(457 days)
Yes
The description mentions that "ESAS was designed to train the algorithm calculating the Withings index of Sleep Rx," implying a trained algorithm, which is characteristic of ML.
No
The device is indicated as an aid for diagnosis of obstructive sleep apnea and provides data to assist healthcare professionals in determining the need for further diagnosis and evaluation, rather than providing direct therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA)." Additionally, the "Device Description" reiterates that it is "a device intended as an aid for diagnosis of obstructive sleep apnea (OSA)."
No
The device description explicitly states that the Withings Sleep Rx is composed of a "Mat (hardware)" in addition to the embedded software and companion app.
Based on the provided information, the Withings Sleep Rx is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Withings Sleep Rx Function: The Withings Sleep Rx operates by being placed under the mattress and collecting data (breathing, heart rate, movement) from the user contactlessly during sleep. It does not analyze samples taken from the body.
- Intended Use: The intended use is to record a "Withings index" as an aid for diagnosis of OSA, and to record heart rate and movement. While the results are used to assist healthcare professionals in determining the need for further diagnosis, this is based on physiological measurements taken externally, not on the analysis of biological samples.
Therefore, the Withings Sleep Rx falls under the category of a medical device that collects physiological data externally, rather than an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA).
The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner.
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.
The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions.
This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in lifethreatening situations.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app.
Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application.
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 environment
Description of the training set, sample size, data source, and annotation protocol
An ESAS study was designed to train the algorithm calculating the Withings index of Sleep Rx, but not to train the estimation of heart rate. Details on the sample size, data source, and annotation protocol are not explicitly provided within the context of the training set description.
Description of the test set, sample size, data source, and annotation protocol
Clinical study NCT04234828 was performed to validate the performance of the Withings Index for the screening of OSA. The subject device was compared with a simultaneous polysomnography (PSG) manually scored by certified specialists, during a single night in a population of 118 patients with suspected obstructive sleep apnea syndrome (OSAS) referred to a PSG test in a sleep laboratory.
For heart rate estimation, a VPASS study was designed to validate the Withings index, but not to train the estimation of heart rate. Data from two clinical studies (ESAS and VPASS) were pooled together for a post-hoc analysis to assess the accuracy of heart rate estimation. Both studies were conducted with the subject device and had the same design, in comparison with simultaneous polysomnography (PSG) scored by a qualified investigator following AASM guidelines. Both studies enrolled patients with a suspicion of sleep apnea syndrome and referred for a sleep study analysis.
For movement detection, an internal study was performed with the subject device to assess its performance for motion detection in conditions simulating movements occurring during sleep. The participants performed predetermined movements (of the legs, the arms, and the full body sequentially) for a given duration, separated by quiet intervals. Timestamping of these movements enabled the unambiguous identification of individual movements and the association with the corresponding movement scores during data analysis. Sample size, data source, and specific annotation protocols for the movement detection study are not explicitly detailed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study for the validation of the Withings' index
- Study Type: Clinical study (NCT04234828) comparing the subject device with simultaneous polysomnography (PSG).
- Sample Size: 118 patients.
- Key Results:
- AHI ≥ 15:
- Sensitivity (Se): 0.88
- Specificity (Sp): 0.886
- AUC: 0.926
- Withings' lower bound of the 95% confidence interval: Se 0.79, Sp 0.733, AUC 0.873
- AHI ≥ 30:
- Sensitivity (Se): 0.86
- Specificity (Sp): 0.912
- AUC: 0.954
- Withings' lower bound of the 95% confidence interval: Se 0.733, Sp 0.818, AUC 0.916
- All acceptance criteria for the 95% confidence interval lower bound (> 0.70 for Se and Sp) were met.
- AHI ≥ 15:
Post-hoc Analysis for the validation of the heart rate estimation
- Study Type: Post-hoc analysis using pooled data from two clinical studies (ESAS and VPASS).
- Sample Size: Not explicitly stated for the pooled analysis.
- Key Results:
- Heart Rate Accuracy: 0.9597
- Lower bound of the 95% confidence interval: 0.9523
- Acceptance Criteria: Lower bound 95% confidence interval > 0.95. The result shows high performance.
Internal human study for the validation of movement detection
- Study Type: Internal human study simulating movements during sleep.
