(65 days)
Yes
The device description explicitly mentions "automatic analysis and reporting" and "automatic scoring function" for various sleep events, which is a strong indicator of algorithmic processing of physiological data. While the terms "AI" or "ML" are not explicitly used, the description of performance studies and key metrics (Sensitivity, Specificity, Kappa, ICC) for these automatic analyses aligns with the evaluation methods used for AI/ML-based algorithms in medical devices. The validation against annotated clinical data further supports the use of such techniques.
No
This device is used for diagnosis and assessment of sleep disorders, not for therapy or treatment.
Yes
The device explicitly states in its "Intended Use / Indications for Use" that it "is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep." Additionally, the "Device Description" section details how the Noxturnal PSG software's "automatic scoring function... is to assist the trained physician in the diagnosis of a patient."
No
The device description explicitly states that the system consists of hardware components (Nox A1 Recorder, Nox C1 Access Point, sensors, and accessories) in addition to the software (Noxturnal PSG, Noxturnal App).
Based on the provided information, the Nox Sleep System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is "as an aid in the diagnosis of different sleep disorders and for the assessment of sleep." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. While the system measures physiological parameters during sleep, the data collected and analyzed is used to aid in the diagnosis of sleep disorders.
- Device Description: The system measures, records, and analyzes physiological parameters (like EEG, EOG, respiratory flow, SpO2, etc.) from the patient. The software performs automatic analysis and scoring of events like sleep stages, apneas, hypopneas, etc. This analysis of physiological data derived from the patient is a key function of an IVD used for diagnostic purposes.
- Automatic Analysis and Reporting: The system generates reports based on the subject's data and performs automatic analysis/scoring of various sleep-related events. While the results require manual verification by a trained physician, the system's function is to process and analyze patient data to provide information relevant to diagnosis.
- Performance Studies: The document includes performance studies validating the automatic scoring algorithms against annotated clinical data. This type of validation is typical for IVD devices that perform analytical functions.
While the device is worn by the patient and collects data in vivo, the crucial aspect that makes it an IVD is the in vitro analysis of the collected physiological data to aid in diagnosis. The system is not simply a monitoring device; it processes and interprets the data to provide diagnostic information.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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.
Product codes
OLZ, KZM
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.
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
The automatic analysis was validated on adult Polygraphy recordings.
The automatic analysis was validated on adult Polysomnography recordings.
Intended User / Care Setting
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.
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
For Bruxism Analysis:
Clinical data set/patient population: The automatic analysis was validated on adult Polygraphy recordings, including masseter EMG signal, recorded from multiple U.S. dental clinics collected as part of clinical routine.
Annotation Protocol: The safety endpoint was determined to be that the analysis would detect at least 90% of oromandibular movements considered by a human expert to be bruxism-related events with 95% confidence.
For PLM Analysis:
Clinical data set/patient population: The automatic analysis was validated on adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
Annotation Protocol: The safety endpoint was defined to ensure interclass correlation of 0.61 or greater and a bias which is unlikely to impact a diagnosis.
For Respiratory Flow Analysis (AHI and ODI Algorithm):
Clinical data set/patient population: The automatic analysis was validated on adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
Annotation Protocol: The analysis was determined to be safe if it met the safety endpoint of having a 95% confidence in not classifying patients with an AHI below 5 as having an AHI greater than or equal to 15 or having a 95% confidence in not classifying patients with an AHI greater than or equal to 15 as having an AHI below 5. Furthermore, the Cohen's kappa was reported.
For Apnea Classification Algorithm:
Clinical data set/patient population: The automatic analysis was validated on adult Polygraphy recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
Annotation Protocol: The acceptance criteria was an ICC comparable to what has been reported in scientific literature of Central Apnea Index 0.46.
For Sleep Staging Analysis:
Clinical data set/patient population: The automatic analysis was validated on adult recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
Annotation Protocol: The safety endpoint was determined to be an average accuracy of at least 60% when scoring wake epochs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical performance testing for automatic scoring algorithms, retrospective analysis of pre-existing clinical data.
Sample Size: Not explicitly stated as a single number for all studies, but patient populations described for each algorithm.
Standalone Performance: Not explicitly stated as standalone performance, but rather comparison against manual scoring.
