(562 days)
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.
DROWZLE is a mobile software used to collect symptom data for sleep apnea 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.
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.
Here's a breakdown of the acceptance criteria and the study proving the Drowzle sleep apnea prescreening device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on the clinical performance against Polysomnography (PSG) rather than explicit acceptance criteria in a tabular format. However, the key performance metrics are stated:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (AHI > 15) |
|---|---|---|
| Sensitivity | High (to avoid false negatives) | 93.7% |
| Specificity | Moderate to High | 63% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Sound recordings from 242 individuals.
- Data Provenance:
- Country of Origin: United States. The study was conducted in "three AASM accredited laboratories in the United States."
- Retrospective/Prospective: Prospective. The study "collected as part of an IRB-approved clinical study" during which "Each subject had sound recordings from one or more consumer mobile computing device placed on the bedside during PSG." This indicates data was collected specifically for this study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. It states that DROWZLE was "tested against the results of in-lab PSG." Polysomnography (PSG) is the gold standard for sleep apnea diagnosis, and it is typically scored by trained polysomnography technologists and interpreted by board-certified sleep physicians. While the number and expertise of these individuals are not explicitly listed, the "AASM accredited laboratories" designation implies that qualified personnel were involved in generating the PSG ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set beyond stating that results were compared against in-lab PSG. Given that PSG itself is the ground truth, an explicit adjudication of the PSG results is not typically needed in this context, assuming standard clinical practices were followed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or detailed in the provided text. The study described compares the device's performance to PSG, not the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The study assesses the DROWZLE algorithm's ability to identify sleep apnea risk by analyzing sound recordings and comparing its output (sensitivity and specificity) directly against PSG results. The device "analyzes and interprets the sleep breathing results, along with the profile data provided by the individual," implying an automated, algorithm-only performance.
7. The Type of Ground Truth Used
The ground truth used was Polysomnography (PSG), which is the clinical gold standard for diagnosing sleep disordered breathing.
8. The Sample Size for the Training Set
The document states: "Separate recording cohorts were used to develop and validate the algorithm used in DROWZLE." However, it does not provide the specific sample size for the training set. It only mentions the total number of individuals from whom sound recordings were collected for the entire study (242), which may have been split into training and validation cohorts.
9. How the Ground Truth for the Training Set was Established
The document implies that the ground truth for both the training and validation cohorts was established using Polysomnography (PSG). It states, "Each subject had sound recordings from one or more consumer mobile computing device placed on the bedside during PSG." This suggests that for both the development and validation of the algorithm, the PSG data served as the reference standard.
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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
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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
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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)
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DROWZLE Substantial Equivalence - 510(k) Summary
| Submitter's information | Contact: Melissa Walker |
|---|---|
| Resonea, Inc11445 E Via Linda, Suite 2Box 224Scottsdale AZ 85259 | 11445 E Via Linda, Suite 2Box 224Scottsdale AZ 85259(314) 753-7790Date: 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 CFRReference | ProductCode | Class | Generic DeviceName | ClassificationDescription |
|---|---|---|---|---|
| §868.2375 | MNR | 2 | Ventilatory EffortRecorder | Breathing frequencymonitor |
Predicate The predicate device for the DROWZLE screening device is described in the table device(s) below.
| KNumber | ProductCode | Class | DeviceName | Indications for Use |
|---|---|---|---|---|
| K112822 | MNR | 2 | SleepStrip II | The SleepStrip II is intended tomeasure apnea hypopnea eventsduring sleep for the purpose ofprescreening patients for sleep apneasyndrome. The device is intended tobe used by adult patients asprescribed by a physician in eitherhome, 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
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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 foruse | DROWZLE is indicated to record a patient's respiratory pattern during sleepfor the purpose of prescreening patients for obstructive sleep apnea (OSA)syndrome. The device is designed for use in home-screening of adults withsuspected possible sleep breathing disorders. Results are used to assist thehealthcare professional in determining the need for further diagnosis andevaluation.The system is not intended as a substitute for full polysomnography whenadditional parameters such as sleep stages, limb movements, or EEGactivity are required. | ||
|---|---|---|---|
| Technology | DROWZLE is a stand-alone software medical device. It operates on amobile computing device with an Apple iPhone 7, iPhone 8 or iPhone Xusing iOS v10.0 or later.Breathing sounds during sleep are recorded using the microphone withinthe mobile device. The sound file is uploaded to a cloud server for analysisusing the results of standard questionnaires and a proprietary algorithm. Areport is generated and provided to the individual and/or their healthcareprovider. Reports are provided within the mobile application and/or viaemail. | ||
| Function: | Predicate DeviceK112822 Sleep Strip II | New DeviceDROWZLE | Reference DeviceK963597 Silent Night 1 |
