Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only.

Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas.

It is intended to be used under the supervision of a clinician in a clinical environment.

Device Description

Noxturnal Web is a web-based software that can be utilized to screen various sleep and respiratoryrelated sleep disorders. The users of Noxturnal Web are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. Users can input a sleep study recording stored on the cloud (electronic medical record repository) using their established credentials. Once the sleep study data has been retrieved, the Noxturnal Web software can be used to display, manually analyze, generate reports and print the prerecorded physiological signals.

Noxturnal Web is used to read sleep study data for the display, analysis, summarization, and retrieval of physiological parameters recorded during sleep and awake. Noxturnal Web facilitates a user to review or manually score a sleep study either before the initiation of treatment or during the treatment follow-up for various sleep and respiratory-related sleep disorders.

Noxturnal Web presents information from the input sleep study data in an organized layout. Multiple visualization layouts (e.g., Study Overview, Respiratory Signal Sheet, etc.) are available to allow the users to optimize the visualization of key data components. The reports generated by Noxturnal Web allow the inclusion of custom user comments, and these reports can then be viewed on the screen and/or printed.

AI/ML Overview

The provided document is a 510(k) summary for the medical device Noxturnal Web. It states that clinical data were not relied upon for a determination of substantial equivalence. Therefore, there is no information in this document regarding a clinical study or a test set with expert-established ground truth.

However, the document does describe the performance expectations and how suitability was determined through non-clinical testing, specifically software verification and validation.

Here's the information based on the provided text, focusing on the non-clinical and comparative aspects:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit quantitative acceptance criteria for performance in a table format with reported numerical device performance. Instead, it describes functional equivalence to the predicate device through comparative analysis and states that the software meets its pre-specified requirements and performs as intended.

The comparison table on pages 8-9 highlights the functional equivalences:

Acceptance Criteria (Inferred from Functional Equivalence)	Reported Device Performance (as stated in document)
Aid/Assist in the diagnosis of sleep and respiratory-related sleep disorders	Yes (Same as predicates)
Arousal Scoring	Yes (Same as predicates)
Respiratory Events Scoring	Yes (Same as predicates)
Leg Movement Events Scoring	Yes (Same as predicates)
Sleep Study Scoring Method (Manual)	Manual (Same as primary predicate; additional predicate also has automatic)
Sleep Stage Scoring (W, N1/N2/N3, R)	Yes (Same as predicates)
Report Generation	Yes (Same as predicates)
Calculation of AASM standardized indices	Yes (Same as predicates)
Data Inputs (EEG, EOG, EMG, ECG, Chest/Abdomen movements, Airflow, Oxygen Saturation, Body Position/Activity)	All "Yes" (Same as predicates for all relevant inputs)
Software Type (Web-based)	Web-based (Same as additional predicate; primary predicate is computer program)
Physical Characteristics (Web-based operating in the cloud with Windows or Mac OS)	Web-based software operating in the cloud with Windows or Mac OS (Similar to additional predicate)
Standard of Scoring Manual	The American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events (Same as predicates)
Backend implementation	Identical to corresponding qualitative and quantitative functionality implemented in the reference device (Nox Sleep System, K192469)
Cybersecurity controls	Implemented in accordance with FDA's Guidance "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"

The general acceptance criterion is that the Noxturnal Web is "as safe and effective as the predicate devices" and "meets its pre-specified requirements."

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical data were not relied upon for a determination of substantial equivalence." Therefore, there is no clinical test set of patient data with ground truth as would be used in a clinical study.

The testing performed was "Software verification and validation testing... to demonstrate safety and performance based on current industry standards," and "Verification and Validation testing of all requirement specifications defined for Noxturnal Web was conducted and passed." This implies that the 'test set' consisted of various software functions and their outputs, but not a large set of patient physiological recordings serving as a "test set" in the context of a clinical performance study. The data provenance and size of this kind of "test set" (software test cases) are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Given that "Clinical data were not relied upon," there was no clinical test set requiring expert-established ground truth in the traditional sense for demonstrating substantial equivalence. The summary highlights that the device supports manual scoring completed by medical professionals who have received training in relevant areas (page 7). This implies that the human-in-the-loop performance is based on the expertise of the user, rather than the device itself establishing ground truth.

