(110 days)
No
The document describes "computer-assisted scoring analyzers" and "automatic detection tools" which are based on "scoring rule parameters" and "user defined settings". While these are automated processes, the description does not mention any learning or adaptive capabilities characteristic of AI/ML. The performance study compares the device's output to expert manual scoring, which is a common validation method for rule-based algorithms in this domain. There is no mention of training or test sets in the context of model development, only a test set for performance evaluation.
No
The device is described as software for recording, displaying, printing, and storing physiological signals to assist in the diagnosis of sleep disorders, and specifically states it "does not provide any diagnostic conclusion about the patient's condition." Its function is diagnostic assistance, not therapeutic intervention.
Yes
The REMbrandt software assists in the diagnosis of various sleep disorders and sleep related respiratory disorders by allowing recording, displaying, printing, and storage of physiological signals and providing tools for analysis.
Yes
The device description explicitly states that the software "require no specialized hardware" and runs on a desktop or laptop computer. While it collects and digitizes physiological signals, this process is external to the software itself, which focuses on analysis, display, and management of the data.
Based on the provided information, the REMbrandt software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- REMbrandt's Function: The REMbrandt software processes physiological signals (electrical voltages) recorded from the patient's body during a polysomnography study. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it assists in the diagnosis of sleep disorders by recording, displaying, printing, and storing physiological signals and providing automated analysis of these signals. It explicitly states it "does not provide any diagnostic conclusion about the patient's condition."
Therefore, while it is a medical device used in diagnosis, it does not meet the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
OLZ
Device Description
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.
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)
B. Scoring/Review & Analysis (REMbrandt Analysis Manager)
C. Report Generation (REMbrandt Analysis Manager)
D. Archiving & Data Management (REMbrandt Manager)
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.
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. 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.
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.
- 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 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.
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.
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.
The REMbrandt software does not make any decisions that result in any 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
qualified and trained medical practitioners, in research and clinical environments. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
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
Total Number of Subjects: 50 per event evaluated Total Number of scored Epochs (30 Sec): > 45.074 Total Number of Hours: 375:37:00 Mean number of epochs per subject: >903.5 Minimum number of epochs per subject: 698 Maximum number of epochs per subject: 1078
Data from 50 subjects were evaluated for respiratory, arousal, limb movement and snore events. All epochs from these subjects were scored.
The raw PSG recordings were de-identified, randomized and provided to three experienced and certified PSG specialists, including one board certified sleep specialist, who independently marked events of interest in each epoch, applying the following criteria:
- Apnea is scored when both of the following criteria are met:
- There is a drop in the peak signal excursion by > 90% of pre-event baseline a. respiratory nasal pressure or flow sensor signal.
- b. The duration of the > 90% drop in sensor signal is > 10 seconds.
- The apnea is Obstructive if it meets apnea criteria and is associated with continued or increased inspiratory effort throughout the entire period of absent airflow.
- The apnea is Central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow.
- The apnea is Mixed if it meets apnea criteria and is associated with absent inspiratory effort in the initial portion of the event followed by resumption of inspiratory effort in the second portion of the event.
- Hypopnea is scored if all of the following criteria are met:
- a. The peak signal excursions drop by > 30% of pre-event baseline using nasal pressure, PAP device flow or alternative hypopnea sensor.
- b. The duration of the >= 30% drop in signal excursion is >= 10 seconds.
- There is a > 3% oxygen desaturation from pre-event baseline or the event C. is associated with an arousal.
- Limb movement is scored if the following significant leg movement (LM) events are indicated:
- a. The minimum duration of a LM event is 0.5 seconds.
- b. The maximum duration of a LM event is 10 seconds.
- The minimum amplitude of a LM event is an 8 µV increase in EMG voltage C. above resting EMG.
- Snore: The scoring of snore events relies on clinical interpretation
- Arousals: Score arousals during sleep stages (N1, N2, N3 or R) if there is an abrupt shift of EEG frequency including alpha, theta and/or frequencies greater than 16 Hz (but not spindles) that lasts at least 3 seconds, with at least 10 seconds of stable sleep preceding the change. Scoring of arousal in REM requires a concurrent increase in submental EMG lasting at least 1 second.
