(562 days)
Unknown
The summary mentions a "proprietary algorithm" used for analysis and interpretation, but does not explicitly state whether this algorithm utilizes AI or ML techniques. While the description of separate development and validation cohorts is consistent with ML model development, it is not definitive proof.
No.
The device is used for prescreening and diagnosis, not for treatment.
Yes.
The device records, analyzes, and interprets sleep breathing patterns and patient-provided profile data to measure and track sleep-related health risks over time, and the results "assist the healthcare professional in determining the need for further diagnosis and evaluation."
Yes
The device description explicitly states "DROWZLE is a stand-alone software medical device." While it operates on a mobile computing device (iPhone), it utilizes the existing hardware (microphone) of that device and does not include any proprietary hardware components. The core functionality and medical device aspects are implemented solely in the software.
Based on the provided information, DROWZLE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- DROWZLE's Function: DROWZLE records and analyzes sound (respiratory patterns) from the patient's body during sleep. It does not analyze biological specimens (blood, tissue, urine, etc.).
- Intended Use: Its intended use is to prescreen for obstructive sleep apnea by analyzing breathing sounds and symptom data, not by analyzing biological samples.
Therefore, DROWZLE falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home-use device for screening patients with possible sleep disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
Description of the training set, sample size, data source, and annotation protocol
Separate recording cohorts were used to develop and validate the algorithm used in DROWZLE.
Description of the test set, sample size, data source, and annotation protocol
Sound recordings from 242 individuals >= 21 years of age undergoing clinically indicated sleep study to assess sleep disordered breathing were 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinically tested against PSG.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity of 93.7% and specificity of 63% (AHI>15).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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)
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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. |