(457 days)
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.
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.
The Withings Sleep Rx device is cleared for recording a patient's "Withings index" during sleep as an aid for diagnosing obstructive sleep apnea (OSA), and for recording heart rate and movement in an automatic, contactless manner. It is intended for home screening of adults with suspected sleep breathing disorders, to assist healthcare professionals in determining the need for further diagnosis.
Here's a breakdown of the acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
| Parameter / Indication | Acceptance Criteria | Reported Device Performance (Withings Sleep Rx) |
|---|---|---|
| Withings Index (OSA Screening) | ||
| Se (Sensitivity) for AHI ≥ 15 | Lower bound of 95% CI > 0.70 | 0.88 (95% CI lower bound: 0.79) |
| Sp (Specificity) for AHI ≥ 15 | Lower bound of 95% CI > 0.70 | 0.886 (95% CI lower bound: 0.733) |
| AUC for AHI ≥ 15 | N.A. | 0.926 (95% CI lower bound: 0.873) |
| Se (Sensitivity) for AHI ≥ 30 | Lower bound of 95% CI > 0.70 | 0.86 (95% CI lower bound: 0.733) |
| Sp (Specificity) for AHI ≥ 30 | Lower bound of 95% CI > 0.70 | 0.912 (95% CI lower bound: 0.818) |
| AUC for AHI ≥ 30 | N.A. | 0.954 (95% CI lower bound: 0.916) |
| Heart Rate Estimation | ||
| Accuracy | Lower bound of 95% CI > 0.95 | 0.9597 (95% CI lower bound: 0.9523) |
| Movement Detection | ||
| Se (Active / non active) | > 0.80 | 0.92 (95% CI: 0.90, 0.94) |
| Sp (Active / non active) | > 0.80 | 0.92 (95% CI: 0.89, 0.94) |
| AUC (Full body / legs) | > 0.80 | 0.94 (95% CI: 0.92, 0.95) |
| AUC (Legs / arms) | > 0.80 | 0.93 (95% CI: 0.91, 0.95) |
| AUC (Arms / no movement) | > 0.80 | 0.89 (95% CI: 0.87, 0.92) |
2. Sample Size and Data Provenance
- Withings Index (OSA Screening):
- Sample Size: 118 patients.
- Data Provenance: The study was conducted with patients referred to a PSG test in a sleep laboratory, suggesting a clinical setting in a specific geographic location (publication mentions "J Clin Sleep Med," and authors are from various institutions, potentially implying an international or multi-center European study due to authors' affiliations). The study involved simultaneous polysomnography (PSG), making it a prospective (or at least concurrent data collection) study.
- Heart Rate Estimation:
- Sample Size: Data pooled from two clinical studies (ESAS and VPASS). Specific combined sample size not directly stated, but the studies were described as enrolling patients with suspected sleep apnea syndrome referred for a sleep study analysis.
- Data Provenance: Both studies were conducted with the subject device and involved simultaneous polysomnography (PSG), implying prospective or concurrent data collection in a clinical setting related to sleep studies.
- Movement Detection:
- Sample Size: Participants in an internal human study. Specific sample size not stated.
- Data Provenance: Internal study with predetermined movements, suggesting a controlled, laboratory-like setting.
3. Number of Experts and Qualifications for Ground Truth - Test Set
- Withings Index (OSA Screening):
- Number of Experts: Not explicitly stated, but "simultaneous polysomnography (PSG) manually scored by certified specialists" implies multiple certified specialists.
- Qualifications: "Certified specialists" in manual scoring of PSG, following AASM guidelines.
- Heart Rate Estimation:
- Number of Experts: Not explicitly stated, but "simultaneous polysomnography (PSG) scored by a qualified investigator following AASM guidelines" implies qualified investigators.
- Qualifications: "Qualified investigator" following AASM (American Academy of Sleep Medicine) guidelines.
- Movement Detection: Not applicable as the ground truth was based on predetermined movements by participants.
4. Adjudication Method for the Test Set
- Withings Index (OSA Screening) and Heart Rate Estimation: The information provided does not specify an explicit adjudication method (e.g., 2+1, 3+1). It states "manually scored by certified specialists" or "scored by a qualified investigator," which might imply single scoring or an internal consensus process, but no detail on a formal adjudication protocol is given.