Key Results:
Bruxism Analysis Summary:
Result: The sensitivity of the analysis was 95.7% (95% CI 93.2% - 97.4%). specificity was 61.0% (95% CI 58.9% - 63.0%), PPV was 34.6% (95% CI 32.0% - 37.3%), NPV was 98.5% (95% CI 97.7% - 99.1%).
PLM Analysis Summary:
Result: The ICC for the Periodic Limb Movement Index was 0.87.
Respiratory Flow Analysis Summary (Cannula, RIP, calibrated RIP (cRIP)):
AHI and ODI Algorithm Summary:
Result: The Cohen's kappa for the Apnea Hypopnea Index (AHI) detection was 0.78 using a cannula, 0.62 (95% CI 0.59-0.66) using RIP flow, and 0.62 (95% CI 0.59-0.66) using cRIP flow. The Cohen's kappa for the Oxygen Desaturation Index (ODI) detection was 0.87.
Apnea Classification Algorithm Summary:
Result: The ICC was 0.91 and Cohen's kappa was 0.89 for the Central Apnea Index.
Sleep Staging Analysis Summary:
Results: The Cohen's Kappa was calculated resulting in
§ 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/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) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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 | Yes | Equivalent |
| #Channels of data
recorded | Nox A1 recorder
Up to 26
Nox C1 Access Point
Up to 16 | Up to 25 + 8 (by use of
Bedside station) | Substantially Equivalent
No impact on use. Both
devices have enough
channels to select from to
be able to perform full
Polysomnography (PSG)
sleep studies or a simpler
Polygraphy (PG) studies. |
| Respiratory Effort
Channels - Abdomen
and Thorax | Yes | Yes | Equivalent |
| Airflow | Yes | Yes | Equivalent |
| Pressure | Yes | Yes | Equivalent |
| Snore | Yes | Yes | Equivalent |
| Respiratory
sound/audio | Yes | Yes | Equivalent |
| Body position | Yes | Yes | Equivalent |
| SpO2 | Yes | Yes | Equivalent |
| Pulse Rate | Yes | Yes | Equivalent |
| Technological
Characteristic | Nox Sleep System | Compumedics Somté
PSG System | Result of Comparison |
| Plethysmograph/Pulse
Waveform | Yes | Yes | Equivalent |
| Oximeter status (signal
quality) | Yes | Yes | Equivalent |
| ECG | Yes | Yes | Equivalent |
| EEG | Yes | Yes | Equivalent |
| EOG | Yes | Yes | Equivalent |
| Submental/chin EMG | Yes | Yes | Equivalent |
| Leg Movement | Yes | Yes | Equivalent |
| Ambient light | Yes | Yes | Equivalent |
| Signals from Auxiliary
Devices | Yes | Yes | Equivalent |
| Video | Yes | Yes | Equivalent |
| Impedance | Yes - both | Yes - both | Equivalent |
| Check/Integrity Check | | | |
| Power Source | Nox A1 Recorder:
One 1.5 V AA battery
Host PC via USB during
data transfer | 2 x AA alkaline or NiMH
batteries | Substantially Equivalent
– Use of battery
Powering by host PC via
USB during data transfer
is substantially equivalent
to Nox T3 (K082113). |
| | Nox C1 Access Point:
By use of medical power
supply
Nominal input:
100-240 V AC +/- 10%,
50-60 Hz, 0.350-0.150
Arms (at max load)
Nominal output: 12 V
DC +/- 5%, 0-1250 mA | Bedside station
(not stated in labeling) | Powering method of Nox
C1 Access Point is
substantially equivalent
to Embletta MPR
(K122516). |
| Communication
Interface | Nox A1 Recorder:
USB and Bluetooth®
wireless technology
Nox C1 Access Point:
Ethernet and Bluetooth
Wireless technology | Ethernet and Bluetooth®
wireless technology | Equivalent - Ethernet and
Bluetooth® wireless
technology
The USB communication
interface is substantially
equivalent to Nox T3
(K082113) |
| Recording time | Up to 8 hours | Up to 24 hours | Substantial Equivalent -
No impact on use. 8
hours of recording is
more than enough for
sleep studies |
| Device Storage Media | Nox A1 Recorder:
Internal Flash 1GByte | CF Card up to 2GByte | Substantially Equivalent
No impact on use |
| Channel Sampling
Rates | 1 Hz-256 kHz channel
dependent | 1Hz -1024 Hz channel
dependent | Substantially Equivalent
No impact on use |
| Channel Storage Rate | 1-200 Hz channel
dependent | 1-200 Hz channel
dependent | Equivalent |
| Signal Processing | 32 bit | 16 bit | Substantially Equivalent
No impact on use |
| Basic Safety and | IEC 60601-1 | IEC 60601-1 | Substantially Equivalent |
| Technological
Characteristic | Nox Sleep System | Compumedics Somté
PSG System | Result of Comparison |
| Essential Performance | IEC 60601-1-6
Nox A1 Recorder
additionally IEC60601-1-11
IEC60601-2-25
IEC60601-2-26
IEC60601-2-40 | | |
| Electromagnetic
Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Equivalent |
| Biocompatibility | Patient contacting
components:
Nox A1 EEG 5 Lead
Gold Electrode Cable and
Nox A1 EEG Head Cable
Patient contacting
materials:
Riteflex, PVC,
