Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states the software is used for "manually score sleep study results" and "facilitates a user to review or manually score a sleep study". There is no mention of automated analysis or algorithms that would suggest AI/ML.

Therapeutic

No
This device is for diagnostic evaluation and diagnosis of sleep disorders, not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that "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."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Noxturnal Web is a software-only medical device". The description focuses solely on the software's functions for analyzing and displaying sleep study data, with no mention of associated hardware components included with the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnosis, monitoring, or screening.
Noxturnal Web's Function: Noxturnal Web is a software-only device that analyzes pre-recorded physiological signals from sleep studies. It does not directly interact with or analyze biological specimens from the patient.
Intended Use: The intended use is for the diagnostic evaluation by a physician to assess sleep quality and aid in the diagnosis of sleep and respiratory-related sleep disorders. This is based on the analysis of physiological data, not the analysis of biological samples.
Device Description: The description clearly states it reads sleep study data for display, analysis, summarization, and retrieval of physiological parameters. It facilitates manual scoring and review of this data.

In summary, Noxturnal Web processes and analyzes data that has already been collected from the patient's body (physiological signals), rather than analyzing biological specimens in vitro. This places it outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OLV

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.

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

Adults only

Intended User / Care Setting

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

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Somnomedics GmbH, SOMNOscreen plus, K201054, Neumetry Medical Inc, SomnoMetry, K221179

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Nox Medical, Nox Sleep System, K192469

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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.

1

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

2

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

3

Indications for Use

Submission Number (if known)

K241288

Device Name

Noxturnal Web

Indications for Use (Describe)

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.

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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4

510(k) Summary

Noxturnal Web (K241288) — Traditional 510(k)

TEMP-0140 Controlled Document Template 04

5

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.

6

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

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.

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

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.

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

7

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".

8

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

| Trade/Device Name | Subiect Device:
Noxturnal Web
(K241288) | Primary Predicate Device:
SOMNOscreen plus
(K201054) | Additional Predicate
Device:
SomnoMetry
(K221179) | Reference Device:
Nox Sleep System
(K192469) | Comparison of Subject,
Predicates, and Reference
Device | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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 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
respiratory-related 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. | The SOMNOscreen® plus is
indicated for use in the
recording, displaying,
monitoring, printing, and
storage of biophysical
parameters for the purpose of
assisting in the diagnosis of
Neurological and Sleep
Disorders. The device is a non-
life-supporting physiological
signal recording device
intended to be used for studies
testing adults and
children/adolescents suspected
of having sleep-related
breathing disorders.
This device is NOT designed to
be used in a Life Support
situation.
This device is not designed for
use on patients with cardiac
pacemakers. | Analyze pre-recorded
physiological data acquired
during sleep and derive
actionable clinical insights. | 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. | Same.
Noxturnal Web, as well as the
predicate devices, is indicated
for use in the displaying,
analysis and printing of pre-
recorded biophysical
parameters for the purpose of
assisting in the diagnosis of
sleep and respiratory-related
sleep disorders.
The intended population of the
subject device, Noxturnal Web
is limited to adults only,
thereby aligning with the
indications for use of the
identified primary predicate
device, SOMNOscreen plus
(K201054) and additional
predicate device, SomnoMetry
(K221179). | |
| Trade/Device Name | Subject Device:
Noxturnal Web
(K241288) | Primary Predicate Device:
SOMNOscreen plus
(K201054) | Additional Predicate
Device:
SomnoMetry
(K221179) | Reference Device:
Nox Sleep System
(K192469) | Comparison of Subject,
Predicates, and Reference
Device | |
| | | | | 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
centers, sleep clinics, or other
test environments, including
patient's home. | | |
| Indications for Use | 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. | The SOMNOscreen® plus is a
non-life-supporting portable
physiological signal recording
device intended to be used for
testing adults and children (age
2 to 12 years)/adolescents (age
12 and above) suspected of
having sleep-related breathing
disorders. | SomnoMetry is intended for
use for 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.

SomnoMetry plus is a
software-only medical device
to be used to analyze
physiological signals and
automatically 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. All automatically
scored events are subject to
verification by a qualified
clinician. | 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- | The primary predicate device
includes hardware that is used
to record the physiological
signals. The subject device
does not contain any hardware
/ recording function. This
difference does not raise any
concerns of safety or
effectiveness.

The primary predicate device
contains software, DOMINO,
that is used for display,
analysis, and printing of the
physiological signals recorded
by the SOMNOscreen plus.

9

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

10

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

11

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

12

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

13

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.