CNS Envision

K192572 · Moberg Research, Inc. · OLT · Dec 17, 2019 · Neurology

Device Facts

• Record ID: K192572
• Device Name: CNS Envision
• Applicant: Moberg Research, Inc.
• Product Code: OLT · Neurology
• Decision Date: Dec 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CNS Envision is intended for use by qualified personnel in the review, and analysis of patient data collected using external physiological monitors. These data are: raw and quantitative EEG, recorded video data, generic vital signs, electrocardiography, electromyography, intracranial pressures, transcranial Doppler measurements, and Glasgow Coma Score. CNS Envision includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveforms. These include, for example, frequency bands, asymmetry, and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The aEEG functionality included in CNS Envision is intended to monitor the state of the brain. CNS Envision is intended for use by a physician or other qualified medical personnel who will exercise professional judgement in using the information. It is intended for use on patients of all ages. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Story

CNS Envision is a Windows-based software application for remote review, annotation, and analysis of physiological data; inputs include raw/quantitative EEG, video, vital signs (HR, RR, SpO2, BP, MAP, Temp), ECG, EMG, ICP, TCD, and GCS. Device transforms raw data into quantitative trends (e.g., density spectral arrays, spectral edge frequency, alpha-delta ratio, aEEG) and displays waveforms. Operated by physicians/qualified personnel in clinical settings; enables customized layouts and montages. Does not perform direct data acquisition; reads data collected by CNS Monitor (K080217). Output is visual display of trends and raw data for clinician interpretation; supports clinical decision-making without providing diagnostic conclusions. Benefits include remote access to patient data and adjustable review speeds for efficient monitoring.

Clinical Evidence

Bench testing only. Software verification and validation testing conducted per FDA guidance (May 2005), including module, integration, and system-level testing. Usability engineering performed per IEC 62366-1:2015. No clinical data presented.

Technological Characteristics

Windows-based software application. Quantitative EEG analysis (frequency bands, asymmetry, burst suppression, aEEG). Connectivity: reads data from CNS Monitor (K080217). User interface: mouse/keyboard input, customizable layouts/montages, adjustable review speed, linear/semi-log scale graphs. Software level of concern: moderate.

Indications for Use

Indicated for use by qualified medical personnel for review, annotation, and analysis of patient data (EEG, video, vital signs, ECG, EMG, ICP, TCD, GCS) collected via external physiological monitors. Intended for patients of all ages. No diagnostic conclusions provided.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Component Neuromonitoring System (K080217)
• Persyst 14 EEG Review and Analysis Software (K182181)

Reference Devices

• Spencer TCD device (K002533)

Submission Summary (Full Text)

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Moberg Research, Inc. Anna Rodriguez, Ph.D. Director of Research 224 S. Maple Street Ambler, Pennsylvania 19002

#### Re: K192572

Trade/Device Name: CNS Envision Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA, OLT, ORT Dated: September 17, 2019 Received: September 18, 2019

#### Dear Dr. Anna Rodriguez:

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 probibitions 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 (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192572

Device Name CNS Envision

#### Indications for Use (Describe)

CNS Envision is intended for use by qualified personnel in the review, and analysis of patient data collected using external physiological monitors. These data are: raw and quantitative EEG, recorded video data, generic vital signs, electrocardiography, electromyography, intracranial pressures, transcranial Doppler measurements, and Glasgow Coma Score.

CNS Envision includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveforms. These include, for example, frequency bands, asymmetry, and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

The aEEG functionality included in CNS Envision is intended to monitor the state of the brain.

CNS Envision is intended for use by a physician or other qualified medical personnel who will exercise professional judgement in using the information. It is intended for use on patients of all ages.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|

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# K192572 Traditional 510(k) Summary

This 510(k) summary was prepared to provide an understanding of the basis for the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.

| Submitter: | Moberg Research, Inc.<br>224 S. Maple Street<br>Ambler, PA 19002<br>[phone] |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anna Rodriguez, Product Manager<br>[e-mail] |
| Date Prepared: | December 17, 2019 |
| Trade Name: | CNS Envision |
| Regulation Name: | Electroencephalograph |
| Regulation Number: | 21 CFR 882.1400 |
| Regulatory Classification: | Class II |
| Product Codes: | OMA amplitude-integrated electroencephalograph (aEEG)<br>(Primary Procode)<br>OLT non-normalizing quantitative electroencephalograph (EEG) software<br>ORT burst suppression detection software for electroencephalograph |
| Review Panel: | Neurological and Physical Medicine Devices (OHT5) |

