DormoTech NLab
Device Facts
| Record ID | K242290 |
|---|---|
| Device Name | DormoTech NLab |
| Applicant | Dormotech Medical, Ltd. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Jan 8, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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.
Device Story
DormoTech Nlab is a wearable, portable physiological data recorder for polysomnography. It collects EEG, EOG, EMG, ECG, airflow (nasal/oral thermistors), snoring, respiratory effort (thoracic/abdominal), body/head position, and SpO2/pulse rate (via integrated plethysmograph). The system comprises a head unit, body unit (two belts), and ExG unit (adhesive electrode patch). Sensors communicate via Bluetooth to a central unit, which stores data on an internal flash drive and transmits it via Wi-Fi to servers for clinical analysis. The device is used by or on the order of a physician. Clinical software processes the recorded data to assist in sleep disorder diagnosis. Reusability is managed via detachable sections and barriers to prevent direct skin contact. The device benefits patients by enabling ambulatory sleep monitoring, facilitating diagnosis of sleep-disordered breathing or periodic limb movement disorders.
Clinical Evidence
Two prospective clinical studies were conducted. Study 1 (n=26, age 6+) compared Nlab to gold-standard PSG; results showed no significant differences in primary (AHI) or secondary sleep endpoints (ODI, Snore, Sleep Stages, Position). Study 2 (n=12) validated the SpO2 sensor against arterial HbO2 (70-100% range) per ISO 80601-2-61, yielding an RMSE of 2.53%, with no systematic differences across skin pigmentation or sex.
Technological Characteristics
Wearable, portable physiological signal amplifier. Sensors: EEG, EOG, EMG, ECG, thermistors (airflow), accelerometers (position), plethysmograph (SpO2/pulse), respiratory effort belts. Connectivity: Bluetooth (sensor-to-central), Wi-Fi (central-to-server). Biocompatibility: ISO 10993 compliant. Reusable design with detachable/barrier-protected patient-contact parts. Supplied non-sterile.
Indications for Use
Indicated for patients > 6 years of age for collection and recording of physiological data during polysomnography and sleep disorder studies. Used in supervised (hospital) or unsupervised (home) environments.
Regulatory Classification
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.
Predicate Devices
- Nox Medical, Nox T3 (K082113)
- Dolphin Medical Inc, Dolphin ONE (K040380)
Reference Devices
- DormoTech, DormoTech Vlab (K230148)
- Nellcor Puritan Bennett Inc., OxiMAX-FAST (K021089)
Related Devices
- K230148 — Vlab · Dormotech Medical, Ltd. · Oct 11, 2023
- K243220 — Onera STS 2 (ONERA STS 2) · Onera B.V. · Jul 3, 2025
- K223573 — Onera Sleep Test System (Onera STS) · Onera B.V. · Aug 18, 2023
- K210593 — Onera Sleep Test System (Onera STS) · Onera B.V. · Apr 6, 2022
- K220631 — NomadAir PMU810 · Neurotronics, Inc. · Jul 15, 2022
Submission Summary (Full Text)
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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"
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(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
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# 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)
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary Page 1 of 9
| Date Prepared: | 8-Jan-25 |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DormoTech Medical Ltd.<br>Yitzhak Rabin 21<br>Afula, Israel<br>+972-4-7799729 |
| Sponsor Contact: | Abed Nassir, Head of Firm |
| Submission Contact: | Paul Dryden<br>ProMedic Consulting LLC |
| Propriety or Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Primary Product Code:<br>Regulation Number:<br>Secondary Product Code: | DormoTech Nlab<br>Ventilatory Effort Recorder<br>Ventilatory Effort Recorder<br>MNR<br>21 CFR 868.2375<br>GWL, DQA |
| Reference Device: | NOX Medical, Nox T3, K082113<br>DormoTech, DormoTech Vlab, K230148 |
| Predicate / Reference<br>PPG sensor | Predicate: Dolphin Medical Inc, Dolphin ONE, K040380<br>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
