No
The document describes a physiological signal amplifier and data system. It explicitly states that the data may be exported for optional display and analysis using third-party software products, and the performance studies focus on signal amplification and usability, not algorithmic analysis. There is no mention of AI, ML, or any form of automated data interpretation within the device itself.
No.
The document states that DreamClear is intended to collect, amplify, and transmit physiological signals for diagnostic procedures, specifically to aid in the diagnosis of sleep disorders. It does not mention any therapeutic capabilities for treating or alleviating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders" and "may be used to amplify physiological signals for any medical diagnostic procedure". The "Device Description" also mentions it captures and streams data "for remote data analysis and diagnosis of sleep disorders."
No
The device description explicitly states that DreamClear is a "physiological signal amplifier" and includes physical components like a chest belt, pulse oximeter, and nasal cannula, as well as analog and digital sensor interface circuits. This indicates it is a hardware device with accompanying software, not a software-only medical device.
Based on the provided text, the DreamClear device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside of the body. The DreamClear device collects physiological signals directly from the patient's body (EEG, EOG, respiration, SpO2, etc.).
- The intended use is to collect, amplify, and transmit physiological signals for diagnostic procedures, primarily sleep disorders. This involves monitoring the body's functions in real-time or near real-time, not analyzing samples in a lab setting.
- The device description focuses on sensors and signal processing for physiological parameters. It doesn't mention any components or processes related to analyzing biological samples.
Therefore, the DreamClear device falls under the category of a physiological signal amplifier and medical device data system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile.
While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve:
- use alone as an apnea monitor or as a critical component in an apnea monitoring system; or
- use alone as a life support device or as a critical component of a life support system.
Product codes (comma separated list FDA assigned to the subject device)
GWL, MNR, DQA
Device Description
DreamClear is a physiological signal amplifier and medical device data system that captures and streams various physiological parameters via Bluetooth for remote data analysis and diagnosis of sleep disorders. DreamClear features analog sensor interface circuits for Electroencephalograph (EEG), Electrooculography (EOG) and Electromyography (EMG) signals. Additionally, the device includes digital sensor interface circuits for nasal and oral airflow (breathing pattern), microphone (snoring), heart rate and blood oxygen saturation with pulse oximeter (SpO2).
The DreamClear may be used in either a Basic Kit or Extended Kit configuration. The DreamClear device in its Basic Kit configuration includes the chest belt, pulse oximeter, and nasal cannula. The Basic Kit configuration has the following channels: thoracic effort, nasal pressure, pulse rate, SpO2, body position, and snore. The data recorded by the Basic Kit may be exported for optional display and analysis using third-party software products.
When the DreamClear device is used in the Extended Kit configuration, the additional channels of EEG and EOG are used, which gives the DreamClear a total of eight (8) channels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and Children
Intended User / Care Setting
Intended for use on the order of a physician.
Use in both supervised (hospital) or unsupervised (home) environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was also established through a testing protocol that used bench data to evaluate the performance of DreamClear. Testing demonstrated that DreamClear amplified physiological signals sufficient for use with polysomnography software to aid in the diagnosis of sleep disorders, which is substantially equivalent to the intended use of the predicate Nomad device. A usability study established that DreamClear could effectively be used in a home setting by lay users. Testing, therefore, demonstrated that DreamClear is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Neurotronics, Inc., Nomad Sleep System Recorder, Model PMU800 (K092699)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Respironics, Inc., Alice PDx (K090484)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
September 4, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SomnoMed Technologies Inc., doing business as REMware % Seth Mailhot Partner Husch Blackwell LLP 1801 Pennyslvania Avenue, N.W., Suite 1000 Washington, District of Columbia 20006
Re: K240646
Trade/Device Name: DreamClear Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, MNR, DQA Dated: August 5, 2024 Received: August 5, 2024
Dear Seth Mailhot:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K240646
Device Name
DreamClear
Indications for Use (Describe)
DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile.
While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve:
-
use alone as an apnea monitor or as a critical component in an apnea monitoring system; or
-
use alone as a life support device or as a critical component of a life support system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
e-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
| Submitted by REMware |
|---|
| Address: 601 South Harbor Island Boulevard, Suite 109 |
| Tampa, FL 33602 |
| Telephone: (813) 364-2670 |
| Contact Name: Arun Ramabadran, CEO |
August 2, 2024 Date Submitted:
| Trade Name: | DreamClear |
|---|---|
| Common Name: | Physiological Signal Amplifier |
Primary Product Code / Regulation: GWL (21 C.F.R. 882.1835)
Secondary Product Codes: MNR, DQA
Predicate Device: Neurotronics, Inc., Nomad Sleep System Recorder, Model PMU800 (K092699)
Reference Device: Respironics, Inc., Alice PDx (K090484)
- Description: DreamClear is a physiological signal amplifier and medical device data system that captures and streams various physiological parameters via Bluetooth for remote data analysis and diagnosis of sleep disorders. DreamClear features analog sensor interface circuits for Electroencephalograph (EEG), Electrooculography (EOG) and Electromyography (EMG) signals. Additionally, the device includes digital sensor interface circuits for nasal and oral airflow (breathing pattern), microphone (snoring), heart rate and blood oxygen saturation with pulse oximeter (SpO2).
The DreamClear may be used in either a Basic Kit or Extended Kit configuration. The DreamClear device in its Basic Kit configuration includes the chest belt, pulse oximeter, and nasal cannula. The Basic Kit configuration has the following channels: thoracic effort, nasal pressure, pulse rate, SpO2, body position, and snore. The data recorded by the Basic Kit may be exported for optional display and analysis using third-party software products.