- Sample Size: Not explicitly stated.
- Key Results (Performance with 95% confidence intervals):
- Active / non active Se: 0.92 [0.90, 0.94] (> 0.80 acceptance criteria)
- Active / non active Sp: 0.92 [0.89, 0.94] (> 0.80 acceptance criteria)
- Full body / legs AUC: 0.94 [0.92, 0.95] (> 0.80 acceptance criteria)
- Legs / arms AUC: 0.93 [0.91, 0.95] (> 0.80 acceptance criteria)
- Arms / no movement AUC: 0.89 [0.87, 0.92] (> 0.80 acceptance criteria)
- All acceptance criteria were passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For Withings' Index (compared to PSG-AHI):
- AHI ≥ 15:
- Sensitivity: 0.88
- Specificity: 0.886
- AUC: 0.926
- AHI ≥ 30:
- Sensitivity: 0.86
- Specificity: 0.912
- AUC: 0.954
For Heart Rate estimation:
- Accuracy: 0.9597
For Movement Detection:
- Active / non active Sensitivity: 0.92
- Active / non active Specificity: 0.92
- Full body / legs AUC: 0.94
- Legs / arms AUC: 0.93
- Arms / no movement AUC: 0.89
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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September 6, 2024
Withings Khushboo Surendran Regulatory Affairs Manager 2 Rue Maurice Hartmann Issy-Les-Moulineaux, Ile-De-France 92130 France
Re: K231667
Trade/Device Name: Withings Sleep Rx Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: August 5, 2024 Received: August 5, 2024
Dear Khushboo Surendran:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Digitally signed by Binoy J. Mathews -S Binoy J. Mathews -S Date: 2024.09.06 14:09:37 -04'00'
For
Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231667
Device Name Withings Sleep Rx
Indications for Use (Describe)
Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA).
The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner.
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.
The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions.
This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in lifethreatening situations.
| 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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510(k) Summary
1. Submitter
| Applicant: | Withings
2 Rue Maurice Hartmann
Issy-Les-Moulineaux
France 92130 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Submission
Correspondent: | Khushboo Surendran
Regulatory Affairs Manager
Phone: 857-233-2681
Email: khushboo.surendran@withings.com |
| Back-Up Consulting
Correspondent: | Michael Daniel
Daniel & Daniel Consulting, LLC
Email: madaniel@clinregconsult.com |
Date Prepared: September 5th, 2024
2. Subject device Information
| Device Name: | Withings Sleep Rx |
|---|---|
| Regulation name: | Breathing frequency monitor |
| Regulation number: | 21 CFR 868.2375 |
| Regulatory Class: | Class II |
| Product Code: | MNR |
| 510(k) review panel: | Anesthesiology |
3. Predicates Information
| Predicate
| Manufacturer: | Resonea, Inc |
|---|---|
| Predicate device name: | Drowzle |
| Predicate 510(k) | |
| number: | K173974 |
| Reference device | |
| Manufacturer: | EarlySense Ltd. |
| Reference device | |
| name: | EarlySense Insight System |
| Reference device | |
| 510(k) number: | K152911 |
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4. Description of the device
The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app.
Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application.
5. Indications for Use
Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA).
The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner.
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.
The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions.
This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations.
6. Comparison table with subject device, predicate and reference device
The following table presents a high-level comparison between the subject device (Withings Sleep Rx), the predicate device (Drowzle) and the reference device (EarlySense Bed Sensing Unit) for the indications for use, technological characteristics, and principle of operation.
