FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the iTEMPSHIELD device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance	Outcome
Accuracy	Laboratory Accuracy (per ISO 80601-2-56)	+/- 0.1C (0.18F) from 25C (77.0F) to 43C (109.4F)	+/- 0.1C (0.18F) from 25C (77.0F) to 43C (109.4F)	Passed
Electrical Safety	IEC 60601-1:2012	All applicable requirements	All applicable requirements were tested and passed.	Passed
Electromagnetic Compatibility	IEC 60601-1-2:2014	All applicable requirements	All applicable requirements were tested and passed.	Passed
Home Healthcare Safety	IEC 60601-1-11:2015	All applicable requirements	All applicable requirements were tested and passed.	Passed
Ingress Protection	IEC 60529:2013/COR1:2019 (IP57)	Dust penetration and water ingress protection	All applicable requirements were tested and passed.	Passed
Usability	IEC 60601-1-6:2010 / AMD1:2013	All applicable requirements	All applicable requirements were tested and passed.	Passed
Usability Engineering	IEC 62366-1:2015	All applicable requirements	All applicable requirements were tested and passed.	Passed
Summative Usability Study	No related standard	Device is safe, efficient to use, and provides ease of use.	Study concluded the device is safe, efficient to use, and provides ease of use to the user/operator.	Passed
Bluetooth Range	No related standard	Mobile app to receive temperature data at 0.1m and 10m.	Mobile app received temperature data from the iTempShield at 0.1m and 10m.	Passed
Disinfection Resistance	No related standard	Device to continue sending temperature data after 60 cleanings with disinfectant wipes, with no visible defects.	Device continued to send temperature data after 60 cleanings using disinfectant wipes. No visible defects.	Passed
Operational Temperature Range	No related standard	Device to function and send temperature data across the specified range (50F (10C) to 109.4F (43C)).	iTempShield continued to function and send temperature data at every temperature within the range.	Passed
Battery Notification	No related standard	Transmit proper battery percentage depletion, display raw temps in DTM mode, pass encrypted data.	iTempShield transmits proper battery percentage depletion, displays raw temperatures in DTM mode and passes encrypted data.	Passed
Product Life/Accelerated Aging	No related standard	Fully functional at end of storage test (23 days at 70C) with no physical defects; functional and transmitted data after 15 days at 60C.	Devices were fully functional at end of storage test (23 days at 70C) with no physical defects. Devices were functional and transmitted data after 15 days at 60C.	Passed
Software V&V (Mobile App)	No related standard	Mobile App meets specified requirements and functions as intended.	V&V testing demonstrated the IDION Shield Mobile App meets specified requirements and functions as intended.	Passed
Software V&V (Firmware)	No related standard	iTempShield firmware meets specified requirements and functions as intended.	V&V testing demonstrated the iTempShield firmware meets specified requirements and functions as intended.	Passed
Biocompatibility (General)	ISO 10993-1:2016	All applicable requirements	All applicable requirements were tested and passed.	Passed
Biocompatibility (Cytotoxicity)	ISO 10993-5:2009	No evidence of causing cell lysis or cytotoxicity.	No evidence of causing cell lysis or cytotoxicity to L-929 cells.	Passed
Biocompatibility (Sensitization)	ISO 10993-10:2021	No evidence of causing delayed dermal contact sensitization.	No evidence of causing delayed dermal contact sensitization in the guinea pig.	Passed
Biocompatibility (Irritation)	ISO 10993-23:2021	No erythema and no edema; primary irritation index of 0.0, categorized as negligible.	No erythema and no edema. Primary irritation index calculated to be 0.0. Response categorized as negligible.	Passed
Wireless Testing	FCC Part 15 and Part 2	All applicable requirements	FCC wireless testing passed all applicable requirements.	Passed
Cybersecurity	No related standards	All applicable cybersecurity testing	Device passed all applicable cybersecurity testing.	Passed
Coexistence Study	No related standards	Coexistence with several wireless active products operating.	Device passed applicable coexistence with several wireless active products operating.	Passed

Study Information:

Sample sizes used for the test set and the data provenance:
- Usability / Summative Study: 45 participants.
  - Provenance: Not specified (e.g., country of origin).
  - Retrospective/Prospective: Not specified, but generally summative usability studies are prospective.
- For other performance bench tests (Bluetooth Range, Disinfection Resistance, Operational Temperature, Battery Notification, Product Life/Accelerated Aging), specific sample sizes for the devices tested are not detailed in the provided information, but the results indicate testing was performed.
- Biocompatibility testing involved in-vitro (cytotoxicity) and animal studies (sensitization, irritation) as per ISO standards. Specific animal numbers are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document does not mention the use of experts to establish "ground truth" in the context of diagnostic accuracy for the temperature measurements. The accuracy is assessed quantitatively against a known standard (laboratory and clinical accuracy per ISO 80601-2-56), not through expert interpretation of data points.
- For the Summative Usability Study, the participants included "healthcare professionals, adult patient/caregivers, and adolescent patients." The number or specific qualifications of the healthcare professionals acting as experts is not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified for this type of device and testing. The tests conducted are primarily quantitative performance measurements and usability assessments, not diagnostic evaluations requiring adjudication of subjective interpretations.
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:
- No MRMC comparative effectiveness study was mentioned. This device is a measurement tool (thermometer), not an AI diagnostic assistant for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, standalone performance testing was conducted for various aspects of the device, including:
  - Laboratory Accuracy (per ISO 80601-2-56)
  - Electrical Safety (IEC 60601-1)
  - Electromagnetic Compatibility (IEC 60601-1-2)
  - Ingress Protection (IEC 60529)
  - Bluetooth Range Testing
  - Disinfection Resistance Testing
  - Operational Temperature Range Testing
  - Battery Notification Test
  - Product Life / Accelerated Aging Test
  - Software / Firmware Verification & Validation
  - Biocompatibility Testing (ISO 10993 series)
  - Wireless Testing (FCC Part 15 and Part 2)
  - Cybersecurity Testing
  - Coexistence Study
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For accuracy, the ground truth is established against a recognized standard as defined by ISO 80601-2-56 for clinical thermometers, which typically involves comparing the device's readings to reference thermometers in controlled environments (laboratory accuracy) and or clinical settings (clinical accuracy).
- For biocompatibility, the ground truth is the biological response based on established test methods and criteria defined by ISO 10993 standards.
- For electrical safety, EMC, ingress protection, wireless, cybersecurity, the ground truth is compliance with the requirements and thresholds set forth by the respective international and national standards (e.g., IEC, FCC).
The sample size for the training set:
- Not applicable. This document describes the performance testing for a hardware medical device (a clinical electronic thermometer) and its associated software, not a machine learning or AI model that requires a "training set" in the conventional sense. The software verification and validation are against specified requirements and functions, not learned from data.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a machine learning or AI model "training set."

Summary

Regulation Number and Section

§ 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.