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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the DreamClear device and focuses on establishing substantial equivalence to a predicate device (Nomad Sleep System Recorder) and a reference device (Alice PDx) for physiological signal amplification. It primarily discusses the device's intended use, functionality, and compliance with general medical device safety standards.

Crucially, this document does NOT contain information about a study that proves the device meets specific performance acceptance criteria related to its accuracy in aiding the diagnosis of sleep disorders (e.g., measuring sleep stages, apnea events, etc.). The text explicitly states: "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." This "bench data" refers to electrical and electromagnetic safety and performance testing, not clinical performance for diagnosis.

Therefore, I cannot fulfill most of your request based on the provided text, as the information regarding specific acceptance criteria for diagnostic performance, a test set, expert involvement, and MRMC studies is absent.

However, I can extract the following relevant information:

Device Name: DreamClear

Device Type: Physiological Signal Amplifier (specifically for sleep studies)

Intended Use: To collect, amplify, and transmit physiological signals (EEG, EOG, limb movement, respiration effort, air pressure, SpO2) for various medical diagnostic procedures, primarily for use with polysomnography software to aid in the diagnosis of sleep disorders.

Here's an attempt to answer your questions based on the limited information provided, and where the information is not present in the text, I will explicitly state that.

Acceptance Criteria and Device Performance (Based on Provided Text)

As the document focuses on substantial equivalence for a physiological signal amplifier rather than a diagnostic algorithm, the acceptance criteria mentioned are primarily related to its ability to collect, amplify, and transmit signals in a physiological range, and its compliance with safety and usability standards.

1. A table of acceptance criteria and the reported device performance

Since the document describes the type of testing performed (bench testing for signal amplification, and usability), but does not provide specific quantitative acceptance criteria or precise performance metrics in a table format, a direct table cannot be created.

However, the general performance claim is:

Acceptance Criterion (Inferred)	Reported Device Performance
Adequate amplification of physiological signals	"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." "Produces signals in a physiological range."
Usability in a home setting by lay users	"A usability study established that DreamClear could effectively be used in a home setting by lay users."
Compliance with electrical & electromagnetic safety standards	Adherence to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, and ANSI AAMI ES60601-1. (This implies it meets the safety and essential performance requirements outlined in these standards, including those related to signal fidelity and absence of harmful interference, but specific quantitative performance thresholds from these tests are not provided.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "bench data" and a "usability study." Bench testing typically involves laboratory setups, not patient data in the sense of a clinical test set. The usability study would have involved human participants, but the number is not provided.
Data Provenance: Not specified. "Bench data" suggests laboratory testing rather than clinical patient data. For the usability study, the origin of participants (e.g., country) is not mentioned.
Retrospective or Prospective: Not specified. "Bench data" implies a controlled, non-clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable for the described studies. The testing described (bench data for signal amplification sufficiency and a usability study) does not involve establishing ground truth for diagnostic purposes in the way you might for an AI algorithm interpreting medical images or signals. The device is an amplifier, not an interpreter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No ground truth establishment for diagnostic performance is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document does not describe an MRMC study. The DreamClear device is a physiological signal amplifier, not an AI that aids human readers in interpretation. It outputs raw physiological signals for third-party polysomnography software and physician interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly in the context of signal amplification. The "bench data" testing of the DreamClear device's ability to amplify physiological signals is a standalone performance evaluation of the hardware's function. However, this is not a diagnostic standalone performance. The device itself does not interpret or diagnose; it provides the raw data for interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of diagnostic ground truth. For the stated purpose of the device (signal amplification), the "ground truth" would be the known input signals used in bench testing to verify the amplified output, adhering to engineering and signal processing principles. For the usability study, the ground truth would be user feedback and observed user behavior against defined usability metrics.

8. The sample size for the training set

Not applicable. This device is a hardware physiological signal amplifier, not an AI/ML diagnostic algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a hardware physiological signal amplifier, not an AI/ML diagnostic algorithm that requires a training set.

Summary

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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"

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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,

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

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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.

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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510(k) Summary

Submitted by REMware
Address: 601 South Harbor Island Boulevard, Suite 109Tampa, 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.

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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	SubstantialEquivalenceComments
510(k) Owner	Neurotronics, Inc.	Respironics Inc., Sleep & HomeRespiratory Group	SomnoMedTechnologies 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 intendedto amplify and recordphysiologic potentialsused forpolysomnography orsleep studies. Thedevice is intended foruse on both adultsand children underthe direction of aphysician or qualifiedsleep technician.	The device is intended to amplify andrecord physiologic potentials used forpolysomnography or sleep studies. Thedevice is intended for use on adultsunder the direction of a physician orqualified sleep technician.	DreamClear is intendedto amplify and transmitphysiologic potentialsused forpolysomnography andrelated diagnosticprocedures, other thanapnea monitoring or lifesupport. DreamClear isintended for use on bothadults and childrenunder the direction of aphysician, qualifiedsleep technician or othermedical professional.	Generally, sameas predicate withadditional language from"Indications for Use"excluding apneamonitoring and lifesupport.
PatientPopulation	Adults and Children	Adults	Adults and Children	Same aspredicate.
Environment ofUse	Various	Use in both supervised (hospital) orunsupervised (home) environments	Use in both supervised(hospital) orunsupervised (home)environments	Same aspredicate andreference.
Number ofChannels	Records 11 channels:2 effort, 2 flow, bodyposition, SpO2, Plethwave, heart rate, legmovements and 1 DCchannel	Ten (10) base channels, and up totwenty-one (21) channels with optionalECG 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 RateΟ Plethysmograph	Records 6 or 8 channels:• EEG, EOG• Nasal airflow• Snore(Microphone),Respiratory• Thoracic Effort,• Body Position,• Pulse Oximetry,including:Ο SpO2Ο Pulse Rate	Differences inchannels andsignals does notpresentdifferences insafety andeffectiveness.
SignalAmplification	Produces signals in aphysiological range.	Produces signals in a physiologicalrange.	Produces signals in aphysiological range.	Same aspredicate andreference.
Interface	Wireless Bluetooth	Secure Digital (SD) Card	Wireless Bluetooth	Same aspredicate.
Data Storage	On system	On system (storage on SD card)	Storage on patientphone	Storage onpatient phonedoes not presentdifferences insafety andeffectiveness.
Sterility	Nonsterile	Nonsterile	Nonsterile	Same aspredicate andreference.

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Substantial equivalence was also established through a testing protocol that used bench data to evaluate the performance of DreamClear. Testing demonstrated that DreamClear amplified

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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.

Regulation Number and Section

§ 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).