(159 days)
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 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.
Here's a breakdown of the acceptance criteria and the studies that prove the DormoTech NLab device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are effectively demonstrated by the "good agreement" between the DormoTech NLab and the gold standard PSG, and the acceptable RMSE for the SpO2 sensor.
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Polysomnography (PSG) Parameters (Compared to Gold Standard PSG) | "Good agreement" between devices, mean difference close to zero, and narrow limits of agreement, indicating interchangeability. Performance considered "substantially equivalent." | |
| AHI (events/h) | Mean Difference: 0.2875 | Accepted |
| ODI (events/h) | Mean Difference: -0.1042 | Accepted |
| Snore (%) | Mean Difference: 1.995 | Accepted |
| Sleep Latency (Minutes) | Mean Difference: 0.9727 | Accepted |
| REM Latency (Minutes) | Mean Difference: -0.2864 | Accepted |
| Wake after Sleep Onset (Minutes) | Mean Difference: -2.091 | Accepted |
| REM (%) | Mean Difference: 0.6045 | Accepted |
| N1 (%) | Mean Difference: -1.659 | Accepted |
| N2 (%) | Mean Difference: -1.095 | Accepted |
| N3 (%) | Mean Difference: 2.173 | Accepted |
| Wake (%) | Mean Difference: -1.127 | Accepted |
| Total Sleep Time (Minutes) | Mean Difference: 4.00 | Accepted |
| Sleep Efficiency (%) | Mean Difference: -0.1773 | Accepted |
| Position (Up) (%) | Mean Difference: -0.2792 | Accepted |
| Position (Supine) (%) | Mean Difference: 1.892 | Accepted |
| Position (Left) (%) | Mean Difference: 0.725 | Accepted |
| Position (Right) (%) | Mean Difference: -0.3042 | Accepted |
| SpO2 Sensor Accuracy (Compared to Arterial HbO2 Saturations) | Root Mean Square Error (RMSE) of 2.53% for 70-100% SpO2, which is explicitly stated as being "within the expected range of accuracy" and allowable per ISO 80601-2-61 (up to 4%). | |
| SpO2 Accuracy (70-100%) | RMSE: 2.53% | Accepted |
| Pulse rate (20-250 bpm) | ±3 bpm | Accepted (similar to reference) |
2. Sample Size Used for the Test Set and Data Provenance
- Polysomnography (PSG) Study:
- Sample Size: 24 subjects (out of 26 recruited) completed the study.
- Data Provenance: Prospective clinical study conducted in two sleep labs in Israel (Shamir Medical Center Be'er Ya'akov, and Millenium Sleep Clinic Be'er Sheva).
- SpO2 Sensor Study:
- Sample Size: 12 patients. 259 data points were included in the analysis.
- Data Provenance: Prospective clinical study. No specific country of origin is mentioned, but it's likely part of the overall clinical trials for the device, potentially in Israel as well.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for human-scored parameters in the PSG study. However, the ground truth for the PSG study is based on a "gold standard polysomnogram (PSG) study," which inherently implies scoring by trained sleep specialists.
For the SpO2 sensor study, the ground truth was established by "simultaneous monitoring of arterial HbO2 saturations at six different levels of oxyhemoglobin saturation between 70-100%," which is a direct physiological measurement, not an expert-based ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1) for the human-scored PSG parameters. The mention of "gold standard PSG" suggests that standard clinical scoring practices were followed, which typically involve certified polysomnography technologists scoring sleep studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The study compares the device's readings directly to a gold-standard PSG for the sleep parameters and directly to arterial blood gas measurements for SpO2, not comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
The device is described as 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 implies that the device itself is a data acquisition unit, and its performance is evaluated in terms of its ability to accurately record these physiological signals compared to established methods.
- For PSG parameters: The "DormoTech NLab" is compared to a "gold standard polysomnogram (PSG)." This is a standalone performance evaluation of the device as a data recorder, with the implicit understanding that the data collected by both the NLab and the predicate PSG would then be analyzed by clinical software (or human scorers). The "mean difference" and "limits of agreement" directly assess the NLab's standalone measurement accuracy against the gold standard.
- For SpO2 sensor: The "DormoTech NLab SpO2 sensor" is compared to "arterial HbO2 saturations." This is a standalone performance evaluation of the sensor's accuracy.
7. Type of Ground Truth Used
- Polysomnography (PSG) Parameters: "Gold standard polysomnogram (PSG) study." This refers to a comprehensive sleep study recorded and scored according to established clinical guidelines, serving as the benchmark for various sleep parameters. It's essentially expert-interpreted physiological data.
- SpO2 Sensor: "Arterial HbO2 saturations." This is direct physiological outcomes data obtained through arterial blood gas measurements, which is considered the most accurate measure of blood oxygen saturation.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for any training set. It focuses on the validation studies, which are test sets. This device primarily functions as a physiological data recorder, not necessarily an AI/machine learning algorithm requiring a separate training set in the typical sense. Any internal calibration or algorithm development would likely have used internal datasets, but these are not detailed in this premarket notification.
