Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physiological data recorder and its components, focusing on data acquisition and transmission. There is no mention of AI, ML, or any algorithms that would process or interpret the data using such technologies. The clinical studies described focus on validating the data recording accuracy and comparing it to a predicate device, not on the performance of any AI/ML-based analysis.

Therapeutic

No
The device is described as a physiological data recorder intended to collect and record data for diagnosis and studies, not to provide therapy or treatment.

Diagnostic

Yes

The device is a physiological data recorder intended to collect and record data for use by clinical software in polysomnography and sleep disorder studies, and its output is used for "further diagnosis." This indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components: Head Unit, Body Unit, ExG Unit, and Central Unit, which acquire, store, and transmit physiological data. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the DormoTech Nlab is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is a "physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies." This describes a device that measures physiological signals directly from the patient's body.
Device Description: The description details sensors that are applied to the patient's body (forehead, below the mouth, stomach, leg/arm/chest) to acquire electrical signals, airflow, heart rate, SpO2, body position, and respiratory effort. These are all in vivo measurements.
Lack of In Vitro Activity: There is no mention of the device analyzing samples taken from the body (like blood, urine, tissue, etc.) in a laboratory setting. IVD devices are specifically designed to perform tests on such samples.

The DormoTech Nlab is a medical device used for in vivo physiological monitoring, specifically for sleep studies. It collects data directly from the patient's body, which is then used by clinical software for diagnosis. This is distinct from the function of an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments.

The DormoTech Nlab SpO2 sensor is indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

Product codes

MNR, GWL, DOA

Device Description

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician and is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environment.

It consists of:

The Head Unit
The head unit acquires electric signals indicative of EEG and eye movement located in the upper part of the unit (on the patient's forehead). Plethysmograph for Heart rate and SpO2 measurements, and head relative position to body position are also measured using accelerometer sensors located in the upper part of the unit. The middle part of the unit is located below the mouth, it contains 2 nasal (one in each nostril) and 1 oral airflow sensors (thermistors), 1 EMG sensor, along with a snoring sensor.

The Body Unit
The body unit is made of 2 belts, the upper belt sits on the lower belt sits on the stomach of the patient. Both belts contain respiratory effort and accelerometer sensors, in addition, the upper belt contains an accelerometer to measure body position.

The ExG Unit
The ExG unit is put on using an adhesive sticker on the leg/arm/chest (either leg/arm is ok). It consists of 3 electrodes that acquire leg/arm/chest ExG signal.

The Central Unit
The head, chest and ExG units communicate with the central unit via Bluetooth, the wearable units send the measured data to the central unit receives the data, stores it within an internal flash drive and then transmits the data via Wi-Fi to online servers for further diagnosis. The central unit is located in the test room (up to 10 meters from the patient). The central unit has no contact with the patient.

To ensure device reusability between sessions or patients, sections of the head unit have been designed to be detachable or with barriers between the sensor and patient's skin to stop direct contact. Specifically, the head unit incorporates (1) a detachable nasal and oral airflow section to allow for replacement of the section between each use of the device, (2) a removable barrier over the plethysmograph recorder to create a separation between the patient's skin and the recording device which is replaced between each use of the device and (3) a detachable textile on the inner side of the head unit (i.e., the side in direct contact with the patient's skin) to allow for replacement between each use of the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Patient's forehead, below the mouth (nasal and oral), leg/arm/chest

Indicated Patient Age Range

Patients greater than 6 years of age.

Intended User / Care Setting

Intended for use by or on the order of a physician. Intended for use in a supervised (hospital) or unsupervised (home) environments.

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

First Clinical Study (Pediatrics over age 6):

Study design: An IEC approved, comparative, self-controlled, randomized, prospective study designed to assess the Nlab and compare its performance to a gold standard polysomnogram (PSG) conducted over 1 night in a sleep lab.
Sample size: 26 patients (50% female), with an average age of 11 years and average BMI of 26. 24 out of 26 subjects completed the test and filled out both questionnaires and were considered for demographics, safety, and usability analysis.
Data source: Simultaneous monitoring of physiological sleep signals via recordings by the subject and predicate devices.
Annotation protocol: Not explicitly stated, but implies comparison of collected data from subject and predicate devices.

