(65 days)
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.
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.
The Nox Sleep System is designed to aid in the diagnosis of sleep disorders and assess sleep quality by measuring, recording, displaying, organizing, analyzing, summarizing, and retrieving physiological parameters during sleep and wake. The system includes automatic scoring functionalities for various sleep events, which are intended to assist trained medical professionals in diagnosis.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document presents separate sections for the performance of different automatic scoring algorithms rather than a single consolidated table. However, the information can be extracted and presented as follows:
| Automatic Scoring Algorithm | Acceptance Criteria (Safety Endpoint/Justification) | Reported Device Performance |
|---|---|---|
| Bruxism Analysis | Detect at least 90% of oromandibular movements considered by a human expert to be bruxism-related events with 95% confidence (Sensitivity). | Sensitivity: 95.7% (95% CI 93.2% - 97.4%)Specificity: 61.0% (95% CI 58.9% - 63.0%)PPV: 34.6% (95% CI 32.0% - 37.3%)NPV: 98.5% (95% CI 97.7% - 99.1%) |
| PLM Analysis | Interclass correlation (ICC) of 0.61 or greater and a bias unlikely to impact a diagnosis for the Periodic Limb Movement Index. | ICC for Periodic Limb Movement Index: 0.87 |
| Respiratory Flow Analysis (AHI) | Not classifying patients with an AHI below 5 as having an AHI greater than or equal to 15 (95% confidence), AND Not classifying patients with an AHI greater than or equal to 15 as having an AHI below 5 (95% confidence). Also, Cohen's kappa reported. | Cohen's Kappa for AHI (Cannula): 0.78Cohen's Kappa for AHI (RIP flow): 0.62 (95% CI 0.59-0.66)Cohen's Kappa for AHI (cRIP flow): 0.62 (95% CI 0.59-0.66) |
| Respiratory Flow Analysis (ODI) | (Implicitly similar to AHI, with Cohen's kappa reported) | Cohen's Kappa for ODI: 0.87 |
| Apnea Classification | ICC comparable to what has been reported in scientific literature for Central Apnea Index (0.46). | ICC for Central Apnea Index: 0.91Cohen's Kappa for Central Apnea Index: 0.89 |
| Sleep Staging Analysis | Average accuracy of at least 60% when scoring wake epochs to ensure total sleep time measurement with 10% error or less (assuming 80% sleep efficiency). | Cohen's Kappa: <=0.67Accuracy for Wake: 66.7%Accuracy for N1: 9.8%Accuracy for N2: 87.0%Accuracy for N3: 83.0%Accuracy for REM: 82.5% |
2. Sample size used for the test set and the data provenance
The document states that the clinical performance testing for the automatic scoring algorithms involved "retrospectively analyzing pre-existing clinical data from sleep studies that had already been collected and manually scored as part of routine clinical care."
- Bruxism Analysis: "adult Polygraphy recordings, including masseter EMG signal, recorded from multiple U.S. dental clinics."
- PLM Analysis: "adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
- Respiratory Flow Analysis (AHI & ODI): "adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
- Apnea Classification: "adult Polygraphy recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
- Sleep Staging Analysis: "adult recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
The exact sample size (number of patients/studies) for each test set is not explicitly provided in the given text. The provenance is retrospective and data was collected from U.S. dental clinics (for bruxism) and a national hospital (for other sleep studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for the test set was established by "qualified polysomnographic technologists" who "followed the American Academy of Sleep Medicine (AASM) scoring guidelines."
The number of experts is not specified. Their qualification is: "qualified polysomnographic technologists." No details on years of experience are provided, but adherence to AASM guidelines suggests a standardized and recognized level of expertise.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document states, "All scorers were qualified polysomnographic technologists and followed the American Academy of Sleep Medicine (AASM) scoring guidelines." It then describes comparison of the automatic scoring results to "the results of the manually scored data."
