(122 days)
Unknown
The document mentions "Automated analysis of physiological signals" and "computer-assisted scoring analyzers" but does not explicitly state that AI or ML techniques are used for this analysis. The description of the validation study focuses on comparing the software's output to expert scoring, which is common for automated analysis systems regardless of whether they use AI/ML. There is no mention of training sets or specific AI/ML algorithms.
No
The device aids in the diagnosis of sleep-related respiratory disorders by recording and analyzing physiological signals, but it does not provide any therapeutic function or treatment. It is explicitly stated that "The RemLogic software does not provide any diagnostic conclusion about the patient's condition."
Yes
The "Intended Use / Indications for Use" states that the software assists "in the diagnosis of various sleep related respiratory disorders" by recording, displaying, and storing physiological signals. While it does not provide a "diagnostic conclusion," it provides tools for medical professionals to interpret sleep studies for diagnostic purposes.
Yes
The device description explicitly states that the RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware.
Based on the provided information, the RemLogic software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, or to monitor therapeutic measures.
- RemLogic's Function: RemLogic processes physiological signals recorded from the human body (Polysomnography studies). It analyzes these signals to assist in the diagnosis of sleep-related respiratory disorders. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use clearly states it's for recording, displaying, and storage of physiological signals and provides automated analysis to assist in diagnosis. It explicitly states it "does not provide any diagnostic conclusion about the patient's condition."
- Device Description: The description confirms it collects and digitizes electrical voltages of patient physiological signals.
Therefore, while RemLogic is a medical device used in the diagnostic process, its function of analyzing physiological signals recorded directly from the patient's body places it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RemLogic software is intended for Polysomnography studies and allows recording, displaying, and storage of physiological signals to assist in the diagnosis of various sleep related respiratory disorders. The RemLogic 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 RemLogic 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 (comma separated list FDA assigned to the subject device)
OLZ
Device Description
The RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used by trained medical professionals to investigate sleep disorders.
The RemLogic application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and analyzers to analyze the signals, which aid in the interpretation of a sleep study. The software consists of three main functional areas:
- Acquisition Real time collection of EEG and other physiological parameters.
- Scoring & Review - Includes functions providing the user with tools to quickly review PSG studies, either during real time collection of data or after the recordings are complete
- Reports - Once the digital polysomnography data has been acquired scored and reviewed by both a polysomnographic technologist and a sleep physician the RemLogic 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 polysomnography and the RemLogic software also includes tools to customize report templates to conform to individual sleep center standards/policies and graphic norms.
During the Acquisition phase, the software collects data based on user selected sampling rates, amplifier set-up, and amplifier calibrations. These three factors define how the software collects and displays the data in real-time. The recording is saved on the hard disk of the user's computer in a raw data format. The user can customize displays, observations, event markers, and tags.
The RemLogic application software contains a number of computer-assisted scoring analyzers. All computer assisted-scoring analyzers are provided to assist trained medical practitioners in the review and analysis of vast amounts of polysomnography data. The computer assisted-scoring analyzers are for analysis of adult patient data only. Each computer-assisted scoring analyzer runs a specific type of event scoring on the patient file. The scoring rule parameters used in the computer-assisted scoring analyzers depend on the montage type associated with the study.
The eight computer-assisted scoring analyzers are:
- Arousal Analyzer
- Respiratory Analyzer
- Limb Movement Analyzer
- Snoring Analyzer
- Desaturation Analyzer
- Heart Rate Analyzer
- Associations Analyzer
- XactTrace module
The RemLogic application software is intended for use by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgement to provide diagnostic conclusions about the patient's condition. The RemLogic software does not control the delivery of energy, the administration of drugs, or any 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
adult (>18 years old) subjects
Intended User / Care Setting
qualified and trained medical practitioners, in research and clinical 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
Fifty-one (51) 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. Total Number of Subjects: 51 per event evaluated Total Number of scored Epochs (30 Sec): > 47,113 Total Number of Hours: 392:36:30 Average number of epochs per subject: 924 Minimum number of epochs per subject: 764. Data from 51 subjects were evaluated for respiratory, arousal, limb movement and snore events. All epochs from these subjects were scored. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study Summary - Respiratory, Limb Movement and Snore Event Assistedscoring Analyzers. 51 diagnostic PSG studies were collected (one per subject), all subjects adult (>18 years old) with clinical indication for sleep study. 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. Positive Percent Agreement (PPA) between RemLogic assisted-scoring analyzers compared to the Reference standard were measured on an epoch basis. Mean PPA values were: Central Apnea 98%, Mixed Apnea 98%, Obstructive Apnea 94%, Hypopnea 86%, Arousal 83%, Limb Movement 86%, Snore 85%. False Detection Rate per hour (FD/h) values were: Central Apnea 2.1, Mixed Apnea 2.4, Obstructive Apnea 7.8, Hypopnea 17.4, Arousal 20.2, Limb Movement 16.8, Snore 17.8. RemLogic assisted-scoring analyzers showed performance levels comparable to the manual markings of expert reviewers and is clinically equivalent to the Reference standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA)
Central Apnea: 98% (95% CI: 96% to 99%)
Mixed Apnea: 98% (95% CI: 96% to 99%)
Obstructive Apnea: 94% (95% CI: 91% to 95%)
Hypopnea: 86% (95% CI: 83% to 87%)
Arousal: 83% (95% CI: 81% to 85%)
Limb Movement: 86% (95% CI: 84% to 88%)
Snore: 85% (95% CI: 83% to 88%)
False Detection Rate Per Hour (FD/h)
Central Apnea: 2.1 (95% CI: 1.2 to 4.1)
Mixed Apnea: 2.4 (95% CI: 1.3 to 5.1)
Obstructive Apnea: 7.8 (95% CI: 5.6 to 10.9)
Hypopnea: 17.4 (95% CI: 15.0 to 20.0)
Arousal: 20.2 (95% CI: 17.8 to 22.6)
Limb Movement: 16.8 (95% CI: 14.0 to 19.9)
Snore: 17.8 (95% CI: 14.9 to 20.9)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them. The emblem is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
Embla Systems Shane T. Sawall Regulatory Affairs Manager 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7
Re: K162140
Trade/Device Name: RemLogic Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: November 1, 2016 Received: November 2, 2016
Dear Shane T. 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
1
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.
