Who is the manufacturer of DROWZLE?

Resonea, Inc. filed the 510(k) submission for DROWZLE (K173974).

What is the FDA product code for DROWZLE?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for DROWZLE?

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

Does DROWZLE use AI or machine learning?

Yes. DROWZLE (K173974) 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 DROWZLE?

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 DROWZLE 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.

DROWZLE

K173974 · Resonea, Inc. · MNR · Jul 14, 2019 · Anesthesiology

Device Facts

Record ID	K173974
Device Name	DROWZLE
Applicant	Resonea, Inc.
Product Code	MNR · Anesthesiology
Decision Date	Jul 14, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Obstructive Sleep Apnea (OSA) screening	—	—	Sensitivity of 93.7% and specificity of 63% (AHI > 15)	Sound recordings from 242 individuals collected in 2015-2016; separate recording cohorts used to develop and validate the algorithm.	—	NCT03288376: 242 individuals undergoing clinically indicated sleep study compared against PSG.	—

Indications for Use

DROWZLE is indicated to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required

Device Story

DROWZLE is a mobile software application for home-based sleep apnea prescreening. It uses the native microphone of a user's smartphone to record sleep breathing sounds. The device captures audio data, which is uploaded to a secure cloud server for analysis. The system processes these sound files alongside patient-provided profile data and standardized questionnaires (STOP-BANG, Epworth Sleepiness Scale). The algorithm identifies respiratory events by detecting gaps in breathing sounds (>10 seconds) and calculates a 'Resonea Index'. The output is a report provided to the patient and/or healthcare provider via the app or email. Clinicians use these results to determine the necessity for further diagnostic evaluation, such as full polysomnography. The device benefits patients by providing an accessible, non-contact method to assess sleep-related health risks.

Clinical Evidence

Clinical study (NCT03288376) conducted 2015-2016 in three AASM-accredited labs with 242 subjects (≥21 years). Sound recordings were collected via consumer mobile devices during in-lab PSG. Performance metrics for AHI >15: sensitivity 93.7%, specificity 63%.

Technological Characteristics

Stand-alone software medical device; operates on iOS (v10.0+) smartphones. Uses native smartphone microphone for acoustic sensing. Cloud-based analysis. No direct patient contact. No biocompatibility, electrical, or EMC testing required as it is software-only.

Indications for Use

Indicated for adults with suspected obstructive sleep apnea (OSA) or sleep breathing disorders for home-based prescreening. Not for use when sleep stages, limb movements, or EEG activity are required.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

SleepStrip II (K112822)