9. How Ground Truth for the Training Set Was Established
Since no training set details are provided, the method for establishing its ground truth is also not mentioned.
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January 8, 2025
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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,
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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.Yitzhak Rabin 21Afula, Israel+972-4-7799729 |
| Sponsor Contact: | Abed Nassir, Head of Firm |
| Submission Contact: | Paul DrydenProMedic Consulting LLC |
| Propriety or Trade Name:Common/Usual Name:Classification Name:Primary Product Code:Regulation Number:Secondary Product Code: | DormoTech NlabVentilatory Effort RecorderVentilatory Effort RecorderMNR21 CFR 868.2375GWL, DQA |
| Reference Device: | NOX Medical, Nox T3, K082113DormoTech, DormoTech Vlab, K230148 |
| Predicate / ReferencePPG sensor | Predicate: Dolphin Medical Inc, Dolphin ONE, K040380Reference: 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 (LowerCI, Upper CI) | LimitUpperofAgreement (Lower CI,Upper CI) | LimitLowerofAgreement (Lower CI,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 | MNRPhysiological Signal Amplifier882.1835 | MNRPhysiological Signal Amplifier882.1835 | Similar |
| Indications foruse | The DormoTech Nlab is aphysiological data recorder intendedto collect and record data frommultiple physiological channels foruse by clinical software used inpolysomnography and sleep disorderstudies. It is intended for use by or onthe order of a physician. It is intendedfor use on patients greater than 6years of age in a supervised (hospital)or unsupervised (home)environments. | The Nox T3 device is intended forambulatory recording ofphysiological signals during sleep.The recorded signals are thendownloaded to a PC where the signalscan be viewed and analyzed by use ofthe Nox T3 application (Noxturnal).The Nox T3 system is indicated foruse in patients greater than 2 years ofage.The Nox T3 system is NOT intendedfor any patient monitoring orautomatic diagnosis. The intendedenvironments are hospitals,institutions, sleep centers, sleepclinics, or other test environments,including patient's home.The Nox T3 system is used forpatients suspected of suffering fromSleep Disordered Breathing (SDB) orPeriodic Limb Movement Disorder(PLMD). | The Indications for Use for theproposed DormoTech Nlabdevice are identical to those ofthe predicate device with theexception that use for patientsage 6 and older is not excludedin the subject DormoTech Nlablabelling. Bench testing of theproposed DormoTech Nlab wasconducted to demonstratesubstantial equivalence to thepredicate device. The proposeddevice has the same intendeduse and employs the samefundamental scientifictechnology. |
| Population | Patients greater than 6 years of age. | Patients greater than 2 years of age. | Subject device was not verifiedin patients under 6 years old. |
| Environment ofUse | Supervised (hospital) or unsupervised(home) environment | Supervised (hospital) or unsupervised(home) environment | Similar |
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510(k) Summary Page 6 of 9
| Principle of Operation | |||
|---|---|---|---|
| Uses sensors to collect signals to beprocessed by cleared analysissoftware | Uses sensors to collect signals to beprocessed by cleared analysissoftware | Similar | |
| Physiologicalsignals collected | EEG, EOG, EMG, ECGAirflowSnoreThoracic and Abdominal EffortBody PositionSpO2 sensor and Heart (pulse) Ratefrom PPG | EEG, EOG, EMG, ECGAirflowSnoreThoracic and Abdominal EffortBody PositionRequires separate SpO2 sensor andHeart (pulse) Rate from PPG | Similar |
| Device is | Wearable and portable | Wearable and portable | Similar |
| Prescriptive | Yes | Yes | Similar |
| Non-clinicalTesting | Respiratory SignalsTotal AirflowSnoreRespiratory Effort (Thoracic andAbdomen)ExG signalsEEGEOGEMGPosition SignalsBody PositionHead PositionPlethysmography signal | Total AirflowSnoreRespiratory Effort (Thoracic andAbdomen)ExG signalsEEGEOGEMGPosition SignalsBody PositionHead PositionPlethysmography signal | In a comparative clinical studythe results demonstrated that theNlab was substantiallyequivalent in measuring thespecified parameters.The study results can be seen inthe previous submission forDormoTech Vlab cleared underK230148.For the SpO2 sensor,DormoTech conducted aclinical validation study |
| Features | Subject DeviceDormoTech Nlab | ReferenceDormoTech Vlab (K230148) | Comments |
|---|---|---|---|
| Classification | GWL, MNRPhysiological Signal Amplifier882.1835 | GWL, MNRPhysiological Signal Amplifier882.1835 | Similar |
