(152 days)
Not Found
Yes
The document explicitly states that the algorithm development used "three stages of a robust Machine Learning algorithm development: training, testing, and validation".
No
The device is described as a monitor that records, stores, and displays ECG data, and detects atrial fibrillation. It does not provide any treatment or therapy.
Yes
The device is described as detecting the presence of atrial fibrillation and classifying ECG signals as Normal Sinus Rhythm, Atrial Fibrillation, Inconclusive, or Noise, which are diagnostic functions.
No
The device description explicitly states it is a "connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities" and mentions "electrical sensors present on the scale" which are hardware components.
Based on the provided information, the Withings Scan Monitor 2.0 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Withings Scan Monitor 2.0 directly measures electrical signals from the body (fingers and feet) to generate an ECG. It does not analyze a sample like blood, urine, or tissue.
- The intended use is for recording, storing, transferring, and analyzing ECG signals. This is a physiological measurement, not an analysis of a biological sample.
- The device description focuses on electrical sensors and ECG analysis. This aligns with a physiological monitoring device, not an IVD.
While the device performs analysis (detecting atrial fibrillation), this analysis is based on the electrical signals directly acquired from the body, not on a sample taken from the body. Therefore, it falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
No
The input document does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
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.
Product codes
DPS, DXH
Device Description
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:
- Normal Sinus Rhythm
- Atrial Fibrillation
- Inconclusive
- Noise - Inconclusive
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Three distinct sets of data were used to design the algorithm. Each dataset is used in one of the usual three stages of a robust Machine Learning algorithm development: training, testing, and validation of the final ("locked") algorithm.
Input Imaging Modality
Not Found
Anatomical Site
Fingers and feet.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
Intended for adult patients in hospitals, clinics, long-term care facilities, and homes.
Description of the training set, sample size, data source, and annotation protocol
Publicly available datasets were utilized for the training datasets consist of several smaller datasets.
Description of the test set, sample size, data source, and annotation protocol
A summary of the demographic characteristics of the test data set is provided in the table below:
Test Data Set 1 (n=137), Test Data Set 2 (n=262).
Demographic Characteristics include Age, Sex, BMI (kg/m²), Height (cm), Weight (kg), Cardiovascular Risk Factors (Hypertension, Dyslipidemia, Overweight or Obesity, Diabetes).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
Study Type: Prospective, cross-sectional, diagnostic, multicentric open-label study.
Sample Size: 274 patients included, 40 excluded from data analysis (final N=321 for confusion matrix including noise). 250 subjects planned (125 AF, 125 SR).
Purpose: To validate a rhythm classification algorithm ECG-SW1 running on the subject device Withings Scan Monitor 2.0 (WBSSM2) and its ability to detect and classify heart rhythms into one of four categories (sinus rhythm (SR), atrial fibrillation (AF), inconclusive or noise) using a six-lead ECG strip. Also to validate the Withings Scan Monitor 2.0 (WBSSM2) ability to generate a 6-lead electrocardiogram (ECG) that is clinically equivalent to a standard 12-lead ECG.
Key Results:
- WBSSM2 classified as "noise" 7.7% of valid ECG records (25/321).
- For remaining signals (at rest + after effort), excluding other arrhythmias:
- Sensitivity: 0.99 with a 95% confidence interval of [0.93, 1.0].
- Specificity: 0.99 with a 95% confidence interval of [0.97, 1.0].
- Accuracies computed on visibility of all ECG waves (P-waves, QRS complexes and T-waves) was above 0.992.
- Polarity accuracy: 0.986 for P-waves, 0.948 for QRS complex, and 0.911 for T-waves.
- Standard deviation of differences of duration of PR interval and QRS width between WBSSM2 and 12-lead gold standard ECG device was
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | ||||
| 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
3
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 |
| 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:
4
- 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
ics | Subject device: Withings
Scan Monitor 2.0 | Predicate device: Scan
Monitor | Comparison to predicate
device |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Name | Withings Scan Monitor 2.0 | Scan Monitor | NA |
| Number of
leads | 6-Lead | 1-Lead | Substantially equivalent. The
only minor difference is that
the subject device records
lead II and lead-III of a
two-channel electrocardiogram
(ECG) and calculates lead I,
whereas the predicate device
analyzes a single-channel
ECG and displays only lead I
ECG. Both devices use ECG
Lead I for rhythm
classification assessment.
