Who is the manufacturer of Sunrise?

Sunrise SA filed the 510(k) submission for Sunrise (K222262).

What is the FDA product code for Sunrise?

QRS. It is classified under 21 CFR 868.2376 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Sunrise?

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

Who can help prepare an FDA 510(k) submission like Sunrise?

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.

Sunrise

Q: What are the predicate devices for Sunrise?

Sunrise Sleep Disorder Diagnostic Aid (DEN210015).

K222262 · Sunrise SA · QRS · Dec 22, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K222262
Device Name	Sunrise
Applicant	Sunrise SA
Product Code	QRS · Ear, Nose, Throat
Decision Date	Dec 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2376
Device Class	Class 2

Intended Use

The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

Device Story

Sunrise is a cloud-based diagnostic aid for obstructive sleep apnea (OSA) evaluation in home settings. The system utilizes a wearable sensor (Sunrise sensor 2) placed on the patient's chin using adhesive. The sensor captures mandibular movement (via accelerometer/gyroscope), SpO2 and pulse rate (via PPG), and airflow (via thermistor). Data is recorded on-board and processed by proprietary cloud-based software. The software analyzes these inputs to detect respiratory events, identify sleep stages, and determine body position. It generates sleep parameters, including AHI (Apnea-Hypopnea Index), ORDI (Oxygen-Respiration Disturbance Index), and sleep architecture metrics. Results are compiled into a report for review by a healthcare provider to assist in clinical decision-making regarding sleep disorder diagnosis. The device benefits patients by providing a non-invasive, home-based alternative to traditional polysomnography (PSG).

Clinical Evidence

Four clinical studies were conducted. Three retrospective studies (n=289, n=31, n=10) compared device-derived sleep parameters (TST, AHI, ORDI) and position accuracy against PSG. Results showed high agreement; sensitivity for OSA severity (AHI>=5, 15, 30) ranged 0.81-1.00 and specificity 0.75-1.00. A fourth study validated SpO2 and pulse rate accuracy per ISO 80601-2-61:2019 (SpO2 rms 2.70% for 70-100% range; pulse rate rms 1.95 bpm for 51-104 bpm range). Thermistor airflow capture was validated as equivalent to PSG oronasal thermal sensors.

Technological Characteristics

Wearable chin-mounted sensor; materials include housing, PPG window, and adhesives (ISO 10993-1 compliant). Sensors: accelerometer, gyroscope, PPG, thermistor. Power: non-rechargeable lithium coin battery. Connectivity: on-board memory for data storage, cloud-based analysis. Software: moderate level of concern, proprietary algorithm for respiratory event detection and sleep staging. Electrical safety: IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare).

Indications for Use

Indicated for patients 18 years and older with suspected sleep breathing disorders to aid in the evaluation of obstructive sleep apnea (OSA).

Regulatory Classification

Identification

A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.

Predicate Devices

Sunrise Sleep Disorder Diagnostic Aid (DEN210015)

Reference Devices

NightOwl (K191031)
SOMNOscreen plus (K201054)