Santoprene and Gold
Finished product has
been tested according to
ISO 10993-5
ISO 10993-10 | Cleared as part of
K072201 | Substantially Equivalent |
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9
1 Multiple Sleep Latency Test (MSLT), Maintenance of Wakefulness Test (MWT)
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Performance Testing Summary
The Nox Sleep System was verified and validated throughout the design process according to requirement specifications, relevant standards and intended use to assure product safety, effectiveness, and reliability. Design and verification testing of all requirement specification defined for the Nox Sleep System was conducted. All labeling content was tested towards predefined labeling requirements considering. regulatory requirements, applicable product standards, labeling standards, and risk output. System level testing were conducted to verify configuration, communication, recording and storage capacity performance, safety, and reliability. All tests confirmed that the Nox Sleep System meets the predetermined acceptance criteria.
The Nox Sleep System has been evaluated and found be compliant to the following electromagnetic compatibility and electrical safety standards:
- . IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
The Nox Sleep System has gone through assessment towards FDA's "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices -Guidance for Industry and Food and Drug Administration Staff'. The conclusion of this design review is that the Nox Sleep System will function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances (emissions) that might interfere with
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other devices.
The Nox A1 Recorder along with patient applied sensors and components intended to be used in the patient's home during ambulatory studies have been evaluated and found to be compliant to the following electrical safety standard for home healthcare environment:
-
. IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
The Nox A1 Recorder, electrode leads and cables have been tested and found to be compliant to the following electrical safety standards: -
IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs,
-
IEC 60601-2-26 Medical electrical equipment - Part 2-26; Particular requirements for the safety of electroencephalographs,
-
IEC 60601-2-40 Medical electrical equipment Part 2-40: Particular requirements for the . safety of electromyographs and evoked response equipment
All body contacting components (Nox A1 EEG 5 Lead Gold Electrode Cable and Nox A1 EEG Head Cable) have gone through successful biocompatibility testing according to biocompatibility standards:
- ISO 10993-5 Third Edition 2009-06-01 Biological evaluation of medical devices Part . 5: Test for in vitro Cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices Part . 10: Tests for irritation and skin sensitization.
Contact is characterized as Surface Contacting with intact skin for a limited (2 Berry RB, Brooks R, Gamaldo CE et al. The AASM Manual for the Scoring of Sleep and Associated Events; Rules, Terminology and Technical Specifications
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Both systems displayed all signals at a resolution necessary for complete sleep staging, ECG analysis and respiratory analysis. The conclusion from this comparison testing is that the method used for recording of physiological signals and the resulting signal waveforms displayed by the Nox Sleep System and the primary predicate Compumedics Somté PSG System may be deemed substantially equivalent.
The Nox Sleep System has undergone usability testing to comply with standard "IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - collateral standard: Usability". The usability testing result was successful and did not raise new questions about safety or effectiveness. All usability goals are passed.
Nox Medical has implemented cybersecurity controls for the Nox Sleep System to assure the medical device cybersecurity and to maintain medical device functionality, safety, and effectiveness. Assessment was performed in accordance with FDA's "Guidance for Industry -Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Software validation in accordance with FDA*s "General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)" was conducted for the Nox Sleep System to ensure software specification conform to user needs and intended uses and that the particular requirements undertaken can be consistently fulfilled.
