(90 days)
No
The summary describes standard signal processing and quantitative analysis of physiological data, with no mention of AI or ML techniques.
No.
The device is a software application for reviewing, analyzing, and annotating patient data from external physiological monitors, and it does not provide any diagnostic conclusions or therapeutic interventions.
No
The Intended Use / Indications for Use section explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user." It is a tool for review and analysis of patient data by qualified personnel who will exercise professional judgment.
Yes
The device is described as a "Microsoft Windows-based software application" that facilitates the review, annotation, and analysis of patient data. It explicitly states that, unlike the predicate device, it "does not perform direct data acquisition," indicating it is solely a software tool for processing data acquired by external monitors.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CNS Envision's function: CNS Envision is a software application that reviews and analyzes patient data collected using external physiological monitors. This data includes things like EEG, vital signs, and other measurements taken from the patient, not on samples taken from the patient.
- Intended Use: The intended use clearly states it's for the review and analysis of data collected from external monitors, not for testing biological samples.
- Device Description: The description reinforces that it processes data from external sources like EEG, ECG, vital signs monitors, etc.
- Lack of mention of biological samples: There is no mention of processing or analyzing biological samples anywhere in the provided text.
Therefore, CNS Envision falls under the category of a medical device that processes and displays physiological data, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
OMA, OLT, ORT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain (EEG, aEEG, ICP), Cardiovascular system (ECG, Heart Rate, Blood Pressure, Cardiac Output), Respiratory system (Respiration Rate, SpO2), Muscles (EMG), Blood vessels (TCD)
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
qualified personnel, physician or other qualified medical personnel.
hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 & 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
1
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
2
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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3
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 Street
Ambler, PA 19002
(215)283-0860 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anna Rodriguez, Product Manager
anna@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) software
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 |
| Predicate) | |
| K182181 Persyst 14 EEG Review and Analysis Software | |
| Device Description: | 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 |
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5
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 | ||
| System | CNS Envision | |
| The Component Neuromonitoring | ||
| System™ is intended to monitor | ||
| the state of the brain by recording | ||
| and displaying EEG signals, and | ||
| can also receive and display a | ||
| variety of vital signs and other | ||
| measurements from third-party | CNS Envision is intended for use | |
| by qualified personnel in the | ||
| review, annotation, and analysis of | ||
| patient data collected using external | ||
| physiological monitors. These data | ||
| are: raw and quantitative EEG, | ||
| recorded video data, generic vital | "CNS Envision is intended for use by | |
| qualified personnel in the review, | ||
| annotation, and analysis of patient | ||
| data collected using external | ||
| physiological monitors. These data | ||
| are: raw and quantitative EEG, | ||
| recorded video data, generic vital | ||
| signs, 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 has | ||
| the optional capability to record | ||
| and display patient video. | ||
| The Component Neuromonitoring | ||
| System is intended for use by a | ||
| physician or other qualified medical | ||
| personnel. It is intended for use on | ||
| patients of all ages within a hospital | ||
| or medical environment, including | ||
| the operating room, intensive care | ||
| unit, emergency room, and clinical | ||
| research settings. | signs, electrocardiography, | |
| electromyography, intracranial | ||
| pressures, transcranial Doppler | ||
| measurements, Glasgow Coma | ||
