Who is the manufacturer of Nox Sleep System?

Nox Medical filed the 510(k) submission for Nox Sleep System (K192469).

What is the FDA product code for Nox Sleep System?

OLZ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Nox Sleep System?

510(k) clearance (submission type: Traditional).

Does Nox Sleep System use AI or machine learning?

Yes. Nox Sleep System (K192469) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Nox Sleep System?

Compumedics Somté PSG System (K072201).

Who can help prepare an FDA 510(k) submission like Nox Sleep System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Nox Sleep System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Nox Sleep System

K192469 · Nox Medical · OLZ · Nov 13, 2019 · Neurology

Device Facts

Record ID	K192469
Device Name	Nox Sleep System
Applicant	Nox Medical
Product Code	OLZ · Neurology
Decision Date	Nov 13, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	AI/ML, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K192469 · Nov 13, 2019	Nox Sleep System	Nox Medical	Retrospective clinical sleep study recordings; Routine clinical care medical records	Retrospective analysis of pre-existing clinical sleep study data was used to validate the performance of the device's automatic scoring algorithms (Bruxism, PLM, Respiratory Flow/AHI/ODI, Apnea Classification, and Sleep Staging) against manual scoring performed by qualified technologists.	Retrospective analysis; Automatic scoring validation; Routine clinical care data

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis of pre-existing clinical data	Adults from multiple U.S. dental clinics; Number of Sites: Multiple U.S. dental clinics	Manual scoring by qualified polysomnographic technologists	Sensitivity, specificity, PPV, NPV for bruxism-related events
Retrospective analysis of pre-existing clinical data	Adults seeking medical attention at a sleep clinic; Number of Sites: National hospital	Manual scoring by qualified polysomnographic technologists	ICC, Cohen's kappa, accuracy of sleep stage prediction

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Bruxism-related events	—	detect at least 90% of oromandibular movements with 95% confidence	sensitivity 95.7% (95% CI 93.2% - 97.4%)	—	—	Adult Polygraphy recordings from multiple U.S. dental clinics	>1 (trained healthcare professional)
Periodic Limb Movement Index	—	interclass correlation of 0.61 or greater	ICC 0.87	—	—	Adult Polysomnography recordings from a national hospital	>1 (polysomnographic technologists)
Apnea Hypopnea Index (AHI)	—	95% confidence in not misclassifying patients between AHI < 5 and AHI >= 15	Cohen's kappa 0.78 (cannula), 0.62 (RIP flow), 0.62 (cRIP flow)	—	—	Adult Polysomnography recordings from a national hospital	>1 (polysomnographic technologists)
Oxygen Desaturation Index (ODI)	—	—	Cohen's kappa 0.87	—	—	Adult Polysomnography recordings from a national hospital	>1 (polysomnographic technologists)
Central Apnea Index	—	ICC comparable to scientific literature of 0.46	ICC 0.91, Cohen's kappa 0.89	—	—	Adult Polygraphy recordings from a national hospital	>1 (polysomnographic technologists)
Sleep Staging	—	average accuracy of at least 60% when scoring wake epochs	Wake accuracy 66.7%, Cohen's Kappa <= 0.67	—	—	Adult recordings from a national hospital	>1 (polysomnographic technologists)

Indications for Use

The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject's data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.

Device Story

Nox Sleep System is a multi-channel physiological recording system for sleep assessment. Components include Nox A1 Recorder (patient-worn, battery-operated), Nox C1 Access Point (mains-powered, remote), Noxturnal App (mobile interface), and Noxturnal PSG software (PC-based). Inputs include EEG, EOG, EMG, respiratory effort (bands/belts), airflow (cannula/thermocouple), SpO2, pulse rate, and body position. System records, displays, and analyzes data; supports manual and automatic scoring of sleep stages, apneas, hypopneas, limb movements, and bruxism-related events. Used in hospitals, clinics, or homes by trained medical professionals. Output is analyzed data and reports for physician review. Automatic scoring assists diagnosis but requires manual verification. Benefits include efficient sleep disorder screening and diagnostic assessment.

Clinical Evidence

Retrospective clinical validation of automatic scoring algorithms using pre-existing clinical sleep study data. Algorithms evaluated: Bruxism (n=adults, sensitivity 95.7%, specificity 61.0%), PLM (ICC 0.87), AHI/ODI (Cohen's kappa 0.62-0.87 depending on signal type), Apnea Classification (ICC 0.91, Cohen's kappa 0.89), and Sleep Staging (accuracy 66.7%-87.0% per stage). Results demonstrate automatic scoring performs comparably to manual scoring by trained technologists.

