Withings Scan Monitor 2.0

K230812 · Withings · DPS · Aug 23, 2023 · Cardiovascular

Device Facts

• Record ID: K230812
• Device Name: Withings Scan Monitor 2.0
• Applicant: Withings
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Atrial Fibrillation Detection	Not explicitly stated as a threshold, but compared against 12-lead gold standard	Sensitivity: 0.99 [95% CI: 0.93, 1.0]; Specificity: 0.99 [95% CI: 0.97, 1.0] (excluding inconclusive/noise)	Training, testing, and validation datasets were used. Publicly available datasets were utilized for training. Test Data Set 1 (n=137) and Test Data Set 2 (n=262) were used for algorithm testing.	Prospective, cross-sectional, diagnostic, multicentric open-label study: 321 valid ECG records from 274 patients (after exclusions)
ECG Waveform Generation (Clinical Equivalence)	Standard deviation of differences < 20 ms for PR interval and QRS width; Heart rate error < 10%	PR interval and QRS width SD < 20 ms; QT interval SD 30.3 ms; Mean heart rate difference -0.96 bpm (SD 3.81 bpm)	Not applicable	Prospective, cross-sectional, diagnostic, multicentric open-label study: 321 valid ECG records from 274 patients (after exclusions)

Indications for Use

The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a two-channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician). The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

Device Story

Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle containing electrical sensors. User stands on scale and holds handle to complete circuit; device records 30-second ECG. Input signals are processed by internal microcontroller using ECG-SW1 algorithm to classify rhythm (Normal Sinus Rhythm, Atrial Fibrillation, Inconclusive, or Noise) and derive leads I, aVF, aVL from lead II/III data. Output is displayed on scale and transferred to companion mobile application for storage, management, and sharing. Used by healthcare professionals, patients, or health-conscious individuals in clinical or home settings. Provides rhythm classification to assist in identifying potential cardiac conditions; enables remote monitoring and physician review of ECG data. Benefits include accessible, non-invasive cardiac rhythm screening and longitudinal data tracking for heart health management.

Clinical Evidence

Prospective, cross-sectional, multicentric, open-label study (n=274, 234 analyzed). Validated ECG-SW1 algorithm and 6-lead ECG clinical equivalence to 12-lead gold standard. Sensitivity 0.99 (95% CI: 0.93-1.0), specificity 0.99 (95% CI: 0.97-1.0) for AFib detection (excluding noise/inconclusive). Mean heart rate difference vs 12-lead ECG was -0.96 bpm (SD 3.81 bpm). Waveform accuracy >0.992; polarity accuracy 0.911-0.986. Standard deviation of interval differences (PR, QRS) <20ms.

Technological Characteristics

Smart scale with retractable handle; 3 ECG measuring electrodes (fingers/feet) and 2 feedback electrodes. 6-lead ECG output (leads I, II, III, aVR, aVF, aVL). Sampling rate 500Hz; 16-bit resolution; 0.033Hz-200Hz bandwidth. Connectivity: BLE and Wi-Fi. Power: Rechargeable Li-ion battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-47, ANSI/AAMI EC57, AAMI TIR69, ANSI IEEE C63.27. Software: ECG-SW1 algorithm (locked).

Indications for Use

Indicated for adult patients with known or suspected heart conditions and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes for recording, storing, and transferring 2-channel ECG (leads II, III) and calculating/displaying leads I, aVF, aVL to detect atrial fibrillation when prescribed or used under physician care.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Scan Monitor (K201456)

Submission Summary (Full Text)

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August 23, 2023

Withings Khushboo Surendran Regulatory Affairs Manager 2 rue Maurice Hartmann Issy-Les-Moulineaux, Ile-De-France 92130 France

Re: K230812

Trade/Device Name: Withings Scan Monitor 2.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DXH Dated: July 21, 2023 Received: July 24, 2023

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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### 5. Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: June 30, 2023 See PRA Statement on last page

510(k) Number (if known)

Device Name

Withings Scan Monitor 2.0

Indications for Use (Describe)

The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a twochannel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician).

