(91 days)
K201456 - Withings Scan Monitor
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using traditional signal processing and algorithms.
No.
This device is designed for monitoring physiological parameters such as heart rate, SpO2, and ECG waveforms by recording and displaying the data for manual interpretation, rather than directly providing therapy.
Yes
The device is intended for the spot-check determination of Heart Rate and functional oxygen saturation (SpO2), and records and displays a single-channel ECG for manual interpretation of heart rate. These functions are used to assess physiological parameters, which is a diagnostic purpose.
No
The device description explicitly states that the Masimo W1 is a "watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm". It also mentions the module incorporates "ECG functionality" and "Masimo SET Pulse Oximetry technology". This indicates the device includes hardware components for signal acquisition (ECG and pulse oximetry), making it a hardware and software combination, not software-only.
Based on the provided information, the Masimo W1 and integrated Masimo W1 module are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Masimo W1 Functionality: The Masimo W1 measures physiological parameters directly from the patient's body (ECG and SpO2) through sensors placed on the wrist. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for spot-check determination of Heart Rate and functional oxygen saturation (SpO2), which are direct physiological measurements, not analyses of biological samples.
Therefore, the Masimo W1 falls under the category of a non-IVD medical device that performs physiological monitoring.
N/A
Intended Use / Indications for Use
Masimo W1™ and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides other continuous parameters technologies (e.g., pulse oximetry).
The Masimo W1™ and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.
Product codes (comma separated list FDA assigned to the subject device)
DPS, DQA, DXH
Device Description
The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The module incorporates ECG functionality for Heart Rate Monitoring and Masimo SET Pulse Oximetry technology so that it can provide both ECG (Heart Rate parameter) and Masimo SET Pulse Oximetry parameter output from the W1 Module is displayed on the touchscreen watch interface.
As part of the Masimo W1 watch, the Masimo W1 Module is integrated into the Masimo W1 watch platform, which consists of a typical IT hardware platform to enable other non-medical smart watch features (e.g., step counting, walking, running, fall detection and rise to wake).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
hospitals, clinics, long-term care facilities, and homes.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
To clinically validate the performance of the heart rate (HR) feature on the Masimo W1 watch, a prospective clinical study was conducted on 61 subjects where the spot-check HR measurements obtained from the W1 module were compared to an FDA cleared ECG reference measurement.
To clinically validate the ECG waveform quality of the Masimo W1, the ECG waveforms collected by the Masimo W1 were compared to Lead I of a gold standard reference of a 12-Lead ECG by three board certified cardiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance bench testing for the Masimo W1 is included in this submission to support both ECG HR and Pulse Oximetry based parameter performance.
Biocompatibility testing in accordance with ISO 10993-1 is included as part of this submission to support the acceptability of the biocompatibility risks.
EMC testing was conducted in accordance with IEC 60601-1-2: 4.1 Edition and the electrical safety in accordance with the IEC 60601-1 standard. Environmental, cleaning, and chemical resistance testing was also provided to support the substantial equivalence of the Masimo W1.
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA Guidance for the Content of Premarket Submissions for Software Device Software Functions, June 2023. The software was found to fit in the category of products that would require Basic Documentation Level because the failure or latent flaw of the device software function would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device or others in the environment of use prior to the implementation of the risk controls. The software does not provide any data that is considered life supporting.
To support the usability of the Masimo W1, human factors and usability risks were evaluated to be acceptably mitigated in accordance with FDA Guidance, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated February 3, 2016. The testing was found to support acceptability of the human factors and usability risks.
Clinical Performance Testing: To support the performance of the Masimo W1, clinical data is provided to support of the performance of the Masimo W1. To address potential concerns related to skin pigment discrepancies in pulse oximetry, the SpO2 clinical testing included 31 subjects with varying skin pigmentations measured using a colorbased scale, Massey-Martin. The results separated by skin pigment supported the performance of the Masimo W1 across different skin tones.
The SpO2 performance testing was conducted in accordance with the ISO 80601-2-61. The prospective clinical study included 31 healthy volunteer subjects, including 13 light, 12 medium and 6 dark pigmented subjects, which exceeded the ISO 80601-2-61 minimum sample size requirements and the minimum number of dark pigmented subjects in accordance with the FDA Guidance for Pulse Oximeters. Subjects were classified as dark and light based upon their Massey-Martin scores, 1-3 classified as "Light", 4-6 classified as "Medium" and 7-10 as "Dark" or subjects with more skin pigment.
The overall performance was 1.62% Arms after adjusting for repeated measures. The results support the specification of 2% Arms across the range of 70%-100% SaO2.
