WAVi SCAN EEG System and Accessories

{0}------------------------------------------------ May 6, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & 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. WAVi Co. David Jones Consultant 3459 Ringsby Ct. Ste. #305 Denver. Colorado 80216 Re: K213900 Trade/Device Name: WAVi SCAN EEG System and Accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GWJ, OLT Dated: December 13, 2021 Received: December 14, 2021 Dear David Jones: 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213900 Device Name WAVi SCAN EEG System and Accessories Indications for Use (Describe) WAV SCAN EEG System is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. | Type of Use (Select one or both, as applicable) | |----------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> 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}------------------------------------------------ # K213900 WAVi™ SCAN EEG System Traditional 510(K) Summary | Submitted by: | WAVi Co.<br>3459 Ringsby Ct. Ste. #305<br>Denver, CO 80216<br>720-203-6970 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | David Jones<br>(281)989-8515<br>djones3016@hotmail.com | | Date Prepared: | May 5, 2022 | | Trade Name: | WAVi™ SCAN EEG System and Accessories (Accessories are the WAVi™<br>Headset and WAVi™ eSoc™ Single Use Electrode Contacts, K162460) | | Common Name: | EEG Amplifier | | Product Code(s): | GWQ (Primary - full-montage standard electroencephalograph),<br>GWJ (stimulator, auditory, evoked response)<br>OLT (non-normalizing quantitative electroencephalograph software) | | Regulation: | 21 CFR § 882.1400 | | Classification: | Class II | | Classification Name: | Electroencephalograph | # Predicate Devices: | 510(k) Number | Trade Name | |---------------|-----------------------------------------------------------------------------------------------| | K171781 | eVox System<br>Evoke Neuroscience<br>200 Valencia Dr. Suite 109<br>Jacksonville. NC 28546 | | K143233 | Mitsar-EEG<br>Nova Tech EEG<br>8503 E. Keats Avenue<br>Mesa, AZ 85209 | | K141316 | COGNISION™ EEG/EP SYSTEM<br>Neuronetrix Solutions<br>1044 E. Chestnut<br>Louisville KY, 40204 | # Device Description: WAVi™ SCAN EEG system (WAVi™ SCAN 1.0) is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis {4}------------------------------------------------ The medical system includes the "WAVi™ EPU" (Electronic Processing Unit), an EEG amplifier intended to be used with EEG accessories cleared in K162460 and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with WAVI™ SCAN 1.0 include an EEG cap, the WAVI™ EPU, headphones, a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device programming. The WAVI EEG System's software includes electronic versions of standardized clinical assessment tools related to psychiatry and neuropsychological evaluation but are provided for convenience and are to be used in accordance with the assessment tools' specific general instructions. These tools do not interact with any other of the EEG system's hardware and software measures and are stand alone. ### Intended Use: WAVI™ SCAN is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. ### Technological Characteristics: WAViTM SCAN EEG system consists of two software components: - · Base Station laptop computer software: pre-loaded WAVi™ SCAN 1.0, and - · Firmware running on the WAVi™ EPU ((PN SW-MSP43)). The Base Station laptop is running on a Windows Operating System and is paired with the EPU through a USB cable. WAVI™ SCAN software runs on the Base Station computer and has a graphic user interface that allows the clinician to set up a patient and create a new patient record, conduct a study to collect EEG and ERP data, view live EEG and ERP data on the Base Station monitor, and export recorded data to a file. Firmware for WAVi™ SCAN resides on the EPU. The purpose of the firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station. The EPU operational mode is controlled via the WAVi™ SCAN software. In addition to 19 channels of EEG recording the device includes a mode to measure the cap electrode impedances. This is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. The primary software outputs are EEG and ERP data files. These data files are written as floating point numbers in binary format, which represent the electrical potential on each of the 19 EEG channels in microvolts. WAVI's qEEG outputs includes Coherence, delta, theta, alpha, beta Power, Audio P300 Delay and Voltage, and Physical Reaction Time. The EPU amplifier device does not come in direct contact with patients. Accessories that contact patients such as the EEG electrode cap are the same as used with legally marketed devices or are comprised of the same materials as legally marketed accessories. WAVITM SCAN is intended for prescription use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician. The