Synchronization Unit | Accessory |
| HD Digital Cable | C0225 | 1m Synchronization Unit Cable | Accessory |
| 3m Patient Lead | C0230 | 3m UE Cable | Consumable |
| 1.5m Patient Lead | C0231 | 1.5m UE Cable | Consumable |
| Interface pole mount | C0233 | Interface Pole Mounting Bracket | Accessory |
| Speaker | C0237 | High Performance Speaker | Core Component |
The Guideline 5 has full featured multi-source stimulation capabilities. Stimulation modes of constant voltage or constant current mode are available with a compliance voltage of ±14V. The UE Interface is capable of microstimulation (±100µA max) through the microelectrode as well as macrostimulation (±10mA max) through the macro-contact. During stimulation, the voltage applied to the electrode is monitored and displayed constantly. The LF provides macro-stimulation. Every channel has its own stimulation circuit, allowing the Guideline 5 to perform the complex simultaneous multi-channel, multireturn stimulation protocols required for current shaping and steering. Channels not involved in the stimulation continue to record activity while an adaptive suppressor minimizes stimulus artifacts.
Integrated Impedance Check functionality for microelectrodes, macro-contacts and LF electrodes can be performed easily for monitoring the state of all connected electrodes. Measurement frequency and duration are user adjustable. The low measurement current of 1μApp minimizes any effect of the measurement on microelectrode properties. Simultaneous measurement of all channels provides quicker results. An automated power on self-test verifies proper operation and calibration of all stimulation and impedance check circuitry prior to every use of the Guideline 5 system.
The Guideline 5 is capable of recording any or all activity on an event-by-event basis or continuously. Recorded waveforms can be reviewed and analyzed intraoperatively or post-operatively. Sample Matlab™ scripts provided allow for more advanced analyses of electrode and auxiliary data suitable for research applications.
5. Statement of Intended Use:
The microtargeting™ Guideline 4000™ 5.0 System is intended to be used by a neurosurgeon, neurologist or clinical neurophysiologist to accurately position depth electrodes during functional neurosurgical procedures. In addition, when external devices such as EMGs or accelerometers are connected to the Guideline 4000™ 5.0, the system is capable of displaying and recording the activity from these external devices. The Guideline 4000™ 5.0 is also intended to be used in functional neurosurgical procedures for physiological mapping of the brain and nervous system; thereby aiding in the accurate placement of electrodes or other instruments.
Statement of Indications for Use: The Guideline 4000™ 5.0 is intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments.
-
- Comparison of Technological Characteristics to Predicate Device:
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The technological characteristics of the Guideline 4000™ 5.0 are the same as those in the predicate device. There is no new technology, materials or method of manufacture introduced. A summary of similarities in the specifications between the Guideline 4000™ 5.0 and its predecessor is provided below.
| Component | Section | Feature | Guideline 4000 | Guideline 4000™ 5.0 |
|---|---|---|---|---|
| SignalAmplifier | SignalConditioner | GainHigh Pass/LowPass Filters | 28.3 - 3764x(Analog)Continuous; 0-1,000/3,000-20,000 | UE: 5.9 - 214x (+3xoptional), LF:1,2,4,6,12,24x (Analog)Continuous: 0-10,000Hz |
| Stimulationcircuit | Isolated | Yes | Yes | |
| Stimulator Type | ConstantCurrent &VoltageSettings | Same | ||
| Settings control | controlled viahardware andsoftware.Activation stillonly a hardwarefunction. | Same | ||
| WaveformDisplayed? | No | Same | ||
| Waveform Type | Arbitrary,Unipolar orBipolar SquareWave | Same | ||
| StimulationModes | Micro | Yes | Same | |
| Macro | Yes | Same | ||
| StimulusControls | Max Micro StimAmplitude | 100 uA | Same | |
| Max Macro StimAmplitude | 10 mA | 10mA | ||
| Frequency | Up to 300 Hz | Up to 300Hz | ||
| Pulse Duration | .05, .1, .2, .5, 1ms | Continuous up to 3.0mS (50% duty cyclemax) | ||
| Train Duration | Manual, 0.5 to20 s | Manual, 0.5s - 60 s | ||
| AdaptiveNoise Filter | Available | Yes | Same | |
| DataAcquisition | Pipeline | USB 2.0 | TCP/IP | |
| Pre-amp | Built in gain | 28.3 x | N/A | |
