(30 days)
The AION TempShield™ is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication to a smart device application. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either healthcare facilities or home environments.
The AION TempShield™ is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet or certified gateway device. When the AION TempShield™ is connected to the device, it sends all temperature measurements automatically. The AION TempShield™ can be worn for up to 90 days to check current temperature and to allow viewing of historical temperature measurements. The device has the ability to share the data with the clinician if the clinician has established an AION account. The temperature measurements are in degrees Fahrenheit (°F), but can also be configured to display in degrees Celsius (°C). Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is used to turn on the device. The device communicates with a phone that has the AION TempShield app installed. The circuit card has two digital temperature sensors and a 32 MHz clock. The device is designed to have a minimum operating range of 10 meters and provides a 2 dBm signal to the radio. The AION TempShield™ is shipped in a shelf mode power condition (4uA) and can be on the shelf for 24 months before the battery is depleted below the 90-day threshold. The Bluetooth transmissions are encrypted using the on-board encryption. Each device has a random pairing code that must be typed in before the sensor and the mobile device can communicate. The modulation for the low energy Bluetooth is QFSK and the device has been certified and registered with the FCC for a class II device (at home use). The hospital use is covered under this classification. The smart phone application requires that the user allow for notifications, has access to location services, and enables both NFC and Bluetooth services to fully activate the AION TempShield™ Each AION TempShield™ has a unique serial number (UUID) and a random pin assigned. This information is accessible via a barcode on the outside of the package and from an NFC read (Similar to apple pay or google pay type of contact with the back of the phone. The NFC read will wake up the AION TempShield™ from deep sleep and initiate the pairing. Once the initial Bluetooth contact has been made the mobile application will present the 6-digit pairing number that the user must type in. Once this is done the mobile device will go into operational mode and send out temperature every five minutes. The Mobile app will look for temperature every five minutes with appropriate guard bands. Every 4hours the mobile application will request a full data offload from the AION TempShield™ to collect previous data that was not collected from the AION TempShield™. The AION TempShield Application communicates with the AION Core (Cloud monitoring service). This service will provide NIH recommendations for fever to the shield to provide indications (alerts)in the data for visualization for the User. There is no PHI stored in the AION cloud. The application has a home screen that displays the last read temperature. The application allows the user to put in activities, to view historical temperature history, and to select time windows to display data. For example: the application will allow the user to only view data for the past 12 hours. The total viewable data window is 48 hours. The application in the settings window will allow the user to view the UUID and will allow the user to replace the AION TempShield™ with another one. The Application will provide the user with the percentage of charge left in the device (battery life indication). When the battery life reaches 10% of charge left, the application will provide an alert that the user should get a new AION TempShield 100 (there will be approximately 1 week of continuous life available. At 5% life the notifications are once per two hours to replace the shield. The AION TempShield TM requires that the user place medical grade silicone tape to hold the AION TempShield™ in place. The AION TempShield™ is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iOS 11 or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.
This document pertains to the AION TempShield™, a wearable clinical electronic thermometer.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| IEC 60601-1:2012 (Electrical Safety) | All applicable requirements were tested and passed. |
| IEC 60601-1-2:2014 (Electromagnetic Disturbance) | All applicable requirements were tested and passed. |
| IEC 60601-1-11:2015 (Safety for Home Healthcare Environment) | All applicable requirements were tested and passed. |
| IEC 60529:2013/COR1:2019 (Ingress: IP57 dust and water protection) | All applicable requirements were tested and passed (including dust penetration and water ingress). |
| IEC 60601-1-6:2010 / AMD1:2013 (Usability) | All applicable requirements were tested and passed. |
| IEC 62366-1:2015 (Usability Engineering to Medical Devices) | All applicable requirements were tested and passed. |
| Clinical Accuracy (ISO 80601-2-56:2017) | ± 0.1C in the range of 25C to 43C (All applicable requirements were tested, including laboratory accuracy, and passed). |
