Masimo W1

K240229 · Masimo Corporation · DPS · Aug 8, 2024 · Cardiovascular

Device Facts

• Record ID: K240229
• Device Name: Masimo W1
• Applicant: Masimo Corporation
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended 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 the spot-checking of other continuous parameters (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.

Device Story

Wrist-worn watch (Masimo W1) with integrated W1 Module; performs spot-check ECG, SpO2, and pulse rate. ECG input via skin contact on wrist and finger-pad on watch face; pulse oximetry input via optical sensors on watch back using photoplethysmography and spectrophotometry (Beer-Lambert law). Device processes signals to calculate HR, SpO2, and PR; displays data on touchscreen. Bluetooth connectivity added to transmit data to smart device applications (e.g., Masimo SafetyNet) for caregiver/professional review. Used in hospitals, clinics, long-term care, and homes by patients or clinicians. Output enables manual interpretation of heart rate and tracking of physiological parameters to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, software verification/validation, wireless testing, cybersecurity assessment, and human factors/usability engineering.

Technological Characteristics

Wrist-worn device with touchscreen; internal rechargeable Li-Ion battery. Sensing: ECG (electrical) and Masimo SET pulse oximetry (optical/LED). Connectivity: Bluetooth (encrypted). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IP24 ingress protection. CF applied part. Software: W1 Module firmware for signal processing and parameter calculation.

Indications for Use

Indicated for adults in hospitals, clinics, long-term care facilities, and homes for spot-check determination of heart rate via single-channel ECG, functional oxygen saturation (SpO2), and pulse rate.

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

• Masimo W1 (K232512)

Submission Summary (Full Text)

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August 8, 2024

Masimo Corporation Sindura Penubarthi Associate Director, Regulatory Affairs 52 Discovery Irvine, California 92618

Re: K240229

Trade/Device Name: Masimo W1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, QDA, DXH Dated: July 12, 2024 Received: July 12, 2024

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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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 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 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)

### K240229

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 the spot-checking of other continuous parameters (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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

X 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 Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the company name is the company's address, which is "52 Discovery, Irvine, CA 92618".

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | January 26, 2024 |
| Contact: | Sindura Penubarthi<br>Associate Director, Regulatory Affairs<br>Masimo Corporation<br>Phone: [phone] |
| Trade Name: | Masimo W1 |
| Common Name: | Electrocardiograph |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2340, Class II/DPS |
| Additional Product Code: | DQA, DXH |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | Addition of Bluetooth connectivity to Masimo W1 |
| Predicate Device: | K232512 - Masimo W1 |

#### 1 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 W1 Module incorporates ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG parameters and Masimo SET pulse oximetry parameters.

As part of this submission, Bluetooth connectivity has been added to the Masimo W1 to support the wireless communication of monitored data to a compatible smart device application, such as the Masimo SafetyNet. The sharing of the parameter data to applications like the Masimo SafetyNet allows for users to see and track their data using their smart phone applications can also help to share information to caregivers and healthcare professionals.

The Masimo W1 specifications are provided in Table 1-1 below:

| Table 1-1 Masimo W1 Specifications | |
|------------------------------------------|----------------|
| Feature | Specifications |
| Remote Access to Parameter Data | Yes |
| Supported Communication | Wireless |
| Types of Wireless Communication | Bluetooth |
| Communication Security | Encryption |
| Continuous Display of Parameter Data | Yes |
| Performance Specifications | |
| SpO2, No Motion/ Low Perfusion (70-100%) | 2% adults |
| Pulse Rate (25-240 bpm) | 3 bpm adults |

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Image /page/4/Picture/0 description: The image contains the logo for Masimo, a medical technology company. The logo features a stylized red circle with a white checkmark-like shape inside, followed by the company name "Masimo" in a bold, sans-serif font. To the right of the logo, there is text that reads "MASIMO CO" followed by the address "52 Discovery, Irvine, CA 92618".

| Table 1-1 Masimo W1 Specifications | | |
|------------------------------------|--------------------------------|--|
| Feature | Specifications | |
| 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 ℃ (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 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 the spot-checking of other continuous parameters (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 Technological Characteristics

### Principle of Operation

There were no changes made to the principles of operation of the subject device, Masimo W1, from the previous clearance under K232512.

#### Pulse oximetry-based parameters

The Masimo W1 still relies on Masimo SET pulse oximetry, which relies on the Beer-Lambert law and the following principles of pulse oximetry to provide estimates of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate:

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Image /page/5/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 a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".

- . 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.

### Electrocardiogram (ECG)

The ECG feature on Masimo W1 still 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 the electrical signals that are propagated so that they can be detected at the skin surface of the wrist.

### Mechanism of Action for Achieving the Intended Effect

There were no changes to the mechanism of action of the Masimo W1 from the previous clearance under K232512, except for the addition of Bluetooth connectivity.

The Masimo W1 still achieves its intended effect through the integrated W1 Module that provides both the electrical and optical sensing technology and parameter algorithms. The W1 Module is integrated into the Masimo 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 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 W1 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 monitored parameters are then continuously updated and displayed on the watch so that it can be viewed, recorded, and/or transferred. As part of this submission, the Masimo W1 is also provided with Bluetooth connectivity to support the wireless communication of the monitored data to a smart device application for supplemental display. 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 Discussion of Similarities and Differences Between Primary Predicate and Subject Device

### Similarities and Differences between Primary Predicate and Subject Device

The subject device, Masimo W1, and the predicate device, Masimo W1 (K232512), have the following key similarities:

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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white checkmark to the left of the word. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

- · 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, Masimo W1 (K232512), have the following key differences:

- · The subject device is provided with Bluetooth connectivity.
Between the subject device and the predicate device, they have the same intended use with a technological difference. The technological difference from the predicate device is that the subject device is provided with Bluetooth connectivity to support the wireless communication of monitored data to a compatible smart device application. To support the addition of the Bluetooth connectivity does not raise different questions of safety and effectiveness, testing was conducted. The testing supported there were no significant differences in the safety of the subject device as compared to the predicate device.