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| Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A) | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | K080217 Component Neuromonitoring System (Primary<br>Predicate)<br>K182181 Persyst 14 EEG Review and Analysis Software |
| Device Description: | CNS Envision is a Microsoft Windows-based software application that facilitates the review, annotation<br>and analysis of patient data and physiological measurements. Some of these data, such as ECG, are<br>displayed in raw format whereas other types, such as EEG, are analyzed and quantified by the software.<br>The specific type of input data that are reviewable by CNS Envision software are:<br>Raw electroencephalography (EEG) Quantitative EEG trends; density spectral arrays (DSA) spectral edge frequency (SEF), alpha-delta ratio (ADR), and amplitude EEG (aEEG) Video Generic vital signs which are heart rate (HR), respiration rate (RR), pulse oximetry (SpO2), blood pressure, arterial blood pressure (ABP), mean arterial pressure (MAP), and body temperature Electrocardiography (ECG) Electromyography (EMG) Intracranial pressure (ICP) Transcranial Doppler (TCD) measurements (e.g. spectral envelope, peak velocity, and pulsatility index; TCD measurement is collected by the predicate K080217 device's interface module which interfaces with the Spencer TCD device cleared in K002533, which was a predicate to the predicate K080217 Glasgow Coma Score (GCS); this parameter is manually entered on the CNS Monitor (K080217) with 3 total GCS scores by the user; the CNS software automatically sums the 3 scores and stores the data to provide a trend graph |

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CNS Envision also has several features to enable ease-of-use. For example, users may select customized layouts that provide data displays that can be tailored to their monitoring needs according to data sources. The subject device also offers customizable EEG montages that present raw EEG data to medical personnel for interpretation.

Unlike the predicate device, Component Neuromonitoring System™, the subject device does not perform direct data acquisition. Instead, it offers the ability to review data remotely or adjust the review speed.

- Intended Use: The CNS Envision software is intended to be used for post-hoc analysis of electroencephalograph (EEG) data using conventional methodology to output and display standard EEG parameters for interpretation by a qualified user.
The device uses software algorithms as a tool to analyze EEG and other physiological recordings, and to calculate conventional EEG parameters. (e.g. spectral edge frequency, percent alpha, asymmetry).

This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.

| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison and differences |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Component Neuromonitoring<br>System | CNS Envision | |
| The Component Neuromonitoring<br>System™ is intended to monitor<br>the state of the brain by recording<br>and displaying EEG signals, and<br>can also receive and display a<br>variety of vital signs and other<br>measurements from third-party | CNS Envision is intended for use<br>by qualified personnel in the<br>review, annotation, and analysis of<br>patient data collected using external<br>physiological monitors. These data<br>are: raw and quantitative EEG,<br>recorded video data, generic vital | "CNS Envision is intended for use by<br>qualified personnel in the review,<br>annotation, and analysis of patient<br>data collected using external<br>physiological monitors. These data<br>are: raw and quantitative EEG,<br>recorded video data, generic vital<br>signs, electrocardiography, |
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison and differences |
| Component Neuromonitoring | CNS Envision | |
| System | | |
| monitoring devices (such as ICP,<br>ECG, SpO2, and others). It also has<br>the optional capability to record<br>and display patient video.<br>The Component Neuromonitoring<br>System is intended for use by a<br>physician or other qualified medical<br>personnel. It is intended for use on<br>patients of all ages within a hospital<br>or medical environment, including<br>the operating room, intensive care<br>unit, emergency room, and clinical<br>research settings. | signs, electrocardiography,<br>electromyography, intracranial<br>pressures, transcranial Doppler<br>measurements, Glasgow Coma<br>Score, and cardiac output.<br>CNS Envision includes the<br>calculation and display of a set of<br>quantitative measures intended to<br>monitor and analyze the EEG<br>waveforms. These include, for<br>example, frequency bands,<br>asymmetry, and burst suppression.<br>These quantitative EEG measures<br>should always be interpreted in<br>conjunction with review of the<br>original EEG waveforms.<br>The aEEG functionality included in<br>CNS Envision is intended to<br>monitor the state of the brain.<br>CNS Envision is intended for use<br>by a physician or other qualified<br>medical personnel who will<br>exercise professional judgement in<br>using the information. It is intended<br>for use on patients of all ages. | electromyography, intracranial<br>pressures, transcranial Doppler<br>measurements, Glasgow Coma Score,<br>and cardiac output"<br>CNS Envision supports medical<br>personnel in the review and analysis of<br>patient data collected during<br>neurological monitoring, with<br>particular focus on EEG. The<br>statement describing this capability is<br>consistent with the compared predicate<br>device's Indications for Use which<br>states:<br>"displaying EEG signals, and can also<br>receive and display a variety of vital<br>signs and other measurements from<br>third-party monitoring devices (such as<br>ICP, ECG, SpO2, and others). It also<br>has the optional capability to record<br>and display patient video."<br>"CNS Envision includes the<br>calculation and display of a set of<br>quantitative measures intended to<br>monitor and analyze the EEG<br>waveform. These include frequency<br>bands, rhythmic patterns, and burst<br>suppression. These quantitative EEG<br>measures should always be |
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison<br>and differences |
| Component Neuromonitoring<br>System | CNS Envision | |
| | This device does not provide any<br>diagnostic conclusion about the<br>patient's condition to the user. | interpreted in conjunction with review<br>of the original EEG waveforms." |
| | | In CNS Envision, the review,<br>monitoring, and analysis of EEG<br>recordings is facilitated by the display<br>of conventional quantitative measures<br>that describe frequency bands,<br>rhythmic patterns, and burst<br>suppression. Such measures are<br>commonly calculated and displayed in<br>other electroencephalographs that<br>belong to the OLT product code, such<br>as the Component Neuromonitoring<br>SystemTM. |
| | | "The aEEG functionality included in<br>CNS Envision is intended to monitor<br>the state of the brain." |
| | | The predicate device is classified<br>under product code OMA, Amplitude-<br>Integrated Electroencephalograph. The<br>statement describing this capability is<br>consistent with that of the compared<br>predicate device:<br>"The Component Neuromonitoring<br>SystemTM is intended to monitor the<br>state of the brain". |
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison and differences |
| Component Neuromonitoring<br>System | CNS Envision | "CNS Envision is intended for use by<br>a physician or other qualified medical<br>personnel who will exercise<br>professional judgement in using the<br>information."<br><br>The predicate device makes a<br>statement regarding the required<br>qualifications of the end user(s).<br>Therefore, CNS Envision makes a<br>similar and consistent statement within<br>its Intended Use/Indications for Use. |
| | | "It is intended for use on patients of<br>all ages."<br><br>This is consistent between CNS<br>Envision and the predicate device<br>about the intended age population. |
| | | "This device does not provide any<br>diagnostic conclusion about the<br>patient's condition to the user."<br><br>Many OLT devices (such as Persyst<br>14) include a statement about the<br>device not providing diagnostic<br>conclusions. Therefore, we believe it is<br>appropriate to include the above<br>similar and consistent statement for<br>CNS Envision |

