Who is the manufacturer of Dreem 3S?

Beacon Biosignals, Inc. filed the 510(k) submission for Dreem 3S (K223539).

What is the FDA product code for Dreem 3S?

OLZ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Dreem 3S?

510(k) clearance (submission type: Traditional).

Does Dreem 3S use AI or machine learning?

Yes. Dreem 3S (K223539) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Dreem 3S?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Dreem 3S get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Dreem 3S

K223539 · Beacon Biosignals, Inc. · OLZ · Aug 18, 2023 · Neurology

Device Facts

Record ID	K223539
Device Name	Dreem 3S
Applicant	Beacon Biosignals, Inc.
Product Code	OLZ · Neurology
Decision Date	Aug 18, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	AI/ML

Intended Use

The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment. The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data.

Device Story

Headband-worn sleep assessment system; utilizes 6 dry EEG electrodes (frontal/occipital) and 3D accelerometer to capture brain activity and head movement. Raw data transmitted to cloud servers for post-sleep analysis. Algorithm performs automatic sleep staging (AASM classification) per 30-second epoch; generates hypnograms and sleep metric reports for healthcare providers. Includes bone-conduction speaker for notifications and LED status indicator. Used in home or clinical environments by adult patients; data reviewed by clinicians to aid sleep disorder diagnosis. Benefits include convenient, non-invasive sleep monitoring outside of traditional sleep labs.

Clinical Evidence

Clinical investigation compared Dreem 3S automated sleep staging against expert-scored PSG in 38 subjects (ages 23-66). Study analyzed 36,447 epochs (approx. 303 hours). Results showed high positive agreement: Wake 88.5%, N2 83.4%, N3 98.2%, REM 91.57%; N1 agreement was 58.0%. EEG data quality study confirmed 96.6% of epochs were acceptable for manual scoring by qualified reviewers. Usability study confirmed successful home use and patient tolerance.

Technological Characteristics

Headband form factor; materials: ABS, soft polyester fabric. Sensors: 6 dry EEG electrodes, 3D accelerometer. Connectivity: Cloud-based analysis. Power: Battery-operated. Software: Artificial neural network for sleep staging. Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-26, 60601-1-6, 62366-1. Biocompatibility: ISO 10993-1, 5, 10.

Indications for Use

Indicated for prescription use in adults (22-65 years) to measure, record, display, transmit, and analyze brain electrical activity to assess sleep and wake states in home or healthcare settings.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

Nox Sleep System (K192469)

Reference Devices

Neuronaute (K170138)