| Bluetooth Range Testing (No related standard) | The mobile app received temperature data from the AION TempShield™ at 0.1m and 10m away from the phone (PASS). |
| Disinfection Resistance Testing (No related standard) | The AION TempShield™ continued to send temperature data after 90 cleanings using disinfectant wipes. There were no visible defects on the device (PASS). |
| Operational Temperature Range Testing (No related standard) | The AION TempShield™ continued to function and send temperature data at every temperature within the range (PASS). (Note: The stated operating range in device description is 10C to 40C). |
| Battery Notification Test (No related standard) | The AION TempShield™ transmits proper battery percentage depletion, displays raw temperatures in DTM mode, and passes encrypted data (PASS). |
| Product Life / Accelerated Aging Test (No related standard) | Devices were fully functional at end of storage test (23 days at 70C) with no physical defects observed. Devices were functional and transmitted data after 15 days at 60C (PASS). |
| Software / Firmware V&V (No related standard) | The V&V testing demonstrated that the AION TempShield Mobile App and firmware meet specified requirements and function as intended (PASS). |
| ISO 10993-1:2016 (Biocompatibility - General) | All applicable requirements were tested and passed. |
| ISO 10993-5:2009 (Biocompatibility - Cytotoxicity) | No evidence of causing cell lysis or cytotoxicity to L-929 cells. Meets requirements for the test. |
| ISO 10993-10:2021 (Biocompatibility - Sensitization) | No evidence of causing delayed dermal contact sensitization in the guinea pig. |
| ISO 10993-23:2021 (Biocompatibility - Irritation) | No erythema and no edema on the skin of the animals treated with the test article. Primary irritation index was 0.0, categorized as negligible. |
| FCC Part 15 and Part 2 (Wireless Testing) | Passed all applicable requirements. |
| Cybersecurity (No related standards) | Passed all applicable cybersecurity testing. |
| Coexistence Study (No related standards) | Passed applicable coexistence with several wireless active products operating. |
| Usability for Age Range (No related standard) | The original study included 137 participants 5 years and old. The addendum study included 39 participants ages 1-4 years. All tested passed and verified accurate body temperature. |
2. Sample size used for the test set and the data provenance
The document indicates a "Usability" study which involved participants to verify accurate body temperature in different age groups. This might be considered a clinical test set.
- Sample Size (for Usability/Clinical test):
- Original study: 137 participants (ages 5 years and older)
- Addendum study: 39 participants (ages 1-4 years)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of "clinical data" supports the expansion of the patient population, suggesting this was prospective clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document mentions "clinical accuracy testing to the IEC 80601-2-56" and "Usability" studies that "verified accurate body temperature," but it does not detail how the ground truth temperature was established (e.g., gold standard thermometer, multiple medical professionals) or the qualifications of evaluators, if any.
4. Adjudication method for the test set
This information is not provided in the document.
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
This is not applicable. The AION TempShield™ is a clinical electronic thermometer measuring body temperature, not an AI-assisted diagnostic imaging or decision support device that would involve "human readers" or "AI assistance" in the typical MRMC study context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device's accuracy and performance are evaluated in a standalone manner, independent of human interpretation or intervention for the core temperature measurement task. The clinical accuracy and performance bench testing described (e.g., ISO 80601-2-56) demonstrate the algorithm/device's ability to measure temperature. The device transmits measurements to an app, but the primary measurement is a standalone function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For clinical accuracy testing, typically a gold standard reference thermometer (e.g., a highly accurate rectal thermometer or a calibrated laboratory reference standard) would be used to establish the ground truth for body temperature measurements following ISO 80601-2-56. While the document mentions "verified accurate body temperature" in the usability study, the specific method for establishing this "ground truth" is not detailed beyond conforming to the standard.
8. The sample size for the training set
This information is not provided in the document. The AION TempShield™ is a hardware-based thermometer with associated firmware/software, not an AI/ML model that typically undergoes a separate "training" phase with a large dataset in the sense of predictive algorithms. The software/firmware development involves verification and validation, but not "training data" in the AI/ML context.
9. How the ground truth for the training set was established
This information is not provided for the reasons mentioned above (not an AI/ML model requiring a training set in that context).
