microTargeting Guideline 4000 5.0 System

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 - 1. Submitter's name, address, telephone number, a contact person, and the date the summary was prepared: FHC, Inc. 1201 Main Street Bowdoin, ME-04287 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-LPP<br>or Intraoperative neurophysiological recording and<br>stimulating 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ | 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 | Catalog<br>Number | 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 Interface<br>Processing 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<br>(existing medical device, not within<br>the 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 {6}------------------------------------------------ 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 microTargeting<br>Controller | 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. - 6. Comparison of Technological Characteristics to Predicate Device: {7}------------------------------------------------ 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 | |--------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Signal<br>Amplifier | Signal<br>Conditioner | Gain<br>High Pass/Low<br>Pass Filters | 28.3 - 3764x<br>(Analog)<br>Continuous; 0-<br>1,000/3,000-<br>20,000 | UE: 5.9 - 214x (+3x<br>optional), LF:<br>1,2,4,6,12,24x (Analog)<br>Continuous: 0-10,000Hz | | | Stimulation<br>circuit | Isolated | Yes | Yes | | | | Stimulator Type | Constant<br>Current &<br>Voltage<br>Settings | Same | | | | Settings control | controlled via<br>hardware and<br>software.<br>Activation still<br>only a hardware<br>function. | Same | | | | Waveform<br>Displayed? | No | Same | | | | Waveform Type | Arbitrary,<br>Unipolar or<br>Bipolar Square<br>Wave | Same | | | Stimulation<br>Modes | Micro | Yes | Same | | | Macro | Yes | Same | | | Stimulus<br>Controls | Max Micro Stim<br>Amplitude | 100 uA | Same | | | | Max Macro Stim<br>Amplitude | 10 mA | 10mA | | | | Frequency | Up to 300 Hz | Up to 300Hz | | | | Pulse Duration | .05, .1, .2, .5, 1<br>ms | Continuous up to 3.0<br>mS (50% duty cycle<br>max) | | | | Train Duration | Manual, 0.5 to<br>20 s | Manual, 0.5s - 60 s | | | Adaptive<br>Noise Filter | Available | Yes | Same | | | Data<br>Acquisition | Pipeline | USB 2.0 | TCP/IP | | | Pre-amp | Built in gain | 28.3 x | N/A | | | | Max Distance<br>to patient | 3 m | Same | | | | Max # of Channels | 10 | 8(16 with two<br>interfaces) | | | | Impedance<br>Check | Activation controlled by | Software | Same | | | | Waveform used | Sinewave | Composite Waveform,<br>Sine @ 200Hz and sine @ 1000Hz | | | | Measurement Range | 10kOhms to<br>10MOhms | 100 Ohms - 5MOhms | | | | Resolution | 2 significant<br>digits | Same | | | Remote | Available | Yes | Same | | | | Stimulation Activation | Yes | Same | | | | Stimulus Amplitude<br>Selector | Yes | Same | | | | Microphone | Yes | Same | | | | Impedance Check<br>Activation | Yes | Same | | | Action<br>Indicators | General Fault | Visual Alarm | Same | | | | Stimulation Error | Visual and Audio<br>Alarm | Same | | | | Stimulation<br>Activated | Visual and Audio<br>Alarm | Same | | | | Impedance<br>Overage | Visual Alarm | Same | | Audio Amp | Source | Un-conditioned<br>Signal | No | Yes | | | | Conditioned Signal | Yes | Yes | | | Audio | Baseline<br>Suppressor | Yes | Same | | | | Bass Control | Yes | Same | | | | Treble Control | Yes | Same | | | | Graphic Equalizer | No | Same | | | Volume | Headphone<br>Control | No, not<br>applicable | Yes | | | | Speaker Control | Yes | Same | | | | System Mute | Yes | Same | | | Inputs | Microphone | Yes | Same | | | Outputs | Headphone<br>Speakers | No | Yes | | Aux Input<br>Unit | | Max number of<br>channels | 4 analog, 2<br>digital | 2 analog, 2 high speed<br>digital, 2 byte digital | | Computer<br>System | 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"<br>UXGA | 15.6" diag, 1920x1080<br>resolution | | | Touchscreen | Yes (option) | No | Multipoint | | | CD-RW | Yes | Yes | No | | | Storage Drive | Yes, Size | No | Yes (1TB min) | | | | | | | | Recording<br>Software | Data Tags | Voice Tags | Yes | Same | | | | Custom Text Tags | Yes | Same | | | | Preloaded Test<br>Tags | No | Same | | | | Drive Depth | Yes | Same | | | Waveform<br>Display | Fast (Spike) -<br>Allows user to<br>focus on single<br>event if needed<br>Slow (Continuous)<br>- default<br>waveform | Yes | Same | | | | displayed for