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 -A
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) K162140
Device Name RemLogic
Indications for Use (Describe)
The RemLogic software is intended for Polysomnography studies and allows recording, displaying, and storage of physiological signals to assist in the diagnosis of various sleep related respiratory disorders. The RemLogic 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 RemLogic 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and modern, and the colors are clean and professional.
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: Oct. 31, 2016
Proprietary Name: RemLogic
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: Embla (K971813); Natus SleepWorks (K090277) - primary
Description:
1. Overview RemLogic Software
The RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used by trained medical professionals to investigate sleep disorders.
2. Main Functional Areas
The RemLogic application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and analyzers to analyze the signals, which aid in the interpretation of a sleep study. The software consists of three main functional areas:
- Acquisition Real time collection of EEG and other physiological . parameters.
4
Image /page/4/Picture/1 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color and a sans-serif font. Below that, the word "neurology" is in a smaller, black, italicized font.
- . Scoring & Review - Includes functions providing the user with tools to quickly review PSG studies, either during real time collection of data or after the recordings are complete
- . Reports - Once the digital polysomnography data has been acquired scored and reviewed by both a polysomnographic technologist and a sleep physician the RemLogic 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 polysomnography and the RemLogic software also includes tools to customize report templates to conform to individual sleep center standards/policies and graphic norms.
3. Typical work flow using the RemLogic Application software
During the Acquisition phase, the software collects data based on user selected sampling rates, amplifier set-up, and amplifier calibrations. These three factors define how the software collects and displays the data in real-time. The recording is saved on the hard disk of the user's computer in a raw data format. The user can customize displays, observations, event markers, and tags.
4. Computer-assisted scoring analyzers
The RemLogic application software contains a number of computer-assisted scoring analyzers. All computer assisted-scoring analyzers are provided to assist trained medical practitioners in the review and analysis of vast amounts of polysomnography data. The computer assisted-scoring analyzers are for analysis of adult patient data only. Each computer-assisted scoring analyzer runs a specific type of event scoring on the patient file. The scoring rule parameters used in the computer-assisted scoring analyzers depend on the montage type associated with the study.
The eight computer-assisted scoring analyzers are:
- Arousal Analyzer
- Respiratory Analyzer
- Limb Movement Analyzer
- Snoring Analyzer
- Desaturation Analyzer
- Heart Rate Analyzer
- · Associations Analyzer
- XactTrace module
5
Image /page/5/Picture/1 description: The image shows the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font. Below "natus" is the word "neurology" in a smaller, black, sans-serif font.
5. Diagnosis
The RemLogic application software is intended for use by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgement to provide diagnostic conclusions about the patient's condition. The RemLogic software does not control the delivery of energy, the administration of drugs, or any form of life sustaining function to the patient.
Indications for Use:
The RemLogic 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 RemLogic software also 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 RemLogic 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.