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March 14, 2025
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AION Biosystems Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K250401
Trade/Device Name: AION TempShield™ Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: February 12, 2025 Received: February 12, 2025
Dear Dave Yungvirt:
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 (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"
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(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
David Walloschek
David Wolloscheck, Ph.D. 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) K250401
Device Name AION TempShield™
Indications for Use (Describe)
The AION TempShield™ is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either facilities or home envirents.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K250401 510(k) Summary Traditional 510(k) AION TEMPSHIELD™
1. SUBMITTER/510(K) HOLDER
AION Biosystems Inc. 175 Cabot street, suite 100, Lowell, MA 01854
Contact Name: Carl Shubitowski (Director of Quality & Regulatory)
Email: Carl.Shubitowski@aionbiosystems.com Telephone: (617) 279-3881
Date Prepared: February 1, 2025
Reason for 510(k): New device
2. DEVICE NAME
| Proprietary / Trade Name: | AION TEMPSHIELD™ |
|---|---|
| Common/Usual Name: | Clinical Electronic Thermometer |
| Classification Name: | Clinical Electronic Thermometer |
| Classification Regulation: | 21 CFR 880.2910 |
| Product code: | FLL |
| Classification: | Class 2 |
| Medical Specialty (Panel): | General Hospital |
3. PREDICATE DEVICES
| Predicate Type | Device Name | Manufacturer | 510(k) | Product Regulation | Code and |
|---|---|---|---|---|---|
| Primary | iTempShield | AION Biosystems | K232010 | FLL, 21 CFDR 880.2910 | |
| ReferenceSecondary | Fever Scout | VivaLNK | K181013 | FLL, 21 CFDR 880.2910 |
4. DEVICE DESCRIPTION
The AION TempShield™ is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet or certified gateway device . When the AION TempShield™ is connected to the device, it sends all temperature measurements automatically.
The AION TempShield™ can be worn for up to 90 days to check current temperature and to allow viewing of historical temperature measurements. The device has the ability to share the data with the clinician if the clinician has established an AION account.
The temperature measurements are in degrees Fahrenheit (°F), but can also be configured to display in degrees Celsius (°C).
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Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is used to turn on the device. The device communicates with a phone that has the AION TempShield app installed. The circuit card has two digital temperature sensors and a 32 MHz clock. The device is designed to have a minimum operating range of 10 meters and provides a 2 dBm signal to the radio. The AION TempShield™ is shipped in a shelf mode power condition (4uA) and can be on the shelf for 24 months before the battery is depleted below the 90-day threshold.
The Bluetooth transmissions are encrypted using the on-board encryption. Each device has a random pairing code that must be typed in before the sensor and the mobile device can communicate. The modulation for the low energy Bluetooth is QFSK and the device has been certified and registered with the FCC for a class II device (at home use). The hospital use is covered under this classification.
The smart phone application requires that the user allow for notifications, has access to location services, and enables both NFC and Bluetooth services to fully activate the AION TempShield™ Each AION TempShield™ has a unique serial number (UUID) and a random pin assigned. This information isaccessible via a barcode on the outside of the package and from an NFC read (Similar to apple pay or google pay type of contact with the back of the phone. The NFC read will wake up the AION TempShield™ from deep sleep and initiate the pairing. Once the initial Bluetooth contact has beenmade the mobile application will present the 6-digit pairing number that the user must type in.
Once this is done the mobile device will go into operational mode and send out temperature every five minutes. The Mobile app will look for temperature every five minutes with appropriate guard bands. Every 4hours the mobile application will request a full data offload from the AION TempShield™ to collect previous data that was not collected from the AION TempShield™.
The AION TempShield Application communicates with the AION Core (Cloud monitoring service). This service will provide NIH recommendations for fever to the shield to provide indications (alerts)in the data for visualization for the User. There is no PHI stored in the AION cloud.
The application has a home screen that displays the last read temperature. The application allows the user to put in activities, to view historical temperature history, and to select time windows to display data. For example: the application will allow the user to only view data for the past 12 hours. The total viewable data window is 48 hours.
The application in the settings window will allow the user to view the UUID and will allow the user to replace the AION TempShield™ with another one. The Application will provide the user with thepercentage of charge left in the device (battery life indication). When the battery life reaches 10% of charge left, the application will provide an alert that the user should get a new AION TempShield 100 (there will be approximately 1 week of continuous life available. At 5% life the notifications are once per two hours to replace the shield.
The AION TempShield TM requires that the user place medical grade silicone tape to hold the AION TempShield™ in place. The AION TempShield™ is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iOS 11 or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.
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Specifications and Configurations
The AION TempShield™ is < 8 grams is approximately 42mm in diameter and 3.2 mm in height. The device is single-person use and is held in place via off the shelf silicone tape. The device is IP x57 dust and waterproof. And the operating range is from 77.0F (25C) to 109.4F (43C) degrees.