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# 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 Difference (Lower<br>CI, Upper CI) | Limit<br>Upper<br>of<br>Agreement (Lower CI,<br>Upper CI) | Limit<br>Lower<br>of<br>Agreement (Lower CI,<br>Upper CI) |
|------------------------|-----------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| AHI | 0.2875 | 4.05 | -3.475 |
| (events/h) | [-0.5231,1.098] | [2.646,5.454] | [-4.879, -2.071] |
| ODI | -0.1042 | 2.358 | -2.566 |
| (events/h) | [-0.6346,0.4262] | [1.439,3.276] | [-3.485, -1.647] |
| Snore | 1.995 | 11.79 | -7.801 |
| (%) | [-0.2207,4.212] | [7.954,15.63] | [-11.64, -3.963] |
| Sleep Latency | 0.9727 | 15.05 | -13.1 |
| (Minutes) | [-2.211,4.156] | [9.531,20.56] | [-18.61, -7.586] |
| REM Latency | -0.2864 | 12.74 | -18.46 |
| (Minutes) | [-6.393,0.6654] | [6.624,18.85] | [-24.58, -12.35] |
| Wake after Sleep Onset | -2.091 | 12.45 | -16.63 |
| (Minutes) | [-5.381, -1.199] | [6.754,18.15] | [-22.33, -10.94] |
| REM | 0.6045 | 8.552 | -7.343 |
| (%) | [-1.193,2.402] | [5.438,11.67] | [-10.46, -4.229] |
| N1 | -1.659 | 8.151 | -11.47 |
| (%) | [-3.878,0.5602] | [4.308,12] | [-15.31, -7.626] |
| N2 | -1.095 | 7.8 | -9.991 |
| (%) | [-3.108, -0.9169] | [4.315,11.29] | [-13.48, -6.506] |
| N3 | 2.173 | 9.58 | -5.235 |
| (%) | [0.497,3.848] | [6.678,12.48] | [-8.137, -2.332] |
| Wake | -1.127 | 4.97 | -7.224 |
| (%) | [-2.506,0.2519] | [2.581,7.358] | [-9.613, -4.835] |
| Total Sleep Time | 4.00 | 44.23 | -36.23 |
| (Minutes) | [-5.1,13.1] | [28.47,59.99] | [-51.99, -20.47] |
| Sleep Efficiency | -0.1773 | 6.988 | -7.342 |
| (%) | [-1.798,1.444] | [4.18,9.795] | [-10.15, -4.535] |
| Position (Up) | -0.2792 | 2.107 | -2.665 |
| (%) | [-0.7932,0.2348] | [1.216,2.997] | [-3.555, -1.775] |
| Position (Supine) | 1.892 | 10.06 | -6.278 |
| (%) | [0.1316,3.652] | [7.013,13.11] | [-9.326, -3.229] |
| Position (Left) | 0.725 | 6.716 | -5.266 |
| (%) | [-0.5657,2.016] | [4.48,8.951] | [-7.501, -3.03] |
| Position (Right) | -0.3042 | 7.91 | -8.518 |
| (%) | [-2.074,1.465] | [4.845,10.97] | [-11.58, -5.453] |
Conclusion:
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# 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<br>Physiological Signal Amplifier<br>882.1835 | MNR<br>Physiological Signal Amplifier<br>882.1835 | Similar |
| Indications for<br>use | The DormoTech Nlab is a<br>physiological data recorder intended<br>to collect and record data from<br>multiple physiological channels for<br>use by clinical software used in<br>polysomnography and sleep disorder<br>studies. It is intended for use by or on<br>the order of a physician. It is intended<br>for use on patients greater than 6<br>years of age in a supervised (hospital)<br>or unsupervised (home)<br>environments. | The Nox T3 device is intended for<br>ambulatory recording of<br>physiological signals during sleep.<br>The recorded signals are then<br>downloaded to a PC where the signals<br>can be viewed and analyzed by use of<br>the Nox T3 application (Noxturnal).<br>The Nox T3 system is indicated for<br>use in patients greater than 2 years of<br>age.<br>The Nox T3 system is NOT intended<br>for any patient monitoring or<br>automatic diagnosis. The intended<br>environments are hospitals,<br>institutions, sleep centers, sleep<br>clinics, or other test environments,<br>including patient's home.<br>The Nox T3 system is used for<br>patients suspected of suffering from<br>Sleep Disordered Breathing (SDB) or<br>Periodic Limb Movement Disorder<br>(PLMD). | The Indications for Use for the<br>proposed DormoTech Nlab<br>device are identical to those of<br>the predicate device with the<br>exception that use for patients<br>age 6 and older is not excluded<br>in the subject DormoTech Nlab<br>labelling. Bench testing of the<br>proposed DormoTech Nlab was<br>conducted to demonstrate<br>substantial equivalence to the<br>predicate device. The proposed<br>device has the same intended<br>use and employs the same<br>fundamental scientific<br>technology. |