| Predicate | Predicate | Subject Device | |
|---|---|---|---|
| Embla K971813 | SleepWorks K090277 | RemLogic | |
| Device Class | Class II | Class II | Class II |
| Class Name | Electroencephalograph | Electroencephalograph | Electroencephalograph |
| Product Code | OLV = Standard | ||
| Polysomnograph with | |||
| Electroencephalograph | OLZ = Automatic Event | ||
| Detection Software for | |||
| Polysomnograph with | |||
| Electroencephalograph | Same as SleepWorks | ||
| Intended User | Medical Professional | Medical Professional | Medical Professional |
| Indications for Use | Embla is a | The Sleepworks software | The RemLogic software |
| polysomnographic | |||
| system that is intended | |||
| to record, display, and | |||
| print EEG and other | |||
| physiological | |||
| information to | |||
| clinicians/physicians. | |||
| The device will be used | |||
| in hospitals, | |||
| institutions, sleep | |||
| centers or clinics, or | |||
| other test environments | |||
| where patients require | |||
| documentation of | |||
| various sleep or other | |||
| physiologic disorders. | 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 | 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 | |||
| RemLogic 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 RemLogic 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 | Yes | Yes |
| Signal digitized | Amplifier included as | ||
| part of the system | By separate proprietary | ||
| amplifier | By separate proprietary | ||
| amplifier | |||
| Software | |||
| Analyzers | |||
| Respiratory | |||
| event marking | Yes (Manual & | ||
| Computer Assisted for | |||
| apneas only) | 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 (Manual & Computer | |
| Assisted) | Yes (Manual & | ||
| Computer Assisted) | |||
| 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 | ||
| and Flattening Index; | |||
| cleared to market via | |||
| K041724 | |||
| Synchronized | |||
| patient video | No | 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/average/duration, | |||
| range based data | |||
| summaries. | |||
| Numeric & graphical | |||
| representations | Yes, customizable templates | Yes, customizable templates | Yes, customizable templates |
Comparison to Predicate Device:
6
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 a small registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and modern.
7
Image /page/7/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below that, the word "neurology" is in a smaller, black, sans-serif font.
8
Image /page/8/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, and the word "neurology" is in a black sans-serif font. The logo is simple and modern, and it is likely used to represent a company that specializes in neurology products or services.
RemLogic 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 RemLogic is K142988 Sleepware G3.
Brief Summary of Performance Tests:
9
Image /page/9/Picture/1 description: The image contains the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font. Below the word "natus" is the word "neurology" written in a smaller, black, sans-serif font. The logo is simple and modern.
Biocompatibility
The RemLogic is a software-only device. Biocompatibility testing is not applicable.
Electrical Safety and EMC
The RemLogic is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable.
Software Verification
Testing of the RemLogic was performed in compliance with the Natus Medical incorporated design control process. It was found that the RemLogic 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 Analyzers
1.1. Participants
Fifty-one (51) 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: 51 per event evaluated Total Number of scored Epochs (30 Sec): > 47,113 Total Number of Hours: 392:36:30 Average number of epochs per subject: 924 Minimum number of epochs per subject: 764
Data from 51 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 RemLogic 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:
- Six (6) Electroencephalogram ([EEG] channels: F3, F4, C3, C4, O1, and O2. .
10
- 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 analysis protocol
All physiologic data were collected and stored on a RemLogic 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.
- The duration of the > 90% drop in sensor signal is > 10 seconds. b.
- . 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: ●
- The peak signal excursions drop by > 30% of pre-event baseline using a. nasal pressure, PAP device flow or alternative hypopnea sensor.
- The duration of the > 30% drop in signal excursion is > 10 seconds. ﻘ
- 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.
- The maximum duration of a LM event is 10 seconds. ﻒ
- The minimum amplitude of a LM event is an 8 µV increase in EMG voltage C. above resting EMG.
11
- . 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 in the EEG frequency that lasts at least 3 seconds (exclude sleep spindles) with at least 10 seconds of stable sleep preceding the change. Scoring arousals in REM requires a concurrent increase in Chin EMG lasting at least 1 second.
Separate from the expert review, all PSG studies were also analyzed by RemLogic assisted-scoring analyzers at default values for:
- Central apnea .
- Mixed apnea ●
- . Obstructive apnea
- Hypopnea
- Limb movement ●
- Snoring
- . Arousals
1.6. Outcomes
Positive Percent Agreement (PPA) between RemLogic assisted-scoring analyzers 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 analyzers are shown in the following table.
PPA and False Detection Rate Per Hour of RemLogic Event Detection Assisted Scoring Analyzers
| RemLogic | ||||
|---|---|---|---|---|
| PPA | FD/h | |||
| Event | Mean | 95% CI | Mean | 95% CI |
| Central Apnea | 98% | 96% to 99% | 2.1 | 1.2 to 4.1 |
| Mixed Apnea | 98% | 96% to 99% | 2.4 | 1.3 to 5.1 |
| Obstructive Apnea | 94% | 91% to 95% | 7.8 | 5.6 to 10.9 |
| Hypopnea | 86% | 83% to 87% | 17.4 | 15.0 to 20.0 |
| Arousal | 83% | 81% to 85% | 20.2 | 17.8 to 22.6 |
| Limb Movement | 86% | 84% to 88% | 16.8 | 14.0 to 19.9 |
| Snore | 85% | 83% to 88% | 17.8 | 14.9 to 20.9 |
12
Image /page/12/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color and a sans-serif font. Below that, the word "neurology" is in a smaller, black, sans-serif font. The logo is simple and modern.
1.7. Clinical Study Conclusion
Compared to the Reference standard. RemLogic assisted-scoring analyzers 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 RemLogic 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 RemLogic device should perform as intended in the specified use conditions. The clinical validation of the computer-assisted scoring analyzers demonstrates that the RemLogic device performs comparably to the predicate device that is currently marketed for the same intended use.