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

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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

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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

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Indications for Use

510(k) Number (if known) K232010

Device Name iTempShield

Indications for Use (Describe)

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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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 temperature measurements are in degrees Fahrenheit (F).

Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is

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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.

Specifications and Configurations

The iTempShield 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.

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5. 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.

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 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. Both devices have an accuracy of +/- 0.1C, conform to ISO 80601-2- 56, are disposable, use a thermistor sensor, have supported use on mobile devices, use Bluetooth, and are powered using a CR2016 LI-Mag coin cell battery.

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.

Technological	Subject Device	Primary Predicate	Comparison
Characteristic	iTempshield	Masimo Radius TK203215
Indications for Use	The iTEMPSHIELDbattery poweredwearable thermometerintended forcontinuousmeasurement ofhuman bodytemperature on theupper chest viawirelesscommunication to asmart deviceapplication.iTempShield isintended for single-use and for personsolder than 5 years inhealthcare facilitiesand homeenvironments.	Radius T wearablethermometer isintended for single-use, continuousnoninvasivemeasurement of bodytemperature on theupper chest viawirelesscommunication to asmart deviceapplication orcompatible patientmonitor (i.e., MasimoRoot, Masimo Rad-97).The Radius T isindicated for single-use, continuous body	EQUIVALENT - Theindications for use areequivalent betweenthe devices.Thepredicate indicationsincludescommunication to apatient monitorwhereas the subjectdevice does notinclude that.

		temperaturemeasurements ofpersons 5 years of ageor older in hospitals,hospital type facilitiesand homeenvironments.
Placement Location	Upper Chest	Upper Chest	IDENTICAL
ClassificationRegulation / ProductCode	21 CFR 880.2910 /FLL	21 CFR 880.2910 /FLL	IDENTICAL
RegulationDescription	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 the principlethat the temperaturemeasured at the skinsurface can beextrapolated to thebody temperature.The sensor within thepredicate devicedetects the heat andmeasures thetemperature using aresistance thatchanges with heat.	IDENTICAL
Laboratory Accuracy	+/- 0.18F (0.1C) from77.0F (25C) to 109.4F(43C)	+/- 0.1C from 25C to43C	IDENTICAL
Validation Method	Conforms to ISO80601-2-56	Conforms to ISO80601-2-56	IDENTICAL
Type of Use (sensor)	Disposable	Disposable	IDENTICAL
Type of Sensor	Thermistor	Thermistor	IDENTICAL
TemperatureMeasurementIntervals	Transmits once per 5minutes	Transmits every 60seconds	Temperaturemeasurement intervalsare shorter for thepredicate device.
Wireless SupportedDevices	Mobile (Android,Apple)	Mobile (Android,Apple), MasimoPatient MonitoringDevices	EQUIVALENT –both devices aresupported by Android.The devices aresupported by thetechnologies for eachcompany (i.e.. RadiusT and Masimo PatientMonitoring Device,and iTempShield withApp).
Wireless Type	Bluetooth BLENFC RFID for powerON and pairing	Bluetooth BLE	IDENTICAL - Bothdevices use Bluetooth.Device is better withNFC pairing (becauseuser friendly)
Type of Application	Wearable	Wearable	IDENTICAL
Overall Dimension	Diameter 42mmThickness 3.2mm	Length 127mmWidth 127mmThickness 12.7mm	The subject device issmaller.

Weight	5 grams	30 grams	The subject device issmaller and weighsless.
Biocompatibility	Conforms to ISO10993-1, 5, 10	Conforms to ISO10993-1, 5, 10	IDENTICAL
Power Source	Internal Battery(Lithium Coin Cell)3V	Internal Battery(Lithium Coin Cell)	IDENTICAL
Battery Life	1440 hours (60 days)of continuous run time	Minimum of 8 days(192 hours) ofcontinuous run time	The battery life issubstantially longerwith the subjectdevice.
Electrical Safety	Conforms to IEC60601-1	Conforms to IEC60601-1	IDENTICAL
ElectromagneticCompatibility	Conforms to IEC60601-1-2	Conforms to IEC60601-1-2	IDENTICAL
Storage / TransportTemperature	32F (0C) to 86F (30C)	-20C to 50C (-4F to122F)	The Storagetemperature range wasreduced to match theinstructions providedby the batterymanufacture. This isonly applicable to thestorage conditions andwill not affect theuser.
Storage / TransportHumidity	40% RH to 75% RH(non-condensing)	10% RH to 95% RH(non-condensing)	The Storage humidityrange was reduced tomatch the instructionsprovided by thebattery manufacture.This is only applicableto the storageconditions and willnot affect the user.
OperatingTemperature	50F (10C) to 109.4F(43C)	10C to 40C	Equivalent
Operating Humidity	10% to 95%	10% to 95%	IDENTICAL
Atmospheric Pressure	700 hPa to 1060 hPa	700 hPa to 1060 hPa	IDENTICAL
Mode of Operation	Continuous	Continuous	IDENTICAL

7. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

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The Subject Device has the equivalent anatomical placement, indications for use, principle of operation, compliance to FDA recognized consensus standards, single use, wearable, use of thermistors, disposable, battery powered, wireless communication to smart devices using Bluetooth, and continuous mode of operation.

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

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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 60 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

SUMMARY OF TESTING
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 disturbances– Requirements 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	Ingress	All applicable
IEC60529:2013/COR1:2019	Degrees of protection provided byenclosures IP57The testing include dust penetration andwater ingress.	requirements 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 / Summative Study	PASS – the summativeusability evaluationincluded 45 participantsconsisting of healthcareprofessionals, adultpatient/caregivers, andadolescent patients. Theconclusion of the studywas that the subject deviceis safe, efficient to use, andprovides ease of use to theuser / operator.
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
No related standard	Bluetooth Range Testing	PASS – the testingconcluded the mobile appreceived temperature datafrom the iTempShield at0.1m and 10m away fromthe phone.
No related standard	Disinfection Resistance Testing	PASS – the testingconcluded that theiTempShield continued tosend temperature data after60 cleanings usingdisinfectant wipes. Therewere no visible defects onthe device.
No related standard	Operational Temperature RangeTesting	PASS – The iTempShieldcontinued to function andsend temperature data atevery temperature withinthe range.
No related standard	Battery Notification Test	PASS – The iTempShieldtransmits proper batterypercentage depletion,displays raw temperaturesin DTM mode and passesencrypted data.

No related standard	Product Life / Accelerated Aging Test	PASS – The devices werefound to be fully functionalat end of storage test (23days at 70C) with nophysical defects observed.The devices were found tobe functional andtransmitted data after 15days at 60C.
	Software / Firmware Verification & Validation
No related standard	Software Verification & ValidationTestingMobile Application Verification andValidation	PASS - The V&V testingdemonstrated that theIDION Shield Mobile Appmeets specifiedrequirements and functionsas intended.
No related standard	Software Verification & ValidationTestingiTempShield Firmware RequirementsV&V Report	PASS - The V&V testingdemonstrated that theiTempShield firmwaremeets specifiedrequirements and functionsas intended.
	Biocompatibility Testing
ISO 10993-1:2016	BiocompatibilityBiological Evaluation of MedicalDevices - Part 1: Evaluation and Testingwithin a Risk Management Process	All applicablerequirements were testedand passed
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 with
		several wireless active products 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 in accordance 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 iTempShield to the predicate device 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 indications for use, technological characteristics, and comparison to predicate device the iTempShield is substantially equivalent to the predicate device and is as safe and effective for the intended use.

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.