Separate from the expert review, all PSG studies were also analyzed by REMbrandt assisted-scoring detectors at default values for:
- Central apnea
- Mixed apnea
- Obstructive apnea
- Hypopnea
- Limb movement
- Snoring
- Arousals
Summary of Performance Studies
Study type: Clinical Study Summary - Respiratory, Limb Movement and Snore Event Assistedscoring Detectors
Sample size: 50 (diagnostic PSG sleep studies), one study per subject.
Key Results: Compared to the Reference standard, REMbrandt assisted-scoring detectors showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices.
Key Metrics
Positive Percent Agreement (PPA) between REMbrandt assisted-scoring detectors compared to the Reference standard were measured on an epoch basis. The mean and 95% confidence interval (CI) of the PPA and false detection rate per hour for event detection assisted-scoring detectors are shown in the following table.
PPA and False Detection Rate Per Hour of REMbrandt Event Detection Assisted Scoring Detectors
| Event | PPA Mean | PPA 95% CI | FD/h Mean | FD/h 95% CI |
|---|---|---|---|---|
| Central Apnea | 99% | 98.3% to 99.4% | 0.7 | 0.4 to 1.5 |
| Mixed Apnea | 99.5% | 98.6% to 99.8% | 0.3 | 0.1 to 0.7 |
| Obstructive Apnea | 98% | 96.6% to 98.7% | 1.6 | 1.0 to 3.0 |
| Hypopnea | 90.4% | 87.9% to 92.1% | 4.0 | 3.2 to 5.1 |
| Arousal | 87.6% | 84.3% to 89.6% | 9.6 | 7.2 to 13.4 |
| Limb Movement | 88.7% | 86.0% to 91.0% | 11.1 | 8.5 to 14.6 |
| Snore | 87.1% | 84.1% to 89.5% | 12.3 | 9.5 to 16.2 |
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).
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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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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.: (800) 356-0007 x8673 E-mail: shane.sawall@natus.com
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.
5
- 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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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 | |
|---|---|---|---|
| Rembrandt K962865 | SleepWorks K090277 | REMbrandt | |
| 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 | |||
| Use | The Medcare | ||
| Rembrandt System is a | |||
| physiological signal | |||
| recorder intended for | |||
| use in sleep | |||
| Laboratories. It is used | |||
| as a paperless | |||
| polygraph, collecting | |||
| raw data. It is used to | |||
| manually analyze the | |||
| recorded data. The | |||
| user may manually tag | |||
| sleep stages, arousals, | |||
| apnea and hypopnea | |||
| and Periodic Leg | |||
| Movement. The | |||
| Rembrandt System | |||
| processes the manual | |||
| scoring to generate | |||
| Summary Reports. | |||
| A polysomnographer | |||
| would typically review | |||
| the recorded signals. | |||
| The Rembrandt | |||
| System by Medcare | |||
| Automation does not | |||
| provide any indications | |||
| during recording. It | |||
| does not do any | |||
| analysis, monitoring or | |||
| diagnosis of the | |||
| patient. It does not | |||
| issue any alarms. | The Sleepworks software | ||
| works in conjunction with | |||
| Connex, Trex or Netlink | |||
| amplifiers | |||
| intended for | |||
| polysomnography studies. | |||
| The software 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 Sleepworks 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 | |||
| are provided 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; | |||
| Sleep Works software | |||
| does not provide any | |||
| diagnostic conclusion | |||
| about the patient's | |||
| condition and is intended | |||
| to be used only by | 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 | |||
| conclusion about the | |||
| patient's condition and | |||
| is intended to be used | |||
| only by qualified and | |||
| trained medical | |||
| qualified and trained | |||
| medical practitioners; | |||
| in research and clinical | |||
| environments. | practitioners, in | ||
| research and clinical | |||
| environments. | |||
| User input | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard |
| Acquire, | |||
| display, store, | |||
| and archive | |||
| PSG data | Yes (post acquisition | ||
| analysis only) | Yes (post acquisition and | ||
| real-time analysis | Yes (post acquisition | ||
| and real-time analysis) | |||
| Signal digitized | Amplifier included as | ||
| part of the system | By separate proprietary | ||
| amplifier | By separate proprietary | ||
| amplifier | |||
| FFT Analysis | |||
| (Spectral | |||
| analysis on any | |||
| digitized | |||
| channel | Yes | Yes | Yes |
| Software | |||
| Detectors | |||
| Respiratory | |||