4. Adjudication method for the test set

Not applicable, as no clinical test set with established ground truth was used for assessing substantial equivalence.

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 study was done, as indicated by the statement "Clinical data were not relied upon for a determination of substantial equivalence." The device's primary function is to facilitate manual scoring by a clinician, not to provide AI-assisted automated interpretations that would then be compared to human-only interpretations via an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "software-only medical device to be used to analyze physiological signals and manually score sleep study results" and "It is intended to be used under the supervision of a clinician in a clinical environment." This indicates that the device is not intended for standalone (algorithm only) performance without human-in-the-loop interaction for interpretation and scoring. The comparative table also notes that both the subject device and the primary predicate "rely on manual scoring."

7. The type of ground truth used

For the purpose of regulatory clearance, the "ground truth" for the device's functionality was its ability to replicate the features and performance of legally marketed predicate devices, as demonstrated through "comparative analysis, software and performance testing." The ground truth for interpreting sleep studies using this device resides with the trained medical professional who manually scores the data according to the "American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events."

8. The sample size for the training set

Not applicable, as this device appears to be a software tool for manual scoring and analysis, rather than an AI/ML algorithm that requires a "training set" in the context of deep learning or machine learning models. The summary makes no mention of AI/ML or training data; its emphasis is on providing tools for manual clinician review.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 23, 2024

Nox Medical ehf % Hrishikesh Gadagkar Senior Principal ROM+ 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146

Re: K241288

Trade/Device Name: Noxturnal Web Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV Dated: May 7, 2024 Received: May 7, 2024

Dear Hrishikesh Gadagkar:

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 (the 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 available 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 prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/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 Advice (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-regulatory

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assistance/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,

Patrick Antkowiak -S

for 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

Submission Number (if known)

K241288

Device Name

Noxturnal Web

Indications for Use (Describe)

It is intended to be used under the supervision of a clinician in a clinical environment.

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

Noxturnal Web (K241288) — Traditional 510(k)

TEMP-0140 Controlled Document Template 04

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510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02

510(k) Summary

APPLICANT INFORMATION

Company:

Nox Medical ehf Katrinartuni 2, IS - 105 Reykjavik, Iceland Telephone: +354 570 7170 Establishment Registration Number: 3007389703

Contact Person:

Kolbrun E Ottosdottir Chief Compliance Officer Katrinartuni 2, IS-105 Reykjavik, Iceland

November 21, 2024

OFFICIAL CORRESPONDENT/CONSULTANT INFORMATION

Dr. Hrishikesh Gadagkar, Sr. Principal ROM+ 2790 Mosside Blvd #800, Monroeville, PA 15146 United States Telephone: +1 (410) 245-0501

PREPARATION DATE

DEVICE INFORMATION

Device Proprietary Name/Trade Name: Device Classification Name:

Regulation Number: Classification: Classification Product Code: 510k Review Panel:

Noxturnal Web Standard Polysomnograph with Electroencephalograph 21 CFR 882.1400 Class II OLV Neurology

PREDICATE DEVICE IDENTIFICATION

Substantial equivalence is claimed to: Primary Predicate Device Somnomedics GmbH, SOMNOscreen plus, K201054 Additional Predicate Device Neumetry Medical Inc, SomnoMetry, K221179 Nox Medical, Nox Sleep System, K192469 Reference Device All predicate and reference devices have not been subject to a design-related recall.

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510(k) Summary Noxturnal Web — Traditional 510(k)

DEVICE DESCRIPTION

INTENDED USE

Noxturnal Web is indicated for use in the displaying, analysis and printing of pre-recorded biophysical parameters acquired during sleep for the purpose of assisting in the diagnosis of sleep and respiratoryrelated sleep disorders.

Noxturnal Web is intended to be used as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only.