| Score, and cardiac output. | ||
| 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. | electromyography, intracranial | |
| pressures, transcranial Doppler | ||
| measurements, Glasgow Coma Score, | ||
| and cardiac output" | ||
| CNS Envision supports medical | ||
| personnel in the review and analysis of | ||
| patient data collected during | ||
| neurological monitoring, with | ||
| particular focus on EEG. The | ||
| statement describing this capability is | ||
| consistent with the compared predicate | ||
| device's Indications for Use which | ||
| states: | ||
| "displaying EEG signals, and can also | ||
| receive and display a variety of vital | ||
| signs and other measurements from | ||
| third-party monitoring devices (such as | ||
| ICP, ECG, SpO2, and others). It also | ||
| has the optional capability to record | ||
| and display patient video." | ||
| "CNS Envision includes the | ||
| calculation and display of a set of | ||
| quantitative measures intended to | ||
| monitor and analyze the EEG | ||
| waveform. These include frequency | ||
| bands, rhythmic patterns, and burst | ||
| suppression. These quantitative EEG | ||
| measures should always be | ||
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison |
| and differences | ||
| Component Neuromonitoring | ||
| System | CNS Envision | |
| This device does not provide any | ||
| diagnostic conclusion about the | ||
| patient's condition to the user. | interpreted in conjunction with review | |
| of the original EEG waveforms." | ||
| In CNS Envision, the review, | ||
| monitoring, and analysis of EEG | ||
| recordings is facilitated by the display | ||
| of conventional quantitative measures | ||
| that describe frequency bands, | ||
| rhythmic patterns, and burst | ||
| suppression. Such measures are | ||
| commonly calculated and displayed in | ||
| other electroencephalographs that | ||
| belong to the OLT product code, such | ||
| as the Component Neuromonitoring | ||
| SystemTM. | ||
| "The aEEG functionality included in | ||
| CNS Envision is intended to monitor | ||
| the state of the brain." | ||
| The predicate device is classified | ||
| under product code OMA, Amplitude- | ||
| Integrated Electroencephalograph. The | ||
| statement describing this capability is | ||
| consistent with that of the compared | ||
| predicate device: | ||
| "The Component Neuromonitoring | ||
| SystemTM is intended to monitor the | ||
| state of the brain". | ||
| Primary Predicate K080217 | Subject Device K192572 | Comments regarding comparison and differences |
| Component Neuromonitoring | ||
| System | CNS Envision | "CNS Envision is intended for use by |
| a physician or other qualified medical | ||
| personnel who will exercise | ||
| professional judgement in using the | ||
| information." |
The predicate device makes a
statement regarding the required
qualifications of the end user(s).
Therefore, CNS Envision makes a
similar and consistent statement within
its Intended Use/Indications for Use. |
| | | "It is intended for use on patients of
all ages."
This is consistent between CNS
Envision and the predicate device
about the intended age population. |
| | | "This device does not provide any
diagnostic conclusion about the
patient's condition to the user."
Many OLT devices (such as Persyst
14) include a statement about the
device not providing diagnostic
conclusions. Therefore, we believe it is
appropriate to include the above
similar and consistent statement for
CNS Envision |
Table 1: Comparison of Indications for Use to Primary Predicate
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| | Component Monitoring
System
Primary Predicate
K080217 | Persyst 14 EEG Review
and Analysis Software
K182181 | CNS Envision
Subject Device
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
Available | 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-threshold
notification | 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-log
scale (for DSA); units of
uV, uV², nW, Hz, s, % or
none (depending on the
selected EEG parameter);
user adjustable scale | Linear scale or semi-log
scale (for DSA); units of
uV, uV², nW, Hz, s, % or
none (depending on the
selected EEG parameter);
user adjustable scale | Linear scale or semi-log
scale (for DSA); units of
uV, uV², nW, Hz, s, % or
none (depending on the
selected EEG parameter);
user adjustable scale | |
| User Adjustable Filters | High-cut and low-cut
filters | Notch, high-cut, and low-
cut filters | Notch, high-cut, and low-
cut filters | |
| aEEG Parameter
Available | Yes | Yes | Yes | |