| event marking | Yes (Manual) | Yes (Manual & Computer | |
| Assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| Sleep staging/ | |||
| scoring | Yes (Manual) | Yes (Manual/computer | |
| assisted) | Yes (Manual) | ||
| Arousal Event | |||
| Marking | Yes (Manual) | Yes (Manual/computer | |
| assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| Limb | |||
| movements | |||
| event marking | Yes (Manual) | Yes (Manual & Computer | |
| Assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| Snore event | |||
| marking | Yes (Manual) | Yes (Manual & Computer | |
| Assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| Oxygen | |||
| Desaturation | |||
| event marking | Yes (Manual) | Yes (Manual & Computer | |
| Assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| Heart Rate data | |||
| trend & | |||
| summary | |||
| (including Heart | |||
| Rate Variability) | No | Yes | Yes |
| CO2 data trend | |||
| & summary | No | Yes | Yes |
| Associate | |||
| related events | No | Yes (Manual & Computer | |
| Assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| Derived | |||
| respiratory | |||
| traces | No | Yes, Effort Sum, | |
| difference, average, Flow | |||
| Volume Loop | Yes, XactTrace module | ||
| cleared to market via | |||
| K162140 | |||
| Synchronized | |||
| patient video | Yes | Yes | Yes |
| Oximetry data | |||
| display and | |||
| reporting | Yes | Yes | Yes |
| Data storage | Local or remote, hard | ||
| disk | Local or remote, hard disk | Local or remote, hard | |
| disk | |||
| Audio/ Visual | |||
| Alerts On | |||
| Calibrated | |||
| Channels | No | Yes | Yes |
| Signals | |||
| recorded | |||
| (output) | Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies | Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies | Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies |
| Report | |||
| generation | |||
| including counts | |||
| indexes, | |||
| max/min/averag | |||
| e/duration, | |||
| range based | |||
| data | |||
| summaries. | |||
| Numeric & | |||
| graphical | |||
| representations | Yes, customizable | ||
| templates | Yes, customizable | ||
| templates | Yes, customizable | ||
| templates |
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REMbrandt also includes 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 the pulse oximeter. The reference predicate for this feature of REMbrandt is K142988 Sleepware G3.
Brief Summary of Performance Tests:
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Biocompatibility
The REMbrandt is a software-only device. Biocompatibility testing is not applicable.
Electrical Safety and EMC
The REMbrandt is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable.
Software Verification
Testing of the REMbrandt was performed in compliance with the Natus Medical incorporated design control process. It was found that the REMbrandt software meets the design specification and performs as specified.
Animal Study
There were no animal studies performed for this submission.
Clinical Study Summary - Respiratory, Limb Movement and Snore Event Assistedscoring Detectors
1.1. Participants
Fifty (50) diagnostic PSG sleep studies were collected (one study per subject). All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study. The subject data were de-identified and applied as subject data to this study.
1.2. Dataset description
Total Number of Subjects: 50 per event evaluated Total Number of scored Epochs (30 Sec): > 45.074 Total Number of Hours: 375:37:00 Mean number of epochs per subject: >903.5 Minimum number of epochs per subject: 698 Maximum number of epochs per subject: 1078
Data from 50 subjects were evaluated for respiratory, arousal, limb movement and snore events. All epochs from these subjects were scored.
1.3. Objective of the study
The goal of the validation study reported here is to establish that REMbrandt performance is equivalent to the performance of the predicate device. For the purpose of this study "Reference standard" is defined using majority rule, that is, at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch.
1.4. PSG acquisition protocol
For this study, the following signals were recorded from each subject:
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- Six (6) Electroencephalogram ([EEG] channels: F3, F4, C3, C4, O1, and O2. ●
- Two (2) Electrooculogram (EOG) channels ●
- Submental and bilateral tibial electromyogram (EMG) .
- . Electrocardiogram (ECG)
- Airflow (nasal-oral thermistor and nasal pressure sensors or PAP flow)
- Chest and abdominal movement using respiratory inductance Plethysmography. ●
- Pulse oximetry (SpO2) and pulse rate ●
- Body position ●
- Snoring .