- Movement Detection: Not applicable, as ground truth was based on pre-defined movements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study to assess the effect size of human readers improving with AI vs. without AI assistance. The studies focused on the performance of the device itself against established clinical standards (PSG).
6. Standalone (Algorithm Only) Performance
- Yes, the studies primarily assessed the standalone performance of the Withings Sleep Rx device.
- The "Withings Index" for OSA screening was compared directly against PSG.
- The heart rate estimation was compared against simultaneous PSG data.
- The movement detection was evaluated based on the device's ability to identify pre-defined participant movements.
7. Type of Ground Truth Used
- Withings Index (OSA Screening) and Heart Rate Estimation: Expert Consensus (PSG scoring). Polysomnography (PSG) manually scored by certified specialists/qualified investigators following AASM guidelines is considered the gold standard for sleep disorder diagnosis.
- Movement Detection: Predefined movements/experimental protocol. The ground truth was based on the participants performing known, predetermined movements for specific durations, allowing for unambiguous identification.
8. Sample Size for the Training Set
- The document explicitly states regarding heart rate estimation:
- "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."
- While these studies mention their role in training or validating the Withings index algorithm, the specific sample size used solely for algorithm training for the Withings Index, heart rate, or movement detection is not provided. The 118 patient study listed under "Clinical study for the validation of the Withings' index" is explicitly for validation of the Withings' index.
9. How the Ground Truth for the Training Set Was Established
- For the ESAS study, which was "designed to train the algorithm calculating the Withings index," the ground truth would have been established through simultaneous polysomnography (PSG) manually scored by certified specialists, similar to the validation studies. However, the exact details of the ground truth establishment specifically for the training set are not fully elaborated in this document, beyond stating its purpose was for training.
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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).
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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).
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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
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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: | Withings2 Rue Maurice HartmannIssy-Les-MoulineauxFrance 92130 |
|---|---|
| SubmissionCorrespondent: | Khushboo SurendranRegulatory Affairs ManagerPhone: 857-233-2681Email: khushboo.surendran@withings.com |
| Back-Up ConsultingCorrespondent: | Michael DanielDaniel & Daniel Consulting, LLCEmail: 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
| PredicateManufacturer: | Resonea, Inc |
|---|---|
| Predicate device name: | Drowzle |
| Predicate 510(k)number: | K173974 |
| Reference deviceManufacturer: | EarlySense Ltd. |
| Reference devicename: | EarlySense Insight System |
| Reference device510(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 deviceWithings Sleep Rx(K231667) | Predicate deviceDrowzle(K173974) | Reference deviceEarlySense BedSensing Unit(K152911) | Comparison(Similarities/Differences) |
|---|---|---|---|---|
| Device Name | Withings Sleep Rx | Drowzle | EarlySense InsightSystem | N.A. |
| Manufacturer | Withings | Resonea, Inc | EarlySense Ltd | N/A |
| Regulation number | 868.2375 | 868.2375 | 868.2375 | Identical |
| Description | Subject deviceWithings Sleep Rx(K231667) | Predicate deviceDrowzle(K173974) | Reference deviceEarlySense BedSensing 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. |
| Intendedenvironment for use | Home environment | Home environment | Home and Clinicalenvironment | Identical to predicate. |
| Intended Use | Home-use device foraiding to diagnosispatients with possiblesleep disorders. | Home-use device forscreening patients withpossible sleepdisorders. | Intended for continuousmeasurement ofrespiration rate, heartrate and movement, inan automatic contact-less manner. | Identical to predicate |