Second Clinical Study (SpO2 sensor):

Study design: A study to determine the accuracy of the DormoTech Nlab SpO2 sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions [510(k)s], in the range of arterial HbO2 saturations from 100% to 70%.
Sample size: 12 patients (33% female) with an average age of 33 years. Subjects represent a diverse group in terms of age, height, weight, ethnicity, and skin types, spanning all six skin types (Type I to Type VI). 259 data points from 12 subjects were included.
Data source: Recording of SpO2 using the subject device and simultaneous monitoring of arterial HbO2 saturations at six different levels of oxyhemoglobin saturation between 70-100%.
Annotation protocol: Not explicitly stated, but involves comparing SpO2 readings from the device to simultaneously monitored arterial HbO2 saturations.

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

First Clinical Study (Pediatrics over age 6):

Study type: Prospective clinical study, comparative, self-controlled, randomized.
Sample size: 26 patients (24 completed).
Key results: Analyses demonstrated no significant differences in primary or secondary sleep endpoint measures between the subject and predicate devices. Most parameters showed good agreement between the devices, as indicated by mean difference values close to zero and narrow limits of agreement. This suggests that for many measures such as AHI, ODI, and Snore, the devices are interchangeable. The performance of the Dormotech Nlab device when compared to the gold-standard PSG is substantially equivalent.

Second Clinical Study (SpO2 sensor):

Study type: Prospective clinical study, clinical validation.
Sample size: 12 patients (259 data points).
Key results: Root Mean Square Error (RMSE) of 2.53% between the SpO2 measurements and arterial HbO2 saturations. Subgroup analyses performed according to skin pigmentation and sex revealed no systematic differences across these parameters. RMSE for light, medium, and dark skin pigmentation was 3.18%, 2.53%, and 1.57% respectively. RMSE for male and female sex was 2.64% and 2.18% respectively. The narrow 95% confidence interval for the mean bias further highlights the precision and reliability of the bias estimate.

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

First Clinical Study (Pediatrics over age 6):

Primary Endpoints: AHI - Apnea-Hypopnea Index Score and Classification
Secondary Endpoints: ODI Oxygen Desaturation as measured by separate SpO2 sensor, Snore Total Snore %, Sleep Total Sleep Time (min), Sleep Efficiency (%), Sleep Stages [Wake, N1, N2, N3, REM] (%), Sleep Latency (min), Wake After Sleep Onset (min), REM Latency (min), Position: Supine position, Left, Right, Up [% from TST]
Agreement metrics (Mean Difference, Limit Upper of Agreement, Limit Lower of Agreement with 95% CI):
- AHI (events/h): Mean Difference 0.2875 [-0.5231,1.098], Limit Upper 4.05 [2.646,5.454], Limit Lower -3.475 [-4.879, -2.071]
- ODI (events/h): Mean Difference -0.1042 [-0.6346,0.4262], Limit Upper 2.358 [1.439,3.276], Limit Lower -2.566 [-3.485, -1.647]
- Snore (%): Mean Difference 1.995 [-0.2207,4.212], Limit Upper 11.79 [7.954,15.63], Limit Lower -7.801 [-11.64, -3.963]
- Sleep Latency (Minutes): Mean Difference 0.9727 [-2.211,4.156], Limit Upper 15.05 [9.531,20.56], Limit Lower -13.1 [-18.61, -7.586]
- REM Latency (Minutes): Mean Difference -0.2864 [-6.393,0.6654], Limit Upper 12.74 [6.624,18.85], Limit Lower -18.46 [-24.58, -12.35]
- Wake after Sleep Onset (Minutes): Mean Difference -2.091 [-5.381, -1.199], Limit Upper 12.45 [6.754,18.15], Limit Lower -16.63 [-22.33, -10.94]
- REM (%): Mean Difference 0.6045 [-1.193,2.402], Limit Upper 8.552 [5.438,11.67], Limit Lower -7.343 [-10.46, -4.229]
- N1 (%): Mean Difference -1.659 [-3.878,0.5602], Limit Upper 8.151 [4.308,12], Limit Lower -11.47 [-15.31, -7.626]
- N2 (%): Mean Difference -1.095 [-3.108, -0.9169], Limit Upper 7.8 [4.315,11.29], Limit Lower -9.991 [-13.48, -6.506]
- N3 (%): Mean Difference 2.173 [0.497,3.848], Limit Upper 9.58 [6.678,12.48], Limit Lower -5.235 [-8.137, -2.332]
- Wake (%): Mean Difference -1.127 [-2.506,0.2519], Limit Upper 4.97 [2.581,7.358], Limit Lower -7.224 [-9.613, -4.835]
- Total Sleep Time (Minutes): Mean Difference 4.00 [-5.1,13.1], Limit Upper 44.23 [28.47,59.99], Limit Lower -36.23 [-51.99, -20.47]
- Sleep Efficiency (%): Mean Difference -0.1773 [-1.798,1.444], Limit Upper 6.988 [4.18,9.795], Limit Lower -7.342 [-10.15, -4.535]
- Position (Up) (%): Mean Difference -0.2792 [-0.7932,0.2348], Limit Upper 2.107 [1.216,2.997], Limit Lower -2.665 [-3.555, -1.775]
- Position (Supine) (%): Mean Difference 1.892 [0.1316,3.652], Limit Upper 10.06 [7.013,13.11], Limit Lower -6.278 [-9.326, -3.229]
- Position (Left) (%): Mean Difference 0.725 [-0.5657,2.016], Limit Upper 6.716 [4.48,8.951], Limit Lower -5.266 [-7.501, -3.03]
- Position (Right) (%): Mean Difference -0.3042 [-2.074,1.465], Limit Upper 7.91 [4.845,10.97], Limit Lower -8.518 [-11.58, -5.453]