When the DreamClear device is used in the Extended Kit configuration, the additional channels of EEG and EOG are used, which gives the DreamClear a total of eight (8) channels.
- Indications for Use: DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals acquired from a patient, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile.
5
While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve:
- use alone as an apnea monitor or as a critical component in an apnea ● monitoring system; or
- . use alone as a life support device or as a critical component of a life support system.
Substantial equivalence of DreamClear is similar in intended use Substantial Equivalence: and functionality to the Nomad Sleep System Recorder, Model PMU800, manufactured by Neurotronics, Inc. (K092699), a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram. The Alice PDx. manufactured by Respironics Inc., (K090484), a ventilatory effort recorder capable of measuring bio-potential signals that may be incorporated into a Polysomnogram, is included as a reference device to support the optional addition of EEG and EOG channels.
| Functionality | Predicate - Nomad
(K092699) | Reference - Alice PDx (K090484) | Submission -
DreamClear | Substantial
Equivalence
Comments |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner | Neurotronics, Inc. | Respironics Inc., Sleep & Home
Respiratory Group | SomnoMed
Technologies Inc. | N/A |
| Functionality | Predicate - Nomad (K092699) | Reference – Alice PDx (K090484) | Submission – DreamClear | Substantial Equivalence Comments |
| Indications for Use | The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram. The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Respiration Effort, and SpO2. The data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep disorders. This device is not to be used alone as an apnea monitor or as a critical component in an apnea monitoring system. This device is intended for use on both adults and children on the order of physician. This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system. The device is not sterile. | 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. | DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals acquired from a patient, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile.
While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve:
use alone as an apnea monitor or as a critical component in an apnea monitoring system; or use alone as a life support device or as a critical component of a life support system. | Indications for use is essentially the same as the predicate, with minor differences in wording and the identification of additional physiological signals amplified by DreamClear (EEG, EOG and air pressure). |
| Functionality | Predicate - Nomad
(K092699) | Reference - Alice PDx (K090484) | Submission – DreamClear | Substantial Equivalence Comments |
| Intended Use | The device is intended
to amplify and record
physiologic potentials
used for
polysomnography or
sleep studies. The
device is intended for
use on both adults
and children under
the direction of a
physician or qualified
sleep technician. | The device is intended to amplify and
record physiologic potentials used for
polysomnography or sleep studies. The
device is intended for use on adults
under the direction of a physician or
qualified sleep technician. | DreamClear is intended
to amplify and transmit
physiologic potentials
used for
polysomnography and
related diagnostic
procedures, other than
apnea monitoring or life
support. DreamClear is
intended for use on both
adults and children
under the direction of a
physician, qualified
sleep technician or other
medical professional. | Generally, same
as predicate with
additional language from
"Indications for Use"
excluding apnea
monitoring and life
support. |
| Patient
Population | Adults and Children | Adults | Adults and Children | Same as
predicate. |
| Environment of
Use | Various | Use in both supervised (hospital) or
unsupervised (home) environments | Use in both supervised
(hospital) or
unsupervised (home)
environments | Same as
predicate and
reference. |
| Number of
Channels | Records 11 channels:
2 effort, 2 flow, body
position, SpO2, Pleth
wave, heart rate, leg
movements and 1 DC
channel | Ten (10) base channels, and up to
twenty-one (21) channels with optional
ECG and ExG yokes:
• EEG, EOG, EMG, ECG
• Nasal/oral Airflow
• Snore
• Thoracic and Abdominal Effort
• Body Position
• Pulse Oximetry, including:
Ο Oxygen Saturation
(SpO2)
Ο Pulse Rate
Ο Plethysmograph | Records 6 or 8 channels:
• EEG, EOG
• Nasal airflow
• Snore
(Microphone),
Respiratory
• Thoracic Effort,
• Body Position,
• Pulse Oximetry,
including:
Ο SpO2
Ο Pulse Rate | Differences in
channels and
signals does not
present
differences in
safety and
effectiveness. |
| Signal
Amplification | Produces signals in a
physiological range. | Produces signals in a physiological
range. | Produces signals in a
physiological range. | Same as
predicate and
reference. |
| Interface | Wireless Bluetooth | Secure Digital (SD) Card | Wireless Bluetooth | Same as
predicate. |
| Data Storage | On system | On system (storage on SD card) | Storage on patient
phone | Storage on
patient phone
does not present
differences in
safety and
effectiveness. |
| Sterility | Nonsterile | Nonsterile | Nonsterile | Same as
predicate and
reference. |
6
7
Substantial equivalence was also established through a testing protocol that used bench data to evaluate the performance of DreamClear. Testing demonstrated that DreamClear amplified
8
physiological signals sufficient for use with polysomnography software to aid in the diagnosis of sleep disorders, which is substantially equivalent to the intended use of the predicate Nomad device. A usability study established that DreamClear could effectively be used in a home setting by lay users. Testing, therefore, demonstrated that DreamClear is substantially equivalent to the predicate device.
In addition to the comparisons in this chart, DreamClear follows the requirements of the following recognized consensus standards for electrical and electromagnetic safety, as provided in the section titled "Declaration of Conformity to a Recognized Standard":
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance - Collateral standard: Usability;
- IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-● 11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment; and
- . ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
For these reasons. DreamClear is considered substantially equivalent to the Nomad predicate device.