(251 days)
There are no predicate devices with K/DEN numbers listed in the provided text. The "Predicate Device(s)" section explicitly states "Not Found".
Not Found
Yes
The document explicitly states, "The Sleep Apnea Feature includes machine learned algorithms."
No.
The device is intended to detect signs of sleep apnea, not to treat it. Its purpose is to provide health information so users can seek medical attention, and it explicitly states it is not intended to replace traditional methods of diagnosis and treatment.
No
Explanation: The "Intended Use" section explicitly states, "Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders." This indicates it is not a diagnostic device.
Yes
The device is explicitly described as an "over-the-counter (OTC) software-only, mobile medical application" operating on compatible, commercial off-the-shelf hardware (Samsung Galaxy Watch and Phone). While it leverages the hardware's sensors (PPG and actigraphy), the device itself is the software application that processes this data for its intended use.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Samsung Sleep Apnea Feature operates by leveraging wrist-worn PPG (photoplethysmography) and actigraphy technology to monitor blood oxygenation and movement during sleep. It analyzes these signals to detect signs of breathing disruptions.
- No Sample Analysis: The device does not analyze any biological samples taken from the user's body. It directly measures physiological signals from the wrist.
Therefore, while it is a medical device intended to provide health information, it does not fit the definition of an In Vitro Diagnostic.
No
The provided input does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked as 'Not Found'.
Intended Use / Indications for Use
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a twonight monitoring period. It is intended for on demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
Product codes
QZW
Device Description
The Samsung Sleep Apnea Feature leverages wrist-worn PPG and actigraphy technology to create an over-the-counter (OTC) assessment of moderate-to-severe obstructive sleep annea for adults. When enabled, the device utilizes the wearable platform's PPG-derived SpO2 to monitor the user's sleep for repetitive, relative decreases in their blood oxygenation indicative of significant breathing disruptions associated with sleep apnea. Each on-demand assessment period requires two successful nights of observation within 10 days. After two qualifying assessment nights. the device will display the result on the wearable, after which, the user is guided to the phone for additional information. This provides the user with health information so that they may seek out medical attention. No raw signal data, including the SpO2 signal, is provided to the user nor is it able to be shared with clinicians.
The Samsung Sleep Apnea Feature consists of two mobile medical applications, one on the wearable (e.g., Samsung Galaxy Watch) and the other on the connected mobile phone (e.g., Samsung Galaxy Phone), both commercial off-the-shelf general computing platforms. Communications between the two devices are accomplished by encrypted Bluetooth/BLE connection via standard protocols for data transfer. The wearable component of the Sleep Apnea Feature runs in the wearable's operating system allowing it to verify the identification/qualification of the hardware, request SpO2/accelerometer signals via private APIs, display information on the screen display, and send data and receive commands to the phone Sleep Apnea Feature on the associated phone. The phone component of the Sleep Apnea feature provides a UI for onboarding, labeling, and status as well as the ability for device updates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The Sleep Apnea Feature includes machine learned algorithms.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult users 22 years and older
Intended User / Care Setting
Over-the-counter (OTC) device for general public. The user receives health information to seek medical attention.
Description of the training set, sample size, data source, and annotation protocol
During their development datasets from representative populations were utilized from over 1000 subjects, split into separate training, tuning, and testing datasets, all maintained independently from the final verification and validation activities.
Description of the test set, sample size, data source, and annotation protocol
During their development datasets from representative populations were utilized from over 1000 subjects, split into separate training, tuning, and testing datasets, all maintained independently from the final verification and validation activities.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A non-randomized, open-label, multi-center, single-blind study was conducted in an enriched adult population with an accredited sleep lab recruiting and enrolling subjects, analyzing study results, and writing the clinical study report. The study compared the result from the Samsung Sleep Apnea Feature, the Device Under Test (DUT), with physician's assessment on corresponding PSG from an FDA-cleared PSG device as the clinical gold standard. The objective was to validate that the Samsung Sleep Apnea Feature is capable of correctly differentiating and identifying general population wearable users who show signs of moderate-to-severe obstructive sleep apnea (AHI ≥15) and those users who do not show signs of moderate-to-severe obstructive sleep apnea (AHI 15). Of these 23 subjects, 10 subjects also had mild sleep apnea (AHI ≥ 5) on their second night and did not have a previous sleep apnea diagnosis. Considering the benefit received by these 10 subjects, a modified calculation increases specificity to 91.1% (95% lower confidence bound of 86.9%) surpassing the pre-specificity acceptance criteria.
