Masimo W1

K232512 · Masimo Corporation · DPS · Nov 17, 2023 · Cardiovascular

Device Facts

• Record ID: K232512
• Device Name: Masimo W1
• Applicant: Masimo Corporation
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 17, 2023
• 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 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.

Device Story

Masimo W1 is a wrist-worn smartwatch integrating the W1 Module for physiological signal detection. Input: electrical signals from wrist skin via ECG sensing pad (contacted by opposing hand) and optical signals (LED light transmission) via bottom-mounted sensors. Operation: W1 Module processes ECG waveforms to calculate heart rate and uses Masimo SET pulse oximetry (Beer-Lambert law/photoplethysmography) to estimate SpO2 and pulse rate. Output: ECG waveforms, heart rate, SpO2, and pulse rate displayed on touchscreen. Used by patients or clinicians in hospitals, clinics, long-term care, or home settings. Healthcare providers use displayed data for manual interpretation of heart rate and monitoring of oxygen saturation. Benefits include convenient, non-invasive spot-check monitoring of vital signs.

Clinical Evidence

Clinical validation included a prospective study of 31 healthy subjects (13 light, 12 medium, 6 dark skin tones) for SpO2 performance per ISO 80601-2-61, showing 1.62% ARMS (adjusted). A separate prospective study of 61 subjects validated heart rate accuracy against an FDA-cleared ECG reference. ECG waveform quality was validated by three board-certified cardiologists comparing W1 output to Lead I of a 12-lead gold standard reference.

Technological Characteristics

Wrist-worn smartwatch with touchscreen. Sensing: ECG (electrical sensing pad) and Masimo SET pulse oximetry (optical LED). Materials: Biocompatible per ISO 10993-1. Power: Internal rechargeable Li-Ion battery. Connectivity: Standalone/integrated module. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-47, ISO 80601-2-61. Software: Basic documentation level.

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, and spot-checking of functional oxygen saturation (SpO2) and pulse rate (PR).

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

• Withings Scan Monitor (K201456)

Reference Devices

• CSF-3 (K221260)

Submission Summary (Full Text)

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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 ([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)

K232512

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<br>Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | November 17, 2023 |
| Contact: | Sindura Penubarthi<br>Associate Director, Regulatory Affairs<br>Masimo Corporation<br>Phone: [phone] |
| Trade Name: | Masimo W1 |
| Common Name: | Electrocardiograph |
| Classification Regulation/ Product Code: | 21 CFR 870.2340, Class II/DPS |
| Additional Product Codes: | DQA<br>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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Image /page/4/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 bold, sans-serif font. The checkmark is a vibrant red color, while the company name is in black.

| 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<br>510(k) Number | Masimo W1<br>Subject Device | Withings Scan Monitor<br>Primary Predicate<br>(K201456) | Comparison to<br>Predicate Device |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Classification<br>Regulation/ Product<br>Code | 21 CFR 870.2340, Class II/DPS | 21 CFR 870.2340, Class II/DPS | Same |
| Product Code(s) | DQA<br>DXH | DQA<br>DXH | Same |
| 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<br>single-channel ECG for the manual<br>interpretation of heart rate. It is worn on the<br>wrist and also provides other-continuous<br>parameters technologies (e.g., pulse oximetry).<br>The Masimo W1TM 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<br>(PR). The Masimo W1 and the integrated<br>Masimo W1 Module are indicated for adults in<br>hospitals, clinics, long-term care facilities, and<br>homes. | The Scan Monitor is intended to record,<br>store and transfer single-channel<br>electrocardiogram (ECG) rhythms. The<br>Scan Monitor also displays ECG rhythms<br>and detects the presence of atrial<br>fibrillation (when the monitor is<br>prescribed or used under the care of a<br>physician). The Scan Monitor is intended<br>for use by healthcare professionals,<br>patients with known or suspected heart<br>conditions and health-conscious<br>individuals.<br>The Scan Monitor is also indicated for<br>use in measuring and displaying<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2). The Scan Monitor is<br>intended for spot-checking of adult<br>patients in hospitals, clinics, long-term<br>care facilities and homes. | Similar. The subject<br>device has similar<br>indications as the<br>predicate for ECG HR<br>and Pulse Oximetry |
| Technological Characteristics | | | |
| Feature<br>510(k) Number | Masimo W1<br>Subject Device | Withings Scan Monitor<br>Primary Predicate<br>(K201456) | Comparison to<br>Predicate Device |
| Principles of Operation | The W1 Module software analyzes the<br>patterns in the ECG waveform to determine<br>manual interpretation of Heart Rate.<br>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<br>blood) differ in their absorption of red<br>and infrared 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<br>well. | The iECG software analyzes the patterns<br>in the ECG waveform to determine<br>different types of known heart activity<br>(e.g., Heart Rate, Atrial Fibrillation).<br>Scan Monitor pulse oximetry technology<br>relies on the differential absorption by<br>blood of red (660nm) and infrared light<br>(940nm) which relies on the Beer-<br>Lambert law for the principles of pulse<br>oximetry. | Similar. The subject<br>device utilizes the same<br>principles related to ECG<br>and Pulse Oximetry. |
| Supported Measured<br>Parameters | HR, SpO2, PR | HR, SpO2 | Different. The subject<br>device provides<br>additional pulse<br>oximetry-based features<br>(i.e., PR).<br>Testing is provided to<br>support the PR<br>performance. |
| Feature<br>510(k) Number | Masimo W1<br>Subject Device | Withings Scan Monitor<br>Primary Predicate<br>(K201456) | Comparison to<br>Predicate Device |
| Supported Calculated<br>features | Pi | HRV, AFib Classification | Different. The subject<br>device provides Pi.<br>Testing is provided to<br>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<br>includes performance<br>testing to support<br>improved specification. |
| Pulse Rate (25-240 bpm) | 3 bpm | Not supported | Different. Subject device<br>includes performance<br>testing to support<br>improved specification. |
| Heart Rate (25-240 bpm) | 5 bpm | Not Known | Testing is provided to<br>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<br>provided to support the<br>substantial equivalence. |
| Weight | 54 g (including watchband) | 58 gms or 83gms | Similar. The weight<br>difference is minor and is<br>consistent with other<br>marketed watches. |
| Environmental Specifications | | | |
| Feature<br>510(k) Number | Masimo W1<br>Subject Device | Withings Scan Monitor<br>Primary Predicate<br>(K201456) | Comparison to<br>Predicate Device |
| Operating Temperature | 0 to 35 °C (32 to 95°F) | -10 to 45 °C (14 to 113°F) | Similar. Testing is<br>provided to support the<br>specification. |
| Operating Humidity | 10% to 95%, non-condensing | Not Known | Testing is provided to<br>support the specification. |
| Storage/Transport<br>Temperature | -20 to 60°C (-4 to 140°F) | -20 to 85°C (4 to 185°F) | Similar. Testing is<br>provided to support the<br>specification. |
| Storage/Transport<br>Humidity | 10% to 95%, non-condensing | Not Known | Testing is provided to<br>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<br>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, s…