REMbrandt

K163617 · Embla Systems · OLZ · Apr 11, 2017 · Neurology

Device Facts

• Record ID: K163617
• Device Name: REMbrandt
• Applicant: Embla Systems
• Product Code: OLZ · Neurology
• Decision Date: Apr 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows: Automated analysis of physiological signals that is intended for use only in adults; An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; The REMbrandt software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

Device Story

REMbrandt is a Windows-based software suite (DataLab, Analysis Manager, REMbrandt Manager) for polysomnography (PSG). It collects/digitizes physiological signals (EEG, EOG, EMG, ECG, airflow, respiratory effort, SpO2, body position, snoring) via a digital amplifier. The software displays waveforms in real-time, archives data, and provides computer-assisted scoring modules to mark events (apneas, hypopneas, limb movements, arousals, snoring, heart rate, CO2). It generates summary reports with trends and statistics. Used in hospitals, sleep clinics, and research environments by trained medical professionals. The software does not provide diagnostic conclusions; all automated outputs require review, acceptance, or modification by a physician. It aids clinical decision-making by streamlining the review of large datasets, potentially improving efficiency in diagnosing sleep disorders.

Clinical Evidence

Clinical validation involved 50 adult PSG studies (>45,074 epochs). Performance of computer-assisted scoring detectors (Apnea, Hypopnea, Limb Movement, Arousal, Snore) was compared against a reference standard (majority rule of three expert scorers). Results showed high Positive Percent Agreement (PPA): Central Apnea (99%), Mixed Apnea (99.5%), Obstructive Apnea (98%), Hypopnea (90.4%), Arousal (87.6%), Limb Movement (88.7%), and Snore (87.1%). False detection rates per hour were also reported. Data demonstrate performance comparable to manual expert review and commercially available predicates.

Technological Characteristics

Software-only device running on desktop/laptop PCs. Collects/digitizes physiological signals via external digital polysomnography amplifier. Features include FFT spectral analysis, computer-assisted event detection, and report generation. Connectivity includes local or network server storage. No specialized hardware required. Not a life-support device.

Indications for Use

Indicated for adult patients (>18 years) undergoing polysomnography to assist in the diagnosis of sleep disorders and sleep-related respiratory disorders. Not for use as life support or continuous medical surveillance in intensive care units.

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

• Natus SleepWorks (K090277)
• REMbrandt (K962865)

Reference Devices

• Sleepware G3 (K142988)
• XactTrace module (K162140)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2017

Embla Systems Shane Sawall Regulatory Affairs Manager 1 Hines Road Suite 202 Kanata, Ontario, CA K2K 3C7

Re: K163617

Trade/Device Name: REMbrandt Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: March 8, 2017 Received: March 10, 2017

Dear Mr. Sawall:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K163617

Device Name REMbrandt

Indications for Use (Describe)

The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows:

Automated analysis of physiological signals that is intended for use only in adults;

An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;

The REMbrandt software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

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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# 510(K) Summary

Submitted by: Embla Systems 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7

Contact Person: Shane Sawall Regulatory Affairs Manager Tel.: [phone] x8673 E-mail: [e-mail]

Date Prepared: March 8, 2017

Proprietary Name: REMbrandt

Common Name: Polysomnograph software

Classification Name: Automatic Event Detection Software for Polysomnograph with Electroencephalograph

Product code: OLZ

Device Class: II

Requlation Number: 21 CFR 882.1400

Predicate Device: Natus SleepWorks K090277 (primary), REMbrandt K962865

# Description:

# 1. Overview REMbrandt Software

The REMbrandt software consists of three applications, DataLab, Analysis Manager and REMbrandt Manager, which run on a desktop or laptop computer and require no specialized hardware. They are Windows based applications used by trained medical professionals to investigate sleep disorders.

# 2. Main Functional Areas

The REMbrandt software collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and detectors to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main functional areas:

# A. Data Acquisition & Display (REMbrandt DataLab)

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Image /page/4/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font. Below it, the word "neurology" is written in a smaller, black, sans-serif font. The logo is simple and modern.

