The Wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is single-use and intended for armpit temperature measurement for persons of all age.

Device Description

The TempTraq™, Model TT-100 patch consists of a temperature sensor integrated circuit mounted to a flexible electronic printed circuit board that also contains a microprocessor and a Bluetooth Low Energy (BLE) radio transmitter. Two 1.5V flexible batteries are attached to the circuit board to supply 3.0V DC internal power. The temperature sensor integrated circuit utilizes diode technology where voltage varies with temperature. The sensor circuit is factory calibrated and converts the voltage to an output temperature. The algorithm for conversion is a proprietary algorithm which compensates for the nearly linear behavior of the diode voltage, providing an extremely accurate temperature measurement.

AI/ML Overview

The Blue Spark Technologies TempTraq™, Model TT-100 is a battery-operated electronic device intended for measuring human body temperature precisely, specifically for armpit temperature measurement for persons of all ages. This device is single-use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (TempTraq™, Model TT-100)
Measurement Range	30 ~ 42.4 °C
Accuracy	±0.1 °C between 30 °C ~ 42.4 °C
Operating Temperature	16 °C ~ 40 °C
Operating Humidity	15% - 95% RH
Signal Transmission	Wireless 2.4G Bluetooth BLE
Valid Transmission Range	Up to 40 feet
Temperature Unit	°C or °F
Intended Use	Measuring human body temperature precisely for armpit measurement in persons of all ages. Single-use.
Anatomical Application	Armpit peel-and-stick contact thermometer sensor
Patient Usage	Single-use
Temperature Measurement Interval	Continuous - transmitter measures body temperature every 10 seconds
Memory Function	Can store up to 24 hours of readings

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Clinical testing was not required to establish equivalency of the device." Therefore, there is no test set of clinical data from human subjects reported in this summary. The performance was demonstrated through "bench tests," "System Verification," "Software Verification and Validation," and compliance with voluntary standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was performed on human subjects for the test set, no experts were used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set
Not applicable, as no clinical test set on human subjects was used.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical testing was not required to establish equivalency of the device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes "bench tests" and "System Verification" which would inherently be standalone performance evaluations of the device itself and its integrated software/firmware. However, it does not explicitly use the term "standalone performance" in the context of an algorithm or AI. The device's primary function is a temperature sensor and transmitter, not an AI-driven diagnostic algorithm. The accuracy specified (±0.1 °C between 30 °C ~ 42.4 °C) likely comes from these standalone bench tests comparing the device's readings against a known accurate temperature source.

7. The Type of Ground Truth Used
For the bench tests and system verification, the ground truth would have been established by known, calibrated reference temperatures generated by laboratory equipment. This is implied by the nature of "bench tests" for thermometer accuracy.

8. The Sample Size for the Training Set
Not applicable. This device is a thermometer, and its core function relies on direct physical measurement via a diode's voltage proportionality to temperature, combined with a proprietary calibration algorithm. This kind of device does not typically involve "training" in the machine learning sense to establish its fundamental measurement accuracy for in-vitro/in-silico testing. The "proprietary algorithm" for temperature conversion is likely a fixed mathematical model based on physical principles and factory calibration, not a trained machine learning model requiring a training dataset.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of a machine learning "training set" for this device. The "factory calibrated" nature of the sensor circuit suggests a one-time calibration process against precise reference temperatures during manufacturing.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 2, 2015

Blue Spark Technologies Inc. c/o Jennifer Cartledge REU Associates, Incorporated 409 Woodridge Drive Seneca, South Carolina 29672

Re: K143267

Trade/Device Name: TempTraq, Model TT-100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 6, 2015 Received: July 31, 2015

Dear Ms. Cartledge:

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. 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 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

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CFR Part 807); labeling (21 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith -S

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Digital Signature Concurrence Table
Reviewer Sign-Off
William M. Burdick
Branch Chief Sign-Off
Richard Chapman
Division Sign-Off
Erin Keith

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143267

Device Name TempTraq, model TT-100

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) Summarv

K143267

Type of submission: Traditional 510(k); this is the first submission for this device.

Preparation of this 510(k) Summary: This 510(k) summary was prepared by Jennifer Cartledge. Submission Correspondent. The contents of the 510(k) were provided by and approved by Blue Spark Technologies.

Date of Submission: November 11, 2014

Name and Address of Manufacturer and 510(k) Owner:

Blue Spark Technologies Inc. 806 Sharon Drive, Suite G. Westlake. OH 44145 USA Phone: 440-249 5400 Fax: 440-249 5421 Establishment registration number: Blue Spark Technologies is not currently registered. This submission represents the first 510(k) and medical device for Blue Spark Technologies. Blue Spark will complete registration within 30 days of manufacturing and distributing the device.