To clinically validate the performance of the heart rate (HR) feature on the Masimo W1 watch, a prospective clinical study was conducted on 61 subjects where the spot-check HR measurements obtained from the W1 module were compared to an FDA cleared ECG reference measurement. The testing supported the claimed heart rate performance and its substantial equivalence.
To clinically validate the ECG waveform quality of the Masimo W1, the ECG waveforms collected by the Masimo W1 were compared to Lead I of a gold standard reference of a 12-Lead ECG by three board certified cardiologists. The testing supported the acceptability of the detected ECG waveforms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2, No Motion/ Low Perfusion (70-100%): 2% adults
Pulse Rate, No Motion (25-240 bpm): 3 bpm adults
Heart Rate (25-240 bpm): ≤ 5 bpm adults
SpO2 clinical testing metrics:
| Pigmentation | Bias | Precision | ARMS | Adjusted Precision | Adjusted ARMS | Adjusted LOA | Nsubj | Npairs |
|---|---|---|---|---|---|---|---|---|
| Dark (Massey 7-10) | 0.37 | 1.64 | 1.68 | 1.78 | 1.82 | [-3.14, 3.88] | 6 | 329 |
| Medium (Massey 4-6) | -0.26 | 1.58 | 1.60 | 1.65 | 1.67 | [-3.49, 2.97] | 12 | 724 |
| Light (Massey 1-3) | 0.56 | 1.41 | 1.51 | 1.48 | 1.58 | [-2.34, 3.46] | 13 | 831 |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K201456 - Withings Scan Monitor
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K221260 - CSF-3
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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November 17, 2023
Masimo Corporation Sindura Penubarthi Associate Director, Regulatory Affairs 52 Discovery Irvine, California 92618
Re: K232512
Trade/Device Name: Masimo W1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQA, DXH Dated: October 23, 2023 Received: October 23, 2023
Dear Sindura Penubarthi:
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 OS 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.
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).
Sincerely,
Jennifer W. Shih -S
Jennifer 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
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Indications for Use
Submission Number (if known)
Device Name
Masimo W1
Indications for Use (Describe)
Masimo W1™ and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides other continuous parameters technologies (e.q., pulse oximetry).
The Masimo W1 ™ and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a stylized red checkmark-like symbol on the left, followed by the company name "Masimo" in a simple, sans-serif black font. The checkmark symbol is rounded and appears to be slightly tilted to the right.
| Submitter and Address of Manufacturing
Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | November 17, 2023 |
| Contact: | Sindura Penubarthi
Associate Director, Regulatory Affairs
Masimo Corporation
Phone: (949) 396-4041 |
| Trade Name: | Masimo W1 |
| Common Name: | Electrocardiograph |
| Classification Regulation/ Product Code: | 21 CFR 870.2340, Class II/DPS |
| Additional Product Codes: | DQA
DXH |
| Establishment Registration Number: | 3011353843 |
| Reason for Premarket Notification: | New Device |
| Predicate Device: | K201456 – Withings Scan Monitor |
| Reference Device: | K221260 - CSF-3 |
1.0 Device Description
The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The module incorporates ECG functionality for Heart Rate Monitoring and Masimo SET Pulse Oximetry technology so that it can provide both ECG (Heart Rate parameter) and Masimo SET Pulse Oximetry parameter output from the W1 Module is displayed on the touchscreen watch interface.
As part of the Masimo W1 watch, the Masimo W1 Module is integrated into the Masimo W1 watch platform, which consists of a typical IT hardware platform to enable other non-medical smart watch features (e.g., step counting, walking, running, fall detection and rise to wake).
See Table 1 below for the Masimo W1 Specifications.
| Table 1 - Specifications | |
|---|---|
| Feature | Specifications |
| Continuous Display of Parameter Data | Yes |
| User Interface | Touchscreen |
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| Table 1 - Specifications | |
|---|---|
| Feature | Specifications |
| Performance Specifications | |
| SpO2, No Motion/ Low Perfusion (70-100%) | 2% adults |
| Pulse Rate, No Motion (25-240 bpm) | 3 bpm adults |
| Heart Rate (25-240 bpm) | ≤ 5 bpm adults |
| Electrical Specifications | |
| Battery | Internal Rechargeable Li-Ion |
| Mechanical Specifications | |
| Size | 40 mm (1.57") |
| Display Type | Touchscreen |
| Weight | 54 g (including watchband) |
| Environmental Specifications | |
| Operating Temperature | 0 to 35 °C (32 to 95°F) |
| Operating Humidity | 10% to 95% RH (non-condensing) |
| Storage/Transport Temperature | -20°C to 60°C (-4°F to 140°F) |
| Storage/Transport Humidity | 10% to 95% RH (non-condensing) |
| Classification per IEC 60601-1 | |
| Electrical Safety | IEC 60601-1 |
| EMC | IEC 60601-1-2 |
| Electrical Isolation Type | Internally Powered |
| Applied Part Type | CF Applied Part |
| Ingress Protection | IP24 |
| Mode of Operation | Continuous |
2.0 Intended Use/ Indications for Use
Masimo W1™ and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides other continuous parameters technologies (e.g., pulse oximetry).