Second Clinical Study for SpO2 sensor:

Accuracy, ARMS (RMSE):
- SpO2 (70-100%): ±2.53%
- According to skin pigmentation: Light: 3.18%, Medium: 2.53%, Dark: 1.57%
- According to sex: Male: 2.64%, Female: 2.18%
Pulse rate: 20-250±3 bpm

Predicate Device(s)

Nox Medical, Nox T3, K082113, Dolphin Medical Inc, Dolphin ONE, K040380

Reference Device(s)

Nellcor Puritan Bennett Inc., OxiMAX-FAST, K021089, DormoTech, DormoTech Vlab, K230148

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).

Summary

0

January 8, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DormoTech Medical LTD % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704

Re: K242290

Trade/Device Name: DormoTech NLab Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, GWL, DOA Dated: December 8, 2024 Received: December 9, 2024

Dear Paul Dryden:

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 (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.

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"

1

(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 (QS) 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 OS 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 Rue"). 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-devices/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 mediation-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-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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Patrick Antkowiak -S" in black text. The text is arranged vertically, with "Patrick" on the top line, "Antkowiak" on the second line, and "-S" on the third line. To the left of the name is a faded blue FDA logo.

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

510(k) Number (if known) K242290

Device Name

DormoTech Nlab

Indications for Use (Describe)

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary Page 1 of 9

Date Prepared:	8-Jan-25
Sponsor:	DormoTech Medical Ltd.
Yitzhak Rabin 21
Afula, Israel
+972-4-7799729
Sponsor Contact:	Abed Nassir, Head of Firm
Submission Contact:	Paul Dryden
ProMedic Consulting LLC
Propriety or Trade Name:
Common/Usual Name:
Classification Name:
Primary Product Code:
Regulation Number:
Secondary Product Code:	DormoTech Nlab
Ventilatory Effort Recorder
Ventilatory Effort Recorder
MNR
21 CFR 868.2375
GWL, DQA
Reference Device:	NOX Medical, Nox T3, K082113
DormoTech, DormoTech Vlab, K230148
Predicate / Reference
PPG sensor	Predicate: Dolphin Medical Inc, Dolphin ONE, K040380
Reference: Nellcor Puritan Bennett Inc., OxiMAX-FAST, K021089

Device Description:

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician and is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environment.

It consists of:

The Head Unit

The head unit acquires electric signals indicative of EEG and eye movement located in the upper part of the unit (on the patient's forehead). Plethysmograph for Heart rate and SpO2 measurements, and head relative position to body position are also measured using accelerometer sensors located in the upper part of the unit. The middle part of the unit is located below the mouth, it contains 2 nasal (one in each nostril) and 1 oral airflow sensors (thermistors), 1 EMG sensor, along with a snoring sensor.

