Radius T wearable thermometer
Device Facts
| Record ID | K203215 |
|---|---|
| Device Name | Radius T wearable thermometer |
| Applicant | Masimo Corporation |
| Product Code | FLL · General Hospital |
| Decision Date | Jun 11, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor (i.e., Masimo Root, Masimo Rad-97). The Radius T is indicated for single-use, continuous body temperature measurements of persons 5 years of age or older in hospitals, hospital-type facilities, and home environments.
Device Story
Radius T is a wearable, battery-powered thermometer for continuous body temperature monitoring. Device applies to upper chest; uses thermistor to measure skin surface temperature; extrapolates body temperature from skin heat flux. Data transmits via Bluetooth Low Energy to smart devices or Masimo monitors (Root, Rad-97). Used in hospitals and home environments by patients or clinicians. Output displayed on connected monitor/app; enables threshold alarms. Benefits include continuous, noninvasive temperature tracking without manual spot checks. Software modifications to Root and Rad-97 support communication/display. Device is single-use; includes disposable adhesive sensor.
Clinical Evidence
Clinical validation study performed per ISO 80601-2-56 comparing Radius T to a reference clinical thermometer. Bench testing confirmed laboratory accuracy of ± 0.1°C (25°C–43°C). Clinical bias reported as -0.2°C with limits of agreement ≤ 1.0°C.
Technological Characteristics
Wearable, battery-powered (lithium coin cell) thermometer. Sensor: thermistor. Connectivity: Bluetooth Low Energy. Dimensions: 5" x 5" x 0.5". Weight: 30g. Biocompatibility: ISO 10993-1, 5, 10. Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Software: Moderate level of concern.
Indications for Use
Indicated for single-use, continuous noninvasive body temperature measurement on the upper chest for persons 5 years of age or older in hospitals, hospital-type facilities, and home environments.
Regulatory Classification
Identification
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
Special Controls
(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
Predicate Devices
- FeverScout Continuous Monitoring Thermometer (K181013)
Reference Devices
Submission Summary (Full Text)
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June 11, 2021
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618
Re: K203215
Trade/Device Name: Radius T Wearable Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 6, 2021 Received: May 17, 2021
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K203215
Device Name Radius T Wearable Thermometer
#### Indications for Use (Describe)
Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor (i.e., Masimo Root, Masimo Rad-97).
The Radius T is indicated for single-use, continuous body temperature measurements of pears of age or older in hospitals, hospital-type facilities, and home environments.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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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 red circle with a white checkmark inside, followed by the company name "Masimo" in a bold, sans-serif font. The checkmark is stylized and appears to be part of the letter "M" in Masimo.
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
### 510(k) Summary - K203215
| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: (949) 297-7541<br>FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | June 8, 2021 |
| Contact: | Sindura Penubarthi<br>Regulatory Affairs Manager<br>Masimo Corporation<br>Phone: (949) 396-4041 |
| Trade Name: | Radius T Wearable Thermometer |
| Common Name: | Electronic Clinical Thermometer |
| Classification Regulation/<br>Product Code: | 21 CFR 880.2910, Class II/ FLL |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | New device |
| Predicate Device: | K181013- FeverScout Continuous Monitoring Thermometer |
### 1. Device Description
Radius T is a wearable, battery powered thermometer that is applied to the body to continuously provide body temperature measurements. The Radius T continuously approximates based upon the surface temperature at the application site. The body temperature data from the Radius T is transferred wirelessly to a monitoring device (e.g., Root, Rad-97) or smart device application for continuous display and monitoring.
As part of this submission, the software of the Root (K191882) and Rad-97 (K193626) is being modified to support the communication and display compatibility for the Radius T.
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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 red circle with a white checkmark inside, followed by the company name in black, stylized font. To the right of the logo is the company's address, which includes the number 52.
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
The performance specifications for Radius T are listed in Table 1.1-1 below:
| Radius T Specifications | |
|-----------------------------------|----------------------------------------------------------------------------------|
| Feature | Specification |
| Temperature Accuracy - Laboratory | $\pm$ 0.1°C ( $\pm$ 0.18°F) in the range of 25°C to 43°C (77°F to 109.4°F) |
| Temperature Accuracy - Clinical | Clinical bias of -0.2°C (-0.36°F) with limits of agreement $\leq$ 1.0°C (1.8°F). |
| Intended Population | 5 years or older |
| Application site | Upper Chest |
| Product use life/Battery life | Minimum of 8 days (192 hours) of continuous run time |
| Environmental | |
| Storage/Transport Temperature | -20°C to 50°C (-4°F to 122°F) |
| Operating Temperature | 10°C to 40°C (50°F to 104°F) |
| Storage/Transport Humidity | 10% RH to 95% RH (non-condensing) |
| Operating Humidity | 10% RH to 95% RH (non-condensing) |
| Atmospheric Pressure | 700 to 1060 hPa @ ambient temperature and humidity |
| Wireless | |
| Type | Bluetooth Low Energy |
### 2. Intended Use/ Indications For Use
Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor (i.e., Masimo Root, Masimo Rad-97).
