(90 days)
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.
CNS Envision is a Microsoft Windows-based software application that facilitates the review, annotation and analysis of patient data and physiological measurements. Some of these data, such as ECG, are displayed in raw format whereas other types, such as EEG, are analyzed and quantified by the software. The specific type of input data that are reviewable by CNS Envision software are: 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
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.
The provided text is a 510(k) summary for the CNS Envision device. It describes the device's intended use, technological characteristics, and comparison to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment details, or any multi-reader multi-case (MRMC) study results.
The document states that "Software verification and validation testing was conducted and documentation provided as recommended by the Guidance for the Content of Software Contained in Medical Devices, issued May 2005. Traceability has been documented between all system specifications to validation test protocols. Verification and validation testing includes module-level testing, integration-level testing, and system-level testing. In addition, tests according to “IEC 62366-1:2015, Medical Devices Part 1—Application of usability engineering to medical devices” were performed."
This indicates that some testing was done to ensure the software functions as intended and meets usability standards, but the specific performance results in terms of clinical accuracy or equivalent metrics are not present in this summary. The summary focuses on establishing substantial equivalence based on intended use and technological characteristics rather than a detailed performance study like those typically expected for AI/ML-based diagnostic devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about the sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for this specific device based on the provided text. The device "CNS Envision" is described as software that analyzes and quantifies EEG, but "does not provide any diagnostic conclusion about the patient's condition to the user" and "does not contain automated detection algorithms," suggesting it's a tool for experts rather than an automated diagnostic AI.
To illustrate what such an answer would look like if the information were available, here's a template:
Hypothetical Example (based on standard AI/ML medical device studies, NOT from the provided text):
Given the provided document does not contain the requested information regarding specific acceptance criteria, performance metrics, training/test set details, or human reader studies, I cannot fill out the detailed table and answer the questions directly from the text.
However, if this were an AI-powered diagnostic device, the requested information would typically be presented as follows:
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example - Data NOT from provided text)
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Standalone Performance | ||
| Sensitivity (for X condition) | ≥ 90% (lower bound of 95% CI) | 92% (95% CI: 90.5-93.5%) |
| Specificity (for X condition) | ≥ 85% (lower bound of 95% CI) | 87% (95% CI: 85.2-88.8%) |
| AUC (for X condition) | ≥ 0.90 | 0.93 |
| Human-in-the-loop Performance | ||
| Reader AUC (w/ AI assistance) | Significantly greater than w/o AI assistance (p < 0.05) | 0.88 (w/ AI) vs. 0.82 (w/o AI), p = 0.001 |
| Reader Sensitivity (w/ AI assistance) | Improvement of ≥ 5% points | Increased by 7% points (from 80% to 87%) |
| Reader Specificity (w/ AI assistance) | No significant decrease | Remained stable (82% to 83%) |
2. Sample size used for the test set and data provenance:
* Test Set Sample Size: [Number] cases (e.g., 500 patient records/EEGs)
* Data Provenance: Retrospective, collected from [e.g., 3 major university hospitals] in [e.g., United States, Germany, Japan].
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Number of Experts: [e.g., 3 board-certified neurologists specializing in epilepsy]
* Qualifications: [e.g., Each expert had 10+ years of experience interpreting EEG, with specific expertise in neurological disorders relevant to the device's intended use. All were blinded to other expert readings and AI output.]
4. Adjudication method for the test set:
* [e.g., 2+1 adjudication: If two experts agreed, that was the ground truth. If there was a disagreement among the initial two, a third, senior expert (the 'tie-breaker') reviewed the case and made the final determination.]
* Alternatively: Consensus reading where all experts discussed and jointly determined the ground truth.
* Alternatively: No adjudication, each expert independently provided a reading.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:
* MRMC Study Done: [Yes/No]
* If Yes: Readers showed a statistically significant improvement in AUC of [e.g., 0.06] when assisted by the AI, moving from an average AUC of [e.g., 0.82] without AI to [e.g., 0.88] with AI assistance (p < 0.001). They also had a [e.g., 7%] increase in sensitivity and maintained specificity.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Standalone Performance Done: [Yes/No]
* If Yes: The algorithm achieved a standalone sensitivity of [e.g., 90%], specificity of [e.g., 85%], and AUC of [e.g., 0.92] on the independent test set.
7. The type of ground truth used:
* [e.g., Expert Consensus: The ground truth for the test set was established by the consensus of multiple independent medical experts, as described in point 3 & 4. This might be further supported by correlating with patient clinical outcomes where available.]
* Alternative: Pathology results.
* Alternative: Long-term clinical outcomes data.
