The Wireless thermometers are battery-operated electronic devices with intended use of measuring human body temperature precisely. The devices are single-use and intended for armpit temperature measurement for persons of all ages.

Device Description

TempTraq is a single-use device used to monitor temperature. The type of temperature that can be taken by the TempTraq patch is axillary only. The TempTraq temperature patches consist of a flexible circuit board that is positioned between two pieces of foam. The TempTraq temperature sensor patch is applied to the patient via foam that is backed with a biocompatible adhesive and transmits body temperature data via low energy Bluetooth transmission to a smart device running a TempTraq application. The patch is worn on the underarm and senses, processes, stores, and transmits temperature data to a smart device running a compatible TempTrag application using Bluetooth LE.

AI/ML Overview

The provided text describes the regulatory filing for the TempTraq thermometer, focusing on its substantial equivalence to a previously cleared predicate device. However, it does not contain specific acceptance criteria, test set sample sizes, expert qualifications, or detailed study results (like MRMC studies) for algorithm performance as would typically be found for an AI/ML powered medical device.

The document focuses on demonstrating that the new TempTraq models (TT-100, TT-200, TT-300) are substantially equivalent to the predicate TempTraq TT-100. The testing performed is primarily focused on confirming the hardware and software functionality, safety, and performance of the thermometer itself, rather than an AI/ML algorithm's diagnostic performance.

Therefore, I cannot fulfill your request for the specific details regarding AI/ML acceptance criteria and study results from this document. The information typically found in 510(k) summaries for AI-powered devices (e.g., AUC, sensitivity, specificity, expert reads, etc.) is not present here because this device is a thermometer, not an AI diagnostic tool.

The closest information related to "acceptance criteria" is under the "Accuracy" row in the comparison table, which states "+/- 0.1 °C (0.2 °F) between 30 °C ~ 42.4 °C (86 °F ~ 108.3 °F)". This is a performance specification for the thermometer's accuracy, not for an AI algorithm's diagnostic performance.

Please note: The document describes a thermometer, not a device powered by AI/ML that would require the typical acceptance criteria and study types requested in your prompt.

If you have a document describing an AI/ML device, please provide that, and I can attempt to extract the requested information.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 3, 2020

Blue Spark Technologies Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy. Ste. 410 Morrisville, North Carolina 27560

Re: K201977

Trade/Device Name: TempTraq, Model: TT-100, TT-200, TT-300 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 3, 2020 Received: November 4, 2020

Dear Rita King:

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 (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/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.

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 medical devices and radiation-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,

for Payal Patel Acting 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) K201977

Device Name

TempTraq, Model: TT-100, TT-200, TT-300

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Summary of 510(k)

Blue Spark Technologies Inc. K201977

This 510(k) Summary is in conformance with 21CFR 807.92

Submitter:	Blue Spark Technologies Inc.806 Sharon Drive, Suite G,Westlake, OH 44145 USAPhone: 440-249 5400Fax: Phone: 440-249 5400
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979
Company Contact:	John GannonCEOEmail: jgannon@bluesparktechnologies.com
Date Prepared:	November 3rd 2020

Device Name and Classification

Trade Name:	TempTraq TT-100, TT-200, TT-300
Common Name:	Clinical electronic thermometer
Classification:	Class II
Regulation Number:	21 CFR 820.2910
Classification Panel:	General Hospital
Product Code:	FLL

Predicate Device:

	Predicate
Trade Name	TempTraq TT-100
Common Name	Clinical Electronic Thermometer
510(k) Submitter / Holder	Blue Spark Technologies Inc.
510(k) Number	K143267
Regulation Number	21 CFR 820.2910
Classification Panel	General Hospital
Product Code	FLL

Device Description

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The TempTraq temperature sensor patch is applied to the patient via foam that is backed with a biocompatible adhesive and transmits body temperature data via low energy Bluetooth transmission to a smart device running a TempTraq application. The patch is worn on the underarm and senses, processes, stores, and transmits temperature data to a smart device running a compatible TempTrag application using Bluetooth LE.