The Body Unit

The body unit is made of 2 belts, the upper belt sits on the lower belt sits on the stomach of the patient. Both belts contain respiratory effort and accelerometer sensors, in addition, the upper belt contains an accelerometer to measure body position.

The ExG Unit

The ExG unit is put on using an adhesive sticker on the leg/arm/chest (either leg/arm is ok). It consists of 3 electrodes that acquire leg/arm/chest ExG signal.

The Central Unit

The head, chest and ExG units communicate with the central unit via Bluetooth, the wearable units send

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510(k) Summary Page 2 of 9

the measured data to the central unit receives the data, stores it within an internal flash drive and then transmits the data via Wi-Fi to online servers for further diagnosis. The central unit is located in the test room (up to 10 meters from the patient). The central unit has no contact with the patient.

To ensure device reusability between sessions or patients, sections of the head unit have been designed to be detachable or with barriers between the sensor and patient's skin to stop direct contact. Specifically, the head unit incorporates (1) a detachable nasal and oral airflow section to allow for replacement of the section between each use of the device, (2) a removable barrier over the plethysmograph recorder to create a separation between the patient's skin and the recording device which is replaced between each use of the device and (3) a detachable textile on the inner side of the head unit (i.e., the side in direct contact with the patient's skin) to allow for replacement between each use of the device.

Principle of Operation:

The device acquires and digitizes signals from sensors and sends them to a polysomnography system. Sensors are:

Direct measurement of electrical potential at the skin (EEG, EMG, EOG). ●
Thermistors (flow)
Accelerometers (movement) ●
. Plethysmograph (pulse rate and SpO2)
Respiratory Effort ●
Snoring Sensor ●

Indications for Use:

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments.

Patient Population:

Patients greater than 6 years of age

Substantial Equivalence:

The subject device, DormoTech Nlab, is substantially equivalent to the Nox Medical, Nox T3 cleared under K082113.

The subject device's SpO2 sensor, Dormotech Nlab SpO2 sensor, is substantially equivalent to Dolphin Medical, Dolphin ONE, cleared under K040380.

Performance Testing:

Substantial equivalence to the predicate is based on performance testing. We evaluated:

Biocompatibility
. Software Verification and Validation
. Electrical Safety
. Electromagnetic Compatibility Compliance
Product Requirements Verification ●
Consumables Verification ●

Clinical trial summary

Two (2) prospective clinical studies were performed. The first for the added population of pediatrics over

6

510(k) Summary Page 3 of 9

the age of 6 compared to a gold standard PSG study and the second for validation of the SpO2 sensor in accordance with ISO 14155 and ISO 80601-2-61.

The first clinical study involving overnight PSG recordings included a total of 26 patients (50% female), with an average age of 11 years and average BMI of 26. The trial involved simultaneous monitoring of physiological sleep signals via recordings by the subject and predicate devices. Analyses demonstrated no significant differences in primary or secondary sleep endpoint measures between the subject and predicate devices.

The second clinical study involving clinical validation of the SpO2 sensor included a total of 12 patients (33% female) with an average age of 33 years and included subgroup analyses for race and ethnicity. The study involved recording of SpO2 using the subject device and simultaneous monitoring of arterial HbO2 saturations at six different levels of oxyhemoglobin saturation between 70-100%. The Root Mean Square Error (RMSE) between the two measurements of 2.53% suggests that the measurement method being evaluated is within the expected range of accuracy. Furthermore, subgroup analyses were performed according to skin pigmentation and sex and revealed no systematic differences across these parameters. According to skin pigmentation, RMSE was 3.18%, 2.53%, 1.57% for light, medium and dark skin pigmentation, respectively. Moreover, subgroup analyses revealed no systematic differences across across across across across across across across across across across across with RMSE values at 2.64% and 2.18% for male and female sex, respectively.

Summarizing the clinical study results:

Clinical Trials for Pediatrics Over the Age of 6:

Study design:

An IEC approved, comparative, self-controlled, randomized, prospective study designed to assess the Nlab and compare its performance to a gold standard polysomnogram (PSG) conducted over 1 night in a sleep lab.