device is not sterile. #### Substantial Equivalence The WAVI™ SCAN EEG system is a portable, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) devices, and is intended for the acquisition, display, and {5}------------------------------------------------ storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. The WAVi™ SCAN EEG system is substantially equivalent to the predicate devices in the following manner: - Same intended use - Same operating principle . - Same fundamental scientific technology . - Same or substantially equivalent materials, including headset and electrodes. . {6}------------------------------------------------ There are no technological differences between the WAVI™ SCAN EEG system and the predicates that raise and effectiveness, and the proposed differences have been addressed via performance testing. The WAVI™ SCAN EEG system is substantially equivalent to the predicate device. | | K213900<br>Subject Device<br>WAVi Scan | K171781<br>eVox System | K143233<br>MITSAR-EEG | K141316<br>Cognision EEG/EP<br>System | Remarks | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Principle of<br>Operation | The WAVi Scan device<br>is used for acquisition of<br>physiological signals<br>using two or more<br>channels of<br>electroencephalography<br>(EEG) from the scalp. It<br>consists of the WAVi<br>Scan amplifier (EPU), a<br>laptop or tablet computer<br>(base station), a patient<br>EEG cap accessory,<br>subject response button,<br>earphones, and a<br>charging cord. The<br>WAVi Scan EPU and<br>software provide a<br>means to:<br>a) initiate a study, track<br>user EEG and ERP data<br>and enter text or<br>questionnaire<br>information,<br>b) acquire and save<br>signals to the memory of<br>the device, | The eVox System<br>device is used for<br>acquisition of<br>physiological signals<br>using two or more<br>channels of<br>electroencephalography<br>(EEG) from the scalp.<br>It consists of an eVox<br>amplifier, a laptop<br>computer (base station),<br>a patient EEG cap,<br>subject response button,<br>ear buds, and a<br>charging cord. The<br>eVox amplifier and<br>software provide a<br>means to:<br>a) initiate a study, track<br>user EEG and ERP data<br>and enter text or<br>questionnaire<br>information,<br>b) acquire and save<br>signals to the memory<br>of the device, | The Mitsar EEG<br>consists of biosignal<br>amplifier, USB<br>cable, USB dongle<br>and software. The<br>medical system<br>includes "Mitsar<br>EEG" device and<br>computer (stationary<br>PC with<br>uninterruptible<br>power supply (UPS)<br>or laptop with<br>internal battery).<br>The Mitsar EEG<br>device is an<br>amplifier which<br>receives patient<br>EEG data from a<br>patient EEG cap or<br>EEG electrodes. | The COGNISION<br>EEG/EP System is a<br>combination device<br>for reduced montage<br>recording and display<br>of<br>electroencephalograp<br>hic (EEG) and<br>evoked potentials<br>(EP) test data. The<br>system uses elastic<br>bands to accurately<br>position 10 electrode<br>pods around the head.<br>EEG signal<br>amplification,<br>conditioning, and<br>A/D conversion is<br>performed by<br>electronic circuits<br>closely coupled to the<br>electrode pods<br>through short flexible<br>printed wires. The<br>headset is connected<br>by a cable to a<br>handheld control unit<br>and data acquisition | Similar;<br>All of these devices:<br>-use skin coupling<br>methods through<br>electrodes which<br>transmits patient EEG and<br>ERP from the surface of<br>the scalp to an amplifier,<br>-use a wired connection<br>between the amplifier and<br>electrodes, -convert the<br>analog data into digital<br>data which are<br>transmitted to a base<br>station (computer),<br>-transmit data to a base<br>station computer,<br>display and store the<br>data on the base station<br>and allow the user to<br>export the data to a file. | | | K213900<br>Subject Device<br>WAVi Scan | K171781<br>eVox System | K143233<br>MITSAR-EEG | K141316<br>Cognision EEG/EP<br>System | Remarks | | | c) transmit signal data<br>from the device,<br>d) Visually inspect the<br>acquired signal.<br>e) Manage Event related<br>Potentials (EEG) from<br>the scalp. | c) transmit signal data<br>from the device,<br>d) Visually inspect the<br>acquired signal.<br>e) Manage Event<br>related Potentials<br>(EEG) from the scalp. | c) transmit signal data<br>from the device, | box (HCU). The<br>HCU communicates<br>via a<br>wireless data link to a<br>Window PC to<br>stream EEG data.<br>Software on the PC is<br>used to setup the tests<br>and view and<br>evaluate the resultant<br>test data using<br>standard EEG/EP<br>display methods. | | | Patient population | All age groups | All age groups | All age groups | Adults | Similar | | Use environment | Intended for use in any<br>healthcare, medical, or<br>athletic or sports clinics,<br>or outside of medical<br>facilities such as in the<br>sports arena under the<br>supervision of a<br>physician.