| Description | Subject device
Withings Sleep Rx
(K231667) | Predicate device
Drowzle
(K173974) | Reference device
EarlySense Bed
Sensing Unit
(K152911) | Comparison
(Similarities/
Differences) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Withings Sleep Rx | Drowzle | EarlySense Insight
System | N.A. |
| Manufacturer | Withings | Resonea, Inc | EarlySense Ltd | N/A |
| Regulation number | 868.2375 | 868.2375 | 868.2375 | Identical |
| Description | Subject device
Withings Sleep Rx
(K231667) | Predicate device
Drowzle
(K173974) | Reference device
EarlySense Bed
Sensing Unit
(K152911) | Comparison
(Similarities/
Differences) |
| Class | II | II | II | Identical |
| Product code | MNR | MNR | BZQ | Identical to predicate |
| 510(k) Review panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical |
| Prescription / OTC | Prescription | Prescription | Prescription | Identical |
| Intended population | Adults | Adults | Adults, adolescents, and children | Identical to predicate. |
| Intended
environment for use | Home environment | Home environment | Home and Clinical
environment | Identical to predicate. |
| Intended Use | Home-use device for
aiding to diagnosis
patients with possible
sleep disorders. | Home-use device for
screening patients with
possible sleep
disorders. | Intended for continuous
measurement of
respiration rate, heart
rate and movement, in
an automatic contact-
less manner. | Identical to predicate |
| Indications for use | Withings Sleep Rx is
indicated to record a
patient's Withings
index during sleep as
an aid for diagnosis of
obstructive sleep
apnea (OSA).
The Withings Sleep Rx
is also indicated to
record heart rate and
movement in an
automatic contactless
manner.
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 | Drowzle is indicated to
record a patient's
respiratory pattern
during sleep for the
purpose of pre-
screening 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 | The EarlySense Bed
Sensing Unit is an
accessory that is
compatible with
bedside units of
EarlySense Systems
(Models 2.0 and
InSight) intended for
continuous
measurement of
respiration rate, heart
rate and movement,
in an automatic
contact-less manner.
Environment of use for
the accessory is
defined as per
compatible cleared
bedside units labeling:
EarlySense 2.0 - at
home, in hospital or
clinic setting and
InSight - in hospital or
clinic setting.
The device is indicated
for use in children,
adolescents and
adults. | Identical to predicate.
In addition, the
indication for
movement detection
and heart rate
estimation in a contact-
less manner is
identical to the
reference device. |
| Description | Subject device
Withings Sleep Rx
(K231667) | Predicate device
Drowzle
(K173974) | Reference device
EarlySense Bed
Sensing Unit
(K152911) | Comparison
(Similarities/
Differences) |
| | movements, or EEG
activity are required.
The device is indicated
for use in adults
weighing ≤ 350 lbs in a
home environment
during sleep and
resting conditions.
This device is not
indicated for active
patient monitoring, as
it does not provide
alarms for timely
response in life-
threatening situations. | when additional
parameters such as
sleep stages, limb
movements, or EEG
activity are required. | The operation of the
EarlySense system
has been studied in
children (weight ≥10
Kg) and adults (weight
10 seconds
Average number of
10 second breathing
sound gaps per hour | Estimated amount of
breathing sound gaps
10 seconds
Average number of
10 second breathing
sound gaps per hour | N/A | Identical to the
predicate device |
| Heart rate range and
accuracy | Range: 37 - 110 beats
per minute
Accuracy as
compared to ECG
heart rate: ±5 BPM | N/A | Range: 30 - 170 beats
per minute
Accuracy as
compared to ECG
heart rate: ±4% or ±5
BPM, whichever is
greater | The range is different.
The subject device
labeling warns that the
subject device is not
intended for users
outside the specified
range. The accuracy is
identical for the subject
device and the
predicate device for
the 37 to 110 beats per
minute range and is
equal to ±5 BPM. |
| Accuracy as
compared to PSG for
AHI ≥ 15 | Withings Index
Sensitivity: 88.0%
Specificity: 88.6%
AUC: 0.926 | Resonae Index
Sensitivity: 93.7%
Specificity: 63.0%
AUC: 0.870 | Unknown | Similar to the predicate
device. |
| Accuracy as
compared to PSG for
AHI ≥ 30 | Withings Index
Sensitivity: 86.0%
Specificity: 91.2%
AUC: 0.954 | Unknown | Unknown | No accuracy data has
been reported for the
predicate device for
AHI ≥ 30. |
| Display type | Companion app
display on smartphone
or other computing
platforms such as
tablets. | Smartphone display. | Displayed on a PC
monitor using Wireless
2000's proprietary
Graphic User Interface
(GUI) software. The
Central Computer
Station (CCS) is
typically
placed at the nursing
station. | Similar to the predicate
device. |
| Reporting method | Results are reported to
the clinician and
patient within the | Results are reported to
the clinician and
patient within the | Results are reported to
the clinician and
patient on the | Similar to the predicate
device. |
| Description | Subject device
Withings Sleep Rx
(K231667) | Predicate device
Drowzle
(K173974) | Reference device
EarlySense Bed
Sensing Unit
(K152911) | Comparison
(Similarities/
Differences) |
| | companion app and a
PDF format for printing
via email | mobile device software
and a PDF format for
printing via email | EarlySense bedside
unit. | |
| Power source | 5 volts | N/A | 5 volts | Similar to the reference
device |
| Ways of
connection/communi
cation | Bluetooth Low Energy
and Wi-Fi | N/A | Communication
protocol
(RS232) and specific
connector | Similar to the reference
device. The subject
device does not
provide serial
communication. |
| Sensor Dimensions | 637 x 195 x 24
(inflated) mm³ | N/A | 420 x 210 x 14 mm | Similar to the reference
device. |
| Sensor Weight | 274 gr. | N/A | 760 gr. | Different. The
difference in weight
does not impact safety
nor performance. |
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7
8
9
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Table 1: High-level comparison between the subject device and reference device
Withings Sleep Rx (subject device) and Drowzle (predicate device) have the same intended use. Both devices are home-use devices for screening patients with possible sleep disorders.