Technological Characteristics

System includes Nox A1 Recorder (ABS/Polycarbonate), Nox C1 Access Point, and sensors (gold electrodes, respiratory bands). Connectivity via Bluetooth, Ethernet, and USB. Software (Noxturnal PSG) performs signal processing and automatic analysis. Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-25/26/40. Data storage via internal flash. 32-bit signal processing.

Indications for Use

Indicated for adult patients undergoing physiological measurements for sleep assessment and screening for sleep disorders. Used by trained medical professionals in clinical or home environments.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

Compumedics Somté PSG System (K072201)

Reference Devices

Nox T3 (K082113)
Embletta MPR (K122516)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Nox Medical % John Smith Partner Hogan Lovells US, LLP 555 Thirteenth Street, NW Washington, DC 20004 ### Re: K192469 Trade/Device Name: Nox Sleep System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, KZM Dated: September 9, 2019 Received: September 9, 2019 ### Dear John Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jay Gupta Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K192469 Device Name Nox Sleep System #### Indications for Use (Describe) The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject's data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <div> ☑ </div> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> ☐ </div> | #### 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}------------------------------------------------ ### 510(k) Summary | Submitter: | Nox Medical Katrinartuni 2 IS-105 Reykjavik Iceland Tel: +354 570 7170 Establishment Registration Number: 3007389703 | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kolbrun E Ottosdottir Chief Compliance Officer Katrinartuni 2 IS-105 Reykjavik Iceland | | Application Correspondent: | John J. Smith, MD, JD Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, D.C. 20004 | | Preparation Date: | November 12, 2019 | | Device: | Device Proprietary Name: Nox Sleep System Device Common or Usual Name: Sleep Assessment System Classification Name: Electroencephalograph, Automatic Event Detection Software for Polysomnograph with Electroencephalograph Regulation Number: 882.1400 Product Code: OLZ, KZM Device Class: II Review Panel: Neurology | | Predicate Devices: | Substantial equivalence is claimed to Compumedics Somté PSG System (K072201) from Compumedics Limited. | | | The Nox T3 (K082113) from Nox Medical and Embletta MPR (K122516) from Embla Systems are used as reference devices. | {4}------------------------------------------------ ### Device Description The Nox Sleep System is intended for patients undergoing physiological measurements, for the assessment of sleep quality and the screening for sleep disorders. The Nox Sleep System does not provide any alarms and is not intended to be used for continuous monitoring where failure to operate can cause injuries or death of the patient. The basic Nox Sleep System consists of two recording/acquisition devices (Nox A1 Recorder and Nox C1 Access Point), a software running on a PC (Noxturnal PSG), an Android application (Noxturnal App) running on mobile platform, along with sensors and accessories. The system supports full Polysomnography (PSG) studies both in ambulatory and online/attended setups but also more simple sleep study setups, recording only few channels. The ambulatory sleep studies may take place in the clinic or in the home environment, but the online/attended sleep studies are only conducted in the clinical environment. The Nox A 1 Recorder is a small battery-operated recording unit that is worn by the patient during the study. It records signals from patient applied sensors that connect to the unit but also supports recording of signals from auxiliary devices over Bluetooth. The Nox A1 Recorder allows for communication over Bluetooth with the Noxturnal App during ambulatory setup and with the Nox C1 Access Point during online setup. The recorder is intended to be worn over clothing. New accessories and sensors as part of this submission are the Nox A 1 EEG 5 Lead Gold Electrode Cable and Nox A1 EEG Head Cable that are used for recording of EEG/EOG. These components are in direct contact with the patient. The Nox C1 Access Point is a separate mains powered unit located remotely from the patient that allows for recording of signals from auxiliary devices. It supports communication over LAN/Ethernet to the Noxturnal PSG, and communication with the Nox A1 Recorder and Noxturnal App over Bluetooth. The Nox C1 Access Point is only used for online study setup and is thus not intended to be used in the home environment. The Noxturnal App is used as a mobile interface to the Nox A1 Recorder and Nox C1 Access Point. The communications are via Bluetooth link. The app is normally used in the beginning of a sleep study, for basic tasks such as device configuration, starting a recording, checking the signal quality of signals being recorded and marking events during bio calibration. The Noxturnal PSG is used for configuration of the Nox recording/acquisition devices, to download a study from ambulatory recording or to collect an online study. The software supports the viewing, retrieving, storing and processing of