Study Locations:

Two sleep labs were used:

Shamir Medical Center Be'er Ya'akov, Israel
· Millenium Sleep Clinic Be'er Sheva, Israel

Patient Population:

· Children 6 years and older
· Male and female (50% female)

· 26 subjects were recruited, not all enrolled subjects completed the study. 24 out of 26 subjects completed the test and filled out both questionnaires and were considered for demographics, safety, and usability analysis.

Primary Endpoints Measures:

· AHI - Apnea-Hypopnea Index Score and Classification

Secondary Endpoints Measures:

· ODI Oxygen Desaturation as measured by separate SpO2 sensor
Snore Total Snore %
· Sleep Total Sleep Time (min), Sleep Efficiency (%), Sleep Stages [Wake, N1, N2, N3, REM] (%),
Sleep Latency (min), Wake After Sleep Onset (min), REM Latency (min)
· Position: Supine position, Left, Right, Up [% from TST]

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510(k) Summary Page 4 of 9

| Parameter | Mean CI, Upper CI) | Limit
Upper
of
Agreement (Lower CI,
Upper CI) | Limit
Lower
of
Agreement (Lower CI,
Upper CI) |
|------------------------|------------ | AHI | 0.2875 | (events/h) | [-0.5231,1.098] | ODI | -0.1042 | (events/h) | [-0.6346,0.4262] | Snore | 1.995 | (%) | [-0.2207,4.212] | Sleep Latency | 0.9727 | (Minutes) | [-2.211,4.156] | REM Latency | -0.2864 | (Minutes) | [-6.393,0.6654] | Wake after Sleep Onset | -2.091 | (Minutes) | [-5.381, -1.199] | REM | 0.6045 | (%) | [-1.193,2.402] | N1 | -1.659 | (%) | [-3.878,0.5602] | N2 | -1.095 | (%) | [-3.108, -0.9169] | N3 | 2.173 | (%) | [0.497,3.848] | Wake | -1.127 | (%) | [-2.506,0.2519] | Total Sleep Time | 4.00 | (Minutes) | [-5.1,13.1] | Sleep Efficiency | -0.1773 | (%) | [-1.798,1.444] | Position (Up) | -0.2792 | (%) | [-0.7932,0.2348] | Position (Supine) | 1.892 | (%) | [0.1316,3.652] | Position (Left) | 0.725 | (%) | [-0.5657,2.016] | Position (Right) | -0.3042 | (%) | [-2.074,1.465] Difference (Lower
-----------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| 4.05 | -3.475 |
| [2.646,5.454] | [-4.879, -2.071] |
| 2.358 | -2.566 |
| [1.439,3.276] | [-3.485, -1.647] |
| 11.79 | -7.801 |
| [7.954,15.63] | [-11.64, -3.963] |
| 15.05 | -13.1 |
| [9.531,20.56] | [-18.61, -7.586] |
| 12.74 | -18.46 |
| [6.624,18.85] | [-24.58, -12.35] |
| 12.45 | -16.63 |
| [6.754,18.15] | [-22.33, -10.94] |
| 8.552 | -7.343 |
| [5.438,11.67] | [-10.46, -4.229] |
| 8.151 | -11.47 |
| [4.308,12] | [-15.31, -7.626] |
| 7.8 | -9.991 |
| [4.315,11.29] | [-13.48, -6.506] |
| 9.58 | -5.235 |
| [6.678,12.48] | [-8.137, -2.332] |
| 4.97 | -7.224 |
| [2.581,7.358] | [-9.613, -4.835] |
| 44.23 | -36.23 |
| [28.47,59.99] | [-51.99, -20.47] |
| 6.988 | -7.342 |
| [4.18,9.795] | [-10.15, -4.535] |
| 2.107 | -2.665 |
| [1.216,2.997] | [-3.555, -1.775] |
| 10.06 | -6.278 |
| [7.013,13.11] | [-9.326, -3.229] |
| 6.716 | -5.266 |
| [4.48,8.951] | [-7.501, -3.03] |
| 7.91 | -8.518 |
| [4.845,10.97] | [-11.58, -5.453] |

Conclusion:

8

510(k) Summary Page 5 of 9

The table above provides a comparison between the two devices across multiple sleeprelated parameters. Most parameters show good agreement between the devices, as indicated by the mean difference values close to zero and narrow limits of agreement. This suggests that for many measures such as AHI, ODI, and Snore, the devices are interchangeable. By considering both the statistical measures and the role of human scoring, the performance of the Dormotech Nlab device when compared to the goldstandard PSG is substantially equivalent.