Lead II, lead III, aVR, aVF and
aVL are for information
purposes only and are
validated in the clinical study
against the gold standard (12
lead ECG). |
| Manufactur
er | Withings | Withings | Identical |
| 510(k) | K230812 | K201456 | NA |
| Regulation
Number | 21 CFR 870.2340
21 CFR 870.2920 | 21 CFR 870.2340
21 CFR 870.2920
21 CFR 870.2700 | Identical, except for the
regulation for oximeter which
does not apply to the subject
device |
| Class | II | II | Identical |
| 510(k)
Review
Panel | Cardiovascular | Cardiovascular | Identical |
| Device
Class/Name | Electrocardiograph
Transmitters and Receivers,
Electrocardiograph,
Telephone | Electrocardiograph
Transmitters and Receivers,
Electrocardiograph, Telephone
Oximeter | Identical, except that the
predicate device can also
measure oxygen saturation of
arterial hemoglobin (%SpO2) |
| | | | and therefore is also an
oximeter |
| Product
Code | DPS, DXH | DPS, DXH, DQA | Identical, except that the
predicate device can also
measure oxygen saturation of
arterial hemoglobin (%SpO2)
and therefore has an
additional product code (DQA) |
| Prescription
/ OTC | Prescription and OTC | Prescription and OTC | Identical for the ECG
acquisition and the atrial
fibrillation detection
functionalities as Scan Monitor
and Withings Scan Monitor
2.0. |
| Intended
use and
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, 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. | Scan Monitor is intended to
record, store and transfer
single-channel
electrocardiogram (ECG)
rhythms.
The Scan Monitor also displays
ECG rhythms and detects the
presence of atrial fibrillation
(when the monitor is prescribed
or used under the care of a
physician).
The Scan Monitor is intended
for use by healthcare
professionals, patients with
known or suspected heart
conditions and health-conscious
individuals.
The Scan Monitor is also
indicated for use in measuring
and displaying functional
oxygen saturation of arterial
hemoglobin (%SpO2).
The Scan Monitor is intended
for adult patients in hospitals,
clinics, long-term care facilities,
and homes. | Substantially equivalent, The
predicate device also allows
for the measurement of
oxygen saturation of arterial
hemoglobin (%SpO2) with the
predicate device. Both devices
record, store and display
ECGs. |
| Intended
population | Adults with known or
suspected heart conditions
and health-conscious
individuals | Adults with known or suspected
heart conditions and
health-conscious individuals | Identical |
| Environment
Use | Hospitals, clinics, long term
care and home use | Hospitals, clinics, long-term
care and home use | Identical |
| Technological
Characteristic | Subject device: Withings
Scan Monitor 2.0 | Predicate device: Scan
Monitor | Comparison to predicate device |
| Hardware Interface | Body Scan (scale) | Scan Watch (watch) | Substantially equivalent. Please refer to
the bench testing and clinical study report
that demonstrate substantially equivalent
performance. Therefore, differences in
hardware interface are substantially
equivalent. |
| Principles of
Operation | User completes the circuit
with skin contact and
hardware collects and
transmits electrical potentials
to the microcontroller unit to
convert and display ECG
waveform. After acquisition,
the Withings Scan Monitor
2.0 uses the ECG waveforms
from the Withings Body
Scan, and the Withings Scan
Monitor 2.0 algorithms
process and classify the
signal and display the
classification to the user. | User completes the circuit
with skin contact and
hardware collects and
transmits electrical potentials
to the microcontroller unit to
convert and display ECG
waveform. After acquisition,
the Scan Monitor uses the
ECG waveforms from the
Withings Scan Watch, and the
Withings Scan Monitor 2.0
algorithms process and
classify the signal and display
the classification to the user. | Identical |
| Anatomical
sites | Fingers and feet. | Left hand fingers to right wrist
or vice versa | Substantially equivalent. The first main
difference between the two devices is the
site of ECG measurement. Please refer
to the bench testing results that show that
the subject device has lower RMSE
distribution with a 12-lead ECG device
than that of the predicate device and
show that ECG waveforms of the
predicate and subject devices are