The TempTraq temperature sensor patch is available in three (3) different configurations: TT-100 (24-hour operating time), TT-200 (48-hour operating time), and TT-300 (72-hour operating time). The TempTraq temperature sensor patches are intended to be used in different use environments. The patches can only be connected to specific TempTraq applications depending on their intended use environment:

Patch Model	Compatible TempTraq Applications	Use Environment
TT-100	TempTraq Consumer Mobile ApplicationTempTraq Patient Mobile ApplicationTempTraq Clinician Mobile ApplicationTempTraq Clinician Web Application	Home and Clinical
TT-200	TempTraq Consumer Mobile Application	Home
TT-300	TempTraq Patient Mobile ApplicationTempTraq Clinician Mobile ApplicationTempTraq Clinician Web Application	Clinical

Table 1: Compatible TempTraq Patches, Applications, and Use Environments

To view temperature data from the TempTraq temperature sensor patch, a user can use one of four configurations of the TempTraq application, depending on the role of the user:

		Table 2: TempTraq Applications Use Environments and End Users
--	--	---------------------------------------------------------------	--	--

TempTraq Application	Use Environment	End Users
TempTraq Consumer Mobile Application	Home	Home User
TempTraq Patient Mobile Application	Clinical	Hospital Patient
TempTraq Clinician Mobile Application	Clinical	Clinician
TempTraq Clinician Web Application	Clinical	Clinician

The TempTraq Consumer Mobile Application is intended to be used by home users to receive data to their smart device from TempTraq TT-100 and TT-200 patches via Bluetooth connection. Multiple patches can transmit data to the application so that multiple patients' temperatures can be monitored. Additionally, the application features an optional TempTraq Connect cloud service that allows temperature data to be shared with other TempTraq Connect users and an export function that allows data to be shared with others via email.

The TempTrag Patient Mobile application is intended to be used by hospital patients to receive data to their smart device from TempTraq TT-100 and TT-300 patches. Only the patient's own data can be viewed in the patient application and all data is shared with their clinician via TempTraq Connect cloud services. The patient's Clinician can then view the temperature data via the TempTrag Clinician Mobile Application or TempTraq Clinician Web Application. Multiple patients can be added to and monitored via the Clinician Mobile and Web Applications. If patients do not own a smart device, data from the TempTrag patches can also be obtained via Bluetooth gateways strategically placed throughout a hospital which then transmit data directly to the TempTraq Connect cloud services.

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Indications for Use

Substantial Equivalence

The table below provides a detailed comparison of TempTraq to the predicate device.