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Image /page/7/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 red oval containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

| Table 4-1 Comparison between subject and predicate device | | | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Masimo W1 | Masimo W1 | Comparison to Predicate |
| 510(k) Number | Subject Device | Predicate Device | Device |
| | | (K232512) | |
| General Information | | | |
| Classification | Class II, Electrocardiograph | Class II, Electrocardiograph | Same |
| Regulation, Product Code | 21 CFR 870.2340, Class II/DPS | 21 CFR 870.2340, Class II/DPS | Same |
| Additional Product<br>Code(s) | DQA | DQA | Same |
| | DXH | DXH | |
| Indications for Use | Masimo W1™ and the integrated Masimo W1<br>module are intended for the spot-check<br>determination of Heart Rate using a single-<br>channel electrocardiogram (ECG). The Masimo<br>W1 and the integrated Masimo W1 module<br>records, stores, transfers, and displays the single-<br>channel ECG for the manual interpretation of<br>heart rate. It is worn on the wrist and also<br>provides other continuous parameters<br>technologies (e.g., pulse oximetry).<br><br>The Masimo W1™ and the integrated Masimo<br>W 1 module are also intended for the spot-<br>checking of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate (PR).<br>The Masimo W1 and the integrated Masimo W1<br>Module are indicated for adults in hospitals,<br>clinics, long-term care facilities, and homes. | Masimo W1™ and the integrated Masimo W1<br>module are intended for the spot-check<br>determination of Heart Rate using a single-<br>channel electrocardiogram (ECG). The Masimo<br>W1 and the integrated Masimo W1 module<br>records, stores, transfers, and displays the single-<br>channel ECG for the manual interpretation of<br>heart rate. It is worn on the wrist and also<br>provides other continuous parameters<br>technologies (e.g., pulse oximetry).<br><br>The Masimo W1™ and the integrated Masimo<br>W1 module are also intended for the spot-<br>checking of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate (PR).<br>The Masimo W1 and the integrated Masimo W1<br>Module are indicated for adults in hospitals,<br>clinics, long-term care facilities, and homes. | Same |
| Technological Characteristics | | | |
| Principles of Operation | The W1 Module software analyzes the patterns<br>in the ECG waveform to determine manual<br>interpretation of Heart Rate. | The W1 Module software analyzes the patterns<br>in the ECG waveform to determine manual<br>interpretation of Heart Rate. | Same |
| Table 4-1 Comparison between subject and predicate device | | | |
| Feature<br>510(k) Number | Masimo W1<br>Subject Device | Masimo W1<br>Predicate Device<br>(K232512) | Comparison to Predicate<br>Device |
| | The Masimo SET pulse oximeter technology<br>relies on the Beer-Lambert law and the<br>following principles of pulse oximetry:<br>Oxyhemoglobin (oxygenated blood) and<br>deoxyhemoglobin (non-oxygenated blood)<br>differ in their absorption of red and infrared<br>light (spectrophotometry). The amount of arterial blood in tissue<br>changes with your pulse<br>(photoplethysmography). Therefore, the<br>amount of light absorbed by the varying<br>quantities of arterial blood changes as well. | The Masimo SET pulse oximeter technology<br>relies on the Beer-Lambert law and the<br>following principles of pulse oximetry:<br>Oxyhemoglobin (oxygenated blood) and<br>deoxyhemoglobin (non-oxygenated blood)<br>differ in their absorption of red and infrared<br>light (spectrophotometry). The amount of arterial blood in tissue<br>changes with your pulse<br>(photoplethysmography). Therefore, the<br>amount of light absorbed by the varying<br>quantities of arterial blood changes as well. | |
| Supported Measured<br>Parameters | HR, SpO2, PR | HR, SpO2, PR | Same |
| Supported Calculated<br>features | Pi | Pi | Same |
| Supported<br>Communication | Wireless | N/A | Different. Subject device is<br>provided with wireless<br>communication<br>(Bluetooth).<br>Testing is provided to<br>support substantial<br>equivalence. |
| Wireless Type | Bluetooth | N/A | Different. Subject device is<br>provided with Bluetooth<br>connectivity to share data. |
| Table 4-1 Comparison between subject and predicate device | | | |
| Feature<br>510(k) Number | Masimo W1<br>Subject Device | Masimo W1<br>Predicate Device<br>(K232512) | Comparison to Predicate<br>Device |
| Communication Security | Encryption | N/A | Testing is provided to<br>support substantial<br>equivalence.<br>Different. Subject device is<br>provided with application<br>layer encryption. |
| User Interface | Touchscreen | Touchscreen | Same |
| Performance Specifications | | | |
| SpO2, (70-100%) | 2%, adults (No Motion/ Low Perfusion) | 2%, adults (No Motion/ Low Perfusion) | Same |
| Pulse Rate (25-240 bpm) | 3 bpm | 3 bpm | Same |
| Heart Rate (25-240 bpm) | 5 bpm | 5 bpm | Same |
| Electrical Specifications | | | |
| Battery | Internal Rechargeable | Internal Rechargeable | Same |
| Mechanical Specifications | | | |
| Watch Face Size | 40 mm (1.57") | 40 mm (1.57") | Same |
| Weight | 54 g (including watchband) | 54 g (including watchband) | Same |
| Environmental Specifications |…