data recorded/collected, manual and automatic analysis and reporting on the results from the recorded studies. The purpose with the automatic scoring function in Noxturnal PSG is to assist the trained physician in the diagnosis of a patient. It is not intended to provide the trained physician with a diagnostic results. The type of automatic analysis events scored by Noxturnal PSG include: Sleep Stages (Wake, N1, N2, N3, REM), Apneas, Hypopneas, Apnea Cassification (Obstructive, Mixed and Central Apneas), Limb Movements, Periodic Limb Movements, SpO2 Desaturation Events. and potential Bruxism-Related Events. The result of the automatic analysis/scoring must always be manually verified by the trained physician prior to diagnosis. {5}------------------------------------------------ ### Indication for Use The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject's data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home. ### Technological Characteristics and Comparison For the purpose of demonstrating substantially equivalency of the Nox Sleep System the Compumedics Somté PSG (K072201) System from Compumedics Limited has been selected as the primary predicate device. Indication for Use: "The Somté PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders. The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a physician. " The primary predicate Compumedics Somté PSG and the new device Nox Sleep System are both used for recording of physiological parameters of various origin to assist with diagnosis of sleep disorders/sleep related disorders and support the same types of sleep studies, i.e. full Polysomnography (PSG) studies both in ambulatory and online/attended setups but also more simple sleep study setups, recording only few channels. The intended environments and user groups are the same for both the primary predicate and the new device, and both devices are for prescription use only. The overall methodology relating to how the sleep studies are conducted and the recorded data displayed and analysed is also very similar for both the new device and the primary predicate. It is thus concluded that the intended use of the Nox Sleep System may be regarded the same as that of the Compumedics Somté PSG System. The comparison table below is provided as a summary of the most relevant characteristics of the Nox Sleep System relative to the primary predicate Compumedics Somté PSG. | Technological Characteristic | Nox Sleep System | Compumedics Somté PSG System | Result of Comparison | |-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Portable design | Yes | Yes | Equivalent | | Technological Characteristic | Nox Sleep System | Compumedics Somté PSG System | Result of Comparison | | Patient worn device | Yes | Yes | Substantially Equivalent | | Physical dimensions | Nox A1 Recorder: 82x63x21 mm Nox C1 Access Point: 135x149x26 mm | Somté PSG Recorder: 113x65x30mm Patient input box: 53x133x25mm Bedside unit (dimensions not stated in labeling) | Substantially Equivalent The Embletta MPR (K122516) includes a separate device located remotely from the patient with very similar size 115x110x26mm | | Weight | Nox A1 Recorder: 92 g (120 g with battery) Nox C1 Access Point: 264 g | Somté PSG Recorder: 110 g (172 g including batteries) Patient input box: 95 g Bedside unit (weight not stated in labeling) | Substantially Equivalent The Embletta MPR (K122516) includes a separate device located remotely from the patient with very similar weight 160g | | Case Material | Plastic, ABS/Polycarbonate blend | Plastic, ABS/Polycarbonate blend | Equivalent | | Method of Connection to Patient | Respiratory bands/belts for respiratory effort Respiratory bands/belts for attaching of device and clip straps to secure position of device Plastic tubing and cannula for pressure sensing Snap on electrode cables with snap-on disposable electrodes for EMG/EOG Thermal flow sensors/thermocouple for measuring of nasal/oral airflow Nox A1 EEG 5 Lead Gold Electrode Cable and Nox A1 EEG Head Cable for EEG/EOG | Respiratory bands/belts for respiratory effort Respiratory bands/belts for attaching of device and optional EZ Vest to secure position of device Plastic tubing and cannula for pressure sensing Snap on electrode cables with snap-on disposable electrodes for EMG/EOG Thermal flow sensors/thermocouple for measuring of nasal/oral airflow | Substantially Equivalent The use of an auxiliary 3rd party wireless oximeter that is wrist worn and connected via Bluteooth® to the recorder is substantially equivalent to Nox T3 (K082113). | | | Surface electrode leads for EEG/EOG/EMG Surface Electrodes for measuring of leg movements Wrist worn oximeter and probes for oximetry worn on finger | Surface electrode leads for EEG/EOG/EMG Surface Piezo Limb Sensor for measuring of leg movements Probes for oximetry worn on finger | | | Acquisition Units | Nox A1 Recorder Nox C1 Access Point | Somté PSG Recorder Patient Interface Box Bedside unit for recording of additional AUX channels | Substantially Equivalent Embletta MPR (K122516) includes a separate device allowing recording of additional AUX channels | | Technological Characteristic | Nox Sleep System | Compumedics Somté PSG System | Result of Comparison | | Local User Interface | Nox A1 Recorder: Display (OLED), push buttons and indicator light on device Nox