| Indications foruse | The DormoTech Nlab is aphysiological data recorder intendedto collect and record data frommultiple physiological channels foruse by clinical software used inpolysomnography and sleep disorderstudies. It is intended for use by or onthe order of a physician. It is intendedfor use on patients greater than 6years of age in a supervised (hospital)or unsupervised (home)environments. | The DormoTech Vlab is aphysiological data recorder intendedto collect and record data frommultiple physiological channels foruse by clinical software used inpolysomnography and sleep disorderstudies. It is intended for use by or onthe order of a physician. It is intendedfor use on adults in a supervised(hospital) or unsupervised (home)environment | The Indications for Use for theproposed DormoTech Nlabdevice are identical to those ofthe reference device with theexception that use for pediatricsage 6 and older is not excludedin the subject DormoTech Nlablabeling. Bench testing of theproposed DormoTech Nlab wasconducted to demonstratesubstantial equivalence to thepredicate device. The proposeddevice has the same intendeduse and employs the samefundamental scientifictechnology. |
| Population | Patients greater than 6 years of age. | Adults | |
| Environment ofUse | Supervised (hospital) or unsupervised(home) environment | Supervised (hospital) or unsupervised(home) environment | Similar |
| Principle ofOperation | Uses sensors to collect signals to beprocessed by cleared analysissoftware | Uses sensors to collect signals to beprocessed by cleared analysissoftware | Similar |
| Physiologicalsignals collected | EEG, EOG, EMG, ECGAirflowSnoreThoracic and Abdominal EffortBody PositionSpO2 sensor and Heart (pulse) Ratefrom PPG | EEG, EOG, EMG, ECGAirflowSnoreThoracic and Abdominal EffortBody PositionRequires separate SpO2 sensor andHeart (pulse) Rate from RPG | Added SpO2 sensor, the SpO2has been tested in accordancewith ISO 14155 and ISO80601-2-61. |
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510(k) Summary
| Device is | Wearable and portable | Wearable and portable | Similar |
|---|---|---|---|
| Prescriptive | Yes | Yes | Similar |
| Non-clinicalTesting | Respiratory Signals | Bench testing was performedagainst the reference whichconfirmed the signal output. | |
| Total Airflow | Total Airflow | ||
| Snore | Snore | ||
| Respiratory Effort (Thoracic andAbdomen) | Respiratory Effort (Thoracic andAbdomen) | ||
| 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 Externallycommunicating Limited duration< 24 hours | Surface contact and Externallycommunicating Limited duration< 24 hours | Similar |
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510(k) Summary Page 8 of 9
| Features | Subject Device | PredicateDolphin Medical, Dolphin ONE, K040380 | ReferenceNellcor OxiMAX MAX-FAST, K021089 | Comments |
|---|---|---|---|---|
| Indications foruse | DormoTech Nlab SpO2 sensorThe DormoTech Nlab SpO2 sensor isindicated for use in continuousmonitoring of arterial oxygen saturationand pulse rate. | The Dolphin ONE Oximetry Sensors areindicated for use in continuous monitoringof arterial oxygen saturation and pulse rate | The Nellcor OxiMAX adhesive foreheadreflectance sensor, model MAX-FAST, isindicated for single-patient use whencontinuous noninvasive arterial oxygensaturation and pulse rate monitoring arerequired for adult or pediatric (≥10 kg)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 ofUse | Supervised (hospital) or unsupervised(home) environment | Supervised (hospital) or unsupervised(home) environment | Supervised (hospital) or unsupervised(home) environment | Similar |
| Principle ofOperation | Pulse oximetry is governed by theprinciples of a) Oxyhemoglobin(oxygenated blood) and b)deoxyhemoglobin (non-\ oxygenatedblood) differ in their absorption of redand infrared light (spectrophotometry).The amount of arterial blood in tissuechanges with your pulse(photoplethysmography). Therefore,the amount of light absorbed by thevarying quantities of arterial bloodchanges as well. | Pulse oximetry is governed by theprinciples of a) Oxyhemoglobin(oxygenated blood) and b)deoxyhemoglobin (non-\ oxygenated blood)differ in their absorption of red and infraredlight (spectrophotometry). The amount ofarterial blood in tissue changes with yourpulse (photoplethysmography). Therefore,the amount of light absorbed by the varyingquantities of arterial blood changes as well. | Pulse oximetry is governed by theprinciples of a) Oxyhemoglobin(oxygenated blood) and b)deoxyhemoglobin (non-\ oxygenated blood)differ in their absorption of red and infraredlight (spectrophotometry). The amount ofarterial blood in tissue changes with yourpulse (photoplethysmography). Therefore,the amount of light absorbed by the varyingquantities of arterial blood changes as well. | Similar |
| Type of use | Reusable | Reusable | Single use | Similar to predicate |
| Reprocessprotocol | Disposable adhesive sticker is put onforehead SpO2 enclosure | Disposable adhesivedisc and headband | NA | Similar to predicate - both havetheir skin-contacting parts asdisposable |
| MeasurementSite | 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% | Device is not meant to be usedin emergency or life threateningsituations. Device is intended tobe used in sleep disorderscreenings with low risk tousers. ISO 80601-2-61 allowsfor Arms of up to 4% |
| Pulse rate | 20-250±3 bpm | Did not include in submission | 20-250±3 bpm | Similar to reference |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | ISO 10993 compliant | Similar |
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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.
§ 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).