Reference Devices

Silent Night 1 (K963597)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 14, 2019 Resonea, Inc. % Melissa Walker President & CTO Graematter Inc 1324 Clarkson Clayton Center #332 St Louis, Missouri 63011 Re: K173974 Trade/Device Name: Drowzle sleep apnea prescreening device Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: June 16, 2019 Received: June 18, 2019 ### Dear Melissa Walker: 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 {1}------------------------------------------------ 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 (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, James Lee Assistant Director DHT1C: Division of ENT, 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K173974 #### Device Name DROWZLE sleep apnea prescreening device #### Indications for Use (Describe) DROWZLE is indicated to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for >> obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected = = = possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. 100 The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required Type of Use (Select one or both, as applicable) > 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." EF Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ ## DROWZLE Substantial Equivalence - 510(k) Summary | Submitter's information | Contact: Melissa Walker | |------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Resonea, Inc 11445 E Via Linda, Suite 2 Box 224 Scottsdale AZ 85259 | 11445 E Via Linda, Suite 2 Box 224 Scottsdale AZ 85259 (314) 753-7790 Date: July 12, 2019 | Device/ classification name The new device trade name and common name are: · Trade Name: DROWZLE sleep apnea prescreening device • Common Name: Ventilatory Effort Recorder | 21 CFR Reference | Product Code | Class | Generic Device Name | Classification Description | |---------------------|-----------------|-------|--------------------------------|--------------------------------| | §868.2375 | MNR | 2 | Ventilatory Effort Recorder | Breathing frequency monitor | Predicate The predicate device for the DROWZLE screening device is described in the table device(s) below. | K Number | Product Code | Class | Device Name | Indications for Use | |-------------|-----------------|-------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K112822 | MNR | 2 | Sleep Strip II | The SleepStrip II is intended to measure apnea hypopnea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings. | Device DROWZLE is a mobile software used to collect symptom data for sleep apnea description risk, including severity of daytime sleepiness and personal chronic disease risk factors. DROWZLE also records sleep breathing patterns and sends the sound files to secure servers in the cloud. DROWZLE then analyzes and interprets the sleep breathing results, along with the profile data provided by the individual, to measure and track sleep-related health risks over time. Continued on next page {4}------------------------------------------------ ## DROWZLE Substantial Equivalence Summary, Continued patients for sleep apnea syndrome. The device is home, hospital or facility intended to be used by adult patients as physician in either prescribed by a use settings. | Indications for use | DROWZLE is indicated to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. | | | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technology | DROWZLE is a stand-alone software medical device. It operates on a mobile computing device with an Apple iPhone 7, iPhone 8 or iPhone X using iOS v10.0 or later. Breathing sounds during sleep are recorded using the microphone within the mobile device. The sound file is uploaded to a cloud server for analysis using the results of standard questionnaires and a proprietary algorithm. A report is generated and provided to the individual and/or their healthcare provider. Reports are provided within the mobile application and/or via email. | | | | Function: | Predicate Device K112822 Sleep Strip II | New Device DROWZLE | Reference Device K963597 Silent Night 1 | | Intended Use | Home-use device for screening patients with possible sleep disorders | Home-use device for screening patients with possible sleep disorders | Home-use device for screening patients with possible sleep disorders | | Indications for Use | The SleepStrip II is intended to measure apnea hypopnea events during sleep for the purpose of prescreening | DROWZLE is indicated to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for | The Silent Night I is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea | | Function: | Predicate Device K112822 Sleep Strip II | New Device DROWZLE | Reference Device K963597 Silent Night 1 | | Trade/Device Name | SleepStrip II | DROWZLE | Silent Night I | | Regulation Number | §868.2375 | §868.2375 | §868.2375 | | Regulation Name | Ventilatory Effort Recorder | Ventilatory Effort Recorder | Ventilatory Effort Recorder | | Product Code | MNR | MNR | MNR | | Target Population | Adults | Adults | Adults | | Intended Environment for Use | Home environment | Home environment | Home environment | | Method of Measurement | Pressure/flow sensor; thermal sensor | Acoustic analysis of breathing sound | Acoustic analysis of breathing sound | | Mode of Action | Analyzes airflow and temperature | Analyzes sound to identify respiratory events indicative of sleep apnea or other disorders | Analyzes sound to identify respiratory events indicative of sleep apnea or other disorders | | Sensor placement site | Rests over the lip, under the nose | Smartphone placed within 24 inches of pillow | Microphone #1 is placed near the patient to capture breathing sounds. Microphone #2 is contained in the device to sense ambient room noise. | | Sensor elements | 3 prongs - two nasal and one oral | Microphone(s) native to smartphone | Microphones | | Patient Contact | Yes | Software only. No direct patient contact. | No patient contact during use. Contact with the recording device during set up. | | Portability | Yes | Yes | Yes | | Recording device | Contained in the device | Mobile device records sound and uploads them into a cloud-based server | Recording device is housed in a metal box consisting of hardware and software. | | Measured variable | Oral and nasal airflow | Oral and nasal breath sounds | Oral and nasal breath sounds | | Breathing events | Respiration amplitude drops >10 seconds | Breath sound gaps >10 seconds | | | Function: | Predicate Device K112822 Sleep Strip II | New Device DROWZLE | Reference Device K963597 Silent Night 1 | | Sensor attachment | Stick-on adhesive- backed | NA | NA | | Display type | LED display | Smartphone display | Liquid crystal display | | Breathing Indicator | Blinking light display | None | Not described | | Signal loss indicator | Yes, on display | NA | Not described | | Breathing interruption counter | 126 per hour maximum | No maximum | Not described | | Generates a calculated index based on breathing | AHI per sleep period | • Counts gaps in breathing sounds • Calculates Resonea Index | • Counts "Disordered Breathing Events" • Calculates "Respiratory Disturbance Index (RDI)" | | Reported Metrics | Counts apnea/hypopnea events | Output: • Number of breathing sound gaps >10 seconds • Average number of >10 second breathing sound gaps per hour • Risk classification based on standard questionnaires: • STOP-BANG • Epworth Sleepiness Scale • Calculated Resonea Index | Output: • Cumulative count of Disordered Breathing Events including snoring, hypopnea, and apnea. | | Display function | Result display element | Results are reported to the clinician and patient • Within the mobile device software and • PDF format for printing via email | Results reported on a liquid crystal display. There is no printing capability. | | Sleep night use | Single night monitoring | Can be used multiple nights | Single night monitoring | | Maximum run- time | 5 hours | No maximum run time | Not described | | Minimum time required | 3 hours | 2 hours | Not described | | Controller | Hardware and firmware | Smartphone microprocessor | Internal to the box | | Airflow signal conditioning | Filtered and digitized | NA | Not described | | Function: | Predicate Device K112822 Sleep Strip II | New Device DROWZLE | Reference Device K963597 Silent Night 1 | | Sampling method | Analog to digital conversion | NA | Not described | | Sample rate | 10 per second continuous | NA | Not described | | Breathing interruption detection criterion | Signal decrease 10 seconds or longer | Breath sounds absent 10 seconds or longer | Not described | | Monitor application | Patient self-applied | NA | NA | | Download | None – display readout only | Wireless transmission of data to cloud storage for report generation | None – display readout only | | Physical Characteristics | Small, non-tether monitor | Software runs on user's smartphone | Box with 2 microphones. 23 cm wide X 17 cm deep X 7.5 cm high | | Power | Battery | Smartphone plugged into wall outlet with built-in battery backup | Plugged into wall outlet | | Clinical Studies | Clinically tested against PSG | Clinically tested against PSG | Clinically tested against PSG | obstructive sleep apnea device is designed for use (OSA) syndrome. The in home-screening of adults with suspected possible sleep breathing to assist the healthcare determining the need for further diagnosis and professional in evaluation. disorders. Results are used It is intended to record a designed for use in home screening of adults with possible sleep disorders. patient's respiratory pattern. The device is {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ Non-clinical As a stand-alone software device non-clinical testing included software performance verification and validation testing. Usability testing demonstrated the data ability of the users to understand the labeling; correctly use the software for recording; and correctly interpret the report. > The DROWZLE software runs on a user-provided mobile device. No biocompatibility testing, electrical safety, or electromagnetic compatibility testing was required. Clinical Sound recordings from 242 individuals ≥ 21 years of age undergoing performance clinically indicated sleep study to assess sleep disordered breathing were data collected as part of an IRB-approved clinical study. The study was conducted from 2015-2016 in three AASM accredited laboratories in the United States (NCT03288376). > Each subject had sound recordings from one or more consumer mobile computing device placed on the bedside during PSG. Recordings were made using the standard audio recording function of each device. Separate recording cohorts were used to develop and validate the algorithm used in DROWZLE. {8}------------------------------------------------ # DROWZLE Substantial Equivalence Summary, Continued | Substantial Equivalence discussion | The new device has the same intended use as the predicate device. Both are intended to be used for identification of adults who may be at risk for sleep apnea and may require further clinical assessment and diagnosis. | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The new device relies on a different technological assessment to assess the risk of sleep apnea. The predicate device measures nasal and oral air flow and the new device uses the sound generated by that air flow to identify breathing events. Information about a cleared device using the same technology is provided in the comparison table above. | | | The new device was tested against the results of in-lab PSG, providing a sensitivity of 93.7% and specificity of 63% (AHI>15). The inclusion of the results from validated sleep apnea risk questionnaires reinforces the effectiveness by providing additional means of assessing risk, further reducing the potential for false negative results. | | Conclusions | Based on the similarity in function and clinical performance, it is concluded that DROWZLE is substantially equivalent to the predicate device. |

DROWZLE

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