(29 days)
Not Found
No
The summary describes a wearable thermometer that measures and transmits temperature data. While it includes a mobile app for viewing historical data and receiving alerts based on NIH recommendations for fever, there is no mention of AI or ML being used for data analysis, prediction, or any other function beyond simple data display and rule-based alerts.
No
The device is a thermometer used for continuous temperature measurement and does not provide any therapeutic function. Its purpose is solely for monitoring, not treatment.
No
The device is a wearable thermometer that measures human body temperature continuously. While temperature can be an indicator of health, the device itself simply measures and displays this physiological parameter; it does not analyze the temperature data to establish a diagnosis, nor does it provide a diagnosis of a condition or disease. The product states it provides NIH recommendations for fever to provide "indications (alerts) in the data for visualization," but this is still presenting information for user interpretation, not making a diagnosis.
No
The device description clearly details hardware components including a circuit board, Bluetooth and NFC chips, digital temperature sensors, and a battery. It also describes physical aspects like being a wearable device and requiring medical grade silicone tape for placement. The performance studies include testing of hardware aspects like Bluetooth range, disinfection resistance, operational temperature range, and battery life.
Based on the provided information, the iTempShield is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease.
- iTempShield's Function: The iTempShield 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 iTempShield falls under the category of a medical device, specifically a thermometer, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iTempShield 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. iTempShield is intended for single use and for persons older than 5 years in healthcare facilities and home environments.
Product codes
FLL
Device Description
The iTempShield is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet. When the iTempShield is connected to the device, it sends all temperature measurements automatically.
The iTempShield can be worn for up to 60 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 IDION account.
The temperature measurements are in degrees Fahrenheit (F).
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 IDION Shield 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 iTempShield is shipped in a shelf mode power condition (4uA) and can be on the shelf for 14 months before the battery is depleted below the 60-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 iTempShield. Each iTempShield 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 NFC read will wake up the iTempShield 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 iTempShield to collect previous data that was not collected from the iTempShield.
The Idion Application communicates with the Idion 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 Idion 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 will allow the user to view the UUID and will allow the user to replace the iTempShield 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 iTempShield (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 iTempShield requires that the user place medical grade silicone tape to hold the iTempShield in place. The iTempShield is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iPhone SE 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
older than 5 years
Intended User / Care Setting
healthcare facilities and 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)
Usability Testing / Human Factors
- Study Type: Usability / Summative Study
- Sample Size: 45 participants
- Key Results: The conclusion of the study was that the subject device is safe, efficient to use, and provides ease of use to the user / operator.
PERFORMANCE BENCH TESTING
- Study Type: Bluetooth Range Testing
- Key Results: The testing concluded the mobile app received temperature data from the iTempShield at 0.1m and 10m away from the phone.
- Study Type: Disinfection Resistance Testing
- Key Results: The testing concluded that the iTempShield continued to send temperature data after 60 cleanings using disinfectant wipes. There were no visible defects on the device.
- Study Type: Operational Temperature Range Testing
- Key Results: The iTempShield continued to function and send temperature data at every temperature within the range.
- Study Type: Battery Notification Test
- Key Results: The iTempShield transmits proper battery percentage depletion, displays raw temperatures in DTM mode and passes encrypted data.
- Study Type: Product Life / Accelerated Aging Test
- Key Results: 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
- Study Type: Software Verification & Validation Testing (Mobile Application)
- Key Results: The V&V testing demonstrated that the IDION Shield Mobile App meets specified requirements and functions as intended.
- Study Type: Software Verification & Validation Testing (iTempShield Firmware)
- Key Results: The V&V testing demonstrated that the iTempShield firmware meets specified requirements and functions as intended.
Biocompatibility Testing
- ISO 10993-5:2009 (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 (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 (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.
Wireless Testing / Cybersecurity
- FCC Part 15 and Part 2 (Wireless Testing): The FCC wireless testing passed all applicable requirements.
- Cybersecurity: The device passed all applicable cybersecurity testing.
- Coexistence Study: 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)
Not Found
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
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August 4, 2023
AION Biosystems Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K232010
Trade/Device Name: iTEMPSHIELD Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 3, 2023 Received: July 6, 2023
Dear Dave Yungvirt:
We have reviewed vour 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/ofdocs/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
1
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 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,
David Walloscher
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
2
Indications for Use
510(k) Number (if known) K232010
Device Name iTempShield
Indications for Use (Describe)
The iTempShield 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. iTempShield is intended for single use and for persons older than 5 years in healthcare facilities and home environments.
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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3
K232010 - 510(k) Summary Third Party Traditional 510(k) Idion iTEMPSHIELD
1. SUBMITTER/510(K) HOLDER
AION Biosystems Inc. 12 Plymouth Road Darien, CT 06820 Contact Name: Joseph Azary (Aztech Regulatory & Quality LLC) Email: jazary@aztechregulatory.com or jazary@erols.com Telephone: (203) 242-6670 Date Prepared: August 4, 2023 Reason for 510(k): New device
2. DEVICE NAME
| Proprietary / Trade Name: | iTEMPSHIELD |
|---|---|
| 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
| Device Name | Manufacturer | 510(k) Number |
|---|---|---|
| Radius T wearable thermometer | Masimo Corporation | K203215 |
4. DEVICE DESCRIPTION
The iTempShield is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet. When the iTempShield is connected to the device, it sends all temperature measurements automatically.
The iTempShield can be worn for up to 60 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 IDION account.
The temperature measurements are in degrees Fahrenheit (F).
Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is
4
used to turn on the device. The device communicates with a phone that has the IDION Shield 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 iTempShield is shipped in a shelf mode power condition (4uA) and can be on the shelf for 14 months before the battery is depleted below the 60-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 iTempShield. Each iTempShield 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 NFC read will wake up the iTempShield 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 iTempShield to collect previous data that was not collected from the iTempShield.
The Idion Application communicates with the Idion 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 Idion 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 will allow the user to view the UUID and will allow the user to replace the iTempShield 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 iTempShield (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 iTempShield requires that the user place medical grade silicone tape to hold the iTempShield in place. The iTempShield is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iPhone SE or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.
Specifications and Configurations
The iTempShield is