(265 days)
No
The summary describes a physiological data recorder and its performance in comparison to a gold standard PSG. There is no mention of AI, ML, or related terms in the device description, intended use, or performance study summaries. The focus is on data collection and comparison of physiological parameters.
No.
The device is described as a "physiological data recorder" and its intended use is to "collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies." There is no mention of it providing any form of therapy or treatment.
No.
Explanation: The device is described as a "physiological data recorder intended to collect and record data from multiple physiological channels." While this data is used for polysomnography and sleep disorder studies, the device itself is a data acquisition tool, not a diagnostic tool that provides a diagnosis or output such as "disease detected" or "negative for disease." The interpretation of the collected data by clinical software or a physician is what leads to a diagnosis.
No
The device description explicitly states it "consists of: The Head Unit, The Body Unit, and The Central Unit," indicating physical hardware components beyond just software.
Based on the provided information, the DormoTech Vlab is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- DormoTech Vlab's Function: The DormoTech Vlab is described as a "physiological data recorder." Its purpose is to collect and record physiological data from the patient's body (head, chest, stomach) using multiple channels.
- Data Use: The collected data is then used by "clinical software used in polysomnography and sleep disorder studies." This indicates the device is collecting in vivo (within the living body) data, not in vitro (outside the living body) specimens.
- Lack of Specimen Examination: There is no mention of the device examining any bodily fluids or tissues.
The DormoTech Vlab falls under the category of a physiological monitoring device used for diagnostic purposes in sleep studies, but it does not meet the definition of an IVD.
N/A
Intended Use / Indications for Use
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 is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Product codes
GWL, MNR
Device Description
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 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). Head relative 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, 1 EMG sensor, along with snoring sensor.
The Body Unit
The body unit is made of 2 belts, the upper belt sits on the chest, and 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 Central Unit
Both the head and chest units communicate with the central units via Bluetooth, the wearable units send the measured data to the central unit. The central unit receives the data, it stores it within an internal Flash drive and then transmits the data via Wi-Fi to online servers for further diagnosis. Central unit, located in the test room (up to 10 meters from the patient). No contact with the patient.
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)
- Respiratory Effort ●
- Snoring Sensor ●
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), chest, and stomach.
Indicated Patient Age Range
Adults, 22 years and older
Intended User / Care Setting
Intended for use by or on the order of a physician. Intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical Study:
Study design: An IEC approved, comparative, self-controlled, randomized, prospective study designed to assess the Vlab and compare its performance to a gold standard polysomnogram (PSG) conducted over 1 night in a sleep lab.
Study Locations:
- Shamir Medical Center – Be'er Ya'akov, Israel
- Millenium Sleep Clinic - Be'er Sheva, Israel
Patient Population: - Adults 22 years and older
- Male and female
- 47 subjects
The participants were patients who were referred by physicians for a full sleep study at the sleep laboratory.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical:
Substantial equivalence to the predicate is based upon performance testing on collecting, recording and transferring data as well as the following:
- Biocompatibility
- Software Verification and Validation
- Electrical Safety
- Electromagnetic Compatibility Compliance
- Product Requirements Verification
- Consumables Verification
Clinical:
A prospective clinical study was performed compared to a gold standard PSG study.
Study design: An IEC approved, comparative, self-controlled, randomized, prospective study designed to assess the Vlab and compare its performance to a gold standard polysomnogram (PSG) conducted over 1 night in a sleep lab.
Sample Size: 47 subjects.
Key Results: The table provides a comprehensive comparison between two devices across multiple sleep-related 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, this table offers a nuanced understanding of the performance and reliability of the Dormotech Vlab device when compared to the gold-standard PSG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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]
Mean Difference, Upper Limit of Agreement, Lower Limit of Agreement provided for each of the above parameters.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
October 11, 2023
FDA U.S. FOOD & DRUG
ADMINISTRATION
DormoTech Medical Ltd. % Paul Dryden Consultant ProMedic Consulting, LLC 131 Bay Point Dr. NE Saint Petersburg, Florida 33704
Re: K230148
Trade/Device Name: Vlab Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, MNR Dated: September 11, 2023 Received: September 11, 2023
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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).
Sincerely,
Patrick Antkowiak -S
for Jay Gupta Assistant Director
2
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)
K230148
Device Name
DormoTech Vlab
Indications for Use (Describe)
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 is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Type of Use (Select one or both, as applicable)
7XX Prescription Use (Part 21 CFR 801 Subpart D)
█ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20) 443-6740
Page 1 of 1
SC Publishing Services (301)
4
| Date Prepared: | 11-Sep-2023 |
|---|---|
| Sponsor: | DormoTech Medical Ltd. Yitzhak |
| Rabin 21 | |
| Afula, Israel |
- 972-4-7799729 |
| Sponsor Contact: | Abed Nassir, Head of Firm |
| Submission Contact: | Paul Dryden
ProMedic, LLC |
| Proprietary or Trade Name:
Common/Usual Name:
Classification Name:
Product Code
Regulation Number | DormoTech Vlab
Physiological Signal Amplifier
Physiological Signal Amplifier
GWL, MNR
21 CFR 882.1835 |
| Predicate Device:
Reference Device: | Respironics, Alice PDx, K090484
NOX, Nox Sleep System,
K102469 |
Device Description:
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 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). Head relative 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, 1 EMG sensor, along with snoring sensor.
The Body Unit
The body unit is made of 2 belts, the upper belt sits on the chest, and 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 Central Unit
Both the head and chest units communicate with the central units via Bluetooth, the wearable units send the measured data to the central unit. The central unit receives the data, it stores it within an internal Flash drive and then transmits the data via Wi-Fi to online servers for further diagnosis. Central unit, located in the test room (up to 10 meters from the patient). No contact with the patient.