INDICATIONS FOR USE

It is intended to be used under the supervision of a clinician in a clinical environment.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Nox Medical believes that the Noxturnal Web is substantially equivalent to the predicate devices SOMNOscreen plus (K201054) and SomnoMetry (K221179) based on the information summarized here:

. The subject device has the same intended use as the predicate devices cleared in K201054 and K221179, i.e., a software intended to analyze pre-recorded physiological data acquired during sleep and derive actionable clinical insights.
. The subject device and the predicates are intended to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders by supporting the display, analysis, summary, and retrieval of physiological parameters already recorded by sleep recording devices/systems. The devices use the same basic data inputs to be analyzed as part of the manual scoring process including sleep staging and marking of respiratory (e.g. apnea and hypopnea) and sleep events (e.g. arousal and leg movements) and do calculate the American Academy of Sleep Medicine (AASM) standardized indices (e.g. AHI) and support report generation.
. The primary predicate device, SOMNOscreen plus (K201054), is a portable physiological signal recording system supporting manual scoring of sleep studies. The subject device, Noxturnal Web (K241288), is Software as a Medical Device (SaMD) and does not include the functionality of recording physiological signals. The substantial equivalence is being drawn to the software portion of SOMNOscreen plus, DOMINO, which is used as a tool to display, analyze, and print the physiological signals recorded by the recording device. Both Noxturnal Web and DOMINO

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510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02

provide a manual scoring workflow for interpreting data recorded by systems (e.g., PSG signals). Both systems rely on manual scoring for sleep stages including sleep stages W, N1/N2/N3, and REM, and sleep and respiratory events. Regarding the data inputs and outputs, both the subject device and the primary predicate device have similarities in the types of physiological signals processed, such as EEG, EOG, EMG, ECG, oxygen saturation, airflow and respiratory effort, and both systems support calculation of AASM standardized indices and generate sleep study reports. Based on the detailed comparison of the workflow, appearance, function, indexes calculated and reporting, it has been demonstrated that the technological characteristics relating to the manual annotation/scoring process of sleep study data may be considered the same or substantially equivalent for the subject device and the primary predicate (K201054).

. The subject device and additional predicate (K221179) are Web-based software operating in the cloud. Both the subject device and additional predicate device do not require installation on the user's computer.
. The Nox Sleep System (K192469) has been selected as a reference device to support the technology and scientific methods of the subject device. The backend implementation for the subject device is identical to the corresponding qualitative and quantitative functionality implemented in the reference device. Nox Medical has implemented cybersecurity controls for Noxturnal Web and Nox Sleep System to assure the medical device cybersecurity and to maintain medical device functionality, safety, and effectiveness. The assessment was performed in accordance with FDA's Guidance "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".

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510(k) Summary Noxturnal Web – Traditional 510(k)