Clinical Trials for SpO2 sensor:

A study is to determine the accuracy of the DormoTech Nlab SpO2 sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions [510(k)s], in the range of arterial HbO2 saturations from 100% to 70% was conducted.

In the analysis, 259 data points from 12 subjects were included. The subjects represent a diverse group in terms of age, height, weight, ethnicity, and skin types, which is beneficial for generalizing findings across different demographics. Subjects span all six types, indicating a wide range of skin types from very fair (Type I) to deeply pigmented dark (Type VI). A Root Mean Square Error (RMSE) of 2.53% for this range suggests that the model or measurement method being evaluated is fairly accurate. Subgroup analyses were performed according to skin pigmentation and sex and revealed no systematic differences across these parameters. According to skin pigmentation, RMSE was 3.18%, 2.53%, 1.57% for light, medium, dark skin pigmentation, respectively. Moreover, subgroup analyses revealed no systematic differences across sex with RMSE values at 2.64% and 2.18% for male and female sex, respectively. Additionally, the narrow 95% confidence interval for the mean bias further highlights the precision and reliability of the bias estimate.

Features	Subject Device	Predicate	Comments
	DormoTech Nlab	Nox T3 (K082113)
Classification	MNR
Physiological Signal Amplifier
882.1835	MNR
Physiological Signal Amplifier
882.1835	Similar
Indications for
use	The DormoTech Nlab is a
physiological data recorder intended
to collect and record data from
multiple physiological channels for
use by clinical software used in
polysomnography and sleep disorder
studies. It is intended for use by or on
the order of a physician. It is intended
for use on patients greater than 6
years of age in a supervised (hospital)
or unsupervised (home)
environments.	The Nox T3 device is intended for
ambulatory recording of
physiological signals during sleep.
The recorded signals are then
downloaded to a PC where the signals
can be viewed and analyzed by use of
the Nox T3 application (Noxturnal).
The Nox T3 system is indicated for
use in patients greater than 2 years of
age.
The Nox T3 system is NOT intended
for any patient monitoring or
automatic diagnosis. The intended
environments are hospitals,
institutions, sleep centers, sleep
clinics, or other test environments,
including patient's home.
The Nox T3 system is used for
patients suspected of suffering from
Sleep Disordered Breathing (SDB) or
Periodic Limb Movement Disorder
(PLMD).	The Indications for Use for the
proposed DormoTech Nlab
device are identical to those of
the predicate device with the
exception that use for patients
age 6 and older is not excluded
in the subject DormoTech Nlab
labelling. Bench testing of the
proposed DormoTech Nlab was
conducted to demonstrate
substantial equivalence to the
predicate device. The proposed
device has the same intended
use and employs the same
fundamental scientific
technology.
Population	Patients greater than 6 years of age.	Patients greater than 2 years of age.	Subject device was not verified
in patients under 6 years old.
Environment of
Use	Supervised (hospital) or unsupervised
(home) environment	Supervised (hospital) or unsupervised
(home) environment	Similar

9

510(k) Summary Page 6 of 9

Principle of Operation
	Uses sensors to collect signals to be
processed by cleared analysis
software	Uses sensors to collect signals to be
processed by cleared analysis
software	Similar
Physiological
signals collected	EEG, EOG, EMG, ECG
Airflow
Snore
Thoracic and Abdominal Effort
Body Position
SpO2 sensor and Heart (pulse) Rate
from PPG	EEG, EOG, EMG, ECG
Airflow
Snore
Thoracic and Abdominal Effort
Body Position
Requires separate SpO2 sensor and
Heart (pulse) Rate from PPG	Similar
Device is	Wearable and portable	Wearable and portable	Similar
Prescriptive	Yes	Yes	Similar
Non-clinical
Testing	Respiratory Signals
Total Airflow
Snore
Respiratory Effort (Thoracic and
Abdomen)
ExG signals
EEG
EOG
EMG
Position Signals
Body Position
Head Position
Plethysmography signal	Total Airflow
Snore
Respiratory Effort (Thoracic and
Abdomen)
ExG signals
EEG
EOG
EMG
Position Signals
Body Position
Head Position
Plethysmography signal	In a comparative clinical study
the results demonstrated that the
Nlab was substantially
equivalent in measuring the
specified parameters.