The technological characteristics of the subject device and the predicate device are different as the subject device uses both an audio sensor and an inflatable bladder with a pressure sensor, while the predicate device is a mobile software that utilizes only the audio sensor of a smartphone. The microphone (audio sensor) of the subject device is embedded into the device to capture breathing sounds. The subject device combines the breathing sounds with pressure changes measured by the pressure sensor to estimate respiratory events indicative of sleep apnea and to then compute the Withings index, whereas the predicate device uses only the breathing sounds to estimate respiratory events indicative of sleep apnea and to compute the Resonae index.
7. Summary of Performance Testing
Non Clinical Testing:
General safety and performance testing was conducted to demonstrate compliance with the FDA guidance documents and recognized standards:
- Software verification and validation was performed per FDA guidance for the . Content of Premarket Submissions for Software Contained in Medical Devices".
- . Cybersecurity testing was performed per FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA
- . ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) ANSI/AAMI 2012 and A2:2010/(R)2012 Medical Electrical Equipment – Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements For . Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility Requirements And Tests
11
- AAMI TIR69:2017/(R2020) Wireless coexistence ●
- ANSI IEEE C63.27-2017 Wireless coexistence ●
- . FCC testing per part 15
- IEC 60601-1-11: Medical electrical equipment Part 1-11: General requirements for basic . safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 62304:2006/Amd 1:2015 - Medical device software
- . AAMI/ANSI/IEC 62366-1: Medical Devices - Part 1: Application of Usability Engineering to Medical Devices : 2015
- . Human Factors evaluation was conducted per FDA quidance document "Applying Human Factors and Usability Enqineering to Medical Devices"
- ISO 14971: Medical Devices Application of Risk Management to Medical Devices : 2019 .
Impulse response: A bench test was also conducted to demonstrate that Within Rx capture the changes in impulse response of mattress due to alterations in mattress type and thickness similar to the reference device (i.e., EarlySense Bed Sensing Unit),
Clinical data collected with the subject device
Clinical study for the validation of the Withings' index
To validate the performance of the Withings Index for the screening of OSA, a clinical study was performed (NCT04234828). The subject device was compared with a simultaneous polysomnography (PSG) manually scored by certified specialists, during a single night in a population of 118 patients with suspected obstructive sleep apnea syndrome (OSAS) referred to a PSG test in a sleep laboratory. The performance of breathing events detection by the Withings Index compared to PSG was evaluated using the sensitivity, the specificity, and AUC (Area Under the Curve) with 95% confidence intervals at the PSG-Apnea Hypopnea Index (AHI) threshold values AHI ≥ 15 events/hour and AHI ≥ 30 events/hour. The results of the study were also published in a peer reviewed journal (Edouard P, Campo D, Bartet P, Yang RY, Bruyneel M, Roisman G. Escourrou P. Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome. J Clin Sleep Med. 2021 Jun 1;17(6):1217-1227. doi: 10.5664/jcsm.9168. PMID: 33590821; PMCID: PMC8314651).