Contact: Jennifer Cartledge, Submission Correspondent 864-506-0097

US contact person:

Jennifer Cartledge REU Associates Inc. 409 Woodridge Drive Seneca, SC 29672 Tel.: (864) 500-0097 Email: jcartledge@reuassociates.com

Device Identification

TempTraq™, Model TT-100 Trade Name: Common names: Clinical electronic thermometer Classification(s) of the device: Thermometer, electronic, clinical, 21CFR 880.2910

Blue Spark Technologies TempTraqTM - Traditional 510(k) 510(k) Summary - Section 5-1 of 7 -

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Product Code: FLL Classification Panel: General Hospital Class II

Equivalent legally marketed devices:

Wireless Thermometer (ST323C/F) by Mesure Technology Co., Ltd (K063542) .
The Raiing Medical iThermonitor (K132761) provides an example of a cleared device that affixes the sensor to the skin under the armpit with an adhesive backed foam and that communicates wirelessly to a smart phone application as the receiver.

Device Description:

The TempTrag™. Model TT-100 Device is functionally identical to the Mesure Wireless Temperature models ST323C and ST323F in intended use, apart from fact that the TempTraq Model TT-100 device is single use. They both utilize equivalent temperature technology to sense, process, store and transmit temperature data. Like the predicate, the TempTraqTM, Model TT-100 device functions to transmit continuous measurements of body temperature wirelessly to a receiver. In the case of the predicate, the Wireless Thermometer (K063542), this information is transmitted to a custom receiver, while the TempTraq™, Model TT-100 device transmits the information to a mobile app, similar to the reference device, the iThermonitor (K132761). The concept of affixing a temperature sensor to the skin under the armpit with an adhesive backed foam has also received pre- market clearance, under K132761, for use with the iThermonitor.

Intended Use:

The TempTraq 114 app is compatible with Wireless 2.4G Bluetooth BLE enabled smart devices running Apple operating system iOS 7.1 through 8.1 or Android operating system 4.3 through 4.4.4

The Indication for Use for the TempTraq™, Model TT-100 Device identical to that of the predicate, apart from the fact that the TempTraq™, Model TT-100 Device is a single use device as compared to the reuseable predicate, and is as follows:

The Wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is Blue Spark Technologies TempTraq™ – Traditional 510(k) 510(k) Summary - Section 5-2 of 7 -

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single-use and intended for armpit temperature measurement for persons of all age.

Comparison to Predicate Device

The TempTraq™, Model TT-100 Device is substantially equivalent to the cleared Mesure Wireless Temperature models ST323C and ST323F in terms of intended use, technology, and performance. Table 5-1 compares the proposed TempTraq™, Model TT-100 with the predicate.

Characteristics	ProposedDeviceTempTraqTM, ModelTT-100(TT-100)Blue SparkTechnologies	PrimaryPredicateWirelessThermometer(ST323C/F)MesureTechnologyCo., Ltd.	ReferencePredicateiThermonitor(WT701)RaiingMedicalCompany	Discussion
510(k)Number	N/A	K063542	K132761	N/A
Product Code	FLL	FLL	FLL	Identical
Regulation #	21CFR880.2910	21CFR880.2910	21CFR880.2910	Identical
Class	Clinicalelectronicthermometers	Clinicalelectronicthermometers	Clinicalelectronicthermometers	Identical