5. INDICATIONS FOR USE
The AION TempShield™ is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication to a smart device application. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either healthcare facilities or home environments.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject device was designed to provide the benefit of continuous temperature measurement that allows wireless communication to smart devices for monitoring.
The subject device and predicate are both single use devices used for continuous temperature monitoring at healthcare facilities (hospital or hospital type facilities) and in home environments. Both devices are placed on the patient's upper chest and based on the principle that temperature measured at the skin surface can be extrapolated to the body temperature. The subject device and primary predicate are both disposable with identical accuracy of +/- 0.1°C, conforming to ISO 80601-2-56, using a thermistor sensor, supporting mobile device compatibility, utilizing Bluetooth, and powered by a CR2016 Li-Mag coin cell battery, while the secondary predicate is non-disposable and has a slightly broader accuracy range for certain temperatures.
The subject device uses Near Field Communications (NFC) RFID for power on and pairing key, is smaller and weighs less, and has a longer battery life. These differences do not affect the safety or effectiveness of the device.
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7. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
| TechnologicalCharacteristic | Subject DeviceAIONTempShield™ | Primary PredicateDeviceiTempshieldK232010 | SecondaryPredicate DeviceFever ScoutK181013 | Comparison |
|---|---|---|---|---|
| Indications for Use | The AIONTempShield™battery poweredwearable thermometerintended forcontinuousmeasurement ofhuman bodytemperature on theupper chest viawirelesscommunication to asmart deviceapplication. AIONTempShield™ isintended for single-use and for personsaged 1 year and olderin healthcare facilitiesand homeenvironments. | The iTempShieldbattery poweredwearablethermometer intendedfor continuousmeasurement ofhuman bodytemperature on theupper chest viawirelesscommunication to asmart deviceapplication.iTempShield isintended for single-use and for personsolder than 5 years inhealthcare facilitiesand homeenvironments. | The wireless FeverScout continuousmonitoringthermometer is anon-invasive andre-usableelectronic devicefor home use. Thisproduct is intendedfor non-urgentambulatorycontinuous armpitbody temperaturemonitoring fromages 29 days andolder. | The Subject Deviceand Primary Predicatehave almost identicalindications for patientpopulation rangeexpanded to cover 1year and older(compared to 5 yearsand older).The SecondaryPredicate Device haspopulation range thatcovers 29 days andolder.The indications foruse for all devicesinclude wirelesscontinuousmeasurement, homeuse for measurementof body temperature. |
| Placement Location | Upper Chest | Upper Chest | Armpit | The Subject Deviceand Primary Predicateare used on the Chestand the SecondaryPredicate is used onArmpit. |
| ClassificationRegulation / ProductCode | 21 CFR 880.2910 /FLL | 21 CFR 880.2910 /FLL | 21 CFR 880.2910 /FLL | IDENTICAL |
| Regulation Description | Clinical electronicthermometer | Clinical electronicthermometer | Clinical electronicthermometer | IDENTICAL |
| Principle of Operation | Based on the principlethat the temperaturemeasured at the skinsurface can beextrapolated to thebody temperature.The sensor within thesubject device detectsthe heat and measuresthe temperature usinga resistance thatchanges with heat. | Based on theprinciple that thetemperature measuredat the skin surface canbe extrapolated to thebody temperature.The sensor within thepredicate devicedetects the heat andmeasures thetemperature using aresistance thatchanges with heat. | Utilizes e-skintechnology withsensors within thedevice to detectheat and measuretemperature usinga resistance thatchanges with heat. | IDENTICAL |
| Laboratory Accuracy | ± 0.1C in the range of25C to 43C | ± 0.1C in the range of25C to 43C | +/- 0.1C from 37Cto 39C | IDENTICAL betweenSubject Device andPrimary Predicate. |
| Validation Method | Conforms to ISO 80601-2-56 | Conforms to ISO 80601-2-56 | Conforms to ASTM E1112-2000 (standard specification for electronic thermometer for intermittent determination of patient temperature) | +/- 0.2C from 35C to 37C and 39C to 42CThe Secondary Predicate has a slightly wide range for some temperatures.IDENTICALBoth standards are recognized by FDA as valid standards for electronic thermometers. |