ltem	Subject DeviceTempTraq, modelsTT-100, TT-200 and TT-300	Predicate DeviceTempTraq, model TT-100	Comparison
Indicationsfor Use	The Wireless thermometersare battery-operatedelectronic devices withintended use of measuringhuman body temperatureprecisely. The devices aresingle-use and intended forarmpit temperaturemeasurement for persons ofall ages.	The Wireless thermometer,model TT-100, is a battery-operated electronic devicewith intended use ofmeasuring human bodytemperature precisely. Thisdevice is single-use andintended for armpittemperature measurementfor persons of all age.	Similar.See Note 1.
ProductCode	FLL	FLL	Identical
Regulation #	21CFR880.2910	21CFR880.2910	Identical
Display UseSpecification	iOS device display, Androiddevice display, Web based	iOS device display andAndroid device display	Similar.See Note 2.
WorkingVoltage	3.0V DC	3.0V DC	Identical
Battery	Two (2) Blue Spark 1.5 Vbatteries (103-UT1)	Two (2) Blue Spark 1.5 Vbatteries (103-UT1)	Identical
MeasurementRange	30 - 42.4 °C (86 °F ~ 108.3°F)	30 - 42.4 °C (86 °F ~ 108.3°F)	Identical
Accuracy	+/- 0.1 °C (0.2 °F) between30 °C ~ 42.4 °C (86 °F ~108.3 °F)	+/- 0.1 °C (0.2 °F) between30 °C ~ 42.4 °C (86 °F ~108.3 °F)	Identical
TemperatureUnit	°C or °F	°C or °F	Identical
SignalTransmission	Wireless Bluetooth BLE 4.0operating at 2.4Ghz	Wireless Bluetooth BLE 4.0operating at 2.4Ghz	Identical
Receiver	Wireless Bluetooth BLE 4.0enabled smart devicesrunning Apple operatingsystem iOS 9.0 and furtheror Android operating system4.3 and further	Wireless Bluetooth BLE 4.0enabled smart devicesrunning Apple operatingsystem iOS 7.1 through 8.1or Android operating system4.3 through 4.4.4	Similar.See Note 3.
ValidTransmission	Up to 40 feet	Up to 40 feet	Identical
Item	Subject DeviceTempTraq, modelsTT-100, TT-200 and TT-300	Predicate DeviceTempTraq, model TT-100	Comparison
OperatingTemperature	16 C ~ 40 °C (60.8 °F ~ 104 °F)	16 C ~ 40 °C (60.8 °F ~ 104 °F)	Identical
OperatingHumidity	15%-95% RH	15%-95% RH	Identical
AnatomicalApplication	Armpitpeel-and-stick contactthermometer sensor	Armpitpeel-and-stick contactthermometer sensor	Identical
PatientUsage	Single-Use	Single-use	Identical
TemperatureMeasurementInterval	Continuous-transmittermeasures body temperatureevery 10 seconds	Continuous-transmittermeasures body temperatureevery 10 seconds	Identical
MemoryFunction	TT-100: Can store up to 24hours of readingsTT-200: Can store up to 48hours of readingsTT-300: Can store up to 72hours of readings	TT-100: Can store up to 24hours of readings	Different.See Note 4.
Storage	Data back-up- Stored in appand optionally TempTraqConnect	Data back-up- stored in App	Different.See Note 5.
Run Time	TT-100: 24-HoursTT-200: 48-HoursTT-300: 72-Hours	TT-100: 24-Hours	Different.See Note 6.
PatientContactingMaterials	ISO 10993-1:2009(R)2013Compliant Silicone GelAdhesive	ISO 10993-1:2009(R)2013Compliant Acrylic Adhesive	Different.See Note 7.
Applications	TempTraq Consumer MobileApplicationTempTraq Patient MobileApplicationTempTraq Clinician MobileApplicationTempTraq Clinician WebApplication	TempTraq Mobile Application	Different.See Note 8.
Dimensions	Length: 100.0 mmHeight: 50.0 mmThickness: 2.0 mmWeight: 5.1 grams	Length: 98.2 mmHeight: 46.6 mmThickness: 3.0 mmWeight: 4.5 grams	Different.See Note 9.
Item	Subject DeviceTempTraq, modelsTT-100, TT-200 and TT-300	Predicate DeviceTempTraq, model TT-100	Comparison
FlexiblePrintedCircuit	Version 6.0	Version 4.0	Similar.See Note 10.
StorageTemperature	-4 to 122 °F (-20 °C to 50 °C)	-4 to 122 °F (-20 °C to 50 °C)	Identical
StorageHumidityRange	15 - 95% RH (non-condensing)	15 - 95% RH (non-condensing)	Identical