The Radius T is indicated for single-use, continuous body temperature measurements of persons 5 years of age or older in hospitals, hospital-type facilities, and home environments.
### 3. Technological Characteristics
### Principle of Action
To achieve its intended purpose, the Radius T relies on the principle that the heat flux generated by the body temperature can be inferred by measuring the skin surface temperature to allow for the estimation of the body temperature.
### Mechanism of Action for Achieving the Intended Effect
The Radius T achieves its intended effect through application of the battery powered thermometer to the skin surface on the patient's chest. The thermometer measures the skin surface temperature and estimates the body
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Image /page/5/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark-like symbol inside, followed by the company name "Masimo" in bold, black font. To the right of the name, there is some smaller text that appears to be the company's address, but it is too blurry to read.
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
temperature continuously. The estimated body temperature is transmitted wirelessly through a secure Bluetooth connection to a compatible device or software application. Once displayed, the temperature data can be stored or used to trigger threshold alarms on the connected device or software application.
### 4. Summary of Technological Characteristics of a Subject Device to the Predicate
The subject device, Radius T, and the predicate device, FeverScout (K181013), have the following key similarities:
- Both devices have the same intended use to continuously measure body temperature;
- Both devices estimate body temperature from a sensor applied to the skin surface;
- Both devices include single use adhesive sensors; ●
- Both devices rely on wireless communication for display of the body temperature. .
The subject device, Radius T and the predicate device, FeverScout (K181013), have the following key differences:
- Subject device is applied to the chest while the predicate device is applied to an axial site; ●
- Subject device is intended for adults and pediatrics 5 years and older while the predicated ● for adults and pediatrics 29 days and older;
- Subject device includes a disposable sensor while the predicate device includes reusable patch with ● disposable tabs.
The subject device and predicate device were found to be substantially equivalent based upon both devices having the same intended use and no technological differences that raise new concerns of safety and effectiveness.
Between to the subject device and predicate device, the main technological difference is that the predicate device estimates body temperature from the armpit while the subject device estimates the body temperature from the chest. To support that this difference along with other technological difference do not significant affect the safety and effectiveness of the Radius T clinical and non-clinical testing was conducted. The test results supported the substantial equivalence of the Radius T.
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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".
| | Radius T Wearable Thermometer | FeverScout<br>(K181013) | Comparison to Predicate Device |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject Device | Predicate Device | |
| General Information | | | |
| Indications for Use (IFU) | Radius T wearable thermometer is intended for<br>single-use, continuous noninvasive measurement of<br>body temperature on the upper chest via wireless<br>communication to a smart device application or<br>compatible patient monitor (i.e., Masimo Root,<br>Masimo Rad-97).<br><br>The Radius T is indicated for single-use, continuous<br>body temperature measurements of persons 5 years<br>of age or older in hospitals, hospital-type facilities,<br>and home environments. | The Wireless FeverScout TM continuous<br>Monitoring thermometer is a non-invasive and re-<br>usable electronic device for home use and non-<br>invasive and single patient use in the hospital.<br>This product is intended for non-urgent<br>ambulatory continuous armpit temperature<br>monitoring from ages 29 days and older | Subject device has a narrower indicated<br>population of persons 5 years of age or<br>older versus the predicate which is<br>indicated for ages 29 days and older. The<br>indicated population of the subject device<br>was narrowed to align to the clinically<br>tested population, age group C (older than<br>5 years) in accordance with ISO 80601-2-<br>56.<br><br>The indication difference does not result<br>in a new intended use as both devices are<br>intended to be used as continuous<br>monitoring thermometers. |
| Classification Regulation/<br>Product Code | 21 CFR 880.2910/ FLL | 21 CFR 880.2910/ FLL | Same |
| Regulation Description | Clinical electronic thermometer | Clinical electronic thermometer | Same |
| Principle of Operation | The Radius T relies on the principle that the<br>temperature measured at the skin surface can be<br>extrapolated to the body temperature.<br><br>The sensor within the Radius T detects the heat and<br>measures the temperature using a resistance that<br>changes with heat. | FeverScout relies on the principle that the<br>temperature measured at skin surface can be<br>extrapolated to the body temperature.<br><br>The sensor within the FeverScout detects the heat<br>and measures the temperature using a resistance that<br>changes with heat. | Similar. The subject device and predicate<br>device are similar in that they both are<br>based upon the principle that the body<br>temperature can be extrapolated from the<br>skin surface temperature. Both devices<br>utilize a thermistor to detect the heat and<br>measure the temperature based upon a<br>resistance that changes with heat. The<br>predicate device utilizes the adjustment<br>from the armpit temperature, while the |