| Type of Use (sensor) | Disposable | Disposable | Reusable | Subject device is identical to primary predicate while the secondary predicate is reusable. |
| Type of Sensor | Thermistor | Thermistor | Thermistor | IDENTICAL |
| Temperature Measurement Intervals | Transmits Maximum once per 5 minutes and Minimum once per 240 minutes. | Transmits Maximum once per 5 minutes and Minimum once per 240 minutes. | Transmit every 15 seconds | Temperature measurement intervals are shorter for the secondary predicate device. |
| Wireless Supported Devices | Mobile (Android, Apple) | Mobile (Android, Apple) | Mobile (Android, Apple) | EQUIVALENT – both devices are supported by Android and Apple. The devices are supported by the technologies for the company (i.e. iTempShield with AION shield App, and TempShield with AION TempShield App). |
| Wireless Type | Bluetooth LE 4.2NFC RFID for power ON and pairing | Bluetooth LE 4.2NFC RFID for power ON and pairing | Bluetooth BLE | IDENTICAL |
| Type of Application | Wearable | Wearable | Wearable | IDENTICAL |
| Overall Dimension | Diameter 42mmThickness 3.2mm | Diameter 42mmThickness 3.2mm | Size 61mm x 41mm*Thickness 5.5mm* | The subject device is identical to the primary predicate device.However, it is smaller than the secondary predicate. |
| Weight | 5 grams | 5 grams | 7.3g* | The subject device is identical to the primary predicate device.However, it is smaller and weighs less than the secondary predicate. |
| 10993-1, 5, 10 | 10993-1, 5, 10 | 10993-1, 5, 10 | ||
| Power Source | Internal Battery(Lithium Coin Cell)3V | Internal Battery(Lithium Coin Cell)3V | Internal Battery(Lithium Rechargeable)3V | IDENTICAL |
| Battery Life | 2160 hours (90 days)of continuous run time | 1440 hours (60 days)of continuous run time | 168 hours (7 days)of continuous run time* | The battery life issubstantially longerfor the subject device. |
| Electrical Safety | Conforms to IEC60601-1 | Conforms to IEC60601-1 | Conforms to IEC60601-1 | IDENTICAL |
| ElectromagneticCompatibility | Conforms to IEC60601-1-2 | Conforms to IEC60601-1-2 | Conforms to IEC60601-1-2 | IDENTICAL |
| Storage / TransportTemperature | 32F to 86 (0C to 30C) | 32F to 86 (0C to 30C) | 50F - 104F* | The Storagetemperature for theSubject device andprimary predicate areidentical.The range for thesecondary predicateincludes highertemperatures. |
| Storage / TransportHumidity | 45% RH to 75% RH(non-condensing) | 45% RH to 75% RH(non-condensing) | 15-85% RH* | The storage RH rangeis identical betweenthe subject device andprimary predicate.The storage range forthe secondarypredicate is wider.The Storage humidityrange for the subjectdevice was developedto match theinstructions providedby the batterymanufacture. This isonly applicable to thestorage conditions andwill not affect theuser. |
| OperatingTemperature | 10C to 40C | 10C to 40C | 50F (10C) to 104(40C) | Equivalent |
| Operating Humidity | 10% RH to 95% RH(non-condensing) | 10% RH to 95% RH(non-condensing) | 15% to 85% RH(non-condensing) | Equivalent |
| Atmospheric Pressure | 700 hPa to 1060 hPa | 700 hPa to 1060 hPa | 700 hPa to 1060hPa* | IDENTICAL |
| Mode of Operation | Continuous | Continuous | Continuous | IDENTICAL |
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- This information is from the Fever Scout Instructions for Use Manual and from the 510(k) Summary
K162137
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Design
The iTempShield was cleared by FDA in August 2023 under K232010. The subject device is the same device except the name was changed to AION TempShieldTM . The primary differences between the subject device and the primary device are:
- Expanded patient population age from 5 years and older to 1 year and older. -
- Expanded battery life from 60 days to 90 days. -
- Changes to firmware for battery life extension -
The iTempShield used the Masimo Radius T (K203215) as the predicate device. The Radius T used Fever Scout (K181013) as their predicate device. The Radius T was applied on the chest and used for 5 years and older whereas their predicate device was placed in the armpit and used for 29 months and older.
The subject device and the primary predicate device identical in all aspects of design, technology, and principles of operations with the exception of the minor differences mentioned above. The expansion of battery life and change to firmware is supported with software validation and bench testing. The expansion of the patient population age range is supported by clinical data.
