RemLogic

{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) | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 | 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| | <i>Embla K971813</i> | <i>SleepWorks K090277</i> | <i>RemLogic</i> | | Device Class | Class II | Class II | Class II | | Class Name | Electroencephalograph | Electroencephalograph | Electroencephalograph | | Product Code | OLV = Standard<br>Polysomnograph with<br>Electroencephalograph | OLZ = Automatic Event<br>Detection Software for<br>Polysomnograph with<br>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<br>system that is intended<br>to record, display, and<br>print EEG and other<br>physiological<br>information to<br>clinicians/physicians.<br>The device will be used<br>in hospitals,<br>institutions, sleep<br>centers or clinics, or<br>other test environments<br>where patients require<br>documentation of<br>various sleep or other<br>physiologic disorders. | 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 | 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>RemLogic 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 RemLogic software<br>does not provide any<br>diagnostic conclusion<br>about the patient's<br>condition and is<br>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 | Yes | Yes | | Signal digitized | Amplifier included as<br>part of the system | By separate proprietary<br>amplifier | By separate proprietary<br>amplifier | | Software<br>Analyzers | | | | | Respiratory<br>event marking | Yes (Manual &<br>Computer Assisted for<br>apneas only) | 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) | | Heart Rate data<br>trend &<br>summary<br>(including Heart<br>Rate Variability) | No | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) | | CO2 data trend<br>& summary | No | Yes | Yes | | Associate<br>related events | No | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) | | Derived<br>respiratory<br>traces | No | Yes, Effort Sum,<br>difference, average, Flow<br>Volume Loop | Yes, XactTrace module<br>and Flattening Index;<br>cleared to market via<br>K041724 | | Synchronized<br>patient video | No | Yes | Yes | | Oximetry data<br>display and<br>reporting…