The study results can be seen in
the previous submission for
DormoTech Vlab cleared under
K230148.

For the SpO2 sensor,
DormoTech conducted a
clinical validation study |

| Features | Subject Device
DormoTech Nlab | Reference
DormoTech Vlab (K230148) | Comments |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | GWL, MNR
Physiological Signal Amplifier
882.1835 | GWL, MNR
Physiological Signal Amplifier
882.1835 | Similar |
| Indications for
use | The DormoTech Nlab is a
physiological data recorder intended
to collect and record data from
multiple physiological channels for
use by clinical software used in
polysomnography and sleep disorder
studies. It is intended for use by or on
the order of a physician. It is intended
for use on patients greater than 6
years of age in a supervised (hospital)
or unsupervised (home)
environments. | The DormoTech Vlab is a
physiological data recorder intended
to collect and record data from
multiple physiological channels for
use by clinical software used in
polysomnography and sleep disorder
studies. It is intended for use by or on
the order of a physician. It is intended
for use on adults in a supervised
(hospital) or unsupervised (home)
environment | The Indications for Use for the
proposed DormoTech Nlab
device are identical to those of
the reference device with the
exception that use for pediatrics
age 6 and older is not excluded
in the subject DormoTech Nlab
labeling. Bench testing of the
proposed DormoTech Nlab was
conducted to demonstrate
substantial equivalence to the
predicate device. The proposed
device has the same intended
use and employs the same
fundamental scientific
technology. |
| Population | Patients greater than 6 years of age. | Adults | |
| Environment of
Use | Supervised (hospital) or unsupervised
(home) environment | Supervised (hospital) or unsupervised
(home) environment | Similar |
| Principle of
Operation | Uses sensors to collect signals to be
processed by cleared analysis
software | Uses sensors to collect signals to be
processed by cleared analysis
software | Similar |
| Physiological
signals collected | EEG, EOG, EMG, ECG
Airflow
Snore
Thoracic and Abdominal Effort
Body Position
SpO2 sensor and Heart (pulse) Rate
from PPG | EEG, EOG, EMG, ECG
Airflow
Snore
Thoracic and Abdominal Effort
Body Position
Requires separate SpO2 sensor and
Heart (pulse) Rate from RPG | Added SpO2 sensor, the SpO2
has been tested in accordance
with ISO 14155 and ISO
80601-2-61. |