<br>Also, investigations can<br>be performed outside of<br>healthcare facilities, as<br>long as they are led by<br>qualified medical<br>personnel. | Intended for use in any<br>healthcare, medical, or<br>athletic or sports<br>clinics, or outside of<br>medical facilities such<br>as in the sports arena<br>under the supervision<br>of a physician.<br>Also, investigations can<br>be performed outside of<br>healthcare facilities, as<br>long as they are led by<br>qualified medical<br>personnel. | Intended for use in<br>Functional<br>diagnostics wards<br>and departments at<br>out-patient clinics,<br>hospitals, health<br>research institutes,<br>health centers and<br>other medical<br>institutions. Also,<br>investigations can be<br>performed outside of<br>healthcare facilities,<br>as long as they are<br>led by qualified<br>medical personnel. | Physicians' Offices | Similar | | Regulatory<br>Classification | Class II | Class II | Class II | Class II | | | | K213900<br>Subject Device<br>WAVi Scan | K171781<br>eVox System | K143233<br>MITSAR-EEG | K141316<br>Cognision EEG/EP<br>System | Remarks | | Biocompatibility | N/A | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | Similar; The patient-<br>contacting components<br>have been previously<br>cleared in K162460 and<br>ISO 10993-1 for these<br>components was covered<br>in that submission | | Intended Use | WAVi Scan is intended<br>for the acquisition,<br>display, and storage, of<br>electrical activity of a<br>patient's brain including<br>electroencephalograph<br>(EEG) and Event-related<br>Potentials (ERP)<br>obtained by placing two<br>or more electrodes on<br>the head to aid in<br>diagnosis. | The eVox System is<br>intended for the<br>acquisition, display,<br>and storage, of<br>electrical activity of a<br>patient's brain<br>including<br>electroencephalograph<br>(EEG) and Event-<br>related Potentials (ERP)<br>obtained by placing two<br>or more electrodes on<br>the head to aid in<br>diagnosis. | The Mitsar-EEG is<br>intended to acquire,<br>display and store the<br>electrical activity of<br>a patient's brain by<br>placing two or more<br>electrodes on the<br>head to aid in<br>diagnosis. | The COGNISION<br>system is a<br>combination device<br>for reduced montage<br>recording and display<br>of<br>electroencephalograp<br>h (EEG) and evoked<br>potentials (EP) test<br>data. | Same | | ERP Stimulus<br>Modality | Auditory | Auditory; Visual | None | Auditory | Similar | | System<br>Components | WAVi Scan EEG<br>System consists of:<br>• a laptop computer<br>(base station),<br>• an amplifier (WAVi<br>EPU), | eVox System consists<br>of:<br>• an eVox amplifier,<br>• a laptop computer<br>(base station),<br>• a patient EEG cap, | "Mitsar EEG"<br>consists of:<br>•biosignal amplifier,<br>• computer<br>(stationary PC with<br>uninterruptible<br>power supply (UPS) | COGNISIONTM<br>consists of:<br>• Headset<br>• Auditory stimulator<br>• Handheld Control<br>Unit | Similar | | | K213900<br>Subject Device<br>WAVi Scan | K171781<br>eVox System | K143233<br>MITSAR-EEG | K141316<br>Cognision EEG/EP<br>System | Remarks | | | • subject response<br>button,<br>• WAVi SCAN EEG<br>software,<br>• earphones, and<br>• charging cord.<br><br>Accessories: WAVi Cap<br>and eSoc K162460 | • subject response<br>button,<br>• ear buds,<br>• and a charging cord. | • or laptop with<br>internal battery)<br>• USB cable,<br>• USB dongle<br>• and software | (HCU) including<br>Interface<br>Software<br>• Connecting Headset<br>cable between the<br>headset and the<br>handheld control unit | | | ERP Paradigm<br>(Auditory and<br>Visual Stimuli) | P300 Oddball<br>- Single Stimulus<br>- Single Deviant | P300 Oddball<br>- Single Stimulus<br>- Single Deviant<br>- 2 Deviant<br>- Active and Passive | None | P300 Oddball<br>- Single Stimulus<br>- Single Deviant<br>- 2 Deviant<br>- Active and Passive | Similar | | ERP Task<br>Response | User Buttons | User Buttons | None | User Buttons | Similar | | Skin Coupling | N/A | Custom Electrode Band<br>and Gel | Custom Electrode<br>Band and Gel | HydroDot Biosensor | Similar; WAVi SCAN<br>can be used with any<br>510(k) cleared EEG gel | | Sterile | No | No | No | No | Similar | | Single Use | No | No | No | No | Similar | | Shelf life | Durable Good | Durable good | Durable good | Durable good | Similar | | Typical<br>Biopotential<br>Signals Recorded | Electroencephalography<br>(EEG), EP/ERP | Electroencephalograph<br>y (EEG), EP/ERP | Electroencephalogra<br>phy (EEG) | Electroencephalograp<br>hy (EEG), EP/ERP | Similar; WAVi Scan,<br>eVox and Cognision<br>record EEG and EP/ERP.<br>Mitsar does not have<br>EP/ERP modality. | | | K213900<br>Subject Device<br>WAVi Scan | K171781<br>eVox System | K143233<br>MITSAR-EEG | K141316<br>Cognision EEG/EP<br>System | Remarks | | Number of Signal<br>Recording<br>Channels | Up to 21 | Up to 21 | Up to 21 | Up to 10 | Similar…