- B. Scoring/Review & Analysis (REMbrandt Analysis Manager)
- C. Report Generation (REMbrandt Analysis Manager)
- D. Archiving & Data Management (REMbrandt Manager)

# Data Acquisition & Display:

The REMbrandt DataLab application collects and displays continuous physiological waveform data (via a digital polysomnography amplifier), and digital audio/video (via standard audio/video equipment). The data is stored and displayed in real time by the REMbrandt DataLab software on the acquisition computer and made available for subsequent review and scoring by a sleep technologist followed by review and interpretation by a certified sleep medicine physician.

# Study Scoring/Review & Analysis:

The REMbrandt Analysis Manager application has features that facilitate study navigation, event marking, sleep stage scoring, review of synchronized digital video, and data trends required by medical professionals in order to properly analyze and interpret sleep study data. (See figure 1). In addition to allowing users to manually mark sleep events including Arousals. Respiratory Events (Apnea & Hypopnea), Oxygen Desaturations, Limb Movements, Snoring and sleep stages, the REMbrandt software also optionally provides computer assisted event marking analyzers for a subset of these events as well as analyzers that summarize digital data in data ranges.

# Computer-assisted scoring modules:

The REMbrandt software contains eight (8) computer-assisted scoring analyzers. All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted scoring analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The scoring rule parameters used in the computer-assisted scoring analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted scoring analyzers require medical professional review and acceptance.

The computer-assisted scoring analyzers are as follows:

- . Apnea/Hypopnea Detector: Marks potential Apneas & Hypopnea events.
- Limb Movement Detector: Marks potential limb movement events .
- . Arousal Detector: Marks arousal events on EEG traces
- Snore Detector: Marks potential snore events
- Desaturation Detector: Marks drops in oxygen saturation based on user . set threshold CO2 Analyzer: Summarizes CO2 data recorded from a third party Capnograph device.

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- Heart Rate Detector: Indicates heart rate by processing EKG waveform ● and shows Heart Rate values; marks tachy-bradycardia events based on heart rate value thresholds that are user configurable.
- . Body Position Detector: Converts DC inputs or values from gravity xv based position sensor into the body positions tagged in sleep studies (Upright, Supine, Left, Right, Prone and Unknown).
- . Pulse Transit Time (PTT) Trace Generator: Derived calculation of pulse transit time (PTT) which is a measure of time difference between the ECG R top and the peak of the pleth waveform from a pulse oximeter.

# Report Generation:

Once the digital polysomnography data has been acquired scored and reviewed by both a polysomnographic technologist and a sleep physician the REMbrandt software is used to generate a summary report of the sleep study which includes summary statistics of sleep staging describing the patients sleep architecture, summary of sleep events including maximum, minimum counts, indexes, duration, and range based data as well as graphical representations of each (trends). The generated sleep reports are part of the digital polysomnograph and the REMbrandt software also includes tools to customize report templates to conform to individual sleep center standards/policies and graphic norms.

# Archiving & Data Management:

All data are stored either locally or on a remote hard disk (network server) Provisions exist for archiving to several appropriate types of digital storage. REMbrandt Manager also allows the user to copy, move, back up, and delete collected studies.

# 3. Diagnosis

The REMbrandt software does not make any decisions that result in anv automatic diagnosis or treatment. All software output is subject to review by the medical professional, and can be modified, overridden or deleted. The software allows the qualified user to review all raw data collected and perform data analysis as required. REMbrandt does not provide any final diagnostic conclusion about the patient's condition. Neither the computer nor the software controls the delivery of energy, the administration of drugs, or another form of life sustaining function to the patient.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. Users of the REMbrandt software are solely responsible for all data collected, and are expected to assess and analyze this data to ensure its accuracy and completeness.

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Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with the "n" and "a" connected. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and modern.

# Indications for Use:

The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows:

- Automated analysis of physiological signals that is intended for use only in adults;
- An optional audio/visual alert for user defined threshold on calibrated DC ● input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
- Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;

The REMbrandt software does not provide any diagnostic conclusions about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