10

510(k) Summary

Device is	Wearable and portable	Wearable and portable	Similar
Prescriptive	Yes	Yes	Similar
Non-clinical
Testing	Respiratory Signals		Bench testing was performed
against the reference which
confirmed the signal output.
	Total Airflow	Total Airflow
	Snore	Snore
	Respiratory Effort (Thoracic and
Abdomen)	Respiratory Effort (Thoracic and
Abdomen)
	ExG signals	ExG signals
	EEG	EEG
	EOG	EOG
	EMG	EMG
	Position Signals	Position Signals
	Body Position	Body Position
	Head Position	Head Position
	Plethysmography signal	Plethysmography signal
	DormoTech Nlab SpO2 sensor	From Nonin SpO2 sensor
Biocompatibility	Surface contact and Externally
communicating Limited duration
30 Kg	Adults and pediatrics weighing > 10 Kg	Similar to reference
Environment of
Use	Supervised (hospital) or unsupervised
(home) environment	Supervised (hospital) or unsupervised
(home) environment	Supervised (hospital) or unsupervised
(home) environment	Similar
Principle of
Operation	Pulse oximetry is governed by the
principles of a) Oxyhemoglobin
(oxygenated blood) and b)
deoxyhemoglobin (non-\ oxygenated
blood) differ in their absorption of red
and infrared light (spectrophotometry).
The amount of arterial blood in tissue
changes with your pulse
(photoplethysmography). Therefore,
the amount of light absorbed by the
varying quantities of arterial blood
changes as well.	Pulse oximetry is governed by the
principles of a) Oxyhemoglobin
(oxygenated blood) and b)
deoxyhemoglobin (non-\ oxygenated blood)
differ in their absorption of red and infrared
light (spectrophotometry). The amount of
arterial blood in tissue changes with your
pulse (photoplethysmography). Therefore,
the amount of light absorbed by the varying
quantities of arterial blood changes as well.	Pulse oximetry is governed by the
principles of a) Oxyhemoglobin
(oxygenated blood) and b)
deoxyhemoglobin (non-\ oxygenated blood)
differ in their absorption of red and infrared
light (spectrophotometry). The amount of
arterial blood in tissue changes with your
pulse (photoplethysmography). Therefore,
the amount of light absorbed by the varying
quantities of arterial blood changes as well.	Similar
Type of use	Reusable	Reusable	Single use
Reprocess
protocol	Disposable adhesive sticker is put on
forehead SpO2 enclosure	Disposable adhesive
disc and headband	NA	Similar to predicate - both have
their skin-contacting parts as
disposable
Measurement
Site	Forehead	Forehead	Forehead
Prescriptive	Yes	Yes	Yes
Sterility	Supplied non-sterile	Supplied non-sterile	Supplied non-sterile
Accuracy, ARMS
SpO2	70-100%±2.53%	70-100%±2%	70-100%±2%
in emergency or life threatening
situations. Device is intended to
be used in sleep disorder
screenings with low risk to
users. ISO 80601-2-61 allows
for Arms of up to 4%
Pulse rate	20-250±3 bpm	Did not include in submission	20-250±3 bpm
Biocompatibility	ISO 10993 compliant	ISO 10993 compliant	ISO 10993 compliant

12

510(k) Summary Page 9 of 9

Discussion of Differences:

The subject and predicate devices are sensor arrays for use in collecting and transmitting data from sleep studies that is analyzed by automated, FDA-cleared software.

The Indications for Use for the proposed Dormotech Nlab device are identical to those of the predicate device with the exception that use for pediatrics age 6 and older, as the device was not validated on pediatrics aged 2-6 years old

Bench testing of the proposed Dormotech Nlab was conducted to demonstrate substantial equivalence to the predicate device.

The DormoTech Nlab acquires and records a SpO2 signal from a plethysmograph (PPG) sensor, while predicate device Nox T3, K082113 uses a separate PPG sensor. To validate DormoTech Nlab sensor, Dormotech conducted a clinical validation study in accordance with ISO 14155 and ISO 80601-2-61. The reference, DormoTech Medical LTD, DormoTech Vlab, K230148 uses the same technology and design as subject device, DormoTech Nlab. DormoTech Nlab adds a leg/arm/chest ExG and a SpO2 signal, that were not present in the reference device. Bench testing and clinical validation were conducted on the Nlab device to ensure safety and accuracy.

The design of the sensor array is similar to both the predicate and reference as they are placed on the head, thoracic and leg/arm/chest. The technology of the sensors is the same as both the predicate and reference. The differences do not raise different concerns or risk for safety or effectiveness when compared to both the predicate and reference.

Substantial Equivalence Discussion:

As presented in the tables above, the subject device is substantially equivalent to the predicate, Nox T3, cleared under K082113, and the reference device, Dormotech Vlab, Cleared under K230148, for indications for use, technological characteristics, environments of use, population and performance. The subject device's SpO2 sensor, Dormotech Nlab SpO2 sensor, to its predicate and reference devices, Dolphin Medical, Dolphin ONE and Nellcor OxiMAX MAX-FAST, cleared under K040380 and K021089, respectfully.

Conclusion:

The comparison of features and performance testing support substantial equivalence to the predicate. Nox Medical Inc. Nox T3, K082113, and for its SpO2 sensor, Dormotech Nlab SpO2 sensor showed equivalence to the reference device, Dolphin Medical, Dolphin ONE, K040380.