C1 Access Point: Light indicator on device, factory reset button Noxturnal App running on Android™ platform | Somté PSG Recorder: Display (LCD) and push buttons and indicator light on device | channels Substantially Equivalent The Noxturnal App is used in a very similar way as the display on the Somté PSG Recorder and may be regarded as an extension of the display screen on the Nox A1 Recorder. | | Data Collection | Yes | Yes | Equivalent | | Display Raw Data during Recording | Yes, By use of the Noxturnal PSG (PC) during in-lab use or by use of Noxturnal App | Yes, PC during in-lab use, or LCD on unit | Substantially Equivalent | | Real-time waveforms preview | Yes - By use of the Noxturnal App including full disclosure waveform preview | Yes - Integrated LCD including full disclosure waveform preview | Substantilly Equivalent | | Data display on PC for interpretation | Yes – during or after recording | Yes - during or after recording | Equivalent | | Data Analysis | Yes - By use of Noxturnal PSG SW (PC application) Automatic, result may be manipulated (manual review/verification must be performed prior to diagnosis) Manual analysis Event marking (scoring) Technician Notes | Yes - By use of Profusion Sleep SW (PC application) Automatic, result may be manipulated (manual review/verification must be performed prior to diagnosis) Manual analysis Event marking (scoring) Technician Notes | Equivalent | | Signal Sheets/Trace Display Layout properties - Adjust by user | Yes - By use of Noxturnal PSG SW (PC application) - such as: Timebase settings Signal grouping/arrangements Grid Markers Epoch Markers Apply changes to data type Background color Cursor color Grid color | Yes - By use of Profusion Sleep SW (PC application) - such as: Timebase settings Signal grouping/arrangements Grid Markers Epoch Markers Apply changes to data type Background color Cursor color Grid color | Equivalent | | Signal trace properties - Adjust by user | Yes - By use of Noxturnal PSG SW (PC application) - such as: Select Input and reference Name Trace color | Yes - By use of Profusion Sleep SW (PC application) - such as: Select Input and reference Name Trace color | Equivalent | | Technological Characteristic | Nox Sleep System | Compumedics Somté PSG System | Result of Comparison | | | Zoom | Zoom | | | | Size | Size | | | | Grids | Grids | | | | Polarity | Polarity | | | | Upper/lower display bounds | Upper/lower display bounds | | | | Filtering (HP/LP/Notch) | Filtering (HP/LP/Notch) | | | | Auto Scale | Auto Scale | | | | Numeric | Numeric | | | | Offset | Offset | | | | Adding/Deleting | Adding/Deleting | | | Display of graphical summary for selected traces and data for the entire study | Yes - By use of Noxturnal PSG SW (PC application) | Yes - By use of Profusion Sleep SW (PC application) | Equivalent | | User defined event types | Yes - By use of Noxturnal PSG SW (PC application) | Yes - By use of Profusion Sleep SW (PC application) | Equivalent | | Automatic Analysis/Detector Output for User Interpretation - per AASM recommendations/scoring rules | Yes - By use of Noxturnal SW (PC application) | Yes - By use of Profusion Sleep SW (PC application) | Substantially Equivalent All automatic analysis provided in the new device is also provided in the primary predicate device. | | | Sleep Stages: Wake, N1, N2, N3, REM | Sleep Stages: Wake, N1, N2, N3, REM | | | | | Arousal detection and arousal classification | Relating to automatic analysis not included in the new device: The raw data necessary for the analysis of these events may be recorded and displayed in the Noxturnal PSG software for manual analysis | | | Apneas, Hypopneas Classification of apneas: Obstructive, Mixed or Central | Apneas, Hypopneas Classification of apneas: Obstructive, Mixed or Central | | | | | Unsure respiratory event | | | | Limb Movements, Periodic Limb Movements | Limb Movements, Periodic Limb Movements | | | | | Snores (detection from sound input baseline) | | | | | Eye movements, singular, anti-phase and in-phase (EOG) | | | | SpO2 desaturation events | SpO2 desaturation events and artifacts, min/max SpO2 values | | | | Potential Bruxism Related events | Potential Bruxism Related events | | | Technological Characteristic | Nox Sleep System | Compumedics Somté PSG System | Result of Comparison | | | | epoch Average CPAP for each epoch Average TcCO2 value for each epoch Peak EtCO2 value of each respiratory cycle PTT event detection pH event detection | | | Report Generation | Yes - By use of Nocturnal PSG SW (PC application) | Yes - By use of Profusion Sleep SW (PC application) | Equivalent | | Statistics available for report fields | Statistics and graphs from manual scored events and automatic analysis | Statistics and graphs from manual scored events and automatic analysis | Equivalent | | MSLT/MWT¹ studies supported | Yes | Yes | Equivalent | | Data Inputs | Generic and custom sensors/auxiliary devices. | Generic and custom sensors/auxiliary devices. | Substantially Equivalent | | Signal Conditioning | Yes | Yes | Substantially Equivalent | | Remote Sleep Surveillance | Yes, via Ethernet | Yes, via Ethernet | Equivalent | | Remote Capability to Monitor Lead Quality | Yes | Yes | Equivalent | | Remote Capability to Monitor Recording Parameters | Yes…

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