| Max Distanceto patient | 3 m | Same | ||
| Max # of Channels | 10 | 8(16 with twointerfaces) | ||
| ImpedanceCheck | Activation controlled by | Software | Same | |
| Waveform used | Sinewave | Composite Waveform,Sine @ 200Hz and sine @ 1000Hz | ||
| Measurement Range | 10kOhms to10MOhms | 100 Ohms - 5MOhms | ||
| Resolution | 2 significantdigits | Same | ||
| Remote | Available | Yes | Same | |
| Stimulation Activation | Yes | Same | ||
| Stimulus AmplitudeSelector | Yes | Same | ||
| Microphone | Yes | Same | ||
| Impedance CheckActivation | Yes | Same | ||
| ActionIndicators | General Fault | Visual Alarm | Same | |
| Stimulation Error | Visual and AudioAlarm | Same | ||
| StimulationActivated | Visual and AudioAlarm | Same | ||
| ImpedanceOverage | Visual Alarm | Same | ||
| Audio Amp | Source | Un-conditionedSignal | No | Yes |
| Conditioned Signal | Yes | Yes | ||
| Audio | BaselineSuppressor | Yes | Same | |
| Bass Control | Yes | Same | ||
| Treble Control | Yes | Same | ||
| Graphic Equalizer | No | Same | ||
| Volume | HeadphoneControl | No, notapplicable | Yes | |
| Speaker Control | Yes | Same | ||
| System Mute | Yes | Same | ||
| Inputs | Microphone | Yes | Same | |
| Outputs | HeadphoneSpeakers | No | Yes | |
| Aux InputUnit | Max number ofchannels | 4 analog, 2digital | 2 analog, 2 high speeddigital, 2 byte digital | |
| ComputerSystem | CPU Speed | At least 1.0 GHz | 2 GHz dual core | Intel, Core I7 (min) |
| RAM | At least 256 MB | 2 GB | 8GB | |
| Monitor | At least 17" w | wide screen 17"UXGA | 15.6" diag, 1920x1080resolution | |
| Touchscreen | Yes (option) | No | Multipoint | |
| CD-RW | Yes | Yes | No | |
| Storage Drive | Yes, Size | No | Yes (1TB min) | |
| RecordingSoftware | Data Tags | Voice Tags | Yes | Same |
| Custom Text Tags | Yes | Same | ||
| Preloaded TestTags | No | Same | ||
| Drive Depth | Yes | Same | ||
| WaveformDisplay | Fast (Spike) -Allows user tofocus on singleevent if neededSlow (Continuous)- defaultwaveform | Yes | Same | |
| displayed for eachchannel. | Yes | Same | ||
| Spectrogram | No | Yes | ||
| SpikeDiscrimination | Window | Yes | Same | |
| Level | Yes | Same |
Table 2: Similarities between Guideline 4000 and Guideline 4000™ 5.0
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Image /page/8/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo features a stylized blue neuron graphic on the left, followed by the letters "FHC" in a bold, sans-serif blue font. Below the letters, the tagline "Neural microTargeting™ Worldwide" is written in a smaller, lighter font.
Tel: +1-207-666-8190 US & Canada: 800-326-2905
Fax: +1-207-666-8292 FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3ª Fl Bucharest 020281 Sector 2 Romania
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Image /page/9/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo consists of a stylized image of a brain cell on the left, followed by the letters "FHC" in a large, sans-serif font. Below the letters, the tagline "Neural microTargeting™ Worldwide" is written in a smaller font.
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281 Sector 2 Romania
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo consists of a stylized image of a brain cell on the left, followed by the letters "FHC" in a bold, sans-serif font. Below the letters, the tagline "Neural microTargeting™ Worldwide" is written in a smaller font.
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl
Bucharest 020281 Sector 2 Romania
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo features a stylized image of a neuron on the left, followed by the letters "FHC" in a bold, sans-serif font. Below the letters, the tagline "Neural microTargeting™ Worldwide" is written in a smaller font. The overall design is clean and professional, conveying a sense of expertise and innovation in the field of neuroscience.
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281 Sector 2 Romania
FHC Latin America Carrera 43 A # 1sur 31 Ed. BBVA oficina 401
Medellín-Colombia
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Image /page/12/Picture/0 description: The image shows the logo for FHC, a company specializing in neural microtargeting worldwide. The logo features a stylized blue brain cell graphic to the left of the letters "FHC" in a bold, sans-serif font, also in blue. Below the letters is the tagline "Neural microTargeting™ Worldwide" in a smaller, lighter font.