The Masimo W1™ and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.
3.0 Technological Characteristics
Principle of Operation
Electrocardiogram (ECG)
The ECG feature on Masimo W1 relies on the principle that the electrical signals can be detected as different parts of the heart contract and relax during a cardiac cycle allowing the detection of heart activity and for the estimation of heart rate (HR). The change in polarization of the heart muscles creates electrical signals that are propagated so that they can be detected at the skin surface of the wrist.
Pulse Oximetry-Based Parameters
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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red checkmark symbol to the left of the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
The Masimo SET pulse oximeter technology relies on the Beer-Lambert law and the following principles of pulse oximetry:
- . Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
- . The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
Mechanism of Action for Achieving the Intended Effect
The Masimo W1 watch achieves its intended effect through the integrated Masimo W1 Module that provides both the electrical and optical sensing technology and parameter algorithms. The W1 Module is integrated into the W1 watch so that the sensing components contact the skin on the wrist. The top of the watch is provided with an electrical sensing pad that is contacted by the two fingers on the opposing hand. Contacting the electrical sensing pad allows for the detection of the ECG signal when the ECG feature is activated on the watch touchscreen. Once the ECG feature is activated, it detects and calculates the heart rate.
The Masimo SET pulse oximetry-based parameters are supported by the W1 Module's optical sensing components located on the bottom of the module that contacts the skin on the wrist. The W 1 Module continuously detects and processes the optical signals that change with the transmission of LED light into the wrist tissue. The W1 Module utilizes multiple wavelengths of light and advanced signal processing techniques to isolate the arterial signal from other static factors (e.g., skin pigment) to establish the ratio used in the estimation of the SpO2. The pulse rate is determined by the periodic changes in the photoplethysmograph (PPG). The parameters are then continuously updated and displayed on the watch so that it can be viewed, recorded, and/or transferred. The use of the Masimo W1 watch can be discontinued by taking off the watch or deactivating the continuous parameters from the watch's touchscreen.
4.0 Summary of Technological Characteristics of Subject Device Compared to Predicate Device
Similarities and Differences between Predicate and Subject Device
The subject device, Masimo W1, and the predicate device, Scan Monitor (K201456), have the following key similarities:
- · Both devices have the same intended use;
- · Both devices rely on the same principles of operation;
- · Both devices are indicated for the same population of prescription and OTC users;
The subject device, Masimo W1, and the predicate device, Scan Monitor (K201456), have the following key differences:
- · The subject device does not support ECG rhythm classifications (e.g., AFib);
- · The subject device continuously updates pulse oximetry parameter data.
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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black letters. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
The subject device and predicate devices were found to have intended use without any technological differences that raise different questions of safety and effectiveness.
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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo features a red circle with a white line running through it on the left, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo, the text "MASIMO CORPORATION" is displayed above the address "52 Discovery, Irvine, CA 92618".
| Feature
510(k) Number | Masimo W1
Subject Device | Withings Scan Monitor
Primary Predicate
(K201456) | Comparison to
Predicate Device |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Classification
Regulation/ Product
Code | 21 CFR 870.2340, Class II/DPS | 21 CFR 870.2340, Class II/DPS | Same |
| Product Code(s) | DQA
DXH | DQA
DXH | Same |
| Indications for Use | Masimo W1™ and the integrated Masimo W1
module are intended for the spot-check
determination of Heart Rate using a single-
channel electrocardiogram (ECG). The Masimo
W1 and the integrated Masimo W1 module
records, stores, transfers, and displays the
single-channel ECG for the manual
interpretation of heart rate. It is worn on the
wrist and also provides other-continuous
parameters technologies (e.g., pulse oximetry).
The Masimo W1TM and the integrated Masimo
W1 module are also intended for the spot-
checking of functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse rate
(PR). The Masimo W1 and the integrated
Masimo W1 Module are indicated for adults in
hospitals, clinics, long-term care facilities, and
homes. | The 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 spot-checking of adult
patients in hospitals, clinics, long-term
care facilities and homes. | Similar. The subject
device has similar
indications as the
predicate for ECG HR
and Pulse Oximetry |
| Technological Characteristics | | | |
| Feature
510(k) Number | Masimo W1
Subject Device | Withings Scan Monitor
Primary Predicate
(K201456) | Comparison to
Predicate Device |
| Principles of Operation | The W1 Module software analyzes the
patterns in the ECG waveform to determine
manual interpretation of Heart Rate.