| Intended Use | Home-use device forscreening patients withpossible sleep disorders | Home-use device forscreening patients withpossible sleep disorders | Home-use device forscreening patients withpossible sleep disorders |
| Indications forUse | The SleepStrip II isintended to measureapnea hypopnea eventsduring sleep for thepurpose of prescreening | DROWZLE is indicated torecord a patient'srespiratory pattern duringsleep for the purpose ofprescreening patients for | The Silent Night I isindicated for use in thediagnostic evaluation ofadults with possibleObstructive Sleep Apnea |
| Function: | Predicate DeviceK112822 Sleep Strip II | New DeviceDROWZLE | Reference DeviceK963597 Silent Night 1 |
| Trade/DeviceName | SleepStrip II | DROWZLE | Silent Night I |
| RegulationNumber | §868.2375 | §868.2375 | §868.2375 |
| RegulationName | Ventilatory EffortRecorder | Ventilatory Effort Recorder | Ventilatory EffortRecorder |
| Product Code | MNR | MNR | MNR |
| TargetPopulation | Adults | Adults | Adults |
| IntendedEnvironmentfor Use | Home environment | Home environment | Home environment |
| Method ofMeasurement | Pressure/flow sensor;thermal sensor | Acoustic analysis ofbreathing sound | Acoustic analysis ofbreathing sound |
| Mode of Action | Analyzes airflow andtemperature | Analyzes sound to identifyrespiratory eventsindicative of sleep apneaor other disorders | Analyzes sound to identifyrespiratory eventsindicative of sleep apneaor other disorders |
| Sensorplacement site | Rests over the lip, underthe nose | Smartphone placed within24 inches of pillow | Microphone #1 is placednear the patient tocapture breathing sounds.Microphone #2 iscontained in the device tosense ambient roomnoise. |
| Sensorelements | 3 prongs - two nasal andone oral | Microphone(s) native tosmartphone | Microphones |
| Patient Contact | Yes | Software only. No directpatient contact. | No patient contact duringuse. Contact with therecording device duringset up. |
| Portability | Yes | Yes | Yes |
| Recordingdevice | Contained in the device | Mobile device recordssound and uploads theminto a cloud-based server | Recording device ishoused in a metal boxconsisting of hardwareand software. |
| Measuredvariable | Oral and nasal airflow | Oral and nasal breathsounds | Oral and nasal breathsounds |
| Breathingevents | Respiration amplitudedrops >10 seconds | Breath sound gaps >10seconds | |
| Function: | Predicate DeviceK112822 Sleep Strip II | New DeviceDROWZLE | Reference DeviceK963597 Silent Night 1 |
| Sensorattachment | Stick-on adhesive-backed | NA | NA |
| Display type | LED display | Smartphone display | Liquid crystal display |
| BreathingIndicator | Blinking light display | None | Not described |
| Signal lossindicator | Yes, on display | NA | Not described |
| Breathinginterruptioncounter | 126 per hour maximum | No maximum | Not described |
| Generates acalculatedindex based onbreathing | AHI per sleep period | • Counts gaps in breathingsounds• Calculates ResoneaIndex | • Counts "DisorderedBreathing Events"• Calculates "RespiratoryDisturbance Index(RDI)" |
| ReportedMetrics | Counts apnea/hypopneaevents | Output:• Number of breathingsound gaps >10 seconds• Average number of >10second breathing soundgaps per hour• Risk classification basedon standardquestionnaires:• STOP-BANG• Epworth SleepinessScale• Calculated ResoneaIndex | Output:• Cumulative count ofDisordered BreathingEvents includingsnoring, hypopnea, andapnea. |
| Displayfunction | Result display element | Results are reported to theclinician and patient• Within the mobiledevice software and• PDF format for printingvia email | Results reported on aliquid crystal display.There is no printingcapability. |
| Sleep night use | Single night monitoring | Can be used multiplenights | Single night monitoring |
| Maximum run-time | 5 hours | No maximum run time | Not described |
| Minimum timerequired | 3 hours | 2 hours | Not described |
| Controller | Hardware and firmware | Smartphonemicroprocessor | Internal to the box |
| Airflow signalconditioning | Filtered and digitized | NA | Not described |
| Function: | Predicate DeviceK112822 Sleep Strip II | New DeviceDROWZLE | Reference DeviceK963597 Silent Night 1 |
| Samplingmethod | Analog to digitalconversion | NA | Not described |
| Sample rate | 10 per secondcontinuous | NA | Not described |
| Breathinginterruptiondetectioncriterion | Signal decrease 10seconds or longer | Breath sounds absent 10seconds or longer | Not described |
| Monitorapplication | Patient self-applied | NA | NA |
| Download | None – display readoutonly | Wireless transmission ofdata to cloud storage forreport generation | None – display readoutonly |
| PhysicalCharacteristics | Small, non-tethermonitor | Software runs on user'ssmartphone | Box with 2 microphones.23 cm wide X 17 cm deepX 7.5 cm high |
| Power | Battery | Smartphone plugged intowall outlet with built-inbattery backup | Plugged into wall outlet |
| Clinical Studies | Clinically tested againstPSG | Clinically tested againstPSG | Clinically tested againstPSG |
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
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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.
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DROWZLE Substantial Equivalence Summary, Continued
| SubstantialEquivalencediscussion | The new device has the same intended use as the predicate device. Bothare intended to be used for identification of adults who may be at risk forsleep apnea and may require further clinical assessment and diagnosis. |
|---|---|
| The new device relies on a different technological assessment to assess therisk of sleep apnea. The predicate device measures nasal and oral air flowand the new device uses the sound generated by that air flow to identifybreathing events. Information about a cleared device using the sametechnology is provided in the comparison table above. | |
| The new device was tested against the results of in-lab PSG, providing asensitivity of 93.7% and specificity of 63% (AHI>15). The inclusion of theresults from validated sleep apnea risk questionnaires reinforces theeffectiveness by providing additional means of assessing risk, furtherreducing the potential for false negative results. | |
| Conclusions | Based on the similarity in function and clinical performance, it is concludedthat DROWZLE is substantially equivalent to the predicate device. |
§ 868.2375 Breathing frequency monitor.
(a)
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.(b)
Classification. Class II (performance standards).