1.5. PSG analvsis protocol
All physiologic data were collected and stored on a REMbrandt System. The ECG, EEG, EMG, EOG and Snoring channels were sampled at 200 Hz. The Airflow and Chest, abdominal movement channels were sampled at 25 Hz. The Pulse oximetry channel was sampled at 10 Hz. The Body Position channel was sampled at 1 Hz.
The raw PSG recordings were de-identified, randomized and provided to three experienced and certified PSG specialists, including one board certified sleep specialist, who independently marked events of interest in each epoch, applying the following criteria:
- Apnea is scored when both of the following criteria are met: ●
- There is a drop in the peak signal excursion by > 90% of pre-event baseline a. respiratory nasal pressure or flow sensor signal.
- b. The duration of the > 90% drop in sensor signal is > 10 seconds.
- The apnea is Obstructive if it meets apnea criteria and is associated with continued or increased inspiratory effort throughout the entire period of absent airflow.
- . The apnea is Central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow.
- . The apnea is Mixed if it meets apnea criteria and is associated with absent inspiratory effort in the initial portion of the event followed by resumption of inspiratory effort in the second portion of the event.
- Hypopnea is scored if all of the following criteria are met: .
- a. The peak signal excursions drop by > 30% of pre-event baseline using nasal pressure, PAP device flow or alternative hypopnea sensor.
- b. The duration of the ≥ 30% drop in signal excursion is ≥ 10 seconds.
- There is a > 3% oxygen desaturation from pre-event baseline or the event C. is associated with an arousal.
- Limb movement is scored if the following significant leg movement (LM) events . are indicated:
- a. The minimum duration of a LM event is 0.5 seconds.
- b. The maximum duration of a LM event is 10 seconds.
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- The minimum amplitude of a LM event is an 8 µV increase in EMG voltage C. above resting EMG.
- . Snore: The scoring of snore events relies on clinical interpretation
- Arousals: Score arousals during sleep stages (N1, N2, N3 or R) if there is an ● abrupt shift of EEG frequency including alpha, theta and/or frequencies greater than 16 Hz (but not spindles) that lasts at least 3 seconds, with at least 10 seconds of stable sleep preceding the change. Scoring of arousal in REM requires a concurrent increase in submental EMG lasting at least 1 second.
Separate from the expert review, all PSG studies were also analyzed by REMbrandt assisted-scoring detectors at default values for:
- Central apnea
- . Mixed apnea
- Obstructive apnea
- Hypopnea ●
- Limb movement ●
- Snoring
- Arousals ●
1.6. Outcomes
Positive Percent Agreement (PPA) between REMbrandt assisted-scoring detectors compared to the Reference standard were measured on an epoch basis. The mean and 95% confidence interval (CI) of the PPA and false detection rate per hour for event detection assisted-scoring detectors are shown in the following table.
PPA and False Detection Rate Per Hour of REMbrandt Event Detection Assisted Scoring Detectors
| REMbrandt | ||||
|---|---|---|---|---|
| PPA | FD/h | |||
| Event | Mean | 95% CI | Mean | 95% CI |
| Central Apnea | 99% | 98.3% to 99.4% | 0.7 | 0.4 to 1.5 |
| Mixed Apnea | 99.5% | 98.6% to 99.8% | 0.3 | 0.1 to 0.7 |
| Obstructive Apnea | 98% | 96.6% to 98.7% | 1.6 | 1.0 to 3.0 |
| Hypopnea | 90.4% | 87.9% to 92.1% | 4.0 | 3.2 to 5.1 |
| Arousal | 87.6% | 84.3% to 89.6% | 9.6 | 7.2 to 13.4 |
| Limb Movement | 88.7% | 86.0% to 91.0% | 11.1 | 8.5 to 14.6 |
| Snore | 87.1% | 84.1% to 89.5% | 12.3 | 9.5 to 16.2 |
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1.7. Clinical Study Conclusion
Compared to the Reference standard, REMbrandt assisted-scoring detectors showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices.
510(k) Summary Conclusions:
The substantial equivalence of the REMbrandt with the predicate Natus SleepWorks product was demonstrated by software verification testing and clinical validation. The non-clinical data support the safety of the device. The software verification and validation demonstrate that REMbrandt device should perform as intended in the specified use conditions. The clinical validation of the computer-assisted scoring detectors demonstrates that the REMbrandt device performs comparably to the predicate device that is currently marketed for the same intended use.