each<br>channel. | Yes | Same | | | | Spectrogram | No | Yes | | | Spike<br>Discrimination | Window | Yes | Same | | | | Level | Yes | Same | # Table 2: Similarities between Guideline 4000 and Guideline 4000™ 5.0 {8}------------------------------------------------ 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 {9}------------------------------------------------ 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 {12}------------------------------------------------ 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 {13}------------------------------------------------ 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 | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electrical<br>Safety | Electrical Safety consistent<br>with IEC 60601 (Class 1 ME<br>Equipment)<br>Internal Testing based on IEC<br>60601 protocols.<br>60601-1 Electrical Safety<br>Testing Performed Externally<br>by 3rd Party entity. | Both internally and externally<br>performed electrical safety testing on<br>subject device per standard IEC<br>60601 passed the acceptance criteria<br>necessary for establishing basic<br>safety. The subject and predicate<br>device were both exposed to the<br>same 60601-1 electrical safety testing<br>therefore a substantive equivalence is<br>established. | | Mechanical<br>Integrity | Mechanical Strength and<br>Integrity testing consistent<br>with standard IEC 60601<br>Internal Testing based on IEC<br>60601 protocols.<br>60601-1 Mechanical Strength<br>Testing Performed Externally<br>by 3rd Party entity. | Both internally and externally<br>performed mechanical strength<br>testing on subject device per<br>standard IEC 60601 passed the<br>acceptance criteria necessary for<br>establishing basic safety. The subject<br>and predicate device were both<br>exposed to the same 60601-1<br>mechanical strength testing therefore<br>a substantive equivalence is<br>established. | | Macro<br>Stimulation | The test method employed is<br>an internally generated<br>protocol in which the subject<br>device is assessed on three<br>key parameters relevant to the<br>safe and effective delivery of<br>therapeutic electrical stimulus.<br>These parameters include:<br>-Accurate output frequency<br>-Accurate pulse duration<br>-Accurate stimulus amplitude | The subject devices met the<br>acceptance criteria necessary for<br>establishing accuracy of stimulator<br>outputs to within ±10% of the User<br>Interface set point for frequency,<br>pulse duration, and amplitude. Given<br>the predicate device provides the<br>same accuracy, a substantive<br>equivalence is established. | | | Each parameter is adjusted via<br>the software user interface.<br>Each parameter is then<br>measured using a NIST<br>traceable oscilloscope with the<br>subject device's output<br>terminated with precision<br>resistive loads which act as<br>microelectrode analogs. | | | Micro<br>Stimulation | The test protocol used for<br>Macro Stimulation mode also<br>applies to Micro stimulation<br>with the exception of the<br>latter outputs an order of<br>magnitude lower stimulus<br>amplitude. | The subject devices met the<br>acceptance criteria necessary for<br>establishing accuracy of stimulator<br>outputs to within ±10% of the User<br>Interface set point for frequency,<br>pulse duration, and amplitude. Given<br>the predicate device provides the<br>same accuracy, a substantive<br>equivalence is established. | | Software<br>regression<br>testing | The internally created<br>software regression test<br>protocol is based on the<br>workflow established in the<br>Usability specification of the<br>predicate device. It is<br>performed iteratively at each<br>software release per IEC<br>62304.<br>All major and minor software<br>functions were tested<br>iteratively prior to each<br>release of a new software<br>revision. Additionally, bugs<br>fixed since the previous round<br>of regression testing were<br>assessed for effectiveness and<br>risk. | All major areas of software<br>functionality were confirmed for the<br>subject device. No remaining bugs<br>had a risk level of greater than<br>Acceptable as defined by risk<br>management plan.<br>Over the course of its life-cycle, the<br>predicate device received similar<br>treatment with respect to bug fixes,<br>bug risk acceptance, software<br>releases, and regression testing. As<br>such, substantive equivalence is<br>established. | {14}------------------------------------------------ # 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.