(192 days)
Not Found
No
The summary describes standard signal processing algorithms for ECG and pulse oximetry, and explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
No
Explanation: The device is intended for spot-check determination and monitoring of physiological parameters like Heart Rate, SpO2, and Pulse Rate. It records, stores, transfers, and displays this data for manual interpretation of heart rate and for users to track their data or share with caregivers/professionals. It does not state that it provides any form of therapy or treatment.
Yes
The device is intended for the "spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG)" and "spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)." These actions involve measuring physiological parameters to obtain information about a patient's health status, which falls under the definition of diagnostic devices.
No
The device description explicitly states that the Masimo W1 is a "watch that incorporates the W1 Module," which is responsible for "physiological signal detection and algorithm." This indicates the presence of hardware components for data acquisition (ECG and pulse oximetry), making it a hardware device with integrated software, not a software-only device.
Based on the provided information, the Masimo W1 and integrated Masimo W1 module are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Masimo W1 Functionality: The Masimo W1 measures physiological parameters directly from the body:
- Heart Rate (ECG): Measures electrical activity of the heart through electrodes on the wrist.
- Oxygen Saturation (SpO2) and Pulse Rate (PPG): Measures light absorption through the skin to determine oxygen levels and pulse.
- No Sample Analysis: The device does not collect or analyze biological samples. It directly measures physiological signals from the user's body.
Therefore, the Masimo W1 falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Masimo W1 and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides 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.
Product codes
DPS, QDA, DXH
Device Description
The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
hospitals, clinics, long-term care facilities, and homes.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Wireless Testing: 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: 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.
Key results for the performance studies are not explicitly detailed in terms of AUC, MRMC, or standalone performance metrics, but the text states that "The testing supported there were no significant differences in the safety of the subject device as compared to the predicate device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
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).
1
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
2
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
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | January 26, 2024 |
| Contact: | Sindura Penubarthi
Associate Director, Regulatory Affairs
Masimo Corporation
Phone: (949) 396-4041 |
| Trade Name: | Masimo W1 |
| Common Name: | Electrocardiograph |
| Classification Regulation/
Product Code: | 21 CFR 870.2340, Class II/DPS |
| Additional Product Code: | DQA, DXH |
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
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) |