8. The sample size for the training set:
* Training Set Sample Size: [e.g., 10,000 patient records/EEGs]
9. How the ground truth for the training set was established:
* [e.g., Ground truth for the training set was established through a combination of initial review by trained data annotators overseen by a senior neurologist, followed by verification by a single board-certified neurologist. In ambiguous cases, a secondary review by a different neurologist was conducted. For some conditions, correlation with electronic health record (EHR) data or other clinical markers was used.]
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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 & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
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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.224 S. Maple StreetAmbler, PA 19002(215)283-0860 |
|---|---|
| Contact Person: | Anna Rodriguez, Product Manageranna@moberg.com |
| 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)(Primary Procode)OLT non-normalizing quantitative electroencephalograph (EEG) softwareORT 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 (PrimaryPredicate)K182181 Persyst 14 EEG Review and Analysis Software |
| Device Description: | CNS Envision is a Microsoft Windows-based software application that facilitates the review, annotationand analysis of patient data and physiological measurements. Some of these data, such as ECG, aredisplayed in raw format whereas other types, such as EEG, are analyzed and quantified by the software.The specific type of input data that are reviewable by CNS Envision software are: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 NeuromonitoringSystem | CNS Envision | |
| The Component NeuromonitoringSystem™ is intended to monitorthe state of the brain by recordingand displaying EEG signals, andcan also receive and display avariety of vital signs and othermeasurements from third-party | CNS Envision is intended for useby qualified personnel in thereview, annotation, and analysis ofpatient data collected using externalphysiological monitors. These dataare: raw and quantitative EEG,recorded video data, generic vital | "CNS Envision is intended for use byqualified personnel in the review,annotation, and analysis of patientdata collected using externalphysiological monitors. These dataare: raw and quantitative EEG,recorded video data, generic vitalsigns, electrocardiography, |
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison and differences |
| Component Neuromonitoring | CNS Envision | |
| System | ||
| monitoring devices (such as ICP,ECG, SpO2, and others). It also hasthe optional capability to recordand display patient video.The Component NeuromonitoringSystem is intended for use by aphysician or other qualified medicalpersonnel. It is intended for use onpatients of all ages within a hospitalor medical environment, includingthe operating room, intensive careunit, emergency room, and clinicalresearch settings. | signs, electrocardiography,electromyography, intracranialpressures, transcranial Dopplermeasurements, Glasgow ComaScore, and cardiac output.CNS Envision includes thecalculation and display of a set ofquantitative measures intended tomonitor and analyze the EEGwaveforms. These include, forexample, frequency bands,asymmetry, and burst suppression.These quantitative EEG measuresshould always be interpreted inconjunction with review of theoriginal EEG waveforms.The aEEG functionality included inCNS Envision is intended tomonitor the state of the brain.CNS Envision is intended for useby a physician or other qualifiedmedical personnel who willexercise professional judgement inusing the information. It is intendedfor use on patients of all ages. | electromyography, intracranialpressures, transcranial Dopplermeasurements, Glasgow Coma Score,and cardiac output"CNS Envision supports medicalpersonnel in the review and analysis ofpatient data collected duringneurological monitoring, withparticular focus on EEG. Thestatement describing this capability isconsistent with the compared predicatedevice's Indications for Use whichstates:"displaying EEG signals, and can alsoreceive and display a variety of vitalsigns and other measurements fromthird-party monitoring devices (such asICP, ECG, SpO2, and others). It alsohas the optional capability to recordand display patient video.""CNS Envision includes thecalculation and display of a set ofquantitative measures intended tomonitor and analyze the EEGwaveform. These include frequencybands, rhythmic patterns, and burstsuppression. These quantitative EEGmeasures should always be |
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparisonand differences |
| Component NeuromonitoringSystem | CNS Envision | |
| This device does not provide anydiagnostic conclusion about thepatient's condition to the user. | interpreted in conjunction with reviewof the original EEG waveforms." | |
| In CNS Envision, the review,monitoring, and analysis of EEGrecordings is facilitated by the displayof conventional quantitative measuresthat describe frequency bands,rhythmic patterns, and burstsuppression. Such measures arecommonly calculated and displayed inother electroencephalographs thatbelong to the OLT product code, suchas the Component NeuromonitoringSystemTM. | ||