equivalent in terms of visibility of P-wave,
T-wave, QRS complex visibility and
polarity and durations. Therefore the
anatomical site differences do not raise
any issue of effectiveness in terms of
ECG signal quality and also atrial
fibrillation detection. |
| Acquisition
position | Standing up on the device | Seated with arms rested on a
table | Substantially equivalent. Please refer to
the bench testing results that show that
the subject device has lower RMSE
distribution with a 12-lead ECG device
than that of the predicate device and
subject devices are equivalent in terms of
visibility of P-wave, T-wave, QRS
complex visibility and polarity and
durations. Therefore the acquisition site
difference does not raise any issue of
effectiveness in terms of ECG signal
quality and also atrial fibrillation detection. |
| Number of ECG
measuring
electrodes | Three ECG measuring
electrodes | Two ECG measuring
electrodes | Substantially equivalent. The second
main difference between the two devices
is the number and function of the ECG
electrodes, resulting in the different
number of leads. The subject device has
three (3) ECG measuring electrodes that
come in contact with left fingers, right
fingers, left foot, whereas the predicate
has two (2) ECG measuring electrodes
that come in contact with the wrist. |
| Number of
feedback
electrodes | Two (2) feedback electrodes | One (1) feedback electrodes | Substantially equivalent. The subject
device has two (2) feedback electrodes
on the sole of the right foot serving as a
feedback mechanism to eliminate
environmental electromagnetic
interference, whereas the predicate has
one reference electrode that comes in
contact with the fingers to eliminate
environmental electromagnetic
interference by a similar feedback
mechanism. |
| ECG acquisition
duration | 30 seconds | 30 seconds | Identical |
| Resolution | 16 bits | 16 bits | Identical |
| Sampling Rate | 500Hz | 300Hz | Substantially equivalent. The subject
device has a higher sampling frequency
that does not affect the performance of
the ECG acquisition |
| Data storage | 8 Mbytes | 8 Mbytes | Identical |
| Analog Filter
Bandwidth | 0.033Hz - 200Hz | 0.34 Hz - 52 Hz | Substantially equivalent. The subject
device has a wider detection bandwidth
that does not affect the performance of
the ECG-SW1 AFib detection as the
Equivalence between Withings Scan
Monitor 2.0 and Withings Scan Monitor
ECG Waveforms report concludes |
| ECG
Classification
Results | Normal Sinus Rhythm
Atrial Fibrillation
Inconclusive
Noise | Normal Sinus Rhythm
Atrial Fibrillation
Inconclusive
Noise | Identical |
| Location of signal
processing | In the device | In the device | Identical |
| Firmware
algorithm | ECG-SW1 algorithm | ECG-SW1 algorithm | Identical |
| Power Supply:
Battery
Battery Life
(typical) | Rechargeable Lithium-ion
battery | Rechargeable Lithium-ion
battery | Identical |
| Degree of
protection | Type BF- Applied parts | Type BF- Applied parts | Identical |
| Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-47
ANSI/AAMI EC57 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-47
ANSI/AAMI EC57 | Identical |
| | AAMI TIR69:2017/(R2020)
ANSI IEEE C63.27-2017
FCC testing per part 15 | AAMI TIR69:2017/(R2020)
ANSI IEEE C63.27-2017
FCC testing per part 15 | |
| Display format | LCD screen
320 x 240 pixels | OLED screen
116 x 80 pixels | Substantially equivalent, no impact on the
display. Bigger screen on the subject
device for the 6-lead display |
| Physical Specs:
Dimensions Weight | 372 x 446 x 45 mm
4.4 kg | 240 x 38.4 x 13.2 mm
0.058 kg | Substantially equivalent. The subject
device is bigger than the predicate device
allowing it to have bigger electrodes and
therefore more reliable ECG signal
acquisitions. |
| Environmental:
Operating Temp
Storage | Operating: +5°C to 35°C
Storage: -10°C to 50°C | Operating: +5°C to 40°C
Storage: -20°C to 70°C | Substantially equivalent |
| Communications,
Companion Mobile
Application | Setup in BLE
Scale used via WIFI and BLE | Setup in BLE
Watch used via BLE | Substantially equivalent |
6. Comparison to the Predicate
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Table 6-1: High-level comparison between the subject device (Withings Scan Monitor 2.0) and previously cleared device (Scan Monitor) for intended use, and indications of use.
