(30 days)
No
The summary describes a standard wearable thermometer with wireless communication and a mobile app for data display and alerts based on pre-defined thresholds (NIH recommendations for fever). There is no mention of algorithms that learn or adapt from data.
No.
The device is solely intended for the continuous measurement of human body temperature. It does not provide any therapeutic intervention or treatment.
No
The device is a thermometer for continuous measurement of human body temperature. While temperature can be a diagnostic indicator, the device itself only measures and displays the temperature, and provides alerts based on NIH recommendations for fever, it does not perform a diagnosis.
No
The device description clearly states it is a "wearable device that senses body temperature" and includes hardware components like a circuit board with Bluetooth and NFC chips, digital temperature sensors, and a battery. While it communicates with a software application, the core temperature sensing and transmission functionality is hardware-based.
Based on the provided information, the AION TempShield™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- AION TempShield™ Function: The AION TempShield™ directly measures human body temperature on the upper chest. It does not analyze any biological specimens.
- Intended Use: The intended use is for continuous measurement of human body temperature, which is a physiological measurement, not an in vitro analysis.
Therefore, the AION TempShield™ falls under the category of a medical device that performs a physiological measurement, but it is not an IVD.
N/A
Intended Use / 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. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either facilities or home envirents.
Product codes
FLL
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper chest
Indicated Patient Age Range
1 year and older
Intended User / Care Setting
healthcare facilities or home environments.
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)
The following standards were used for testing of the subject device:
- 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): All applicable requirements were tested and passed.
- IEC 60601-1-6:2010 / AMD1:2013 Usability: All applicable requirements were tested and passed.
- IEC 62366-1:2015 Usability: All applicable requirements were tested and passed.
- Usability (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.
- ISO 80601-2-56:2017 Clinical Thermometer Performance: All applicable requirements were tested including laboratory accuracy and passed.
- Bluetooth Range Testing (No related standard): PASS - the testing concluded the mobile app received temperature data from the AION TempShield™ at 0.1m and 10m away from the phone.
- Disinfection Resistance Testing (No related standard): 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.
- Operational Temperature Range Testing (No related standard): PASS – The AION TempShield™ continued to function and send temperature data at every temperature within the range.
- Battery Notification Test (No related standard): PASS - The AION TempShield™ transmits proper battery percentage depletion, displays raw temperaturesin DTM mode and passes encrypted data.
- Product Life / Accelerated Aging Test (No related standard): 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.
- Software / Firmware Verification & Validation (No related standard): PASS - The V&V testing demonstrated that the AION TempShield Mobile App meets specified requirements and functions as intended.
- Software Verification & Validation Testing, AION TempShield™ Firmware RequirementsV&V Report (No related standard): PASS - The V&V testing demonstrated that the AION TempShield™ firmware meets specified requirements and functions as intended.
- ISO 10993-1:2016 Biocompatibility Testing: All applicable requirements were tested and passed.
- ISO 10993-5:2009 Biocompatibility - Cytotoxicity: The test article showed no evidence of causing cell lysis or cytotoxicity to L-929 cells. The test article meets the requirements for the test.
- ISO 10993-10: 2021 Biocompatibility - Sensitization: The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. Results and conclusions apply only to the test article tested.
- ISO 10933-23: 2021 Biocompatibility - Irritation: There was no erythema and no edema on the skin of the animals treated with the test article. The primary irritation index for the test article was calculated to be 0.0. The response of test article was categorized as negligible.
- FCC Part 15 and Part 2 Wireless Testing: PASS – The FCC wireless testing passed all applicable requirements.
- Cybersecurity (No related standards): PASS - The device passed all applicable cybersecurity testing.
- Coexistence Study (No related standards): PASS – The device passed applicable coexistence with several wireless active products operating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
March 14, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
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"
1
(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).
2
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
3
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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4
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 | |
| Reference | |||||
| Secondary | 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).
5
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.
6
Specifications and Configurations
The AION TempShield™ is