| Population | Patients greater than 6 years of age. | Patients greater than 2 years of age. | Subject device was not verified<br>in patients under 6 years old. |
| Environment of<br>Use | Supervised (hospital) or unsupervised<br>(home) environment | Supervised (hospital) or unsupervised<br>(home) environment | Similar |
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# 510(k) Summary Page 6 of 9
| Principle of Operation | | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Uses sensors to collect signals to be<br>processed by cleared analysis<br>software | Uses sensors to collect signals to be<br>processed by cleared analysis<br>software | Similar |
| Physiological<br>signals collected | EEG, EOG, EMG, ECG<br>Airflow<br>Snore<br>Thoracic and Abdominal Effort<br>Body Position<br>SpO2 sensor and Heart (pulse) Rate<br>from PPG | EEG, EOG, EMG, ECG<br>Airflow<br>Snore<br>Thoracic and Abdominal Effort<br>Body Position<br>Requires separate SpO2 sensor and<br>Heart (pulse) Rate from PPG | Similar |
| Device is | Wearable and portable | Wearable and portable | Similar |
| Prescriptive | Yes | Yes | Similar |
| Non-clinical<br>Testing | Respiratory Signals<br>Total Airflow<br>Snore<br>Respiratory Effort (Thoracic and<br>Abdomen)<br>ExG signals<br>EEG<br>EOG<br>EMG<br>Position Signals<br>Body Position<br>Head Position<br>Plethysmography signal | Total Airflow<br>Snore<br>Respiratory Effort (Thoracic and<br>Abdomen)<br>ExG signals<br>EEG<br>EOG<br>EMG<br>Position Signals<br>Body Position<br>Head Position<br>Plethysmography signal | In a comparative clinical study<br>the results demonstrated that the<br>Nlab was substantially<br>equivalent in measuring the<br>specified parameters.<br><br>The study results can be seen in<br>the previous submission for<br>DormoTech Vlab cleared under<br>K230148.<br><br>For the SpO2 sensor,<br>DormoTech conducted a<br>clinical validation study |
| Features | Subject Device<br>DormoTech Nlab | Reference<br>DormoTech Vlab (K230148) | Comments |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | GWL, MNR<br>Physiological Signal Amplifier<br>882.1835 | GWL, MNR<br>Physiological Signal Amplifier<br>882.1835 | Similar |
| Indications for<br>use | The DormoTech Nlab is a<br>physiological data recorder intended<br>to collect and record data from<br>multiple physiological channels for<br>use by clinical software used in<br>polysomnography and sleep disorder<br>studies. It is intended for use by or on<br>the order of a physician. It is intended<br>for use on patients greater than 6<br>years of age in a supervised (hospital)<br>or unsupervised (home)<br>environments. | The DormoTech Vlab is a<br>physiological data recorder intended<br>to collect and record data from<br>multiple physiological channels for<br>use by clinical software used in<br>polysomnography and sleep disorder<br>studies. It is intended for use by or on<br>the order of a physician. It is intended<br>for use on adults in a supervised<br>(hospital) or unsupervised (home)<br>environment | The Indications for Use for the<br>proposed DormoTech Nlab<br>device are identical to those of<br>the reference device with the<br>exception that use for pediatrics<br>age 6 and older is not excluded<br>in the subject DormoTech Nlab<br>labeling. Bench testing of the<br>proposed DormoTech Nlab was<br>conducted to demonstrate<br>substantial equivalence to the<br>predicate device. The proposed<br>device has the same intended<br>use and employs the same<br>fundamental scientific<br>technology. |
| Population | Patients greater than 6 years of age. | Adults | |
| Environment of<br>Use | Supervised (hospital) or unsupervised<br>(home) environment | Supervised (hospital) or unsupervised<br>(home) environment | Similar |
| Principle of<br>Operation | Uses sensors to collect signals to be<br>processed by cleared analysis<br>software | Uses sensors to collect signals to be<br>processed by cleared analysis<br>software | Similar |