Trade/Device Name	Subiect Device:Noxturnal Web(K241288)	Primary Predicate Device:SOMNOscreen plus(K201054)	Additional PredicateDevice:SomnoMetry(K221179)	Reference Device:Nox Sleep System(K192469)	Comparison of Subject,Predicates, and ReferenceDevice
Description
Manufacturer	Nox Medical	Somnomedics GmbH	Neumetry Medical, Inc.	Nox Medical	N/A
510(k) Number	K241288	K201054	K221179	K192469	N/A
Regulation Description	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1400	Same.
Regulation Name	Electroencephalograph	Electroencephalograph	Electroencephalograph	Electroencephalograph	Same.
Regulatory Class	Class II	Class II	Class II	Class II	Same.
Product Code(s)	OLV	Main: OLV; Sub: MNR	OLZ	Main: OLZ; Sub: KZM	Same as primary predicate.
Comparison of Intended and Indications of Use
Intended Use	Noxturnal Web is indicated foruse in the displaying, analysisand printing of pre-recordedbiophysical parametersacquired during sleep for thepurpose of assisting in thediagnosis of sleep andrespiratory-related sleepdisorders.Noxturnal Web is intended tobe used as an aid for thediagnosis of sleep andrespiratory-related sleepdisorders in adults only.	The SOMNOscreen® plus isindicated for use in therecording, displaying,monitoring, printing, andstorage of biophysicalparameters for the purpose ofassisting in the diagnosis ofNeurological and SleepDisorders. The device is a non-life-supporting physiologicalsignal recording deviceintended to be used for studiestesting adults andchildren/adolescents suspectedof having sleep-relatedbreathing disorders.This device is NOT designed tobe used in a Life Supportsituation.This device is not designed foruse on patients with cardiacpacemakers.	Analyze pre-recordedphysiological data acquiredduring sleep and deriveactionable clinical insights.	The Nox Sleep System is usedas an aid in the diagnosis ofdifferent sleep disorders andfor the assessment of sleep.The Nox Sleep System is usedto measure, record, display,organize, analyze, summarize,and retrieve physiologicalparameters during sleep andwake.The Nox Sleep System allowsthe user to decide on thecomplexity of the study byvarying the number and typesof physiological signalsmeasured.The Nox Sleep System allowsfor generation of user/pre-defined reports based onsubject's data.	Same.Noxturnal Web, as well as thepredicate devices, is indicatedfor use in the displaying,analysis and printing of pre-recorded biophysicalparameters for the purpose ofassisting in the diagnosis ofsleep and respiratory-relatedsleep disorders.The intended population of thesubject device, Noxturnal Webis limited to adults only,thereby aligning with theindications for use of theidentified primary predicatedevice, SOMNOscreen plus(K201054) and additionalpredicate device, SomnoMetry(K221179).
Trade/Device Name	Subject Device:Noxturnal Web(K241288)	Primary Predicate Device:SOMNOscreen plus(K201054)	Additional PredicateDevice:SomnoMetry(K221179)	Reference Device:Nox Sleep System(K192469)	Comparison of Subject,Predicates, and ReferenceDevice
				The user of the Nox SleepSystem are medicalprofessionals who havereceived training in the areasof hospital/clinical procedures,physiological monitoring ofhuman subjects, or sleepdisorder investigation.The intended environments arehospitals, institutions, sleepcenters, sleep clinics, or othertest environments, includingpatient's home.
Indications for Use	Noxturnal Web is intended tobe used for the diagnosticevaluation by a physician toassess sleep quality and as anaid for the diagnosis of sleepand respiratory-related sleepdisorders in adults only.Noxturnal Web is a software-only medical device to be usedto analyze physiological signalsand manually score sleep studyresults, including the staging ofsleep, AHI, and detection ofsleep disordered breathingevents including obstructiveapneas.It is intended to be used underthe supervision of a clinician ina clinical environment.	The SOMNOscreen® plus is anon-life-supporting portablephysiological signal recordingdevice intended to be used fortesting adults and children (age2 to 12 years)/adolescents (age12 and above) suspected ofhaving sleep-related breathingdisorders.	SomnoMetry is intended foruse for diagnostic evaluationby a physician to assess sleepquality and as an aid for thediagnosis of sleep andrespiratory-related sleepdisorders in adults only.SomnoMetry plus is asoftware-only medical deviceto be used to analyzephysiological signals andautomatically score sleep studyresults, including the staging ofsleep, AHI, and detection ofsleep-disordered breathingevents including obstructiveapneas. It is intended to beused under the supervision ofa clinician in a clinicalenvironment. All automaticallyscored events are subject toverification by a qualifiedclinician.	The Nox Sleep System is usedas an aid in the diagnosis ofdifferent sleep disorders andfor the assessment of sleep.The Nox Sleep System is usedto measure, record, display,organize, analyze, summarize,and retrieve physiologicalparameters during sleep andwake.The Nox Sleep System allowsthe user to decide on thecomplexity of the study byvarying the number and typesof physiological signalsmeasured.The Nox Sleep System allowsfor generation of user/pre-	The primary predicate deviceincludes hardware that is usedto record the physiologicalsignals. The subject devicedoes not contain any hardware/ recording function. Thisdifference does not raise anyconcerns of safety oreffectiveness.The primary predicate devicecontains software, DOMINO,that is used for display,analysis, and printing of thephysiological signals recordedby the SOMNOscreen plus.Same target patient population.The intended population of thesubject device, Noxturnal Web,is limited to adults only,thereby aligning with theindications for use of the