| AHI ≥ 15 | AHI ≥ 30 | |||||
|---|---|---|---|---|---|---|
| Se | Sp | AUC | Se | Sp | AUC | |
| Withings' Index Estimated Value | 0.88 | 0.886 | 0.926 | 0.86 | 0.912 | 0.954 |
| Withings' lower bound of the 95% confidence interval | 0.79 | 0.733 | 0.873 | 0.733 | 0.818 | 0.916 |
| Acceptance criteria for the 95% confidence interval lower bound | > 0.70 | > 0.70 | N.A. | > 0.70 | > 0.70 | N.A. |
Table 2 summarizes the results of the clinical validation study:
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Table 2: Subject device Withings' Index sensitivity and lower bound of the 95% confidence interval) for the classification of apnea severity as compared to the PSG for two PSG-AHI threshold values: AHI ≥ 15 events/hour, and AHI ≥ 30 events/hour. N.A. means not applicable.
The subject device Withings' Index has acceptable sensitivities and specificities for the estimation of breathing events as compared to the PSG for the PSG-AHI threshold values: AHI ≥ 15 events/hour, and AHI ≥ 30 and passed all the acceptance criteria.
Post-hoc Analysis for the validation of the heart rate estimation
A post-hoc analysis was performed using data from two clinical studies that were pooled together to assess the accuracy for the estimation of heart rate (HR). The two clinical studies are:
- . ESAS was designed to train the algorithm calculating the Withings index of Sleep Rx, but not to train the estimation of heart rate.
- VPASS was designed to validate the Withings index, but not to train the estimation of heart ● rate.
Both studies were conducted with the subject device and had the same design, in comparison with simultaneous polysomnography (PSG) scored by a qualified investigator following AASM guidelines. Both studies enrolled patients with a suspicion of sleep apnea syndrome and referred for a sleep study analysis.
Table 3 presents the accuracy for the estimation of heart rate (HR) obtained for the subject device:
| Parameter | Accuracy | Lower bound of
the 95%
confidence
interval | Acceptance
Criteria |
|------------|----------|-----------------------------------------------------|--------------------------------------------------|
| Heart Rate | 0.9597 | 0.9523 | Lower bound 95%
confidence interval
0.95 |
Table 3: Result of clinical studies performed with the subject device for the estimation of heart rate (HR).
These results show that the subject device has a high performance for the estimation of HR with a lower bound of the confidence interval of the accuracy above 0.95 (meeting the acceptance criteria).
Internal human study for the validation of movement detection
An internal study was performed with the subject device to assess its performance for motion detection in conditions simulating movements occurring during sleep.
The co-primary objectives of this study were to assess the subject device's ability to 1) detect movement, 2) separate movements of different energy levels.
The participants performed predetermined movements (of the legs, the arms, and the full body sequentially) for a qiven duration, separated by quiet intervals. Timestamping of these movements enabled the unambiquous identification of individual movements and the association with the corresponding movement scores during data analysis.
Table 4 provides the performance of the subject device to detect different types of movements:
| Endpoint | Result | Acceptance Criteria |
|---|---|---|
| ---------- | -------- | --------------------- |
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| Active / non active Se | 0.92 [0.90, 0.94] | > 0.80 |
|---|---|---|
| Active / non active Sp | 0.92 [0.89, 0.94] | > 0.80 |
| Full body / legs AUC | 0.94 [0.92, 0.95] | > 0.80 |
| Legs / arms AUC | 0.93 [0.91, 0.95] | > 0.80 |
| Arms / no movement AUC | 0.89 [0.87, 0.92] | > 0.80 |
Table 4: Performance (Sensitivity (Se), Specificity (Sp), Area under the Curve (AUC) with 95% confidence intervals) of subject device on binary classifications active, full body / legs, legs / arms, and arms / no movement, with the acceptance criteria and the pass/fail results.
The subject device performance was evaluated by the sensitivity and specificity and was found to pass all the acceptance criteria.
8. Conclusion
The Withings Sleep Rx has the same intended use as the predicate device. In addition, the indication for movement detection and heart rate estimation in a contact-less manner is identical to the reference device. Differences in technological characteristics were assessed through clinical testing to show that the differences do not raise different questions of safety and effectiveness compared to the predicate device. Software verification and validation, non-clinical testing, human factors and clinical study data demonstrate that the Withings Sleep Rx is substantially equivalent to the predicate device.