| Physiological<br>signals collected | EEG, EOG, EMG, ECG<br>Airflow<br>Snore<br>Thoracic and Abdominal Effort<br>Body Position<br>SpO2 sensor and Heart (pulse) Rate<br>from PPG | EEG, EOG, EMG, ECG<br>Airflow<br>Snore<br>Thoracic and Abdominal Effort<br>Body Position<br>Requires separate SpO2 sensor and<br>Heart (pulse) Rate from RPG | Added SpO2 sensor, the SpO2<br>has been tested in accordance<br>with ISO 14155 and ISO<br>80601-2-61. |
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# 510(k) Summary
| Device is | Wearable and portable | Wearable and portable | Similar |
|-------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Prescriptive | Yes | Yes | Similar |
| Non-clinical<br>Testing | Respiratory Signals | | Bench testing was performed<br>against the reference which<br>confirmed the signal output. |
| | Total Airflow | Total Airflow | |
| | Snore | Snore | |
| | Respiratory Effort (Thoracic and<br>Abdomen) | Respiratory Effort (Thoracic and<br>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<br>communicating Limited duration<br>< 24 hours | Surface contact and Externally<br>communicating Limited duration<br>< 24 hours | Similar |
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# 510(k) Summary Page 8 of 9
| Features | Subject Device | Predicate<br>Dolphin Medical, Dolphin ONE, K040380 | Reference<br>Nellcor OxiMAX MAX-FAST, K021089 | Comments |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | DormoTech Nlab SpO2 sensor<br>The DormoTech Nlab SpO2 sensor is<br>indicated for use in continuous<br>monitoring of arterial oxygen saturation<br>and pulse rate. | The Dolphin ONE Oximetry Sensors are<br>indicated for use in continuous monitoring<br>of arterial oxygen saturation and pulse rate | The Nellcor OxiMAX adhesive forehead<br>reflectance sensor, model MAX-FAST, is<br>indicated for single-patient use when<br>continuous noninvasive arterial oxygen<br>saturation and pulse rate monitoring are<br>required for adult or pediatric (≥10 kg)<br>patients. | Similar |
| Population | Patients greater than 6 years old | Adults and pediatrics weighing > 30 Kg | Adults and pediatrics weighing > 10 Kg | Similar to reference |
| Environment of<br>Use | Supervised (hospital) or unsupervised<br>(home) environment | Supervised (hospital) or unsupervised<br>(home) environment | Supervised (hospital) or unsupervised<br>(home) environment | Similar |
| Principle of<br>Operation | Pulse oximetry is governed by the<br>principles of a) Oxyhemoglobin<br>(oxygenated blood) and b)<br>deoxyhemoglobin (non-\ oxygenated<br>blood) differ in their absorption of red<br>and infrared light (spectrophotometry).<br>The amount of arterial blood in tissue<br>changes with your pulse<br>(photoplethysmography). Therefore,<br>the amount of light absorbed by the<br>varying quantities of arterial blood<br>changes as well. | Pulse oximetry is governed by the<br>principles of a) Oxyhemoglobin<br>(oxygenated blood) and b)<br>deoxyhemoglobin (non-\ oxygenated blood)<br>differ in their absorption of red and infrared<br>light (spectrophotometry). The amount of<br>arterial blood in tissue changes with your<br>pulse (photoplethysmography). Therefore,<br>the amount of light absorbed by the varying<br>quantities of arterial blood changes as well. | Pulse oximetry is governed by the<br>principles of a) Oxyhemoglobin<br>(oxygenated blood) and b)<br>deoxyhemoglobin (non-\ oxygenated blood)<br>differ in their absorption of red and infrared<br>light (spectrophotometry). The amount of<br>arterial blood in tissue changes with your<br>pulse (photoplethysmography). Therefore,<br>the amount of light absorbed by the varying<br>quantities of arterial blood changes as well. | Similar |
| Type of use | Reusable | Reusable | Single use | Similar to predicate |
| Reprocess<br>protocol | Disposable adhesive sticker is put on<br>forehead SpO2 enclosure | Disposable adhesive<br>disc and headband | NA | Similar to predicate - both have<br>their skin-contacting parts as<br>disposable |
| Measurement<br>Site | Forehead | Forehead | Forehead | Similar |
| Prescriptive | Yes | Yes | Yes | Similar |
| Sterility | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile | Similar |
| Accuracy, ARMS | | | | |
| SpO2 | 70-100%±2.53% | 70-100%±2% | 70-100%±2%…