Both devices are intended to record, store and transfer electrocardiogram (ECG) and display ECG rhythms and detect the presence of atrial fibrillation.
Both devices have a similar intended population, i.e. healthcare professionals, patients with known or suspected heart conditions, health-conscious individuals and adults.
Both devices are intended for adult patients in hospitals, clinics, long-term care facilities, and homes.
6
Both devices consist of the combination of the electromechanical assembly (Scan Watch for the predicate device and Body Scan for the subject device) and the related software brick included in the Health Mate companion app. For the ECG feature, both devices are intended to be used when prescribed or used under the care of a physician.
7
8
Table 6-2: High-level comparison between the subject device (Withings Scan Monitor 2.0) and previously cleared device (Scan Monitor) for technological characteristics.
At a high level, the subject device records a two channel ECG utilizing three electrodes on the smart scale that can then be transferred and displayed to the user or healthcare professional on the companion mobile application. Similarly, the predicate device records a single channel ECG using three electrodes on the smart watch and displays the results on a companion mobile application.
The subject device has the same intended use and indications for use as the predicate device including the intended use population and intended use environment. Both devices are intended to record, store and transfer electrocardiogram (ECG) and display ECG rhythms and detect the presence of atrial fibrillation. Minor differences in the number of leads is intended to provide additional information but does not affect the substantial equivalence of the device and does not alter the intended clinical application.
The fundamental technology of using stainless steel electrodes to measure ECG and detect atrial fibrillation is the same for the subject device and the predicate device. The minor technical differences do not raise different questions of safety and effectiveness because the non clinical testing, usability testing and clinical testing demonstrate equivalent device performance as the predicate device.
7. Summary of Performance Testing
Non Clinical Testing
All necessary performance testings were conducted on the subject device to support a determination of substantial equivalence to the predicate device. This testing included testing to the following standards:
- IEC 60601-1:2005, ANSI AAMI ES60601-1:2005/A2:2021 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, and
9
- IEC 60601-2-47:2012 Medical Electrical Equipment Part 2-47: Particular Requirements ● For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.
- 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.
- ANSI/AAMI EC57: Testing and reporting performance results of cardiac rhythm and ● ST-segment measurement algorithms.
- . AAMI TIR69:2017/(R2020) - Technical Information Report Risk management of radio-frequency, wireless coexistence for medical devices and systems
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless ● Coexistence
- FCC testing per part 15
The device was tested for cytotoxicity, sensitization, irritation and intracutaneous irritation as per according to "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", 2020.
Software verification and validation was performed per FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for Withings Scan Monitor 2.0 is considered to have a "moderate" level of concern.
Human Factors Testing
Human Factors Validation testing was performed on the Withing Scan Monitor 2.0 to demonstrate substantial equivalence for the intended users, uses and use environments. Testing was conducted per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". The Human Factor Validation study was performed in the U.S. with US participants and was conducted with 2 user groups:
-
- Adult lay users of ages 22-64 vears, and
-
- Elderly lay users of ages 65+ years
Both user groups included participants who are a mix of lay users with and without AFib. The validation protocol included simulated use scenarios, critical knowledge task questions, and interview questions to collective and subjective data to help determine potential root causes of any use errors and difficulties related to the user interface.