### Table 1: Comparison of Indications for Use to Primary Predicate

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| | Component Monitoring<br>System<br>Primary Predicate<br>K080217 | Persyst 14 EEG Review<br>and Analysis Software<br>K182181 | CNS Envision<br>Subject Device<br>K192572 | Comments |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical State | Software-only | Software-only | Software-only | |
| Device Class | Class II | Class II | Class II | |
| Class Name | EEG | EEG | EEG | |
| Classifying Regulation | 882.1400 | 882.1400 | 882.1400 | |
| Intended User | Medical Professionals | Medical Professionals | Medical Professionals | |
| User Input | Mouse/Keyboard | Mouse/Keyboard | Mouse/Keyboard | |
| EEG Parameter Analysis<br>Available | Yes | Yes | Yes | |
| Notification Available | No | Yes | No | |
| Data Input | Optional EEG amplifier | EEG data only; user-<br>selected channels | EEG data only; user-<br>selected channels | |
| Data & Analysis Output | Graph | Graph; Over-threshold<br>notification | Graph | |
| X-Axis | Linear scale; units of time;<br>user-adjustable | Linear scale; units of time;<br>user-adjustable | Linear scale; units of time;<br>user-adjustable | |
| Y-Axis | Linear scale or semi-log<br>scale (for DSA); units of<br>uV, uV², nW, Hz, s, % or<br>none (depending on the<br>selected EEG parameter);<br>user adjustable scale | Linear scale or semi-log<br>scale (for DSA); units of<br>uV, uV², nW, Hz, s, % or<br>none (depending on the<br>selected EEG parameter);<br>user adjustable scale | Linear scale or semi-log<br>scale (for DSA); units of<br>uV, uV², nW, Hz, s, % or<br>none (depending on the<br>selected EEG parameter);<br>user adjustable scale | |
| User Adjustable Filters | High-cut and low-cut<br>filters | Notch, high-cut, and low-<br>cut filters | Notch, high-cut, and low-<br>cut filters | |
| aEEG Parameter<br>Available | Yes | Yes | Yes | |
| Notification Available | No | No | No | |
| | Component Monitoring<br>System<br>Primary Predicate<br>K080217 | Persyst 14 EEG Review<br>and Analysis Software<br>K182181 | CNS Envision<br>Subject Device<br>K192572 | Comments |
| Data Input | Optional EEG amplifier | EEG data only; user-<br>selected channels | EEG data only; user-<br>selected channels | |
| Data & Analysis Output | Graph | Graph | Graph | |
| X-Axis | Linear scale; units of time;<br>user-adjustable | Linear scale; units of time;<br>user-adjustable | Linear scale; units of time;<br>user-adjustable | |
| Y-Axis | Semi-log scale; units of<br>uV | Semi-log scale; units of<br>uV | Semi-log scale; units of<br>uV…