Tel: +1-207-666-8190 US & Canada: 800-326-2905 Fax: +1-207-666-8292
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281 Sector 2 Romania
FHC Latin America Carrera 43 A # 1sur 31 Ed. BBVA oficina 401
Medellín-Colombia
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Image /page/13/Figure/0 description: The image shows a table with the words "Waveform analysis", "Template Matching", "Yes", and "No" written in it. The words "Waveform analysis" and "Template Matching" are in the first row, while "Yes" and "No" are in the second row. The image also contains the logo for Neural microTargeting.
7. Nonclinical performance Data:
Performance data of the microTargeting™ Guideline 4000™ 5.0 System is documented in the verification and validation reports. Electrical Safety Test, Mechanical Integrity test, Macrostimulation test, Microstimulation test and Software regression test results show the system to be the equivalent to the predicate system.
| Test | Test Method Summary | Results |
|---|---|---|
| ElectricalSafety | Electrical Safety consistentwith IEC 60601 (Class 1 MEEquipment)Internal Testing based on IEC60601 protocols.60601-1 Electrical SafetyTesting Performed Externallyby 3rd Party entity. | Both internally and externallyperformed electrical safety testing onsubject device per standard IEC60601 passed the acceptance criterianecessary for establishing basicsafety. The subject and predicatedevice were both exposed to thesame 60601-1 electrical safety testingtherefore a substantive equivalence isestablished. |
| MechanicalIntegrity | Mechanical Strength andIntegrity testing consistentwith standard IEC 60601Internal Testing based on IEC60601 protocols.60601-1 Mechanical StrengthTesting Performed Externallyby 3rd Party entity. | Both internally and externallyperformed mechanical strengthtesting on subject device perstandard IEC 60601 passed theacceptance criteria necessary forestablishing basic safety. The subjectand predicate device were bothexposed to the same 60601-1mechanical strength testing thereforea substantive equivalence isestablished. |
| MacroStimulation | The test method employed isan internally generatedprotocol in which the subjectdevice is assessed on threekey parameters relevant to thesafe and effective delivery oftherapeutic electrical stimulus.These parameters include:-Accurate output frequency-Accurate pulse duration-Accurate stimulus amplitude | The subject devices met theacceptance criteria necessary forestablishing accuracy of stimulatoroutputs to within ±10% of the UserInterface set point for frequency,pulse duration, and amplitude. Giventhe predicate device provides thesame accuracy, a substantiveequivalence is established. |
| Each parameter is adjusted viathe software user interface.Each parameter is thenmeasured using a NISTtraceable oscilloscope with thesubject device's outputterminated with precisionresistive loads which act asmicroelectrode analogs. | ||
| MicroStimulation | The test protocol used forMacro Stimulation mode alsoapplies to Micro stimulationwith the exception of thelatter outputs an order ofmagnitude lower stimulusamplitude. | The subject devices met theacceptance criteria necessary forestablishing accuracy of stimulatoroutputs to within ±10% of the UserInterface set point for frequency,pulse duration, and amplitude. Giventhe predicate device provides thesame accuracy, a substantiveequivalence is established. |
| Softwareregressiontesting | The internally createdsoftware regression testprotocol is based on theworkflow established in theUsability specification of thepredicate device. It isperformed iteratively at eachsoftware release per IEC62304.All major and minor softwarefunctions were testediteratively prior to eachrelease of a new softwarerevision. Additionally, bugsfixed since the previous roundof regression testing wereassessed for effectiveness andrisk. | All major areas of softwarefunctionality were confirmed for thesubject device. No remaining bugshad a risk level of greater thanAcceptable as defined by riskmanagement plan.Over the course of its life-cycle, thepredicate device received similartreatment with respect to bug fixes,bug risk acceptance, softwarereleases, and regression testing. Assuch, substantive equivalence isestablished. |
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8. Substantial Equivalence statement:
The microTargeting™ Guideline 4000™ 5.0 System is substantially equivalent in design, construction, materials, intended use and performance characteristics to its predicative devices, FHC, Inc.'s microTargeting "Guideline 4000 System (K071364), which was cleared under 510(k) K071364, July 25th, 2007.
§ 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).