(192 days)
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.
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.
This document is a 510(k) premarket notification from the FDA, indicating that the Masimo W1 device, with the addition of Bluetooth connectivity, has been found substantially equivalent to its predicate device (K232512). It does not contain detailed acceptance criteria and study results for the device's original performance claims (e.g., accuracy of Heart Rate, SpO2, and Pulse Rate measurements), but rather focuses on demonstrating that the addition of Bluetooth connectivity does not introduce new safety or effectiveness concerns.
Therefore, the requested information regarding acceptance criteria and performance studies for the core functionalities (like ECG heart rate, SpO2, and PR accuracy), multi-reader multi-case studies, ground truth establishment, and training set details, are not available in the provided document. The document primarily focuses on explaining that the Bluetooth addition was tested and found to not negatively impact the device's safety and effectiveness.
Here's an attempt to answer the questions based only on the information provided, highlighting what is not available:
Device: Masimo W1 (with added Bluetooth connectivity)
Device Name: Electrocardiograph (also measures SpO2 and Pulse Rate)
K Number: K240229
1. A table of acceptance criteria and the reported device performance
The document states that the Masimo W1 maintains the same performance specifications as its predicate device (K232512) for its core functionalities, implying these specifications were met in previous testing for the predicate. For the new Bluetooth functionality, the acceptance criterion was effectively that its addition does not degrade the existing performance or introduce new safety/effectiveness issues.
| Feature | Acceptance Criteria (from predicate) | Reported Device Performance (for subject device) |
|---|---|---|
| SpO2 (70-100%) | $\leq$ 2% adults (No Motion/Low Perf) | 2%, adults (No Motion/ Low Perfusion) - Same as predicate |
| Pulse Rate (25-240 bpm) | $\leq$ 3 bpm adults | 3 bpm adults - Same as predicate |
| Heart Rate (25-240 bpm) | $\leq$ 5 bpm adults | 5 bpm adults - Same as predicate |
| Bluetooth Functionality | No degradation of existing performance (safety/effectiveness) | Testing was conducted to support this; found substantially equivalent. |
| Communication Security | Encryption | Application layer encryption (Implicitly met expectation) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "non-clinical testing" including "Bench testing," "Software Verification and Validation Testing," "Wireless Testing," "Cybersecurity Testing," and "Human Factors and Usability Testing" to support the Bluetooth addition.
However, specific sample sizes for these tests are not provided.
Data provenance (country of origin, retrospective/prospective) is not specified. The studies are non-clinical and focus on functional performance and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic imaging AI). The tests described here are primarily technical and performance-based for a vital signs monitoring device. The ground truth for SpO2, PR, and HR measurement accuracy would have been established using reference standards (e.g., arterial blood gas analysis, ECG machine) during the original clearance of the predicate device, but details are not included here for this new submission (which focuses on Bluetooth).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are typically used in clinical studies where expert consensus is required for ground truth, particularly in diagnostic or AI-assisted interpretation. This document describes technical and performance validation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or described. The device is a vital signs monitor, not an AI diagnostic tool that assists human readers in interpreting images or data. The focus of this submission is adding Bluetooth connectivity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself operates without a human in the loop for the measurement of parameters (Heart Rate, SpO2, PR). The "manual interpretation of heart rate" mentioned in the Indications for Use refers to a human looking at the displayed ECG and determining the rate, not the device performing an interpretation for diagnosis. The performance specifications listed (e.g., SpO2, PR, HR accuracy) are standalone claims for the device's measurement capabilities. However, details of the studies proving these specific accuracies were part of the predicate device's clearance and are not reiterated here, as this submission focuses on the addition of Bluetooth.
The document states: "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." This implies the device provides the data, and a human performs the interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the core measurements (SpO2, PR, HR), the ground truth for the predicate device's original clearance would likely have been established using reference medical devices/methods (e.g., CO-oximeter for SpO2, reference ECG for HR, reference pulse oximeter for PR) in controlled clinical or laboratory settings. This document does not detail how the ground truth was established, as it focuses on the new Bluetooth feature. For the Bluetooth feature, the ground truth would relate to successful data transfer, communication security, and non-interference with primary functions.