# Comparison to Predicate Device:

| | Predicate | Predicate | Subject Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <i>Rembrandt K962865</i> | <i>SleepWorks K090277</i> | <i>REMbrandt</i> |
| Device Class | Class II | Class II | Class II |
| Class Name | Apnea Monitor | Electroencephalograph | Electroencephalograph |
| Product Code | FLS = Monitor (Apnea Detector), Ventilatory Effort | OLZ = Automatic Event Detection Software for Polysomnograph with Electroencephalograph | Same as SleepWorks |
| Intended User | Medical Professional | Medical Professional | Medical Professional |
| | | | |
| Indications for<br>Use | The Medcare<br>Rembrandt System is a<br>physiological signal<br>recorder intended for<br>use in sleep<br>Laboratories. It is used<br>as a paperless<br>polygraph, collecting<br>raw data. It is used to<br>manually analyze the<br>recorded data. The<br>user may manually tag<br>sleep stages, arousals,<br>apnea and hypopnea<br>and Periodic Leg<br>Movement. The<br>Rembrandt System<br>processes the manual<br>scoring to generate<br>Summary Reports.<br>A polysomnographer<br>would typically review<br>the recorded signals.<br>The Rembrandt<br>System by Medcare<br>Automation does not<br>provide any indications<br>during recording. It<br>does not do any<br>analysis, monitoring or<br>diagnosis of the<br>patient. It does not<br>issue any alarms. | The Sleepworks software<br>works in conjunction with<br>Connex, Trex or Netlink<br>amplifiers<br>intended for<br>polysomnography studies.<br>The software allows<br>recording, displaying,<br>analysis, printing and<br>storage of physiological<br>signals to assist in the<br>diagnosis of various<br>sleep disorders and sleep<br>related respiratory<br>disorders.<br>The Sleepworks allows:<br>Automated analysis of<br>physiological signals that<br>is intended for use only in<br>adults.<br>An optional Audio /<br>visual alert for user<br>defined threshold on<br>calibrated DC input.<br>These alerts are not<br>intended for use as life<br>support such as vital<br>signs monitoring<br>or continuous medical<br>surveillance in intensive<br>care units.<br>Sleep report templates<br>are provided which<br>summarize recorded and<br>scored sleep<br>data using simple<br>measures including count,<br>average, maximum and<br>minimum<br>values as well as data<br>ranges for trended values;<br>Sleep Works software<br>does not provide any<br>diagnostic conclusion<br>about the patient's<br>condition and is intended<br>to be used only by | The REMbrandt<br>software is intended for<br>Polysomnography<br>studies and allows<br>recording, displaying,<br>analysis, printing and<br>storage of physiological<br>signals to assist in the<br>diagnosis of various<br>sleep disorders and<br>sleep related respiratory<br>disorders. The<br>REMbrandt software<br>allows:<br>Automated analysis<br>of physiological signals<br>that is intended for use<br>only in adults;<br>An optional<br>audio/visual alert for<br>user defined threshold<br>on calibrated DC input.<br>These alerts are not<br>intended for use as life<br>support such as vital<br>signs monitoring or<br>continuous medical<br>surveillance in intensive<br>care units.<br>Sleep report<br>templates which<br>summarize recorded<br>and scored sleep data<br>using simple measures<br>including count,<br>average, maximum and<br>minimum values as well<br>as data ranges for<br>trended values;<br>The REMbrandt<br>software does not<br>provide any diagnostic<br>conclusion about the<br>patient's condition and<br>is intended to be used<br>only by qualified and<br>trained medical |
| | | qualified and trained<br>medical practitioners;<br>in research and clinical<br>environments. | practitioners, in<br>research and clinical<br>environments. |
| User input | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard |
| Acquire,<br>display, store,<br>and archive<br>PSG data | Yes (post acquisition<br>analysis only) | Yes (post acquisition and<br>real-time analysis | Yes (post acquisition<br>and real-time analysis) |
| Signal digitized | Amplifier included as<br>part of the system | By separate proprietary<br>amplifier | By separate proprietary<br>amplifier |
| FFT Analysis<br>(Spectral<br>analysis on any<br>digitized<br>channel | Yes | Yes | Yes |
| Software<br>Detectors | | | |
| Respiratory<br>event marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Sleep staging/<br>scoring | Yes (Manual) | Yes (Manual/computer<br>assisted) | Yes (Manual) |
| Arousal Event<br>Marking | Yes (Manual) | Yes (Manual/computer<br>assisted) | Yes (Manual &<br>Computer Assisted) |
| Limb<br>movements<br>event marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Snore event<br>marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Oxygen<br>Desaturation<br>event marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted)…