The secondary predicate is being utilized to provide a predicate that has an age group similar to the age group being pursued for the AION TempShieldTM. The subject device has a longer battery life, has different anatomical placement, has different measurement intervals and is smaller in size compared to the secondary predicate.
Based on the substantial equivalence comparison and provided testing, the above differences do not impact the safety or effectiveness of the device.
Operational and Technological Characteristics
Both the subject and predicate devices are based on similar principles of operation, battery powered and use Bluetooth wireless technology to communicate data. The devices have the similar accuracy and support similar wireless devices.
The subject device and primary predicate are identical in characteristics except as mentioned with the expanded battery life, firmware change to support the battery life expansion and expansion in patient population age range.
The subject device and the secondary predicate have similar characteristics except for measurement intervals, anatomical placement, and size.
The difference in transmission time (measurement interval) does not impact safety or effectiveness as this device is not measuring vital physiological parameters (such as heartrate or respiration). The longer battery life offers benefit to the clinician and user to allow for longer period of time for monitoring the patient. The clinical data supports that the expanded patient population range (which is similar to the secondary predicate device).
The Subject Device has the equivalent anatomical placement, indications for use (except for patient age range), principle of operation, compliance to test standards with the updated 80601 standard-1, single use, wearable, use of thermistors, disposable, battery powered, wireless communication to smart devices using Bluetooth, and continuous mode of operation as the primary predicate device. The main differences are between patient population age range, battery life expansion and firmware change to support battery life expansion.
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Summary of Similarities and Differences
The Subject Device has similar characteristics as the secondary predicate which exception of:
- Subject device has faster measurement intervals. -
- Subiect device is smaller and weighs less than the secondary predicate. -
- -Subject device and primary predicate are placed on the chest, whereas the secondary predicate is placed in the armpit.
The minor differences in design and technology do not present an increased risk of safety and effectiveness of the device nor do they raise different questions of safety and effectiveness as supported by the compliance testing to the electrical safety IEC 60601-1 series standards, laboratory and clinical accuracy testing to the IEC 80601-2-56, biocompatibility testing to the ISO 10993 series standards as well as the performance bench testing and human factors evaluation.
8. PERFORMANCE TESTING
The following standards were used for testing of the subject device:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60529
- IEC 60601-1-6
- IEC 62366
- IEC 60601-1-11
- ISO 80601-2-56
Biocompatibility evaluation for the following contact classification was conducted:
- For Contact Type: Surface Skin ●
- Contact Duration: Up to 90 days
- Classification: C (Intact Skin, Greater than 30 days) ●
The classification and endpoints: cytotoxicity, skin irritation, and sensitization, associated with this classification have been assessed in accordance with:
- ISO 10993-1
- ISO 10993-5
- ISO 10993-10 ●
- ISO 10993-23 .
The following FDA guidance documents were utilized:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices – Issued May 2005
- . FDA Guidance on the content of premarket notification 510(k) submissions for clinical electronic thermometers - March 1993
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| Standard | Description of Test | Results |
|---|---|---|
| Electromagnetic Compatibility, Electrical Safety, and Home Healthcare Safety | ||
| IEC 60601-1:2012 | Electrical SafetyMedical Electrical Equipment – Part 1:General Requirements for Basic Safetyand Essential Performance | All applicablerequirements were testedand passed. |
| IEC 60601-1-2:2014 | Electromagnetic DisturbanceMedical Electrical Equipment – Part 1-2:General Requirements for Basic Safetyand Essential Performance – CollateralStandard: Electromagnetic disturbancesRequirements and Tests | All applicablerequirements were testedand passed. |
| IEC 60601-1-11:2015 | Safety for Home HealthcareEnvironmentMedical Electrical Equipment – Part 1-11: General Requirements for basicsafety and essential performance –Collateral Standard: Requirements forMedical Electrical Equipment andMedical Electrical Systems Used in theHome Healthcare Environment | All applicablerequirements were testedand passed. |
| Ingress Testing | ||
| IEC 60529:2013/COR1:2019 | IngressDegrees of protection provided byenclosures IP57The testing include dust penetration andwater ingress. | All applicablerequirements were testedand passed. |
| Usability Testing / Human Factors | ||