This implies that the manual scoring by the polysomnographic technologists served as the ground truth. There is no explicit mention of an adjudication method (like 2+1 or 3+1) among multiple human scorers for establishing the ground truth. It seems to rely on single-expert scoring as the reference standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was described where human readers' performance with and without AI assistance was evaluated. The study focused on the standalone performance of the automatic scoring algorithms against human-scored ground truth. The device is intended as an aid for professionals, requiring manual verification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance was done. The clinical performance testing directly compared the output of the automatic scoring algorithms to the manually scored ground truth data. The results (sensitivity, specificity, PPV, NPV, ICC, Cohen's Kappa, and accuracy) reported are measures of the algorithm's performance on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was expert consensus (manual scoring by qualified polysomnographic technologists) following the American Academy of Sleep Medicine (AASM) scoring guidelines. This is a form of expert consensus, even if the "consensus" here refers to the adherence to established scoring rules rather than explicit multi-reader agreement on individual cases.
8. The sample size for the training set
The document details the "clinical performance testing," which involved "retrospectively analyzing pre-existing clinical data." This section describes the test set used for validation.
The sample size for the training set is not provided or mentioned in this document. Information about the training data used to develop the automatic scoring algorithms is absent.
9. How the ground truth for the training set was established
Since the document does not discuss the training set, there is no information provided on how its ground truth was established.
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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
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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
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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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510(k) Summary
| Submitter: | Nox MedicalKatrinartuni 2IS-105 ReykjavikIcelandTel: +354 570 7170Establishment Registration Number: 3007389703 |
|---|---|
| Contact Person: | Kolbrun E OttosdottirChief Compliance OfficerKatrinartuni 2IS-105 ReykjavikIceland |
| ApplicationCorrespondent: | John J. Smith, MD, JDPartnerHogan Lovells US LLP555 Thirteenth Street, NWWashington, D.C. 20004 |
| Preparation Date: | November 12, 2019 |
| Device: | Device Proprietary Name: Nox Sleep SystemDevice Common or Usual Name: Sleep Assessment SystemClassification Name: Electroencephalograph, AutomaticEvent Detection Software for Polysomnograph withElectroencephalographRegulation Number: 882.1400Product Code: OLZ, KZMDevice Class: IIReview Panel: Neurology |
| Predicate Devices: | Substantial equivalence is claimed to Compumedics SomtéPSG System (K072201) from Compumedics Limited. |
| The Nox T3 (K082113) from Nox Medical and EmblettaMPR (K122516) from Embla Systems are used as referencedevices. |
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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.
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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.
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
|---|---|---|---|
| Portable design | Yes | Yes | Equivalent |
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
| Patient worn device | Yes | Yes | Substantially Equivalent |
| Physical dimensions | Nox A1 Recorder:82x63x21 mmNox C1 Access Point:135x149x26 mm | Somté PSG Recorder:113x65x30mmPatient input box:53x133x25mmBedside unit (dimensionsnot stated in labeling) | Substantially EquivalentThe Embletta MPR(K122516) includes aseparate device locatedremotely from the patientwith very similar size115x110x26mm |
| Weight | Nox A1 Recorder:92 g (120 g with battery)Nox C1 Access Point:264 g | Somté PSG Recorder:110 g (172 g includingbatteries)Patient input box: 95 gBedside unit (weight notstated in labeling) | Substantially EquivalentThe Embletta MPR(K122516) includes aseparate device locatedremotely from the patientwith very similar weight160g |