| Indications for use | Withings Sleep Rx isindicated to record apatient's Withingsindex during sleep asan aid for diagnosis ofobstructive sleepapnea (OSA).The Withings Sleep Rxis also indicated torecord heart rate andmovement in anautomatic contactlessmanner.The device is designedfor use in home-screening of adultswith suspectedpossible sleepbreathing disorders.Results are used toassist the healthcareprofessional indetermining the needfor further diagnosisand evaluation. Thesystem is not intendedas a substitute for fullpolysomnographywhen additionalparameters such assleep stages, limb | Drowzle is indicated torecord a patient'srespiratory patternduring sleep for thepurpose of pre-screening patients forobstructive sleepapnea (OSA)syndrome.The device is designedfor use in home-screening of adultswith suspectedpossible sleepbreathing disorders.Results are used toassist the healthcareprofessional indetermining the needfor further diagnosisand evaluation. Thesystem is not intendedas a substitute for fullpolysomnography | The EarlySense BedSensing Unit is anaccessory that iscompatible withbedside units ofEarlySense Systems(Models 2.0 andInSight) intended forcontinuousmeasurement ofrespiration rate, heartrate and movement,in an automaticcontact-less manner.Environment of use forthe accessory isdefined as percompatible clearedbedside units labeling:EarlySense 2.0 - athome, in hospital orclinic setting andInSight - in hospital orclinic setting.The device is indicatedfor use in children,adolescents andadults. | Identical to predicate.In addition, theindication formovement detectionand heart rateestimation in a contact-less manner isidentical to thereference device. |
| Description | Subject deviceWithings Sleep Rx(K231667) | Predicate deviceDrowzle(K173974) | Reference deviceEarlySense BedSensing Unit(K152911) | Comparison(Similarities/Differences) |
| movements, or EEGactivity are required.The device is indicatedfor use in adultsweighing ≤ 350 lbs in ahome environmentduring sleep andresting conditions.This device is notindicated for activepatient monitoring, asit does not providealarms for timelyresponse in life-threatening situations. | when additionalparameters such assleep stages, limbmovements, or EEGactivity are required. | The operation of theEarlySense systemhas been studied inchildren (weight ≥10Kg) and adults (weight<111 Kg) during sleepand resting condition. | ||
| Device placementand patient contact | The Withings Sleep Rxis placed under thebed mattress - nottouching the patient | Smartphone placedwithin 24 inches ofpillow | The Bed Sensing Unitis placed under thebed mattress - nottouching the patient | Identical. All thedevices arecontactless. |
| Sensor Technology | A pneumatic bladderwith a pressure sensoris used to detectmotion signals(mechanicalmovements) in acontact-less manner.These signals areconverted into anelectrical signal,sampled, filtered andtransferred to theembeddedmicrocontroller wherethey are analyzed bythe device's software(algorithms) to providethe Withings index,heart rate (HR), andmovement. Bed exitsignal is also detectedand available. Thesignal of the pneumaticsensor is alsodecomposed into abreathing componentby the algorithm (notshown to the patient). | N/A | Piezoelectric ceramicsensing element isused to detect motionsignals (mechanicalmovements) in acontact-less manner.These signals areconverted into anelectric signal,sampled, filtered andtransferred to theBedside Unit wherethey are analyzed bythe Bedside unit'ssoftware (algorithms)to provide therespiration rate (RR),heart rate (HR), andmotion. Bed exit signalis also detected andavailable. | Similar to the referencedevice. Both devicesdetectmotion signals(mechanicalmovements) in acontact less-manner.Both devicesestimate the sameparameters:heart rate (HR),movement and bedexit detection exceptfor respiratory rate. |
| Device also includesan audio sensor | Microphone(s) nativeto smartphone placed | N/A | Similar to the predicatedevice. Both devices | |
| Description | Subject deviceWithings Sleep Rx(K231667) | Predicate deviceDrowzle(K173974) | Reference deviceEarlySense BedSensing Unit(K152911) | Comparison(Similarities/Differences) |
| (microphone) thatanalyzes sound toidentify breathingsound and estimatesgaps in breathingsounds. | within 24 inches ofpillow analyzes soundto identify breathingsound and estimatesgaps in breathingsounds. | are placed close to theuser in a contactlessmanner to recordbreathing sounds. Thesubject devicecombines thebreathing sounds withpressure changesmeasured by thepressure sensorto estimate respiratoryevents indicative ofsleep apnea whereasthe predicate deviceuses only thebreathing sounds toestimate respiratoryevents indicative ofsleep apnea. | ||
| Material used | Inner bladder:thermoplasticpolyurethaneOuter Protective fabric:Polyester | N/A | ABS/Polycarbonateplate | Different. Thisdifference does notaffect safety due to thecontactless nature ofthe device. |