| "The aEEG functionality included inCNS Envision is intended to monitorthe state of the brain." | ||
| The predicate device is classifiedunder product code OMA, Amplitude-Integrated Electroencephalograph. Thestatement describing this capability isconsistent with that of the comparedpredicate device:"The Component NeuromonitoringSystemTM is intended to monitor thestate of the brain". | ||
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison and differences |
| Component NeuromonitoringSystem | CNS Envision | "CNS Envision is intended for use bya physician or other qualified medicalpersonnel who will exerciseprofessional judgement in using theinformation."The predicate device makes astatement regarding the requiredqualifications of the end user(s).Therefore, CNS Envision makes asimilar and consistent statement withinits Intended Use/Indications for Use. |
| "It is intended for use on patients ofall ages."This is consistent between CNSEnvision and the predicate deviceabout the intended age population. | ||
| "This device does not provide anydiagnostic conclusion about thepatient's condition to the user."Many OLT devices (such as Persyst14) include a statement about thedevice not providing diagnosticconclusions. Therefore, we believe it isappropriate to include the abovesimilar and consistent statement forCNS Envision |
Table 1: Comparison of Indications for Use to Primary Predicate
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| Component MonitoringSystemPrimary PredicateK080217 | Persyst 14 EEG Reviewand Analysis SoftwareK182181 | CNS EnvisionSubject DeviceK192572 | 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 AnalysisAvailable | Yes | Yes | Yes | |
| Notification Available | No | Yes | No | |
| Data Input | Optional EEG amplifier | EEG data only; user-selected channels | EEG data only; user-selected channels | |
| Data & Analysis Output | Graph | Graph; Over-thresholdnotification | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale or semi-logscale (for DSA); units ofuV, uV², nW, Hz, s, % ornone (depending on theselected EEG parameter);user adjustable scale | Linear scale or semi-logscale (for DSA); units ofuV, uV², nW, Hz, s, % ornone (depending on theselected EEG parameter);user adjustable scale | Linear scale or semi-logscale (for DSA); units ofuV, uV², nW, Hz, s, % ornone (depending on theselected EEG parameter);user adjustable scale | |
| User Adjustable Filters | High-cut and low-cutfilters | Notch, high-cut, and low-cut filters | Notch, high-cut, and low-cut filters | |
| aEEG ParameterAvailable | Yes | Yes | Yes | |
| Notification Available | No | No | No | |
| Component MonitoringSystemPrimary PredicateK080217 | Persyst 14 EEG Reviewand Analysis SoftwareK182181 | CNS EnvisionSubject DeviceK192572 | Comments | |
| Data Input | Optional EEG amplifier | EEG data only; user-selected channels | EEG data only; user-selected channels | |
| Data & Analysis Output | Graph | Graph | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | |
| Y-Axis | Semi-log scale; units ofuV | Semi-log scale; units ofuV | Semi-log scale; units ofuV | |
| User Adjustable Filters | No | No | No | |
| Electrocardiography(ECG) ParameterAnalysis Available | No – Raw data displayonly | No– Raw data displayonly | No - Raw data displayonly | |
| Notification Available | No | No | No | |
| Data Input | Optional EEG amplifier orexternal source device | External source device | CNS Monitor; K080217 | |
| Data Output Format | Graph | Graph | Graph | |
| X-Axis | Linear scale; units of time:user-adjustable | Linear scale; units of time:user-adjustable | Linear scale; units of time:user-adjustable | |
| Y-Axis | Linear scale; units of mV;user adjustable scale | Linear scale; units of mV;user adjustable scale | Linear scale; units of mV;user adjustable scale | |
| User Adjustable Filters | No | No | No | |
| Electromyography(EMG) ParameterAnalysis Available | No - Raw data displayonly | No - Raw data displayonly | No - Raw data displayonly | |
| Notification Available | No | No | No | |
| Data Input | Optional EEG amplifier orexternal source device | External source device | CNS Monitor; K080217 | |
| Data Output Format | Graph | Graph | Graph | |
| Component MonitoringSystemPrimary PredicateK080217 | Persyst 14 EEG Reviewand Analysis SoftwareK182181 | CNS EnvisionSubject DeviceK192572 | Comments | |
| X-Axis | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale; units of mV;user adjustable scale | Linear scale; units of mV;user adjustable scale | Linear scale; units of mV;user adjustable scale | |
| User Adjustable Filters | No | No | No | |
| Vital Signs Parameter | No - Raw data displayonly | No- Raw data displayonly | No - Raw data displayonly | |
| Notification Available | No | No | No | |
| Data Input | External source device | External source device | CNS Monitor; K080217 | |
| Data Output Format | Graph | Graph | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale; units basedon selected vital sign; useradjustable scale | Linear scale; units basedon selected vital sign; useradjustable scale | Linear scale; units basedon selected vital sign; useradjustable scale | |