Related Devices

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K142825 — Zmachine · Consolidated Research of Richmond, Inc. · Jan 20, 2015
K231546 — Somfit · Compumedics Limited · Nov 30, 2023
K101830 — ZMACHINE, MODEL DT-100 · Consolidated Research of Richmond, Inc. · Mar 31, 2011
K243220 — Onera STS 2 (ONERA STS 2) · Onera B.V. · Jul 3, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ August 18, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. Beacon Biosignals, Inc. % Delphine Lemoine Regulatory Affairs Project Manager 17-21 rue Saint-Fiacre Paris, 75002, France #### Re: K223539 Trade/Device Name: Dreem 3S Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, OLV Dated: July 19, 2023 Received: July 20, 2023 #### Dear Delphine Lemoine: 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 (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 located 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. 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 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K223539 Device Name Dreem 3S #### Indications for Use (Describe) The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment. The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # dreem ### 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92. #### General Information - Submitter: Beacon Biosignals, Inc. 22 Boston Wharf Rd., 7th Floor, unit 41, Boston, MA 02210 USA Contact Person: Delphine Lemoine Regulatory Affairs project manager 17-21 rue Saint-Fiacre Paris France Date Prepared: 19 July 2023 #### Device Information Trade name: Dreem 3S Common Name: Sleep Assessment System Regulation: 21 CFR 882.1400, Electroencephalograph Product code: OLZ, OLV Device Class: 2 Review Panel: Neurology #### Predicate Device Nox Medical, Nox Sleep System - K192469. Device Description The Dreem 3S headband contains microelectronics, within a flexible case made of plastic, foam, and fabric. It includes 6 EEG electrodes and a 3D accelerometer sensor. {4}------------------------------------------------ The EEG signal is measured by two electrodes in the frontal position) and two at the back of the head (occipital position), along with one reference electrode and one ground electrode. The 3D accelerometer is embedded in the top of the headband to ensure accurate measurements of the wearer's head movement during the night. The raw EEG and accelerometer data are transferred to Dreem's servers for further analysis after the night is over. The device includes a bone-conduction speaker with volume control to provide notifications to the wearer, and a power button circled by a multicolor LED light The device generates a sleep report that includes a sleep staging for each 30-second epoch during the night. This output is produced using an algorithm that analyzes data from the headband EEG and accelerometer sensors. A raw data file is also available in EDF format. The algorithm uses raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification. The algorithm is implemented with an artificial neural network. Frequency spectrums are computed from raw data and then passed to several neural network layers including recurrent layers and attention layers. The algorithm outputs prediction for several epochs of 30 seconds at the same time, every 30 seconds. The various outputs for a single epoch of 30 seconds are combined to provide robust sleep scoring. #### Indication for use The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep in the home or healthcare environment. The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data. #### Technological Characteristics and Comparison The Dreem 3S is substantially equivalent to the Nox Sleep System (K192469) from Nox Medical based on the technological and performance characteristics as described in the summary table below. The subject device Dreem 3S and the predicate Nox Sleep System are both for the assessment of sleep and are both used to measure, record, display, transmit and analyze physiological parameters during sleep and wake in the home and healthcare facility. Both subject and predicate devices are used to aid diagnosis of adult patients with disturbed sleep. Both devices allow for the generation of user/predefined reports based on the subject's data. Both the subject and predicate devices may be used in home and healthcare facilities. Both devices are for prescription use only. #### It is thus concluded that the intended use of the Dreem 3S is substantially equivalent to the Nox Sleep System. The comparison table below is provided as a summary of the most relevant characteristics of the Dreem 3S relative to the primary predicate Nox Sleep System. | Technological | Subject Device | Predicate Device | Comparison to | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | | Predicate Device | | | Device Name | Dreem 3S | Nox Sleep System | N/A | | Manufacturer | Beacon Biosignals, Inc. | NOX MEDICAL | N/A | | 510(k) # | K223539 | K192469 | N/A | | Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 | Same | | Class | 2 | 2 | Same | | Device Classification Name | Automatic Event Detection Software for PSG with EEG | Automatic Event Detection Software For PSG With EEG | Same Like the Predicate Device, the Dreem 3S is composed of a software for automatic analysis and staging of the EEG measurements. | | Product Codes | OLZ, OLV | OLZ, KZM | Same regulation and primary product code 882.1400 | | Portable Design | Yes | Yes | same | | Patient Worn Device | Yes | Yes | same | | Physical dimensions | Head perimeter 540mm to 620mm. One size fits all. Adjustable with XS, S, M, L spacers. | Nox A1 Recorder: 82x63x21 mm Nox C1 Access Point: 135x149x26 mm | same | | Weight | 130g | Nox A1 Recorder: 92 g (120 g with battery) Nox C1 Access Point: 264 g | No significant difference | | Materials | ABS Soft polyester fabric | Plastic, ABS/Polycarbonate blend | Similar materials of construction. | | Method of Connection to Patient | 6 dry electrodes for EEG assessment on the headband. 