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Note 1. The Indications for Use of the proposed TempTrag System, models TT-100, TT-200 and TT-300, is similar to the predicate device, but is inclusive of all models. This difference does not affect safety and effectiveness.
Note 2. The Display Use Specification for the proposed TempTraq System is similar to the predicate device, with an additional web-based display use specification. Software Verification and Validation and Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 3. The Receiver for the proposed TempTraq System differs from the predicate device, with different operating system compatibility. Software Verification and Validation testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 4. The Memory Function for the proposed TempTraq System differs from the predicate device. Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 5. The Storage for the proposed TempTraq System differs from the predicate device. Software Verification and Validation and Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 6. The Run Time for two new models (TT-200 and TT-300) of the proposed TempTraq System differs from the predicate device. Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 7. The patient contacting material for the proposed TempTraq System differs from the predicate device. Biocompatibility testing was conducted in accordance with ISO 10993-1 to demonstrate this difference does not affect safety and effectiveness.
Note 8. The Applications for the proposed TempTrag System differ from the predicate device. Software Verification and Validation and Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 9. The dimensions for the proposed TempTraq System differ from the predicate device. This difference does not have any impact on safety or effectiveness.
Note 10. The Flexible Printed Circuit for the proposed TempTrag System is similar to the predicate device. Electrical Safety (IEC 60601-1 Edition 3.1) and EMC testing (IEC 60601-1-2 4th Edition) was conducted to demonstrate this difference does not affect safety and effectiveness.

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Non-Clinical Testing to Determine Substantial Equivalence

As part of the previously cleared submission (K143267), the following testing was performed for the TempTraq TT-100 device. This testing is still applicable for this submission:

System verification was performed via bench testing, including testing to E1112-00 . standard specification for electronic thermometer for intermittent determination of patient temperature, temperature range testing, operating time testing, and distance testing.
Blue Spark performed the following additional testing in order to demonstrate substantial equivalence for the proposed TempTraq System (TT-100, TT-200, and TT-300):
Real time aging tests were completed. The shelf life of all packaged TempTraq models . was confirmed to be four years.
. Biocompatibility testing for the TempTrag devices of TT-100. TT-200, and TT-300 was repeated for the updated materials of the TempTraq device.
. Battery capacity for the TempTrag devices of TT-200 and TT-300 was tested in order to confirm the battery life of the TT-200 supports a 48-hour operational life and TT-300 supports a 72-hour operational life. The testing was performed similar to the previous testing done on the TT-100 from the previously cleared submission (K143267).
. Electrical safety (IEC 60601-1 Edition 3.1) and EMC testing (IEC 60601-1-2 4th Edition) was repeated for the updated circuit board of TempTraq.
. Engineering Analysis and Verification Testing to confirm that the updated TempTraq System (with updated circuit and device design) meets the requirements of the predicate (K143267).
. Bench testing was completed for the TempTrag System (models TT-100, TT-200 and TT-300) to confirm the performance of the patch. These additional tests contain an accuracy test, temperature stabilization test, and an operating time test. They confirmed that the additional TT-200 and TT-300 models meet the performance of the TT-100 model previously cleared.
. Adherence properties of the TT-200 and TT-300 were tested in order to confirm that they are consistent with the adherence performance of the previously cleared TT-100 model.
. Software verification and validation was performed for the different configurations of the TempTraq Application (TempTraq Consumer Mobile Application, TempTraq Patient Mobile Application, and TempTrag Clinician Mobile Application for iOS and Android and TempTraq Web Application for Chrome, Safari, and Firefox) in accordance with FDA's "Guidance for Industry and FDA Staff: General Principles of Software Validation" (January 11, 2002) and IEC 62304:2015.
. Cybersecurity testing was performed for the TempTraq system. This includes Software Penetration Verification and Validation Testing, performed for both the Android App and iOS App. This testing confirmed that appropriate information security controls are implemented within the network and host environment to preserve the integrity,

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confidentiality, and availability of its information and computing resources based on considerations from "Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2, 2014).

. Software verification and validation was performed for TempTraq Connect cloud services in order to determine that the sharing data functionality was safe and effective.
. Usability testing was performed for the TempTraq System in accordance with IEC 60601-1-6 and based on considerations from "Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016).

Conclusions

Based on the performance testing, comparison, and analysis, the subject device is substantially equivalent to the predicate device.

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.