| User Adjustable Filters | No | No | No | |
| Intracranial Pressure(ICP) Parameter | No - Raw data displayonly | No- Raw data displayonly | No - Raw data displayonly | |
| Analysis Available | ||||
| Notification Available | No | No | No | |
| Data Input | External source device | External source device | CNS Monitor; K080217 | |
| Data Output Format | Graph | Graph | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale; units ofmmHg, kPa, or cmH2O;user adjustable scale | Linear scale; units ofmmHg, kPa, or cmH2O;user adjustable scale | Linear scale; units ofmmHg, kPa, or cmH2O;user adjustable scale | |
| User Adjustable Filters | No | No | No | |
| Component MonitoringSystem | Persyst 14 EEG Reviewand Analysis Software | CNS EnvisionSubject Device | Comments | |
| Primary PredicateK080217 | K182181 | K192572 | ||
| Transcranial Doppler(TCD) ParametersAnalysis Available | No - Raw data displayonly | No | No - Raw data displayonly | |
| Notification Available | No | N/A | No | |
| Data Input | External source device | N/A | CNS Monitor; K080217 | |
| Data Output Format | Graph | N/A | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | N/A | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale; units basedon selected TCDparameter; user adjustablescale | N/A | Linear scale; units basedon selected TCDparameter; user adjustablescale | |
| User Adjustable Filters | No | N/A | No | |
| Glasgow Coma Scare(GCS) ParametersAnalysis Available | No - Raw data displayonly | No - Raw data displayonly | No - Raw data displayonly | |
| Notification Available | No | No | No | |
| Data Input | External source device | External source device | CNS Monitor; K080217 | |
| Data Output Format | Graph | Graph | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale; no units; useradjustable scale | Linear scale; no units; useradjustable scale | Linear scale; no units; useradjustable scale | |
| User Adjustable Filters | No | No | No | |
| Cardiac OutputParameters AnalysisAvailable | No - Raw data displayonly | No | No - Raw data displayonly | |
| Notification Available | No | N/A | No | |
| Component MonitoringSystemPrimary PredicateK080217 | Persyst 14 EEG Reviewand Analysis SoftwareK182181 | CNS EnvisionSubject DeviceK192572 | Comments | |
| Data Input | External source device | N/A | CNS Monitor; K080217 | |
| Data Output Foramt | Graph | N/A | Graph | |
| X-Axis | Linear scale; units of time;user-adjustable | N/A | Linear scale; units of time;user-adjustable | |
| Y-Axis | Linear scale; units basedon selected CardiacOutput parameter; useradjustable scale | N/A | Linear scale; units basedon selected CardiacOutput parameter; useradjustable scale | |
| User Adjustable Filters | No | N/A | No | |
| Direct data collectionfrom external sourcedevices | Yes | No | No | The primary predicatedevice performs directdata collection fromexternal source devices atthe bedside. The subjectdevice instead reads datacollected by the CNSMonitor (K080217),similar to Persyst 14(K182181). |
| Remote review | No | Yes | Yes | The CNS Monitor(K080217) is intended forbedside use, while thesubject device is meant forcare providers to reviewdata remotely, similar toPersyst 14 (K182181). |
| Component MonitoringSystemPrimary PredicateK080217 | Persyst 14 EEG Reviewand Analysis SoftwareK182181 | CNS EnvisionSubject DeviceK192572 | Comments | |
| Adjustable review speed | No | Yes | Yes | Unlike the CNS Monitor(K080217), the subjectdevice offers adjustablereview speed to meet theneeds of remote review,similarly to Persyst 14(K182181). This speedadjustment means thatusers can change theoutput using a low to highspeed variable functionbar to choose the pace atwhich to view the datameasurement traces aspart of the display. |
Table 2: Comparison of Subject Device's Technological Characteristics to Predicates
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| Electrical Safety and Electromagnetic Compatibility Testing: | Not Applicable; Software-only |
|---|---|
| Non-Clinical Performance Testing: | Software verification and validation testing was conducted and documentation provided as recommended by the Guidance for the Content of Software Contained in Medical Devices, issued May 2005. Traceability has been documented between all system specifications to validation test protocols. Verification and validation testing includes module-level testing, integration-level testing, and system-level testing.In addition, tests according to “IEC 62366-1:2015, Medical Devices Part 1—Application of usability engineering to medical devices” were performed.The software for this device is determined as a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.Verification and validation activities established the safety and performance characteristics of the subject device with respect to the predicate device. |
| Conclusion: | Based on the intended use, technological characteristics as compared to predicates, and performance testing performed, the CNS Envision software is substantially equivalent to the Predicate Device. |
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).