| IEC 60601-1-6:2010 /AMD1:2013 | UsabilityMedical Electrical Equipment Part 1-6:General Requirements for Basic Safetyand Essential Performance – CollateralStandard: Usability | All applicablerequirements were testedand passed. |
| IEC 62366-1:2015 | UsabilityMedical Device – Application ofUsability Engineering to MedicalDevices | PASS – all applicablerequirements were testedand passed. |
| No related standard | Usability | PASS – The original studyincluded 137 participants 5years and old, theaddendum study included39 participants ages 1-4years. All tested passedand verified accurate bodytemperature. |
| PERFORMANCE BENCH TESTING | ||
| ISO 80601-2-56:2017 | Clinical Thermometer PerformanceMedical Electrical Equipment – Part 2-56: Particular Requirements for BasicSafety and Essential Performance ofClinical Thermometers for BodyTemperature Measurement | All applicablerequirements were testedincluding laboratoryaccuracy and passed |
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| No related standard | Bluetooth Range Testing | PASS - the testing concluded the mobile app received temperature data from the AION TempShield™ at 0.1m and 10m away from the phone. | |||
|---|---|---|---|---|---|
| No related standard | Disinfection Resistance Testing | PASS - the testing concluded that the AION TempShield™ continued to send temperature data after 90 cleanings using disinfectant wipes. There were no visible defects on the device. | |||
| No related standard | Operational Temperature Range Testing | PASS – The AION TempShield™ continued to function and send temperature data at every temperature within the range. | |||
| No related standard | Battery Notification Test | PASS - The AION TempShield™ transmits proper battery percentage depletion, displays raw temperaturesin DTM mode and passes encrypted data. | |||
| No related standard | Product Life / Accelerated Aging Test | PASS – The devices were found to be fully functional at end of storage test (23 days at 70C) with no physical defects observed.The devices were found to be functional and transmitted data after 15 days at 60C. | |||
| No related standard | Software / Firmware Verification & ValidationSoftware Verification & Validation TestingMobile Application Verification and Validation | PASS - The V&V testing demonstrated that the AION TempShield Mobile App meets specified requirements and functions as intended. | |||
| No related standard | Software Verification & Validation TestingAION TempShield™ Firmware RequirementsV&V Report | PASS - The V&V testing demonstrated that the AION TempShield™ firmware meets specified requirements and functions as intended. | |||
| ISO 10993-1:2016 | Biocompatibility TestingBiocompatibilityBiological Evaluation of Medical | Devices – Part 1: Evaluation and Testingwithin a Risk Management Process | All applicable requirements were tested | and passed |
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| ISO 10993-5:2009 | Biocompatibility - CytotoxicityBiological Evaluation of MedicalDevices – Part 5: Tests for In VitroCytotoxicity | The test article showed noevidence of causing celllysis or cytotoxicity to L-929 cells. The test articlemeets the requirements forthe test. |
|---|---|---|
| ISO 10993-10: 2021 | Biocompatibility - SensitizationBiological Evaluation of MedicalDevices - Part 10: Tests for SkinSensitization | The test article showed noevidence of causingdelayed dermal contactsensitization in the guineapig. Results andconclusions apply only tothe test article tested. |
| ISO 10933-23: 2021 | Biocompatibility - IrritationBiological Evaluation of MedicalDevices - Part 23: Tests for Irritation | There was no erythema andno edema on the skin of theanimals treated with thetest article. The primaryirritation index for the testarticle was calculated to be0.0. The response of testarticle was categorized asnegligible. |
| Wireless Testing / Cybersecurity | ||
| FCC Part 15 and Part 2 | Wireless TestingTesting to FCC part 2 and part 15 | PASS – The FCC wirelesstesting passed allapplicable requirements. |
| No related standards | Cybersecurity | PASS - The device passedall applicable cybersecuritytesting. |
| No related standards | Coexistence Study | PASS – The device passedapplicable coexistence withseveral wireless activeproducts operating. |
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9. SAFETY AND EFFICACY
The subject device has been tested to and complicable consensus standards. Additionally, the software contained within the medical device has been developed and tested inaccordance with FDA guidance for software. All of the testing passed and there were no identified issues that would impact the safety, performance, or efficacy of the subject device.
10. CONCLUSION
The information presented supports substantial equivalence of the AION TempShield™ to the predicatedevice based on the intended use and similarities in design, principles of operation and performance specifications.
The company concluded that based on testing, compliance to consensus standards, the indicationsfor use, technological characteristics, and comparison to predicate device the AION TempShield™ is substantially equivalent to the predicate device and is as safe and effective for the intended use.
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.