8. The sample size for the training set
Not applicable/Not provided. This device is not described as using machine learning models that require a "training set" in the conventional sense. The "algorithm" for physiological signal detection and parameter determination would be deterministic or signal-processing based, not a learned model from a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided (as no training set is described).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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 (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)
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 ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592 |
|---|---|
| Date: | January 26, 2024 |
| Contact: | Sindura PenubarthiAssociate Director, Regulatory AffairsMasimo CorporationPhone: (949) 396-4041 |
| Trade Name: | Masimo W1 |
| Common Name: | Electrocardiograph |
| Classification Regulation/Product Code: | 21 CFR 870.2340, Class II/DPS |
| Additional Product Code: | DQA, DXH |
| Establishment RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | 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 ProductCode(s) | DQA | DQA | Same |
| DXH | DXH | ||
| Indications for Use | Masimo W1™ and the integrated Masimo W1module are intended for the spot-checkdetermination of Heart Rate using a single-channel electrocardiogram (ECG). The MasimoW1 and the integrated Masimo W1 modulerecords, stores, transfers, and displays the single-channel ECG for the manual interpretation ofheart rate. It is worn on the wrist and alsoprovides other continuous parameterstechnologies (e.g., pulse oximetry).The Masimo W1™ and the integrated MasimoW 1 module are also intended for the spot-checking of functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate (PR).The Masimo W1 and the integrated Masimo W1Module are indicated for adults in hospitals,clinics, long-term care facilities, and homes. | Masimo W1™ and the integrated Masimo W1module are intended for the spot-checkdetermination of Heart Rate using a single-channel electrocardiogram (ECG). The MasimoW1 and the integrated Masimo W1 modulerecords, stores, transfers, and displays the single-channel ECG for the manual interpretation ofheart rate. It is worn on the wrist and alsoprovides other continuous parameterstechnologies (e.g., pulse oximetry).The Masimo W1™ and the integrated MasimoW1 module are also intended for the spot-checking of functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate (PR).The Masimo W1 and the integrated Masimo W1Module are indicated for adults in hospitals,clinics, long-term care facilities, and homes. | Same |
| Technological Characteristics | |||
| Principles of Operation | The W1 Module software analyzes the patternsin the ECG waveform to determine manualinterpretation of Heart Rate. | The W1 Module software analyzes the patternsin the ECG waveform to determine manualinterpretation of Heart Rate. | Same |
| Table 4-1 Comparison between subject and predicate device | |||
| Feature510(k) Number | Masimo W1Subject Device | Masimo W1Predicate Device(K232512) | Comparison to PredicateDevice |
| The Masimo SET pulse oximeter technologyrelies on the Beer-Lambert law and thefollowing principles of pulse oximetry:Oxyhemoglobin (oxygenated blood) anddeoxyhemoglobin (non-oxygenated blood)differ in their absorption of red and infraredlight (spectrophotometry). The amount of arterial blood in tissuechanges with your pulse(photoplethysmography). Therefore, theamount of light absorbed by the varyingquantities of arterial blood changes as well. | The Masimo SET pulse oximeter technologyrelies on the Beer-Lambert law and thefollowing principles of pulse oximetry:Oxyhemoglobin (oxygenated blood) anddeoxyhemoglobin (non-oxygenated blood)differ in their absorption of red and infraredlight (spectrophotometry). The amount of arterial blood in tissuechanges with your pulse(photoplethysmography). Therefore, theamount of light absorbed by the varyingquantities of arterial blood changes as well. | ||
| Supported MeasuredParameters | HR, SpO2, PR | HR, SpO2, PR | Same |
| Supported Calculatedfeatures | Pi | Pi | Same |
| SupportedCommunication | Wireless | N/A | Different. Subject device isprovided with wirelesscommunication(Bluetooth).Testing is provided tosupport substantialequivalence. |
| Wireless Type | Bluetooth | N/A | Different. Subject device isprovided with Bluetoothconnectivity to share data. |
| Table 4-1 Comparison between subject and predicate device | |||
| Feature510(k) Number | Masimo W1Subject Device | Masimo W1Predicate Device(K232512) | Comparison to PredicateDevice |
| Communication Security | Encryption | N/A | Testing is provided tosupport substantialequivalence.Different. Subject device isprovided with applicationlayer 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 | |||
| Operating Temperature | 0 to 35 °C (32 to 95°F) | 0 to 35 °C (32 to 95°F) | Same |
| Operating Humidity | 10% to 95%, non-condensing | 10% to 95%, non-condensing | Same |
| Storage/TransportTemperature | -20 to 60°C (-4 to 140°F) | -20 to 60°C (-4 to 140°F) | Same |
| Storage/TransportHumidity | 10% to 95%, non-condensing | 10% to 95%, non-condensing | Same |
| 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 | IP24 | Same |
| Table 4-1 Comparison between subject and predicate device | |||
| Feature510(k) Number | Masimo W1Subject Device | Masimo W1Predicate Device(K232512) | Comparison to PredicateDevice |
| Mode of Operation | Continuous | Continuous | Same |
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Image /page/8/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo is a red circle with a white checkmark inside, followed by the word "Masimo" in bold black letters. The address is "52 Discovery, Irvine, CA 92618" and is located to the right of the logo.
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Image /page/9/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" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/10/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 circle containing a white checkmark 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".
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Image /page/11/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 word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
5 Performance Data
As part of this submission, non-clinical testing was included to support the addition of the Bluetooth connectivity and the substantial equivalence of the subject device.
Performance Bench Testing
Bench testing for the Masimo W1 was included in this submission to support the addition of the Bluetooth capability.
Biocompatibility Testing
As there were no changes made to the patient contacting materials of the subject device, Masimo W1, from the previous clearance under K232512, no new biocompatibility testing was included in this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no hardware changes made to the subject device, Masimo W1, from the previous clearance under K232512, no new electrical safety, environmental, and cleaning testing was included as part of this submission.
Software Verification and Validation Testing
Software verification and validation testing were conducted as part of this submission as recommended by the FDA Guidance, "Content of Premarket Submissions for Software Device Software Functions '', June 2023 to support the addition of the Bluetooth connectivity.
The Masimo W1 software was found to fit 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.
Wireless Testing
The Masimo W1 is provided with Bluetooth connectivity to support the wireless communication of the monitored data. Wireless testing was conducted in accordance with the FDA Guidance, "Radio-Frequency Wireless Technology in Medical Devices", August 14, 2013, to support the Bluetooth feature provided as part of the device.
Cybersecurity Testing
Cybersecurity documentation was provided as part of this submission in accordance with the FDA Guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". The cybersecurity of the Masimo W1 was implemented using a risk-based approach using the NIST 800-30 framework.
Human Factors and Usability Testing
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Image /page/12/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 word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
Usability testing has been conducted to support human factors and usability risks associated with the use of the Masimo W1 Bluetooth connectivity is acceptable. The human factors and usability process was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016.
Clinical Testing
No clinical testing was needed to support the addition of the Bluetooth feature to the subject device.
6 Conclusion
Based on the data provided as part of this subject device, Masimo W1, was found to be substantially equivalent.
§ 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).