The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.

The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

| Type of Use (Select one or both, as applicable) | | | | |
|------------------------------------------------------------|-------------------------------------|--|--|--|
| Prescription Use (Part 21 CFR 801 Subpart D)<br>Subpart C) | >> Over-The-Counter Use (21 CFR 801 | | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | | |
| | | | | |

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs. qov

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### 510(k) Summary

#### 1. Submitter

| Applicant: | Withings<br>2 Rue Maurice Hartmann<br>Issy-Les-Moulineaux<br>France 92130 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Khushboo Surendran<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 23, 2023 |
| 2. Subject device Information | |

| Device Name: | Withings Scan Monitor 2.0 |
|----------------------|---------------------------|
| Regulation name: | Electrocardiograph |
| Regulation number: | 21 CFR 870.2340 |
| Regulatory Class: | Class II |
| Product Code: | DPS, DXH |
| 510(k) review panel: | Cardiovascular |

#### 3. Predicate device Information

| Predicate Manufacturer: | Withings |
|--------------------------|--------------|
| Predicate device name: | Scan Monitor |
| Predicate 510(k) number: | K201456 |

#### 4. Description of the device

The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities that connects to a companion mobile application. The Withings Scan Monitor 2.0 is intended to create, record, store, transfer and display lead-III of a two-channel electrocardiogram (ECG).

When a user stands on the scale and holds the handle attached to it, a 30 second ECG recording begins. The Withings Scan Monitor 2.0 software analyzes data collected by the electrical sensors present on the scale to generate lead-III simultaneously and derive lead-I and leads aVR, aVF and aVL, calculate heart rate, and provide a rhythm classification to the user that is displayed on the scale. The companion application is intended to display, store, manage and share data.

The Withings Scan Monitor 2.0 classifies ECG signals as follows:

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- Normal Sinus Rhythm ●
- Atrial Fibrillation ●
- Inconclusive
- . Noise - Inconclusive

## 5. Indications for Use/Intended Use:

The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II of a two-channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVR, aVF, aVL.The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician).

The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.