Related Devices

K250874 — Sunrise · Sunrise SA · Aug 29, 2025
DEN210015 — Sunrise Sleep Disorder Diagnostic Aid · Sunrise · Jan 7, 2022
K243092 — AcuPebble Ox (200) · Acurable Limited · Mar 19, 2025
K220028 — NightOwl · Ectosense NV · Feb 24, 2022
K110705 — APNEA RISK EVALUATION SYSTEM (ARES) · Advanced Brain Monitoring, Inc. · Apr 14, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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. December 22, 2022 Sunrise SA Gregoire Lejeune R&D project manager Chaussee de Marche 598/02 Namur, 5101 Belgium Re: K222262 Trade/Device Name: Sunrise Regulation Number: 21 CFR 868.2376 Regulation Name: Device For Sleep Apnea Testing Based On Mandibular Movement Regulatory Class: Class II Product Code: QRS Dated: November 14, 2022 Received: November 18, 2022 Dear Gregoire Lejeune: 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 {1}------------------------------------------------ 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 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 (OS) 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 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, # Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number K22262 Device Name Sunrise #### Indications for Use (Describe) The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders. | 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}------------------------------------------------ # 510(K) SUMMARY ## 1. SUBMITTER Sunrise SA Chaussée de Marche 598/02 5101 Namur Belgium Phone: +32 81 26 11 26 Contact Person: Grégoire Lejeune Date Prepared: December 22, 2022 ## 2. DEVICE Name of Device: Sunrise Common or Usual Name: Sleep apnea testing Classification Name: Device for sleep apnea testing based on mandibular movement Regulatory Class: II Product Code: QRS Regulation: 21 CFR 868.2376 Classification Panel: Anesthesiology ## 3. PREDICATE DEVICE Predicate Device: Sunrise Sleep Disorder Diagnostic Aid (DEN210015) Reference Devices: NightOwl (K191031), SOMNOscreen plus (K201054) ## 4. DEVICE DESCRIPTION The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider. {4}------------------------------------------------ ## 5. INDICATIONS FOR USE The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders. ## 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The Sunrise software, subject of the De Novo DEN210015 with the Sunrise sensor 1, is now compatible with the Sunrise sensor 2. The Sunrise algorithm, component of the Sunrise software, has been updated to provide new sleep parameters. The Sunrise sensor 2 presents the same features as the Sunrise sensor 1, with the following improvements: - Addition of a PPG sensor to provide SpO2 and pulse rate measurement; ● - Addition of a thermistor to provide airflow measurement; ● - Battery for up to three nights of recording (compared to one night for the Sunrise sensor 1): - On-board memory to record raw data for transfer at the end of the night. ● | Item | Subject device Sunrise | Predicate device Sunrise sleep disorder diagnostic aid (DEN210015) | Reference device 1 NightOwl (K191031) | Reference device 2 SOMNOscreen plus (K201054) | Comparison | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use/indication s for use | The Sunrise medical device is a non- invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders. | The Sunrise SDDA device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders. | The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting | The SOMNOscreen® plus is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders. The device is a non- life-supporting physiological signal recording device intended to be used for studies testing adults and | Same as predicate device | | Item | Subject device | Predicate device | Reference device 1 | Reference device 2 | Comparison | | | Sunrise | Sunrise sleep disorder diagnostic aid (DEN210015) | NightOwl (K191031) | SOMNOscreen plus (K201054) | | | | | | use under the direction of a Healthcare Professional (HCP). | children/adolescents suspected of having sleep-related breathing disorders. This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers. | | | Target population | 18 years and older | 18 years and older | 22 years and older | 2 years and older | Same as predicate device | | Type of use | Prescription | Prescription | Prescription | Prescription | Same as predicate device | | Intended use environment | Home | Home | Home | Clinical or home | Same as predicate device | | Wearable sensor location | Chin | Chin | Fingertip | Multiple locations including chin and fingertip | Same as predicate device | | Sensors | Accelerometer Gyroscope PPG (Sunrise sensor 2 only) Thermistor (Sunrise sensor 2 only) | Accelerometer Gyroscope | Accelerometer PPG | Multiple sensors including accelerometer, PPG and thermistor | Same