The single night classification percent agreement between PSG and DUT is 84.2% (791 out of 930 nights). The device data insufficiency rate is 16.7% (205 out of 1229 nights).
There were no device related adverse events.
Subgroup Analyses:
Age:
- under 40 years old (n = 160. sensitivity of 73.7%, specificity of 92.6%)
- between 40 and 55 years old (n = 150, sensitivity of 87.9%, specificity of 86.9%)
- over 55 years old (n = 160, sensitivity of 82.7%, specificity of 79%)
Gender:
- male (n = 244, sensitivity of 86.1%, specificity of 83.5%)
- female (n = 226, sensitivity of 76.7%, specificity of 90.9%)
BMI:
- BMI lower than 25 (n = 99, sensitivity of 70%, specificity of 91%)
- BMI greater than 25 (n = 371. sensitivity of 83.3%. specificity of 86%)
Skin tone:
- light skin tone (Fitzpatrick Scale 1 and 2, n = 116, sensitivity of 74.1%, specificity of 94.8%)
- medium skin tone (Fitzpatrick Scale 3 and 4, n = 245, sensitivity of 85.7%, specificity of 82.7%)
- darker skin tone (Fitzpatrick Scale 5 and 6, n = 109, sensitivity of 87.5%, specificity of 90.9%)
For 47 subjects with low baseline perfusion, sensitivity was 100% and specificity was 94.1%.
Human Factors and Usability Study: A Self-Selection portion with 20 adult consumers (16 correctly identified as intended users, 4 as non-intended users). A Performance Testing with 5 simulated use scenarios and knowledge questions. One critical use error observed, but overall, participants were successful in onboarding and understood safe use and limitations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 82.7% (95% CI: [76.7%, 87.6%])
Specificity: 87.7% (95% CI: [83.1%, 91.4%])
Modified Specificity (post-hoc analysis): 91.1% (95% lower confidence bound of 86.9%)
Single night classification percent agreement between PSG and DUT: 84.2%
Device data insufficiency rate: 16.7%
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR SLEEP APNEA FEATURE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Over-the-counter device to assess risk of sleep apnea. An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.
NEW REGULATION NUMBER: 21 CFR 868.2378
CLASSIFICATION: Class II
PRODUCT CODE: QZW
BACKGROUND
DEVICE NAME: Sleep Apnea Feature
SUBMISSION NUMBER: DEN230041
DATE DE NOVO RECEIVED: May 31, 2023
SPONSOR INFORMATION:
Samsung Electronics Co., Ltd Samsung Research America 665 Clyde Avenue, Mountain View. CA 94043 USA
INDICATIONS FOR USE
The Sleep Apnea Feature is indicated as follows:
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a twonight monitoring period. It is intended for on demand use.
1
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
LIMITATIONS
DON'T use this Sleep apnea feature if you've already been diagnosed with sleep apnea.
DON'T use this Sleep apnea feature if you're under 22 years old.
Your Galaxy Watch can't catch every case of obstructive sleep apnea. The watch only checks for possible moderate to severe obstructive sleep apnea and can't detect central sleep apnea.
DON'T use this Sleep apnea feature if you've been diagnosed with any of these conditions:
- · Movement related conditions: Parkinson's, Tremor, Periodic Leg Movement During Sleep (PLMS)
- . Cardiac conditions: Congestive Heart Failure (CHF), atrial fibrillation
- Lung conditions: Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, . emphysema, pulmonary fibrosis.