The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

| Characterist<br>ics | Subject device: Withings<br>Scan Monitor 2.0 | Predicate device: Scan<br>Monitor | Comparison to predicate<br>device |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name | Withings Scan Monitor 2.0 | Scan Monitor | NA |
| Number of<br>leads | 6-Lead | 1-Lead | Substantially equivalent. The<br>only minor difference is that<br>the subject device records<br>lead II and lead-III of a<br>two-channel electrocardiogram<br>(ECG) and calculates lead I,<br>whereas the predicate device<br>analyzes a single-channel<br>ECG and displays only lead I<br>ECG. Both devices use ECG<br>Lead I for rhythm<br>classification assessment.<br>Lead II, lead III, aVR, aVF and<br>aVL are for information<br>purposes only and are<br>validated in the clinical study<br>against the gold standard (12<br>lead ECG). |
| Manufactur<br>er | Withings | Withings | Identical |
| 510(k) | K230812 | K201456 | NA |
| Regulation<br>Number | 21 CFR 870.2340<br>21 CFR 870.2920 | 21 CFR 870.2340<br>21 CFR 870.2920<br>21 CFR 870.2700 | Identical, except for the<br>regulation for oximeter which<br>does not apply to the subject<br>device |
| Class | II | II | Identical |
| 510(k)<br>Review<br>Panel | Cardiovascular | Cardiovascular | Identical |
| Device<br>Class/Name | Electrocardiograph<br>Transmitters and Receivers,<br>Electrocardiograph,<br>Telephone | Electrocardiograph<br>Transmitters and Receivers,<br>Electrocardiograph, Telephone<br>Oximeter | Identical, except that the<br>predicate device can also<br>measure oxygen saturation of<br>arterial hemoglobin (%SpO2) |
| | | | and therefore is also an<br>oximeter |
| Product<br>Code | DPS, DXH | DPS, DXH, DQA | Identical, except that the<br>predicate device can also<br>measure oxygen saturation of<br>arterial hemoglobin (%SpO2)<br>and therefore has an<br>additional product code (DQA) |
| Prescription<br>/ OTC | Prescription and OTC | Prescription and OTC | Identical for the ECG<br>acquisition and the atrial<br>fibrillation detection<br>functionalities as Scan Monitor<br>and Withings Scan Monitor<br>2.0. |
| Intended<br>use and<br>Indications<br>for Use | The Withings Scan Monitor<br>2.0 is intended to record,<br>store and transfer lead II and<br>lead-III of a two-channel<br>electrocardiogram (ECG). In<br>addition, it calculates and<br>displays leads I, aVR, aVF,<br>aVL.<br>The Withings Scan Monitor<br>2.0 also displays ECG<br>rhythms and detects the<br>presence of atrial fibrillation<br>(when the monitor is<br>prescribed or used under care<br>of a physician).<br>The Withings Scan Monitor<br>2.0 is intended for use by<br>healthcare professionals,<br>patients with known or<br>suspected heart conditions<br>and health-conscious<br>individuals.<br>The Withings Scan Monitor<br>2.0 is intended for adult<br>patients in hospitals, clinics,<br>long-term care facilities, and<br>homes. | Scan Monitor is intended to<br>record, store and transfer<br>single-channel<br>electrocardiogram (ECG)<br>rhythms.<br>The Scan Monitor also displays<br>ECG rhythms and detects the<br>presence of atrial fibrillation<br>(when the monitor is prescribed<br>or used under the care of a<br>physician).<br>The Scan Monitor is intended<br>for use by healthcare<br>professionals, patients with<br>known or suspected heart<br>conditions and health-conscious<br>individuals.<br>The Scan Monitor is also<br>indicated for use in measuring<br>and displaying functional<br>oxygen saturation of arterial<br>hemoglobin (%SpO2).<br>The Scan Monitor is intended<br>for adult patients in hospitals,<br>clinics, long-term care facilities,<br>and homes. | Substantially equivalent, The<br>predicate device also allows<br>for the measurement of<br>oxygen saturation of arterial<br>hemoglobin (%SpO2) with the<br>predicate device. Both devices<br>record, store and display<br>ECGs. |
| Intended<br>population | Adults with known or<br>suspected heart conditions<br>and health-conscious<br>individuals | Adults with known or suspected<br>heart conditions and<br>health-conscious individuals | Identical |
| Environment<br>Use | Hospitals, clinics, long term<br>care and home use | Hospitals, clinics, long-term<br>care and home use | Identical |
| Technological<br>Characteristic | Subject device: Withings<br>Scan Monitor 2.0 | Predicate device: Scan<br>Monitor | Comparison to predicate device |
| Hardware Interface | Body Scan (scale) | Scan Watch (watch) | Substantially equivalent. Please refer to<br>the bench testing and clinical study report<br>that demonstrate substantially equivalent<br>performance. Therefore, differences in<br>hardware interface are substantially<br>equivalent. |