The Masimo SET pulse oximeter technology
relies on the Beer-Lambert law and the
following principles of pulse oximetry:
Oxyhemoglobin (oxygenated blood) and
deoxyhemoglobin (non-oxygenated
blood) differ in their absorption of red
and infrared light (spectrophotometry).The amount of arterial blood in tissue
changes with your pulse
(photoplethysmography). Therefore, the
amount of light absorbed by the varying
quantities of arterial blood changes as
well. | The iECG software analyzes the patterns
in the ECG waveform to determine
different types of known heart activity
(e.g., Heart Rate, Atrial Fibrillation).
Scan Monitor pulse oximetry technology
relies on the differential absorption by
blood of red (660nm) and infrared light
(940nm) which relies on the Beer-
Lambert law for the principles of pulse
oximetry. | Similar. The subject
device utilizes the same
principles related to ECG
and Pulse Oximetry. |
| Supported Measured
Parameters | HR, SpO2, PR | HR, SpO2 | Different. The subject
device provides
additional pulse
oximetry-based features
(i.e., PR).
Testing is provided to
support the PR
performance. |
| Feature
510(k) Number | Masimo W1
Subject Device | Withings Scan Monitor
Primary Predicate
(K201456) | Comparison to
Predicate Device |
| Supported Calculated
features | Pi | HRV, AFib Classification | Different. The subject
device provides Pi.
Testing is provided to
support the Pi feature. |
| User Interface | Touchscreen | Touchscreen | Same |
| Performance Specifications (Arms) | | | |
| SpO2 (70-100%) | 2%, adults (No Motion/ Low Perfusion) | 3%, adults (No Motion) | Different. Subject device
includes performance
testing to support
improved specification. |
| Pulse Rate (25-240 bpm) | 3 bpm | Not supported | Different. Subject device
includes performance
testing to support
improved specification. |
| Heart Rate (25-240 bpm) | 5 bpm | Not Known | Testing is provided to
support the specification. |
| Electrical Specifications | | | |
| Battery | Internal Rechargeable | Internal Rechargeable | Same |
| Mechanical Specifications | | | |
| Watch Face Size | 40 mm (1.57") | 38 mm or 42 mm | Similar. Testing is
provided to support the
substantial equivalence. |
| Weight | 54 g (including watchband) | 58 gms or 83gms | Similar. The weight
difference is minor and is
consistent with other
marketed watches. |
| Environmental Specifications | | | |
| Feature
510(k) Number | Masimo W1
Subject Device | Withings Scan Monitor
Primary Predicate
(K201456) | Comparison to
Predicate Device |
| Operating Temperature | 0 to 35 °C (32 to 95°F) | -10 to 45 °C (14 to 113°F) | Similar. Testing is
provided to support the
specification. |
| Operating Humidity | 10% to 95%, non-condensing | Not Known | Testing is provided to
support the specification. |
| Storage/Transport
Temperature | -20 to 60°C (-4 to 140°F) | -20 to 85°C (4 to 185°F) | Similar. Testing is
provided to support the
specification. |
| Storage/Transport
Humidity | 10% to 95%, non-condensing | Not Known | Testing is provided to
support the specification. |
| Classification per IEC 60601-1 | | | |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Ingress Protection | IP24 | Not Known | Testing is provided to
support the specification. |
| Mode of Operation | Continuous | Continuous | Same |
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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in black, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, gray, sans-serif font, followed by the address "82 Discovery, Irvine, CA 92618" also in a smaller, gray, sans-serif font.
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Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a stylized red symbol to the left of the word. To the right of the logo is the text "MASIMO CORPORATION", followed by the address "52 Discovery, Irvine, CA 92618" in a smaller font.
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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the company name is the text "MASIMO CORPORATION, 52 Discovery, Irvine, CA 92618" in a smaller, lighter font.
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Image /page/11/Picture/0 description: The image shows the logo for Masimo Corp. The logo consists of a red symbol on the left, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" are the words "MASIMO CORP" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".
5.0 Performance Data
The following non-clinical testing was provided to support the non-parameter specifications and the substantial equivalence of the subject device.