Trade/Device Name	Subject Device:Noxturnal Web(K241288)	Primary Predicate Device:SOMNOscreen plus(K201054)	Additional PredicateDevice:SomnoMetry(K221179)	Reference Device:Nox Sleep System(K192469)	Comparison of Subject,Predicates, and ReferenceDevice
				defined reports based onsubject's data.The user of the Nox SleepSystem are medicalprofessionals who havereceived training in the areasof hospital/clinical procedures,physiological monitoring ofhuman subjects, or sleepdisorder investigation.The intended environments arehospitals, institutions, sleepcenters, sleep clinics, or othertest environments, includingpatient's home.	identified primary predicatedevice, SOMNOscreen plus(K201054) and additionalpredicate device, SomnoMetry(K221179).Same intended use.The subject and predicatedevices are intended to beused as an aid for thediagnosis of sleep andrespiratory-related sleepdisorders.
Environment of Use	Clinical Environment	Clinical Environment	Clinical Environment	Clinical Environment / HomeEnvironment	Same.
Target Users	Medical Professionals	Medical Professionals	Medical Professionals	Medical Professionals	Same.
Target PatientPopulation	Adults only	General Population (adults andchildren/adolescents)	Adults only	General Population (adults andchildren/adolescents)	Same.
Type of Use	Prescription Use only	Prescription Use only	Prescription Use only	Prescription Use only	Same.
Comparison of Technological Characteristics
Clinical Criteria:
Aid/Assist in thediagnosis of sleep andrespiratory-relatedsleep disorders	Yes	Yes	Yes	Yes	Same.
Arousal Scoring	Yes	Yes	Yes	Yes	Same.
Respiratory EventsScoring	Yes	Yes	Yes	Yes	Same.
Leg Movement EventsScoring	Yes	Yes	Yes	Yes	Same.
Sleep Study ScoringMethod	Manual	Manual	Automatic and Manual	Automatic and Manual	Same.
Trade/Device Name	Subject Device:Noxturnal Web(K241288)	Primary Predicate Device:SOMNOscreen plus(K201054)	Additional PredicateDevice:SomnoMetry(K221179)	Reference Device:Nox Sleep System(K192469)	Comparison of Subject,Predicates, and ReferenceDevice
					The subject device providestools for manual scoring ofsleep parameters, similar to thesoftware features of DOMINOin the primary predicate device,SOMNOscreen plus.
Sleep Stage Scoring(Stage W, StagesN1/N2/N3, Stage R)	Yes	Yes	Yes	Yes	Same.
Report Generation	Yes	Yes	Yes	Yes	Same.
Calculation of AASMstandardized indices	Yes	Yes	Yes	Yes	Same.
Data inputs
EEG	Yes	Yes	Yes	Yes	Same.
EOG	Yes	Yes	Yes	Yes	Same.
EMG	Yes	Yes	Yes	Yes	Same.
ECG	Yes	Yes	Yes	Yes	Same.
Chest/Abdomenmovements /Respiratory Effort	Yes	Yes	Yes	Yes	Same.
Airflow	Yes	Yes	Yes	Yes	Same.
Oxygen Saturation	Yes	Yes	Yes	Yes	Same.
Body Position / Activity	Yes	Yes	Information not available	Yes	Same.
Device Characteristics
Hardware Components	Not included	Included	Not included	Included	Same as the additionalpredicate device; NoxturnalWeb and SomnoMetry aresoftware-only devices.
Software Type	Web-based	Computer program	Web-based	Computer program	Same as the additionalpredicate; Noxturnal Web andSomnoMetry are web-basedand, therefore, installation isnot required.
Physical Characteristics	Web-based software operatingin the cloud with Windows orMac OS	MS Windows-based application	Web-based software operatingin the cloud with Windows,Linux, or Mac OS	MS Windows-based application	Similar to the additionalpredicate; Noxturnal Web andSomnoMetry are web-based
Trade/Device Name	Subject Device:Noxturnal Web(K241288)	Primary Predicate Device:SOMNOscreen plus(K201054)	Additional PredicateDevice:SomnoMetry(K221179)	Reference Device:Nox Sleep System(K192469)	Comparison of Subject,Predicates, and ReferenceDevice
					and, therefore, installation isnot required.
Other:
Performance Testing	• IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION• ANSI AAMI ISO 14971:2019• ANSI AAMI SW96:2023• IEC 82304-1 Edition 1.02016-10• ISO 20417 First edition 2021-04 Corrected version 2021-12• ISO IEC 29147 First edition2014-02-15• AAMI TIR57:2016• ANSI AAMI IEC 62366-1:2015+AMD1:2020(Consolidated Text)	• IEC/ANSI 60601-1:2005• EN 60601-1-2:2015• IEC 62366-1:2015	• IEC 62304:2006+A1:2015• ISO 14971:2007	• IEC 62304:2006• ISO 14971:2007	The subject device is Softwareas a Medical Device and, assuch, relevant standards havebeen applied. This differencedoes not raise any concernsrelating to safety oreffectiveness.
Standard of ScoringManual	The American Academy ofSleep Medicine (AASM) Manualfor the Scoring of Sleep andAssociated Events	The American Academy ofSleep Medicine (AASM) Manualfor the Scoring of Sleep andAssociated Events	The American Academy ofSleep Medicine (AASM) Manualfor the Scoring of Sleep andAssociated Events	The American Academy ofSleep Medicine (AASM) Manualfor the Scoring of Sleep andAssociated Events	Same.