| Case Material | Plastic,ABS/Polycarbonate blend | Plastic,ABS/Polycarbonate blend | Equivalent |
| Method of Connectionto Patient | Respiratory bands/beltsfor respiratory effortRespiratory bands/beltsfor attaching of deviceand clip straps to secureposition of devicePlastic tubing andcannula for pressuresensingSnap on electrode cableswith snap-on disposableelectrodes for EMG/EOGThermal flowsensors/thermocouple formeasuring of nasal/oralairflowNox A1 EEG 5 LeadGold Electrode Cable andNox A1 EEG Head Cablefor EEG/EOG | Respiratory bands/beltsfor respiratory effortRespiratory bands/beltsfor attaching of deviceand optional EZ Vest tosecure position of devicePlastic tubing andcannula for pressuresensingSnap on electrode cableswith snap-on disposableelectrodes for EMG/EOGThermal flowsensors/thermocouple formeasuring of nasal/oralairflow | Substantially EquivalentThe use of an auxiliary3rd party wirelessoximeter that is wristworn and connected viaBluteooth® to therecorder is substantiallyequivalent to Nox T3(K082113). |
| Surface electrode leadsfor EEG/EOG/EMGSurface Electrodes formeasuring of legmovementsWrist worn oximeter andprobes for oximetry wornon finger | Surface electrode leadsfor EEG/EOG/EMGSurface Piezo LimbSensor for measuring ofleg movementsProbes for oximetry wornon finger | ||
| Acquisition Units | Nox A1 RecorderNox C1 Access Point | Somté PSG RecorderPatient Interface BoxBedside unit forrecording of additionalAUX channels | Substantially EquivalentEmbletta MPR(K122516) includes aseparate device allowingrecording of additionalAUX channels |
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
| Local User Interface | Nox A1 Recorder:Display (OLED), pushbuttons and indicatorlight on deviceNox C1 Access Point:Light indicator on device,factory reset buttonNoxturnal App runningon Android™ platform | Somté PSG Recorder:Display (LCD) and pushbuttons and indicatorlight on device | channelsSubstantially EquivalentThe Noxturnal App isused in a very similarway as the display on theSomté PSG Recorder andmay be regarded as anextension of the displayscreen on the Nox A1Recorder. |
| Data Collection | Yes | Yes | Equivalent |
| Display Raw Dataduring Recording | Yes, By use of theNoxturnal PSG (PC)during in-lab use or byuse of Noxturnal App | Yes, PC during in-labuse, or LCD on unit | Substantially Equivalent |
| Real-time waveformspreview | Yes - By use of theNoxturnal App includingfull disclosure waveformpreview | Yes - Integrated LCDincluding full disclosurewaveform preview | Substantilly Equivalent |
| Data display on PC forinterpretation | Yes – during or afterrecording | Yes - during or afterrecording | Equivalent |
| Data Analysis | Yes - By use ofNoxturnal PSG SW (PCapplication)Automatic, result may bemanipulated (manualreview/verification mustbe performed prior todiagnosis)Manual analysisEvent marking (scoring)Technician Notes | Yes - By use ofProfusion Sleep SW (PCapplication)Automatic, result may bemanipulated (manualreview/verification mustbe performed prior todiagnosis)Manual analysisEvent marking (scoring)Technician Notes | Equivalent |
| Signal Sheets/TraceDisplay Layoutproperties - Adjust byuser | Yes - By use ofNoxturnal PSG SW (PCapplication) - such as:Timebase settingsSignalgrouping/arrangementsGrid MarkersEpoch MarkersApply changes to datatypeBackground colorCursor colorGrid color | Yes - By use ofProfusion Sleep SW (PCapplication) - such as:Timebase settingsSignalgrouping/arrangementsGrid MarkersEpoch MarkersApply changes to datatypeBackground colorCursor colorGrid color | Equivalent |
| Signal trace properties- Adjust by user | Yes - By use ofNoxturnal PSG SW (PCapplication) - such as:Select Input andreferenceNameTrace color | Yes - By use ofProfusion Sleep SW (PCapplication) - such as:Select Input andreferenceNameTrace color | Equivalent |
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
| Zoom | Zoom | ||
| Size | Size | ||
| Grids | Grids | ||
| Polarity | Polarity | ||
| Upper/lower displaybounds | Upper/lower displaybounds | ||
| Filtering (HP/LP/Notch) | Filtering (HP/LP/Notch) | ||
| Auto Scale | Auto Scale | ||
| Numeric | Numeric | ||
| Offset | Offset | ||
| Adding/Deleting | Adding/Deleting | ||