You shouldn't use this sleep apnea feature if you're pregnant or have temporary symptoms of impaired breathing from flu, allergies, asthma, or any other condition, because your results may be inaccurate.
DON'T change the dose or schedule of any medications based on results from this feature. Always talk to your doctor first.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Samsung Sleep Apnea Feature leverages wrist-worn PPG and actigraphy technology to create an over-the-counter (OTC) assessment of moderate-to-severe obstructive sleep annea for adults. When enabled, the device utilizes the wearable platform's PPG-derived SpO2 to monitor the user's sleep for repetitive, relative decreases in their blood oxygenation indicative of significant breathing disruptions associated with sleep apnea. Each on-demand assessment period requires two successful nights of observation within 10 days. After two qualifying assessment nights. the device will display the result on the wearable, after which, the user is guided to the phone for additional information. This provides the user with health information so that they may seek out medical attention. No raw signal data, including the SpO2 signal, is provided to the user nor is it able to be shared with clinicians.
The Samsung Sleep Apnea Feature consists of two mobile medical applications, one on the wearable (e.g., Samsung Galaxy Watch) and the other on the connected mobile phone (e.g.,
2
Samsung Galaxy Phone), both commercial off-the-shelf general computing platforms. Communications between the two devices are accomplished by encrypted Bluetooth/BLE connection via standard protocols for data transfer. The wearable component of the Sleep Apnea Feature runs in the wearable's operating system allowing it to verify the identification/qualification of the hardware, request SpO2/accelerometer signals via private APIs, display information on the screen display, and send data and receive commands to the phone Sleep Apnea Feature on the associated phone. The phone component of the Sleep Apnea feature provides a UI for onboarding, labeling, and status as well as the ability for device updates.
Sleep Apnea Classification Algorithm
The Sleep Apnea Feature evaluates sleep sessions by leveraging the platform's capabilities to acquire PPG signals and derive SpO2 values from those signals. After performing PPG and SpO2 signal quality checks, the algorithm performs this function using 3 steps.
-
- Pre-Processing: SpO2 signal interpolation, segmentation, and feature extraction.
-
- Respiratory Event Classification: Identify presence of relative SpO2 drop in each 1minute window.
-
- eAHI Estimation and Classification: Enumerate relative SpO2 dips, per-night comparison to the 15 events/hour estimated Apnea/Hypopnea Index (eAHI) threshold.
To account for internight variability, the device requires two nights of sleep data indicating moderate-to-severe sleep apnea within 10 days. The possible combinations for this two-night voting, and if it results in a notification of insufficient data or a classification, are provided in Table 1.
| Classification | Night 1 | Night 2 |
|---|---|---|
| Didn't detect signs of Moderate-to-Severe Obstructive Sleep | ||
| Apnea | eAHI 15). Of these 23 subjects, 10 subjects also had mild sleep apnea (AHI ≥ 5) on their second night and did not have a previous sleep apnea diagnosis. Though false positives by definition of the study design, the positive DUT classification benefited these 10 previously undiagnosed subjects, directing them to appropriate care and potential treatment. Considering the benefit received by these 10 subjects, a modified calculation increases specificity to 91.1% (95% lower confidence bound of 86.9%) surpassing the pre-specificity acceptance criteria. |
Subgroup Analyses
Performance variations were observed among different subpopulation during this study. While demographic subgroups were not statistically powered for conclusive comparisons of performance, the observed performance trends in these subgroups were found to be acceptable.
During the study. 399 subjects exhibited consistent PSG results across both nights of the study; 89 subjects had a normal PSG, 108 subjects had mild OSA. 91 subjects had moderate OSA, and 111 subjects had as severe PSG. The feature correctly identified all 89 normal subjects, 98 of the 108 mild subjects, 60 of the 91 moderate subjects, and 107 of the 111 severe subjects. A follow-up analysis of the False Negative subjects within the moderate group indicated that in 22 out of the 31 subjects, the reference reported