| Principles of<br>Operation | User completes the circuit<br>with skin contact and<br>hardware collects and<br>transmits electrical potentials<br>to the microcontroller unit to<br>convert and display ECG<br>waveform. After acquisition,<br>the Withings Scan Monitor<br>2.0 uses the ECG waveforms<br>from the Withings Body<br>Scan, and the Withings Scan<br>Monitor 2.0 algorithms<br>process and classify the<br>signal and display the<br>classification to the user. | User completes the circuit<br>with skin contact and<br>hardware collects and<br>transmits electrical potentials<br>to the microcontroller unit to<br>convert and display ECG<br>waveform. After acquisition,<br>the Scan Monitor uses the<br>ECG waveforms from the<br>Withings Scan Watch, and the<br>Withings Scan Monitor 2.0<br>algorithms process and<br>classify the signal and display<br>the classification to the user. | Identical |
| Anatomical<br>sites | Fingers and feet. | Left hand fingers to right wrist<br>or vice versa | Substantially equivalent. The first main<br>difference between the two devices is the<br>site of ECG measurement. Please refer<br>to the bench testing results that show that<br>the subject device has lower RMSE<br>distribution with a 12-lead ECG device<br>than that of the predicate device and<br>show that ECG waveforms of the<br>predicate and subject devices are<br>equivalent in terms of visibility of P-wave,<br>T-wave, QRS complex visibility and<br>polarity and durations. Therefore the<br>anatomical site differences do not raise<br>any issue of effectiveness in terms of<br>ECG signal quality and also atrial<br>fibrillation detection. |
| Acquisition<br>position | Standing up on the device | Seated with arms rested on a<br>table | Substantially equivalent. Please refer to<br>the bench testing results that show that<br>the subject device has lower RMSE<br>distribution with a 12-lead ECG device<br>than that of the predicate device and<br>subject devices are equivalent in terms of<br>visibility of P-wave, T-wave, QRS<br>complex visibility and polarity and<br>durations. Therefore the acquisition site<br>difference does not raise any issue of<br>effectiveness in terms of ECG signal<br>quality and also atrial fibrillation detection. |
| Number of ECG<br>measuring<br>electrodes | Three ECG measuring<br>electrodes | Two ECG measuring<br>electrodes | Substantially equivalent. The second<br>main difference between the two devices<br>is the number and function of the ECG<br>electrodes, resulting in the different<br>number of leads. The subject device has<br>three (3) ECG measuring electrodes that<br>come in contact with left fingers, right<br>fingers, left foot, whereas the predicate<br>has two (2) ECG measuring electrodes<br>that come in contact with the wrist. |
| Number of<br>feedback<br>electrodes | Two (2) feedback electrodes | One (1) feedback electrodes | Substantially equivalent. The subject<br>device has two (2) feedback electrodes<br>on the sole of the right foot serving as a<br>feedback mechanism to eliminate<br>environmental electromagnetic<br>interference, whereas the predicate has<br>one reference electrode that comes in<br>contact with the fingers to eliminate<br>environmental electromagnetic<br>interference by a similar feedback<br>mechanism. |
| ECG acquisition<br>duration | 30 seconds | 30 seconds | Identical |
| Resolution | 16 bits | 16 bits | Identical |
| Sampling Rate | 500Hz | 300Hz | Substantially equivalent. The subject<br>device has a higher sampling frequency<br>that does not affect the performance of<br>the ECG acquisition |
| Data storage | 8 Mbytes | 8 Mbytes | Identical |
| Analog Filter<br>Bandwidth | 0.033Hz - 200Hz | 0.34 Hz - 52 Hz | Substantially equivalent. The subject<br>device has a wider detection bandwidth<br>that does not affect the performance of<br>the ECG-SW1 AFib detection as the<br>Equivalence between Withings Scan<br>Monitor 2.0 and Withings Scan Monitor<br>ECG Waveforms report concludes |
| ECG<br>Classification<br>Results | Normal Sinus Rhythm<br>Atrial Fibrillation<br>Inconclusive<br>Noise | Normal Sinus Rhythm<br>Atrial Fibrillation<br>Inconclusive<br>Noise | Identical |
| Location of signal<br>processing | In the device | In the device | Identical |
| Firmware<br>algorithm | ECG-SW1 algorithm | ECG-SW1 algorithm | Identical |
| Power Supply:<br>Battery<br>Battery Life<br>(typical) | Rechargeable Lithium-ion<br>battery | Rechargeable Lithium-ion<br>battery | Identical |
| Degree of<br>protection…