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)
- Respiratory Effort ●
- Snoring Sensor ●
5
Indications for Use:
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 is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Patient Population:
Adults, 22 years and older
Substantial Equivalence:
The subject device, DormoTech Vlab, is substantially equivalent to the Respironics Alice PDx cleared under K090484 when compared to a cleared PSG system, the NOX Sleep system, K192496.
Performance Testing:
Non-clinical
Substantial equivalence to the predicate is based upon performance testing on collecting, recording and transferring data as well as the following.
- Biocompatibility
- Software Verification and Validation
- Electrical Safety
- Electromagnetic Compatibility Compliance
- . Product Requirements Verification
- . Consumables Verification
Clinical
We performed a prospective clinical study compared to a gold standard PSG study.
Summarizing the clinical study:
Study design:
An IEC approved, comparative, self-controlled, randomized, prospective study designed to assess the Vlab 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:
- Adults 22 years and older ●
- Male and female .
- 47 subjects .
The participants were patients who were referred by physicians for a full sleep study at the sleep laboratory.
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]
6
510(k) Summary Page 3 of 8
| Parameter | Mean Difference
(Lower CI, Upper
CI) | Upper Limit of
Agreement (Lower CI,
Upper CI) | Lower Limit of
Agreement
(Lower
Upper CI) |
|-------------------------------------|--------------------------------------------|-----------------------------------------------------|----------------------------------------------------|
| AHI
(events/h) | -0.1927
(-1.323, 0.9372) | 6.823
(4.866, 8.78) | -7.209
(-9.166, -5.252) |
| ODI
(events/h) | -0.3244
(-1.108, 0.4597) | 4.544
(3.186, 5.902) | -5.193
(-6.551, -3.835) |
| Snore (%) | 1.085
(-0.525, 2.523) | 10.01
(7.524, 12.5) | -7.843
(-10.33, -5.353) |
| Sleep Latency (Minutes) | 4.653
(-0.9411, 10.25) | 38.01
(28.32, 47.7) | -28.7
(-38.39, -19.01) |
| REM Latency | -15.64
(-25.95, -5.327) | 44.98
(27.12, 62.85) | -76.27
(-94.13, -58.4) |
| Wake after Sleep Onset
(Minutes) | -4.300
(-10.53, 1.926) | 31.77
(20.98, -42.55) | -40.37
(-51.15, -29.58) |
| REM (%) | 0.4816
(-0.801, 1.764) | 8.129
(5.908, 10.35) | -7.166
(-9.388, -4.945) |
| N1 (%) | 0.3263
(-1.839, 2.492) | 13.24
(9.488, 16.99) | -12.59
(-16.34, -8.836) |
| N2 (%) | -2.484
(-5.084, 0.1152) | 13.02
(8.513, 17.52) | -17.98
(-22.49, -13.48) |
| N3 (%) | 1.011
(-0.07236, 2.093) | 7.468
(5.592, 9.343) | -5.447
(-7.322, -3.571) |
| Wake (%) | 0.1972
(-1.301, 1.696) | 8.877
(6.282, 11.47) | -8.483
(-11.08, -5.887) |
| Total Sleep Time (Minutes) | 0.72222
(-6.869, 8.313) | 44.69
(31.55, 57.84) | -43.25
(-56.4, -30.1) |
| Sleep Efficiency (%) | -0.03333
(-1.536, 1.47) | 8.673
(6.07, 11.28) | -8.74
(-11.34, -6.136) |
| Position (Up) (%) | 0.01316
(-0.4649, 0.4913) | 2.864
(2.036, 3.692) | -2.838
(-3.666, -2.01) |
| Position (Supine) (%) | 0.9974
(-0.3433, 2.338) | 8.991
(6.669, 11.31) | -6.997
(-9.319, -4.675) |
| Position (Left) (%) | 0.3579
(-0.9967, 1.712) | 8.435
(6.089, 10.78) | -7.719
(-10.07, -5.373) |
| Position (Right) (%) | -0.3974
(-1.61, 0.8149) | 6.831
(4.732, 8.931) | -7.626
(-9.726, -5.526) |
a d
Conclusion:
The table above provides a comprehensive comparison between two devices across multiple sleep-related 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, this table offers a nuanced understanding of the performance and reliability of the Dormotech Vlab device when compared to the gold-standard PSG.
7
510(k) Summary Page 4 of 8
Table 1 – Comparison of Predicate
| Features | Subject Device | Predicate | Comments |
|---|---|---|---|
| DormoTech Vlab | Alice PDx - K090484 | ||
| Classification | GWL, MNR | ||
| Physiological Signal Amplifier | |||
| 882.1835 | GWL, MNR, DQA | ||
| Physiological Signal Amplifier | |||
| 882.1835 | |||
| Indications for use | 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 Alice PDx 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. | Similar | ||
| Population | Adults | Adults | Similar |
| 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 | |||
| Requires separate 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 | Bench testing was performed | |
| against the reference which | |||
| confirmed the signal output. | |||
| Then all measured parameters | |||
| were compared in clinical study to | |||
| NOX Sleep System - K192469 | |||
| Total Airflow | |||
| Snore | |||
| Respiratory Effort (Thoracic & Abdominal) | |||
| Features | Subject Device | Predicate | Comments |
| DormoTech Vlab | Alice PDx - K090484 | ||
| EXG Signals | |||
| EEG | |||
| EOG | |||
| EMG | |||
| Position Signals | |||
| Body Position | |||
| Head Position | |||
| From recommended Nonin SpO2 sensor | From recommended Nonin SpO2 sensor | ||
| Biocompatibility | Surface contact and Externally communicataing | ||
| Limited duration |