- Biocompatibility in accordance with ISO 10993-1 ●
- EMC testing per IEC 60601-1-2
- . Electrical safety testing per IEC 60601-1
- Environmental and Mechanical testing
- Cleaning Validation
- Software verification and validation testing per FDA Software Guidance ●
- Human Factors Usability testing per FDA Human Factors and Usability Guidance
The following are the list of standards that were used as part of the evaluation:
- IEC 60601-1:2005/2012
- IEC 60601-1-2:2014
- IEC 60601-1-6:2013 ●
- IEC 60601-1-11:2015
- IEC 60601-2-27:2011 ●
- IEC 60601-2-47:2012
- ISO 80601-2-61:2017 ●
- ISO 10993-1:2018
- IEC 62304:2015
- IEC 62366-1:2015
Performance Bench Testing
Performance bench testing for the Masimo W1 is included in this submission to support both ECG HR and Pulse Oximetry based parameter performance.
Biocompatibility Testing
Biocompatibility testing in accordance with ISO 10993-1 is included as part of this submission to support the acceptability of the biocompatibility risks.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
EMC testing was conducted in accordance with IEC 60601-1-2: 4.1 Edition and the electrical safety in accordance with the IEC 60601-1 standard. Environmental, cleaning, and chemical resistance testing was also provided to support the substantial equivalence of the Masimo W1.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as
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Image /page/12/Picture/0 description: The image shows the logo for Masimo Corporation. The logo features a red circle with a white checkmark inside, followed by the word "Masimo" in black, sans-serif font. To the right of the logo, the text "MASIMO CORPORATION" is displayed, along with the address "62 Discovery, Irvine, CA 92618".
recommended by FDA Guidance for the Content of Premarket Submissions for Software Device Software Functions, June 2023. The software was found to fit in the category of products that would require Basic Documentation Level because the failure or latent flaw of the device software function would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device or others in the environment of use prior to the implementation of the risk controls. The software does not provide any data that is considered life supporting.
Human Factors Usability Testing
To support the usability of the Masimo W1, human factors and usability risks were evaluated to be acceptably mitigated in accordance with FDA Guidance, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated February 3, 2016. The testing was found to support acceptability of the human factors and usability risks.
Clinical Performance Testing
To support the performance of the Masimo W1, clinical data is provided to support of the performance of the Masimo W1. To address potential concerns related to skin pigment discrepancies in pulse oximetry, the SpO2 clinical testing included 31 subjects with varying skin pigmentations measured using a colorbased scale, Massey-Martin. The results separated by skin pigment supported the performance of the Masimo W1 across different skin tones.
The SpO2 performance testing was conducted in accordance with the ISO 80601-2-61. The prospective clinical study included 31 healthy volunteer subjects, including 13 light, 12 medium and 6 dark pigmented subjects, which exceeded the ISO 80601-2-61 minimum sample size requirements and the minimum number of dark pigmented subjects in accordance with the FDA Guidance for Pulse Oximeters. Subjects were classified as dark and light based upon their Massey-Martin scores, 1-3 classified as "Light", 4-6 classified as "Medium" and 7-10 as "Dark" or subjects with more skin pigment.
The overall performance was 1.62% Arms after adjusting for repeated measures. The results support the specification of 2% Arms across the range of 70%-100% SaO2. The breakdown of the performance for dark, medium, and light subjects is provided below.
| Pigmentation | Bias | Precision | ARMS | Adjusted
Precision | Adjusted
ARMS | Adjusted
LOA | Nsubj | Npairs |
|------------------------|-------|-----------|------|-----------------------|------------------|-----------------|-------|--------|
| Dark
(Massey 7-10) | 0.37 | 1.64 | 1.68 | 1.78 | 1.82 | [-3.14, 3.88] | 6 | 329 |
| Medium
(Massey 4-6) | -0.26 | 1.58 | 1.60 | 1.65 | 1.67 | [-3.49, 2.97] | 12 | 724 |
| Light
(Massey 1-3) | 0.56 | 1.41 | 1.51 | 1.48 | 1.58 | [-2.34, 3.46] | 13 | 831 |
To clinically validate the performance of the heart rate (HR) feature on the Masimo W1 watch, a prospective clinical study was conducted on 61 subjects where the spot-check HR measurements obtained
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Image /page/13/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black letters. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
from the W1 module were compared to an FDA cleared ECG reference measurement. The testing supported the claimed heart rate performance and its substantial equivalence.
To clinically validate the ECG waveform quality of the Masimo W1, the ECG waveforms collected by the Masimo W1 were compared to Lead I of a gold standard reference of a 12-Lead ECG by three board certified cardiologists. The testing supported the acceptability of the detected ECG waveforms.
6.0 Conclusion
The data supported the substantial equivalence of the Masimo W1.