| Notification Available | No | No | No | |
| | Component Monitoring
System
Primary Predicate
K080217 | Persyst 14 EEG Review
and Analysis Software
K182181 | CNS Envision
Subject Device
K192572 | 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 of
uV | Semi-log scale; units of
uV | Semi-log scale; units of
uV | |
| User Adjustable Filters | No | No | No | |
| Electrocardiography
(ECG) Parameter
Analysis Available | No – Raw data display
only | No– Raw data display
only | No - Raw data display
only | |
| Notification Available | No | No | No | |
| Data Input | Optional EEG amplifier or
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 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) Parameter
Analysis Available | No - Raw data display
only | No - Raw data display
only | No - Raw data display
only | |
| Notification Available | No | No | No | |
| Data Input | Optional EEG amplifier or
external source device | External source device | CNS Monitor; K080217 | |
| Data Output Format | Graph | Graph | Graph | |
| | Component Monitoring
System
Primary Predicate
K080217 | Persyst 14 EEG Review
and Analysis Software
K182181 | CNS Envision
Subject Device
K192572 | 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 display
only | No- Raw data display
only | No - Raw data display
only | |
| 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 based
on selected vital sign; user
adjustable scale | Linear scale; units based
on selected vital sign; user
adjustable scale | Linear scale; units based
on selected vital sign; user
adjustable scale | |
| User Adjustable Filters | No | No | No | |
| Intracranial Pressure
(ICP) Parameter | No - Raw data display
only | No- Raw data display
only | No - Raw data display
only | |
| 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 of
mmHg, kPa, or cmH2O;
user adjustable scale | Linear scale; units of
mmHg, kPa, or cmH2O;
user adjustable scale | Linear scale; units of
mmHg, kPa, or cmH2O;
user adjustable scale | |
| User Adjustable Filters | No | No | No | |
| | Component Monitoring
System | Persyst 14 EEG Review
and Analysis Software | CNS Envision
Subject Device | Comments |
| | Primary Predicate
K080217 | K182181 | K192572 | |
| Transcranial Doppler
(TCD) Parameters
Analysis Available | No - Raw data display
only | No | No - Raw data display
only | |
| 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 based
on selected TCD
parameter; user adjustable
scale | N/A | Linear scale; units based
on selected TCD
parameter; user adjustable
scale | |
| User Adjustable Filters | No | N/A | No | |
| Glasgow Coma Scare
(GCS) Parameters
Analysis Available | No - Raw data display
only | No - Raw data display
only | No - Raw data display
only | |
| 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; user
adjustable scale | Linear scale; no units; user
adjustable scale | Linear scale; no units; user
adjustable scale | |
| User Adjustable Filters | No | No | No | |
| Cardiac Output
Parameters Analysis
Available | No - Raw data display
only | No | No - Raw data display
only | |
| Notification Available | No | N/A | No | |
| | Component Monitoring
System
Primary Predicate
K080217 | Persyst 14 EEG Review
and Analysis Software
K182181 | CNS Envision
Subject Device
K192572 | 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 based
on selected Cardiac
Output parameter; user
adjustable scale | N/A | Linear scale; units based
on selected Cardiac
Output parameter; user
adjustable scale | |
| User Adjustable Filters | No | N/A | No | |
| Direct data collection
from external source
devices | Yes | No | No | The primary predicate
device performs direct
data collection from
external source devices at
the bedside. The subject
device instead reads data
collected by the CNS
Monitor (K080217),
similar to Persyst 14
(K182181). |
| Remote review | No | Yes | Yes | The CNS Monitor
(K080217) is intended for
bedside use, while the
subject device is meant for
care providers to review
data remotely, similar to
Persyst 14 (K182181). |
| | Component Monitoring
System
Primary Predicate
K080217 | Persyst 14 EEG Review
and Analysis Software
K182181 | CNS Envision
Subject Device
K192572 | Comments |
| Adjustable review speed | No | Yes | Yes | Unlike the CNS Monitor
(K080217), the subject
device offers adjustable
review speed to meet the
needs of remote review,
similarly to Persyst 14
(K182181). This speed
adjustment means that
users can change the
output using a low to high
speed variable function
bar to choose the pace at
which to view the data
measurement traces as
part 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. |