| Signals acquired | Sounds fromrespiration.Pressure changes dueto body motion, chestmovement(respiration), andvibrations created bythe heart. | Sounds fromrespiration. | Piezoelectric signalgenerated byvariations of pressureapplied on the devicedue to body motion,chest movement(respiration), andvibrations created bythe heart. | Similar to predicateand reference device |
| Algorithm processing | Analyzes sound andpressure signals toidentify respiratoryevents indicative ofsleep apnea or otherdisorders.Analyzes the pressuresignal to calculateheart rate and detectmovements. | Analyzes the soundsignal to identifyrespiratory eventsindicative of sleepapnea or otherdisorders | Analyzes thepiezoelectric signal tocalculate heart rateand respiration rate,and to detectmovements. | The subject deviceanalyzes the measuredsignals similarly to thepredicate andreference device. |
| Algorithm outputsdisplayed to the user | Withings index(estimated frequencyof breathing eventsduring sleep). | Resonea index(frequency of breathingevents during sleep) | N/A | Similar to the predicatedevice |
| Description | Subject deviceWithings Sleep Rx(K231667) | Predicate deviceDrowzle(K173974) | Reference deviceEarlySense BedSensing Unit(K152911) | Comparison(Similarities/Differences) |
| - Heart Rate- Movement | N/A | - Heart Rate,- Motion- Respiration Rate- Bed occupancydata- Alerts | The subject andreference devicesdisplay heart rate andmovement during thenight. The subjectdevice does notdisplay respiration ratenor provides alerts. | |
| Definition ofbreathing events | Estimated amount ofbreathing sound gaps>10 secondsAverage number of>10 second breathingsound gaps per hour | Estimated amount ofbreathing sound gaps>10 secondsAverage number of>10 second breathingsound gaps per hour | N/A | Identical to thepredicate device |
| Heart rate range andaccuracy | Range: 37 - 110 beatsper minuteAccuracy ascompared to ECGheart rate: ±5 BPM | N/A | Range: 30 - 170 beatsper minuteAccuracy ascompared to ECGheart rate: ±4% or ±5BPM, whichever isgreater | The range is different.The subject devicelabeling warns that thesubject device is notintended for usersoutside the specifiedrange. The accuracy isidentical for the subjectdevice and thepredicate device forthe 37 to 110 beats perminute range and isequal to ±5 BPM. |
| Accuracy ascompared to PSG forAHI ≥ 15 | Withings IndexSensitivity: 88.0%Specificity: 88.6%AUC: 0.926 | Resonae IndexSensitivity: 93.7%Specificity: 63.0%AUC: 0.870 | Unknown | Similar to the predicatedevice. |
| Accuracy ascompared to PSG forAHI ≥ 30 | Withings IndexSensitivity: 86.0%Specificity: 91.2%AUC: 0.954 | Unknown | Unknown | No accuracy data hasbeen reported for thepredicate device forAHI ≥ 30. |
| Display type | Companion appdisplay on smartphoneor other computingplatforms such astablets. | Smartphone display. | Displayed on a PCmonitor using Wireless2000's proprietaryGraphic User Interface(GUI) software. TheCentral ComputerStation (CCS) istypicallyplaced at the nursingstation. | Similar to the predicatedevice. |
| Reporting method | Results are reported tothe clinician andpatient within the | Results are reported tothe clinician andpatient within the | Results are reported tothe clinician andpatient on the | Similar to the predicatedevice. |
| Description | Subject deviceWithings Sleep Rx(K231667) | Predicate deviceDrowzle(K173974) | Reference deviceEarlySense BedSensing Unit(K152911) | Comparison(Similarities/Differences) |
| companion app and aPDF format for printingvia email | mobile device softwareand a PDF format forprinting via email | EarlySense bedsideunit. | ||
| Power source | 5 volts | N/A | 5 volts | Similar to the referencedevice |
| Ways ofconnection/communication | Bluetooth Low Energyand Wi-Fi | N/A | Communicationprotocol(RS232) and specificconnector | Similar to the referencedevice. The subjectdevice does notprovide serialcommunication. |
| Sensor Dimensions | 637 x 195 x 24(inflated) mm³ | N/A | 420 x 210 x 14 mm | Similar to the referencedevice. |
| Sensor Weight | 274 gr. | N/A | 760 gr. | Different. Thedifference in weightdoes not impact safetynor performance. |
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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
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- 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 ofthe 95%confidenceinterval | AcceptanceCriteria |
|---|---|---|---|
| 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.
§ 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).