| Display of graphicalsummary for selectedtraces and data for theentire study | Yes - By use ofNoxturnal PSG SW (PCapplication) | Yes - By use of ProfusionSleep SW (PCapplication) | Equivalent |
| User defined event types | Yes - By use ofNoxturnal PSG SW (PCapplication) | Yes - By use of ProfusionSleep SW (PCapplication) | Equivalent |
| AutomaticAnalysis/DetectorOutput for UserInterpretation - perAASMrecommendations/scoringrules | Yes - By use ofNoxturnal SW (PCapplication) | Yes - By use of ProfusionSleep SW (PCapplication) | Substantially EquivalentAll automatic analysisprovided in the newdevice is also provided inthe primary predicatedevice. |
| Sleep Stages: Wake, N1,N2, N3, REM | Sleep Stages: Wake, N1,N2, N3, REM | ||
| Arousal detection andarousal classification | Relating to automaticanalysis not included inthe new device: The rawdata necessary for theanalysis of these eventsmay be recorded anddisplayed in theNoxturnal PSG softwarefor manual analysis | ||
| Apneas, HypopneasClassification of apneas:Obstructive, Mixed orCentral | Apneas, HypopneasClassification of apneas:Obstructive, Mixed orCentral | ||
| Unsure respiratory event | |||
| Limb Movements,Periodic LimbMovements | Limb Movements,Periodic LimbMovements | ||
| Snores (detection fromsound input baseline) | |||
| Eye movements, singular,anti-phase and in-phase(EOG) | |||
| SpO2 desaturation events | SpO2 desaturation eventsand artifacts, min/maxSpO2 values | ||
| Potential BruxismRelated events | Potential BruxismRelated events | ||
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
| epochAverage CPAP for eachepochAverage TcCO2 value foreach epochPeak EtCO2 value ofeach respiratory cyclePTT event detectionpH event detection | |||
| Report Generation | Yes - By use ofNocturnal PSG SW (PCapplication) | Yes - By use ofProfusion Sleep SW (PCapplication) | Equivalent |
| Statistics available forreport fields | Statistics and graphs frommanual scored events andautomatic analysis | Statistics and graphs frommanual scored events andautomatic analysis | Equivalent |
| MSLT/MWT¹ studiessupported | Yes | Yes | Equivalent |
| Data Inputs | Generic and customsensors/auxiliary devices. | Generic and customsensors/auxiliary devices. | Substantially Equivalent |
| Signal Conditioning | Yes | Yes | Substantially Equivalent |
| Remote SleepSurveillance | Yes, via Ethernet | Yes, via Ethernet | Equivalent |
| Remote Capability toMonitor Lead Quality | Yes | Yes | Equivalent |
| Remote Capability toMonitor RecordingParameters | Yes | Yes | Equivalent |
| #Channels of datarecorded | Nox A1 recorderUp to 26Nox C1 Access PointUp to 16 | Up to 25 + 8 (by use ofBedside station) | Substantially EquivalentNo impact on use. Bothdevices have enoughchannels to select from tobe able to perform fullPolysomnography (PSG)sleep studies or a simplerPolygraphy (PG) studies. |
| Respiratory EffortChannels - Abdomenand Thorax | Yes | Yes | Equivalent |
| Airflow | Yes | Yes | Equivalent |
| Pressure | Yes | Yes | Equivalent |
| Snore | Yes | Yes | Equivalent |
| Respiratorysound/audio | Yes | Yes | Equivalent |
| Body position | Yes | Yes | Equivalent |
| SpO2 | Yes | Yes | Equivalent |
| Pulse Rate | Yes | Yes | Equivalent |
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
| Plethysmograph/PulseWaveform | Yes | Yes | Equivalent |
| Oximeter status (signalquality) | 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 AuxiliaryDevices | 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 batteryHost PC via USB duringdata transfer | 2 x AA alkaline or NiMHbatteries | Substantially Equivalent– Use of batteryPowering by host PC viaUSB during data transferis substantially equivalentto Nox T3 (K082113). |
| Nox C1 Access Point:By use of medical powersupplyNominal input:100-240 V AC +/- 10%,50-60 Hz, 0.350-0.150Arms (at max load)Nominal output: 12 VDC +/- 5%, 0-1250 mA | Bedside station(not stated in labeling) | Powering method of NoxC1 Access Point issubstantially equivalentto Embletta MPR(K122516). | |
| CommunicationInterface | Nox A1 Recorder:USB and Bluetooth®wireless technologyNox C1 Access Point:Ethernet and BluetoothWireless technology | Ethernet and Bluetooth®wireless technology | Equivalent - Ethernet andBluetooth® wirelesstechnologyThe USB communicationinterface is substantiallyequivalent to Nox T3(K082113) |