The Nox Sleep System has gone through assessment towards "Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration". The overall conclusion of this review is that the system is well designed and suited for its intended use in the home environment and meets the instructions set by this guidance.
The Nox Sleep System has gone through assessment towards the FDA s "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff'. Based on this guidance, the Nox Sleep System complies well with its instructions. Nox Medical has conducted wireless coexistence risk analysis and testing/evaluation according to the guidelines and FDA recognized consensus standards and telecommunication rules recommended in the agency's RF wireless technology guidance document.
The Nox Sleep System has undergone extensive benchtop performance testing to verify that the use of the Nox Sleep System in online and ambulatory setup delivers all configured signals for the entire duration of recordings and that no error occurs which would impact the intended use, and/or safety and efficiency of the system.
Design validation of the Nox Sleep System was conducted to demonstrate that the system is safe and effective for its intended use. The valiation testing conducted included both ambulatory and online recordings/setup and were run in a simulated clinical environment at Nox Medical, and in a home environment. The signals recorded were the gold standard signals used in polysomnography (PSG) to measure brain waves, respiration, and other signals during sleep for diagnostic of sleep disorders. The validation included standard clinical tasks including, but not limiting to hook up of patient, configuration of the devices, impedance check, bio calibration, review of real time data, analysis of data, view of reports, data downloading and review, and storage of data.
The non-clinical performance testing support the safety of the Nox Sleep System and the hardware and software verification and validation demonstrate that the Nox Sleep System should perform as intended in the specified use conditions. Based on the extensive performance bench
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testing undertaken it may be concluded that the Nox Sleep System performs comparably with the predicate Compumedics Somté PSG System that is currently marketed for the same intended use and presents no new concerns about safety or effectiveness.
Clinical performance testing was conducted for the automatic scoring algorithms implemented in Nox Sleep System to demonstrate safety and effectiveness of the new device and to support substantial equivalence to the primary predicate Compumedics Somté PSG System. The clinical performance testing consisted of retrospectively analyzing pre-existing clinical data from sleep studies that had already been collected and manually scored as part of routine clinical care. All scorers were qualified polysomnographic technologists and followed the American Academy of Sleep Medicine (AASM) scoring guidelines. The study protocol consisted of exporting the reported indices/events from the pre-existing manual scoring and then running the automatic scoring algorithm in Noxturnal PSG on the same clinical data. The results of the automatic scoring were exported and compared to the results of the manually scored data. The overall conclusion of comparison of conditions of use and the clinical performance testing is that the Noxturnal PSG's automatic scoring tools are found to be acceptable as a scoring aid in the clinical routine and that the automatic function of the Nox Sleep System may perform comparably with those of the predicate Compumedics Somté PSG System that is currently marketed for the same intended use and presents no new concerns about safety or effectiveness. More details are given below for each automatic scoring algorithm:
Bruxism Analysis Summary:
The clinical purpose is to improve the efficiency of scoring EMG data that is consistent with potential bruxism-related events by labeling mandibular movements as measured by masseter EMG for review and confirmation by a trained healthcare professional.
Clinical data set/patient population: The automatic analysis was validated on adult Polygraphy recordings, including masseter EMG signal, recorded from multiple U.S. dental clinics collected as part of clinical routine.
| Sex | Age [yrs] | Height [cm] | Weight [kg] | BMI | |
|---|---|---|---|---|---|
| Averages | Male 60% | 44.5 | 181.2 | 96.8 | 29.6 |
| Female 40% | 53 | 166.7 | 80.3 | 29.0 |
Justification: Due to the frequent occurrence of normal oromandibular movements during sleep the analysis was determined to be safe if it would reliable detect oromandibular movements, allowing the physician to review the analysis results and remove events which they determine to be normal. The safety endpoint was determined to be that the analysis would detect at least 90% of oromandibular movements considered by a human expert to be bruxism-related events with 95% confidence.
Result: The sensitivity of the analysis was 95.7% (95% CI 93.2% - 97.4%). specificity was 61.0% (95% CI 58.9% - 63.0%), PPV was 34.6% (95% CI 32.0% - 37.3%), NPV was 98.5% (95% CI 97.7% - 99.1%).
PLM Analysis Summary:
The clinical purpose is to improve the efficiency of scoring periodic limb movement events.