Users demonstrated a very good level of understanding and usage of the product. Overall users were able to record the ECG measurements, interpret the results and understand when it is appropriate to seek medical help. They were also able to answer simple and more complex questions around the contraindications and warnings of the product.
Algorithm Testing
Three distinct sets of data were used to design the algorithm. Each dataset is used in one of the usual three stages of a robust Machine Learning algorithm development: training, testing, and validation of the final ("locked") algorithm. In order to prevent any data leak or overfitting, there is no overlap between these three datasets. In particular, the data used for validation is independent from any training or testing since the recordings come from separate, independent sources: devices, patients, ECG reviewers and centers were all different.
10
Publicly available datasets were utilized for the training datasets consist of several smaller datasets. A summary of the demographic characteristics of the test data set is provided in the table below:
| Test Data Set 1 (n=137) | Test Data Set 2 (n=262) | ||||
|---|---|---|---|---|---|
| Demographic | |||||
| Characteristics | Demographic | ||||
| Characteristics | |||||
| Age | Age | ||||
| 66.6 +/- 13.5 | 68.2 +/- 14.8 | ||||
| Sex | Sex | ||||
| (N) | (%) | (N) | (%) | ||
| Male | 81 | 59 | Male | 160 | 61 |
| Female | 56 | 41 | Female | 102 | 39 |
| BMI (kg/m²) | BMI (kg/m²) | ||||
| 27.8 +/- 5.9 | 27.5 +/- 5.7 | ||||
| Height (cm) | Height (cm) | ||||
| 169.1 +/- 10.1 | 169.2 +/- 9.2 | ||||
| Weight (kg) | Weight (kg) | ||||
| 81.3 +/- 20.7 | 78.9 +/- 17.6 | ||||
| Cardiovascular Risk Factors | Cardiovascular Risk Factors | ||||
| Hypertension | Hypertension | ||||
| 59/137 (43%) | 135/262 (52%) | ||||
| Dyslipidemia | Dyslipidemia | ||||
| 29/137 (21%) | 90/262 (34%) | ||||
| Overweight or Obesity | Overweight or Obesity | ||||
| 75/137 (55%) | 111/262 (42%) | ||||
| Diabetes | Diabetes | ||||
| 16/137 (22%) | 57/262 (22%) |
Table 6-3: Demographic Characteristics of the ECG-SW1 algorithm test data set.
11
Clinical Study
The clinical study was a prospective, cross-sectional, diagnostic, multicentric open-label study with the anticipated total number of subjects that were planned to be recruited to meet the target was 250 patients of which 125 subjects with a known diagnosis of AF and 125 subjects with a known diagnosis of SR. The purpose of the study was to validate a rhythm classification algorithm ECG-SW1 running on the subject device Withings Scan Monitor 2.0 (WBSSM2) and its ability to detect and classify heart rhythms into one of four categories (sinus rhythm (SR), atrial fibrillation (AF), inconclusive or noise) using a six-lead ECG strip and to validate the Withings Scan Monitor 2.0 (WBSSM2) ability to generate a 6-lead electrocardiogram (ECG) that is clinically equivalent to a standard 12-lead ECG. 274 patients were included in the present study. 40 patients had to be excluded from the data analysis. Withings Scan Monitor 2.0 (WBSSM2) classified as "noise" 7.7% of the valid ECG records (25/321). Of the remaining signals (at rest + after effort), excluding other arrhythmias, Withings Scan Monitor 2.0 (WBSSM2) reached a sensitivity of 0.99 with a 95% confidence interval of [0.93, 1.0] and a specificity of 0.99 with a 95% confidence interval of [0.97, 1.0]. Withings Scan Monitor 2.0 (WBSSM2) accuracies computed on the visibility of all ECG waves (P-waves, QRS complexes and T-waves) was above 0.992. Polarity accuracy was 0.986 for P-waves, 0.948 for QRS complex, and 0.911 for T-waves. The standard deviation of the differences of duration of PR interval and QRS width between the signals of Withings Scan Monitor 2.0 (WBSSM2) and the 12-lead gold standard ECG device was