| Recording time | Up to 8 hours | Up to 24 hours | Substantial Equivalent -No impact on use. 8hours of recording ismore than enough forsleep studies |
| Device Storage Media | Nox A1 Recorder:Internal Flash 1GByte | CF Card up to 2GByte | Substantially EquivalentNo impact on use |
| Channel SamplingRates | 1 Hz-256 kHz channeldependent | 1Hz -1024 Hz channeldependent | Substantially EquivalentNo impact on use |
| Channel Storage Rate | 1-200 Hz channeldependent | 1-200 Hz channeldependent | Equivalent |
| Signal Processing | 32 bit | 16 bit | Substantially EquivalentNo impact on use |
| Basic Safety and | IEC 60601-1 | IEC 60601-1 | Substantially Equivalent |
| TechnologicalCharacteristic | Nox Sleep System | Compumedics SomtéPSG System | Result of Comparison |
| Essential Performance | IEC 60601-1-6Nox A1 Recorderadditionally IEC60601-1-11IEC60601-2-25IEC60601-2-26IEC60601-2-40 | ||
| ElectromagneticCompatibility | IEC 60601-1-2 | IEC 60601-1-2 | Equivalent |
| Biocompatibility | Patient contactingcomponents:Nox A1 EEG 5 LeadGold Electrode Cable andNox A1 EEG Head CablePatient contactingmaterials:Riteflex, PVC,Santoprene and GoldFinished product hasbeen tested according toISO 10993-5ISO 10993-10 | Cleared as part ofK072201 | Substantially Equivalent |
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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 (< 24 hour) duration in accordance with ISO 10993-1 and FDA's "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part; 1 Evaluation and testing within a risk management process".
All Nox Sleep System lead wires and patient cable connectors are in compliance with "21 CFR 898 - FDA Performance Standard for Electrode Lead Wires and Patient Cables ".
Signals recorded by the Nox Sleep System underwent performance testing demonstrating that all the signal types being recorded comply with the performance criteria set forth by Nox Medical that includes the minimum performance specification recommended by the American Academy of Sleep Medicine (AASM)2.
The signals recorded with the Nox Sleep System were compared to signals recorded with the primary predicate device Compumedics Somté PSG System. All signals required for the recording, scoring and reporting of standard Polygraphy and Polysomnography variables were present and displayed all expected changes in morphology during associated sleep and respiratory events. Furthermore, both systems showed the same characteristics over a standard clinically used timescale and were capable of adding, removing, re-referencing and filtering all signals as needed.
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+ | ||
|---|---|---|---|---|---|
| AHIManualscoring | 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+ | ||
|---|---|---|---|---|---|
| AHIManualscoring | 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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Table 3 Contingency table for AHI scoring using cRIP flow.
| 0-5 | 5-15 | 15-30 | 30+ | ||
|---|---|---|---|---|---|
| AHIManualscoring | 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+ | ||
| ODIManualscoring | 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 <=0.67. The results of the stage-by-stage ICC comparison are shown in Table 5. The accuracy of predicting the sleep stages resulted in N1 (9.8%), N2 (87.0%), N3 (83.0%), Wake (66.7%) and REM (82.5%).
| Automatic Analysis | ||||||||
|---|---|---|---|---|---|---|---|---|
| W | N1 | N2 | N3 | REM | Unassigned | Epoch Count | ||
| Manual Staging | W | 66.7% | 3.4% | 19.8% | 3.6% | 6.3% | 0.2% | 2,207 |
| N1 | 22.5% | 9.8% | 46.6% | 0.7% | 20.3% | 0.2% | 2,032 | |
| N2 | 1.5% | 1.6% | 87.0% | 7.2% | 2.5% | 0.3% | 11,560 | |
| N3 | 0.3% | 0.1% | 16.1% | 83.0% | 0.3% | 0.3% | 4,838 | |
| REM | 2.6% | 1.0% | 12.6% | 0.7% | 82.5% | 0.7% | 4,557 |
Table 5 Confusion matrix comparing the classification of sleep stages with manual and automatic scoring.
Conclusion
Based on the comparison to the predicate devices, and extensive safety and performance testing, it is the conclusion of Nox Medical that the Nox Sleep System is substantially equivalent to the currently U.S. legally marketed device Compumedics Somté PSG System (K072201) and presents no new concerns about safety or effectiveness.
§ 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).