3D-accelerometer for movement/body position assessment. Bone conduction audio system. | Respiratory bands/belts for respiratory effort. Respiratory bands/belts for attaching the device and clip straps to secure the position of the device Plastic tubing and cannula for pressure sensing. Snap-on electrode cables with snap-on disposable electrodes for EMG/EOG. Thermal flow sensors/thermocouple for measuring nasal/oral airflow. Nox A1 EEG 5 Lead Gold Electrode Cable and Nox A1 | The Dreem 3S only utilizes EEG electrodes unlike the predicate, which has additional inputs which can be selected by the user if needed. The use of only EEG electrodes does not impact the subject device's performance for the intended use in automatic sleep scoring. | | | | | | | | | EEG Head Cable for EEG/EOG. Surface electrode leads for EEG/EOG/EMG. Surface Electrodes for measuring of leg movements. Wrist-worn oximeter and probes for oximetry worn on the finger. | | | Data Analysis | Automatic scoring and derived sleep metrics are provided to the health care provider through a specific report, in a pdf file. Manual analysis and marking are available on raw data. | Yes, by use of Noxturnal PSG SW (PC). Automatic results may be manipulated (manual review/verification must be performed prior to diagnosis). Manual analysis. Event marking (scoring). Technician Notes. | Both devices allow the generation of reports with accurate data analysis and provide access to the patient's raw data. | | #Channels of data recorded | 5 EEG channels from 5 electrodes: Frontal - Occipital Frontal - Occipital Frontal - Frontal | Nox A1 recorder: up to 26 Nox C1 Access Point: up to 16 | The subject device has fewer EEG channels than the predicate device. | | Operating Time | Up to 24 hours | Up to 8 hours | Subject device has longer battery life. | | Sensors | - EEG dry electrodes x6 - Accelerometer | - Nox A1 EEG 5 Lead Gold Electrode Cable - Disposable electrodes for EMG/EOG - Thermal flow sensors / thermocouple - Surface Electrodes for measuring leg movements - Oximeter and probes for oximetry | The Subject Device's sensors are a subset of the Predicate Device's sensors. Also, we note that, while the predicate device does not use dry EEG electrodes, the. Neuronaute (K170138) is an example of a FDA cleared device that does use dry EEG electrodes. | | Recording Time Same as the operating time. Up to 24 hours. | | Up to 8 hours | Subject device has longer recording time | {5}------------------------------------------------ {6}------------------------------------------------ #### Non-Clinical Performance The Dreem 3S has been evaluated against the following electromagnetic compatibility and electrical safety standards: - . IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests {7}------------------------------------------------ - IEC TR 60601-4-2:2016 Medical electrical equipment – Part 4-2: Guidance and interpretation =Electromagnetic immunity: performance of medical equipment and medical electrical systems - . IEC 60601-2-26 Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs The Dreem 3S is intended to be used in the patient's home and has been evaluated against the following electrical safety and performance standard for home healthcare environment: - . IEC 60601-1-11:2015 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 The Dreem 3S has undergone usability testing to comply with standards "IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability" and "IEC 62366-1:2015/Amd1:2020 Medical devices — Part 1: Application of usability engineering to medical devices – Amendment 1". All body contacting components (fabric inside the headband, front and back electrodes, bone conduction, pod) have gone through successful biocompatibility testing according to biocompatibility standards: - ISO 10993-1 Fifth Edition 2018 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process - ISO 10993-5 Third Edition 2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity - ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization #### Clinical Performance The Dreem 3S performance has been assessed through the following investigations: Performance compared to lab PSG. A clinical investigation was completed that compared Dreem 3S sleep staging output with a 510(k)-cleared PSG system in a sleep lab setting on patients with disturbed sleep. This study included 38 subjects ranging from 23 to 66 years old with a mean ± standard deviation age of 35.8 ± 11.6 years. Subjects were equally split between male and female, and included individuals self-identified as White, Black African American, Asian, Hispanic and some not identified. A total of 36447 epochs, corresponding to about 303 hours and 43 minutes of sleep were included the study. Data from this study is summarized in a confusion matrix below in table 2 comparing the performance of the Dreem device with expert-scored sleep stages from a cleared device. Table 3 provides subject-level positive agreement for each stage with bootstrapped confidence interval. {8}------------------------------------------------ Dreem 3S | | Consensus from manual staging | | | | | |----------------------------------|-------------------------------|-------|-------|-------|-------| | | W | N1 | N2 | N3 | REM | | Dreem 3S (Automated analysis) | | | | | | | W | 90.7% | 14.1% | 0.6% | 0.1% | 1.4% | | N1 | 4.4% | 55.2% | 1.8% | 0.0% | 1.0% | | N2 | 0.8% | 21.8% | 83.7% | 2.1% | 2.2% | | N3 | 0.2% | 0.2% | 11.7% | 97.8% | 0.0% | | REM | 3.8% | 8.7% | 2.2% | 0.0% | 90.7% | | Unassigned | 0.01% | 0.0% | 0.0% | 0.0% | 0.0% | | Epoch count | 6719 | 2582 | 17534 | 3922 | 5690 | Table 2: Confusion matrix comparing Dreem 3S and consensus of expert-scored PSG for all sleep epochs is summarized as percentages in the table below. Table 3: Average subject-level positive agreement (PA) per sleep stage of the Dreem 3S compared to the expert-scored PSG with bootstrapped confidence intervals (CI). | Stage | Dreem 3S Positive Agreement with Bootstrapped CI estimates (2.5%, 97.5%) | |-------|--------------------------------------------------------------------------------| | Wake | 88.5% (85.1%, 91.3%) | | N1 | 58.0% (52.7%, 63.0%) | | N2 | 83.4% (80.7%, 85.7%) | | N3 | 98.2% (96.73%, 99.3%) | | REM | 91.57% (86.63%, 95.72%) | EEG data quality. A study was conducted to establish that EEG data quality from Dreem 3S is sufficient for manual review and scoring of data. 96.6% epochs per night of recording were determined to be acceptable for manual scoring and sleep staging by at least two out of three {9}------------------------------------------------ reviewers qualified to read EEG and/or PSG data. All data recordings reviewed had ≥4 hours of data considered to be scoreable by at least two out three reviewers. Usability Study. An investigation was completed to assess usability in the home setting and showed that the device could be successfully used and was tolerated by study subjects. #### Conclusions Based on the comparison to the predicate device and performance studies, the Dreem 3S is substantially equivalent to the currently U.S. legally marketed device Nox Sleep System (K192469) and presents no new concerns about safety or effectiveness.