| | Radius T Wearable Thermometer | FeverScout<br>(K181013) | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Predicate Device | |
| | | | subject device utilizes temperature at the<br>upper chest. |
| | | | To support the difference does not<br>significantly affect the safety and<br>effectiveness of the subject device, the<br>test methods described in the ISO 80601-<br>2-56 standard were used. |
| Technological<br>Characteristics | | | |
| Laboratory Accuracy | $\pm$ 0.1°C in the range of 25°C to 43°C ( $\pm$ 0.18°F in the<br>range of 77°F to 109.4°F) | $\pm$ 0.1°C in the range of 37 to 39°C ( $\pm$ 0.18°F in the<br>range of 98.6 to 102.2°F),<br>$\pm$ 0.2°C in the range of 35 to 37°C and 39 to 42°C<br>( $\pm$ 0.36°F in the range of 95 to 98.6°F and 102.2 to<br>107.6°F) | Similar. Subject device has a tighter<br>accuracy specification across a wider<br>performance range. Provided the wider<br>performance range there is no significant<br>impact to the safety and effectiveness of<br>the subject device. |
| Application Site | Upper Chest | Axillary | Different. The difference in application<br>site was address through performance<br>testing in accordance with ISO 80601-2-<br>56. The testing supported the difference<br>does not raise different questions of safety<br>and effectiveness. |
| Validation Method | Conformed to ISO 80601-2-56 | Conformed to ASTM E1112 | Subject device is validated in accordance<br>with ISO 80601-2-56 while the predicate<br>device was validated in accordance with<br>ASTM E1112. As the ISO 80601-2-56 is<br>also recognized by the FDA, the use of |
| | Radius T Wearable Thermometer | FeverScout<br>(K181013) | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Predicate Device | |
| Type of Use (Sensor) | Disposable | Disposable for hospital use; Reusable for OTC | Similar. As both the subject and predicate devices can be used as a disposable, the difference was not found to result in a new intended use. |
| Type of Sensor | Thermistor | Thermistor | Same |
| Temperature<br>Measurement Intervals | Transmits every 60 seconds | Transmits every 15 seconds | Similar. Subject device transmits data less frequently than the predicate. Although the data transmission frequencies are different, the difference is not significant as compared the expected timeframe for meaningful change in body temperature. |
| Wireless communication<br>Supported Devices | Mobile (Android, Apple), Masimo Patient<br>Monitoring Devices (i.e., Rad-97, Root) | Mobile (Android, Apple) | Subject device includes communication to Masimo Patient Monitoring Devices (Root and Rad-97).<br>Software integration testing performed supports the difference is not significant. |
| Types | Bluetooth BLE | Bluetooth BLE | Same |
| Mechanical<br>Type of Applicable | Wearable | Wearable | Same |
| Overall Dimension | 5" x 5" x 0.5" | 2.4" x 1.6" x 0.2" | Subject device is provided with a different form factor.<br>Human factors and usability evaluation supports the difference in form factor. |
| | Radius T Wearable Thermometer | FeverScout<br>(K181013) | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Predicate Device | |
| Weight | 30 gms | 7.2 gms | does not significantly affect the safety and effectiveness of the subject device.<br>Subject device has a different weight.<br>Human factors and usability evaluation supports the difference in form factor does not significantly affect the safety and effectiveness of the subject device. |
| Biocompatibility | Conformed to ISO 10993-1, 5, 10 | Conformed to ISO 10993-1, 5, 10 | Same |
| Electrical | | | |
| Power Source | Internal Battery (Lithium Coin Cell) | Internal Battery (Lithium Rechargeable) | Similar. Both devices are provided with internal batteries. Subject device is disposable and therefore a rechargeable battery is not applicable. Therefore, the difference was not significant. |
| Battery Life | Minimum of 8 days (192 hours) of continuous run time | Minimum of 7 days of continuous run time | Similar. Subject device has a longer battery life. As the battery life was longer, the difference was not found to be significant. |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | Same |
| Electromagnetic compatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Same |
| Environmental | | | |
| Operating Temperature | 10°C to 40°C<br>50°F to 104°F | 10°C to 40°C<br>50°F to 104°F | Same |
| Operating Humidity | 10% RH to 95% RH (non-condensing) | 15% RH to 85% RH | Similar. Subject device is provided with a wider environmental specification; |
| | Radius T Wearable Thermometer | FeverScout<br>(K181013) | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Predicate Device | |
| Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | therefore, the difference was not found to<br>be significant. |
| Operating Temperature | 10°C to 40°C<br>50°F to 104°F | 10°C to 40°C<br>50°F to 104°F | Same |
| Storage/ Transport<br>Temperature | -20°C to 50°C<br>-4°F to 122°F | - | Predicate device does not disclose the<br>storage or transport environmental<br>conditions. The environmental condition<br>testing conducted supports the subject<br>device specifications for reasonable<br>transport and storage conditions. As<br>result, any difference was not found to be<br>significant. |
| Storage/ Transport<br>Humidity | 10% RH to 95% RH (non-condensing) | - | Predicate device does not disclose the<br>storage or transport environmental<br>conditions. The environmental condition<br>testing conducted supports the subject<br>device specifications for reasonable<br>transport and storage conditions. As<br>result, any difference was not found to be<br>significant. |
| Mode of Operation per<br>IEC 60601-1 | | | |
| Mode of Operation | Continuous | Continuous | Same |
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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 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/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Ma…