as predicate device for accelerometer and gyroscope, same as reference device 1 for PPG and same as reference device 2 for thermistor | | Channels | Mandibular movements Discrete position SpO2 (Sunrise sensor 2 only) Pulse rate (Sunrise sensor 2 only) | Mandibular movements Discrete position | PAT SpO2 Pulse rate | Multiple channels including discrete position, SpO2, pulse rate and airflow | Same as predicate device for mandibular movements and discrete position, same as reference device 1 for SpO2 and pulse rate and same | | Item | Subject device Sunrise | Predicate device | Reference device 1 | Reference device 2 | Comparison | | | | Sunrise sleep disorder diagnostic aid (DEN210015) | NightOwl (K191031) | SOMNOscreen plus (K201054) | | | | Airflow (Sunrise sensor 2 only) | | | | as reference device 2 for airflow | | Size and weight | 42x17x6mm - 3g (Sunrise sensor 1) 40x22x12mm - 8g (Sunrise sensor 2) | 42x17x6mm - 3g | 19x28x11mm - 6g | Multiple sensors of different sizes and weights | Same as predicate device (Sunrise sensor 1) Substantially equivalent to predicate device (Sunrise sensor 2) | | Raw data recording | Streamed to smartphone (Sunrise sensor 1) or on-board memory (Sunrise sensor 2) | Streamed to smartphone | Streamed to smartphone or on-board memory | Streamed to computer or on- board memory | Same as predicate device (Sunrise sensor 1) Substantially equivalent to predicate device and same as reference device 1 (Sunrise sensor 2) | | Power supply | Non- rechargeable lithium coin battery | Non- rechargeable lithium coin battery | Rechargeable lithium ion battery | Rechargeable lithium ion battery | Same as predicate device | | User interface | Smartphone and computer | Smartphone and computer | Smartphone and computer | Computer | Same as predicate device | | Patient contact type | In contact with intact skin surfaces for limited duration | In contact with intact skin surfaces for limited duration | In contact with intact skin surfaces for limited duration | In contact with intact skin surfaces for limited duration | Same as predicate device | | Wearable sensor software | Firmware is limited to control the recording and communication s processes | Firmware is limited to control the recording and communication s processes | Firmware is limited to control the recording and communication s processes | Firmware is limited to control the recording and communications processes | Same as predicate device | | Analysis software | Analysis performed off the recording device, exclusively | Analysis performed off the recording device, exclusively | Analysis performed off the recording device, exclusively | Analysis performed off the recording by the proprietary software | Same as predicate device | | Item | Subject device Sunrise | Predicate device Sunrise sleep disorder diagnostic aid (DEN210015) | Reference device 1 NightOwl (K191031) | Reference device 2 SOMNOscreen plus (K201054) | Comparison | | | the proprietary software | the proprietary software | the proprietary software | | | | Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same as predicate device | | Reported parameters | TST, SOL, WASO, SE, awakening index, ArI, light/deep/REM sleep, REM sleep latency, AHI, AHI supine, AHI non supine, AHI REM, AHI NREM, ORDI, ORDI supine, ORDI non supine, ORDI REM, ORDI NREM, RDI, OAHI, CAHI, AHI (4%), RERA index, RE, sleep time in supine position and sleep time in non supine position SpO2 and pulse rate statistics (Sunrise sensor 2 only) | TST, SOL, WASO, SE, ArI, ORDI, sleep time in supine position and sleep time in non supine position | TST, REM sleep, AHI, AHI (4%), SpO2 and pulse rate statistics | TST, SOL, WASO, SE, awakening index, ArI, light/deep/REM sleep, REM sleep latency, AHI, AHI supine, AHI non supine, AHI REM, AHI NREM, ORDI, ORDI supine, ORDI non supine, ORDI REM, ORDI NREM, RDI, OAHI, CAHI, AHI (4%), RERA index, RE, sleep time in supine position, sleep time in non supine position, SpO2 and pulse rate statistics | Same as predicate device for TST, SOL, WASO, SE, ArI, ORDI, sleep time in supine position and sleep time in non supine position, same as reference device 1 for TST, REM sleep, AHI, AHI (4%), SpO2 and pulse rate statistics, and same as reference device 2 for TST, SOL, WASO, SE, awakening index, ArI, light/deep/RE M sleep, REM sleep latency, AHI, AHI supine, AHI non supine, AHI REM, AHI NREM, ORDI, ORDI supine, ORDI non supine, ORDI REM, ORDI NREM, RDI, OAHI, CAHI, AHI (4%), RERA index, RE, sleep time in supine position, sleep time in non supine | | Item | Subject device Sunrise | Predicate device Sunrise sleep disorder diagnostic aid (DEN210015) | Reference device 1 NightOwl (K191031) | Reference device 2 SOMNOscreen plus (K201054) | Comparison | | | | | | | non supine position, SpO2 and pulse rate statistics | | Pulse rate accuracy and measurement range | Accuracy (rms value) was found to be 1.95 beats per minute (bpm) for a claimed measurement range of 51 to 104 bpm (Sunrise sensor 2 only) | Not applicable | Accuracy (rms) value was found to be 2.26 beats per minute (bpm) for a claimed measurement range of 50 to 118 bpm | Claimed measurement range of 18 to 300 beats per minute (bpm) | Substantially equivalent to reference device 1 | | Means of attachment | Adhesives | Adhesives | Adhesives | Multiple means including adhesives | Same as predicate device | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # 7. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility The device includes four patient-contacting components which are in contact with the skin of the chin of the patient during the sleep study: housing, PPG window, double-sided adhesive and additional adhesive bandage. Biocompatibility evaluation was conducted, and documentation was provided as recommended by the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process". ### Software The device has a moderate level of concern software component. Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA guidance document Guidance for the Content of Premarket Submissions for Software contained in Medical Devices. Documentation was provided in accordance with the FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Device to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle. {9}------------------------------------------------ ### Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted on the device to demonstrate compliance with IEC 60601-1 standard for safety, IEC 60601-1-2 standard for EMC and IEC 60601-1-11 standard for home healthcare environment. #### Bench Testing Bench testing was conducted to demonstrate technical equivalency between the subject device and the predicate device. The measured signals of the accelerometer and of the gyroscope between the two sensors were compared and performance found to be equivalent. #### Clinical Studies The primary objective of the first three clinical studies was to compare the agreement of sleep parameters between the device and the gold-standard PSG. The algorithm was used to analyze sensor data and evaluate the performance of the device compared to PSG. The performance of the device for sleep parameters was evaluated by Bland-Altman analysis and percentiles-based limits of agreement (LOA) against pre-determined thresholds of clinical acceptability. The performance of the device for OSA severity output was evaluated as standard diagnostic metrics compared to the PSG at three different AHI cut-offs. The first clinical study was a retrospective, comparative and open study performed in Belgium in 289 patients. Median measurement bias and LOA were -4.50 min (-41.74 to +35.67), -0.46 event/h (-13.52 to +9.00) and +0.15 event/h (-10.70 to +10.12) for TST, AHI and ORDI. respectively. Performance for OSA severity was as following: sensitivity of 0.99, 0.92, 0.81 and specificity of 0.86, 0.94 and 0.99 for AHI>=5, AHI>=15 and AHI>=30, respectively. The second clinical study was a retrospective, comparative and open study performed in France in 31 patients. Median measurement bias and LOA were -10.50 min (-37.42 to +25.79), +0.20 event/h (-12.30 to +6.30) and +1.01 event/h (-11.24 to +6.21) for TST, AHI and ORDI, respectively. Performance for OSA severity was as following: sensitivity of 1.00, 0.94, 0.87 and specificity of 0.75, 1.00 and 1.00 for AHI>=5, AHI>=15 and AHI>=30. respectively. The third clinical study was a retrospective, comparative and open study performed in Belgium in 10 patients. The performance of the device for position discrete states was evaluated as global accuracy compared to the PSG: 93%. For the fourth clinical study, SpO2 and pulse rate accuracies for the Sunrise sensor 2 were validated in accordance with ISO 80601-2-61:2019 201.12.1.101.2 and Annex EE.2 as recommended by the FDA guidance document Pulse Oximeters - Premarket Notification Submissions [510(k)s]. The SpO2 accuracy (rms value) was found to be 2.70% over the range of 70-100%. The pulse rate accuracy (rms value) was found to be 1.95 beats per minute (bpm) for a claimed measurement range of 51 to 104 bpm. In addition, a validation study was conducted to demonstrate the ability of the Sunrise {10}------------------------------------------------ sensor 2 thermistor to capture airflow. The signal measured by the Sunrise sensor 2 thermistor was compared to that of an oronasal thermal airflow sensor used in PSG and the performance was found to be equivalent for capturing breathing patterns. # 8. CONCLUSION Based on the performance data, the Sunrise device is as safe and as effective as the predicate device and performs equivalently. Therefore, the Sunrise device is substantially equivalent to the predicate device.