Clinical data set/patient population: The automatic analysis was validated on adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
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Justification: The safety endpoint was defined to ensure interclass correlation of 0.61 or greater and a bias which is unlikely to impact a diagnosis
Result: The ICC for the Periodic Limb Movement Index was 0.87.
Respiratory Flow Analysis Summary (Cannula, RIP, calibrated RIP (cRIP))
1) AHI and ODI Algorithm Summary
The clinical purpose is to improve the efficiency of scoring Apneas (using cannula, RIP or calibrated RIP (cRIP) signals) and desaturation events from oximeter.
Clinical data set/patient population: The automatic analysis was validated on adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
Justification: The analysis was determined to be safe if it met the safety endpoint of having a 95% confidence in not classifying patients with an AHI below 5 as having an AHI greater than or equal to 15 or having a 95% confidence in not classifying patients with an AHI greater than or equal to 15 as having an AHI below 5. Furthermore, the Cohen's kappa was reported.
Result: The Cohen's kappa for the Apnea Hypopnea Index (AHI) detection was 0.78 using a cannula, 0.62 (95% CI 0.59-0.66) using RIP flow, and 0.62 (95% CI 0.59-0.66) using cRIP flow. The Cohen's kappa for the Oxygen Desaturation Index (ODI) detection was 0.87.
Table 1 Contingency table for AHI scoring using cannula.
| 0-5 | 5-15 | 15-30 | 30+ | ||
|---|---|---|---|---|---|
| AHI | |||||
| Manual | |||||
| scoring | 0-5 | 76% | 7% | 0% | 0% |
| 5-15 | 0% | 9% | 3% | 0% | |
| 15-30 | 0% | 1% | 3% | 0% | |
| 30+ | 0% | 0% | 1% | 1% |
AHI Automatic scoring
Table 2 Contingency table for AHI scoring using RIP flow.
AHI Automatic scoring
| 0-5 | 5-15 | 15-30 | 30+ | ||
|---|---|---|---|---|---|
| AHI | |||||
| Manual | |||||
| scoring | 0-5 | 65% | 19% | 0% | 0% |
| 5-15 | 1% | 7% | 2% | 0% | |
| 15-30 | 0% | 0% | 4% | 0% | |
| 30+ | 0% | 0% | 1% | 1% |
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nox m
Table 3 Contingency table for AHI scoring using cRIP flow.
| 0-5 | 5-15 | 15-30 | 30+ | ||
|---|---|---|---|---|---|
| AHI | |||||
| Manual | |||||
| scoring | 0-5 | 65% | 18% | 0% | 0% |
| 5-15 | 2% | 8% | 3% | 0% | |
| 15-30 | 0% | 0% | 3% | 1% | |
| 30+ | 0% | 0% | 1% | 1% |
AHI Automatic scoring
Table 4 Contingency table for ODI scoring.
| ODI Automatic scoring | |||||
|---|---|---|---|---|---|
| 0-5 | 5-15 | 15-30 | 30+ | ||
| ODI | |||||
| Manual | |||||
| scoring | 0-5 | 83% | 3% | 0% | 0% |
| 5-15 | 0% | 8% | 1% | 0% | |
| 15-30 | 0% | 1% | 3% | 0% | |
| 30+ | 0% | 0% | 0% | 0% |
ODI Automatic scoring
- Apnea Classification Algorithm Summary:
The clinical purpose is to improve the efficiency of classifying apneas into central apneas, mixed apneas or neither.
Clinical data set/patient population: The automatic analysis was validated on adult Polygraphy recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
Justification: The acceptance criteria was an ICC comparable to what has been reported in scientific literature of Central Apnea Index 0.46.
Result: The ICC was 0.91 and Cohen's kappa was 0.89 for the Central Apnea Index.
Sleep Staging Analysis Summary:
The clinical purpose is to improve the efficiency of scoring sleep stages with the intent of estimating total sleep time.
The following events are scored: Sleep stage W (Wake), Stage N2, Stage N2, Stage N3 and Stage R (REM).
Clinical data set/patient population: The automatic analysis was validated on adult recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic.
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Justification: To measure total sleep time with 10% error or less assuming 80% sleep efficiency, results in the required accuracy of wake detection of 60% or better. The safety endpoint was determined to be an average accuracy of at least 60% when scoring wake epochs.
Results: The Cohen's Kappa was calculated resulting in