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510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02

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510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02

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510(k) Summary Noxturnal Web – Traditional 510(k)

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510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02

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510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02

SUMMARY OF NON-CLINICAL TESTING

The FDA-recognized standards were applied throughout the design process of Noxturnal Web. Verification and Validation testing of all requirement specifications defined for Noxturnal Web was conducted and passed according to the device's intended use to ensure product safety, effectiveness, and reliability.

Software verification and validation testing was performed per IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes to demonstrate safety and performance based on current industry standards.

The substantial equivalence between Noxturnal Web (K241288) and the software application, DOMINO, of the primary predicate (K201054) has been demonstrated through a comparative analysis concluding that both software applications support the same main functions of selecting and opening an existing sleep study, displaying and navigating the signals/sleep study data, manually annotating/scoring the sleep study data by adding applicable events/markers on top of the signal traces, calculating the AASM standardized indexes, providing trend/summary overviews, creating interpretation reports, and saving/storing the scored recording. The software applications both visualize the signals and events in essentially the same way, allow the same editing to be made on the scored events, provide the same basic information for the scorer and physician in the form of overviews and indexes and report the basic AASM standardized sleep indexes/parameters into editable reports that aid the physician in the sleep study data interpretation and diagnosis.

SUMMARY OF CLINICAL TESTING

Clinical data were not relied upon for a determination of substantial equivalence.

CONCLUSION

Noxturnal Web (K241288) is substantially equivalent to the predicate devices. SOMNOscreen plus (K201054) and SomnoMetry (K221179). Noxturnal Web has the same intended use and the indications for use fall within the scope of that for the predicate devices. Many of the technological characteristics are the same for the subject and predicate devices. The differences in technological characteristics between the subject and predicate devices have been addressed through software verification/validation testing and performance testing. The results of the comparative analysis, software and performance testing validate that Noxturnal Web meets its pre-specified requirements, performs as intended, and is as safe and effective as the predicate devices. No new concerns or questions about safety or effectiveness have been raised.

Based on the methods and results of comparative analysis, software verification and validation testing, it is determined that Noxturnal Web is substantially equivalent to the predicate devices and is safe and effective for its intended use in the adult patient population.

Regulation Number and Section

§ 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).