Table 5-1: Substantial Equivalence Table

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Intended Use	The Wirelessthermometer,	The Wirelessthermometer,	The WirelessThermometer	Equivalent
	model TT-100, is	model ST323C and	is a battery-
	a battery-operated	ST323F is the	operated
	electronic device	battery-operated	electronic
	with intended use	electronic devices	device with
	of measuring	with intended use	intended use
	human body	of measuring	of measuring
	temperature	human body	human armpit
	precisely. This	temperature	temperature
	device is single-	precisely. This	continuously
	use and intended	device is reusable	via wireless
	for armpit	and intended for	signal
	temperature	armpit temperature	transmission
	measurement for	measurement for	of the
	persons of all age.	persons of all age.	measuring
			results. This
			system isreusable andintended forarmpitmonitoringfor personsover twoyears old.
Display UseSpecification	iOS devicedisplayand Androiddevice display	Custom receiver	iOS devicedisplay	Equivalent
WorkingVoltage	3.0V DC	3.0V DC	3.0V DC	Identical
Battery	Two (2) BlueSpark 1.5 Vbatteries (103-UT1)	3V x 1(CR2032)	The buttonbattery 3.0 V,210mAh	Equivalent
MeasurementRange	30 ~ 42.4 C	10.0°C ~~43.0°C(50.0°F~~109.4°F)	25 ~ 45° C	Equivalent
Accuracy	+0.1°Cbetween 30°C~ 42.4°C	0.1°C / 0.2°Fbetween 32°C ~~43.0°C (89.6°F~~ 109.4°F)	=0.05° C (35-38.5° C);+0.1° C (25-34.99° C);+0.1°C(38.51-45°C)	Equivalent
TemperatureUnit	°C or °F	°C or °F	°C or °F	Identical
SignalTransmission	Wireless 2.4GBluetoothBLE	Wireless	Wireless 2.4GBluetoothBLE	Identical
Receiver	Wireless 2.4GBluetoothBLE enabledsmart devicesrunning Appleoperatingsystem iOS7.1 through	Custom receiver	Wireless 2.4GBluetoothBLE enabledsmart devicesrunning Appleoperatingsystem iPhone4S, iPhone 5,	Equivalent
	8.1 or Androidoperatingsystem 4.3through 4.4.4			iPad (3rdgeneration),iPad (4thgeneration),iPad mini,iPod (5thgeneration)
ValidTransmission	Up to 40 feet	160 feetdistance(approx.50M)in an openspace. If thereare objects inthat space, thetransmissiondistance will beaffected	Up to 5meters	Equivalent
OperatingTemperature	16°C ~ 40°C	N/A	5°C ~ 40 °C	Identical/Equivalent
OperatingHumidity	15% - 95% RH	15% - 95% RH	15-85%	Equivalent
AnatomicalApplication	Armpitpeel-and-stickcontactthermometersensor	Armpitwearable w/outadhesive	Armpitpeel-and-stickcontactthermometersensor	Identical/Equivalent
Patient Usage	Single-use	reusable	reusable	Equivalent
TemperatureMeasurementInterval :	Continuous -transmittermeasures bodytemperatureevery 10seconds	Continuous -transmittermeasures bodytemperatureonce every 15seconds	Continuous -transmittermeasuresbodytemperatureevery 4seconds	Equivalent
MemoryFunction :	Can store upto 24 hours ofreadings	200 sets	can store upto 72 hours ofreadings	Equivalent
Storage:	Data back-up	Data back-up	Cloud Storage	Equivalent

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Blue Spark Technologies TempTraq™ – Traditional 510(k)
510(k) Summary - Section 5-5 of 7 -

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Summary of technological characteristics / performance data:

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The TempTraq™, Model TT-100 device has equivalent indications for use and technological characteristics as the predicate device.

1.) There is no major change or modification in the intended use of the device (cf. 21 CFR 807.81 (a) (3) (ii)) in comparison to the predicate. Compared to the Mesure Wireless Temperature models ST323C and ST323F, the intended use of the device is equivalent, apart from the fact that the TempTraq™, Model TT-100 device is intended to be a single use, disposable sensor.
2.) There is no difference in the used technologies.

Like the predicate, the TempTraq™, Model TT-100 device functions to transmit continuous measurements of body wirelessly to a receiver. In the case of the predicate, the Wireless Thermometer (K063542), this information is transmitted to a custom receiver, while the TempTraqTM, Model TT-100 device transmits the information to a mobile app, similar to the reference device, the iThermonitor (K132761). Additionally, the Wireless Thermometer (K063542), utilizes elastic/compression to secure the temperature sensor, while the TempTraqTM Model TT-100 device secures the sensor with a biocompatible adhesive like the reference device, the iThermonitor (K132761).

3.) The identified differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate devices (cf. section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)).
4.) Although some specifications are slightly different than the predicate device, the Wireless Thermometer (K063542), the hypothetical resulting difference does not impact the intended use, as demonstrated in the system verification.
5.) Performance information and evidence of compliance to recognized standards demonstrate the device is as safe and effective as the predicate devices.

Based upon the intended use, and upon the similarity of materials, product configuration and administration, it can be concluded the TempTraq™, Model TT-100 device is substantially equivalent to the identified predicate device in terms of intended use, safety and effectiveness.

Description of Testing

The safe and effective performance of the TempTraq™ System has been clearly demonstrated by bench tests:

System Verification ●

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Software Verification and Validation, in accordance with the Guidance for the ● Content of Premarket Submissions for Software Contained in Medical Devices
Performance data demonstrates conformance with 21 CFR Part 1020 or compliance with voluntary standards:
ES60601-1:2005/(R) 2012 And C1:2009/(R) 2012: Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance
IEC 60601-1-2:2007: Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
ISO 14971: 2007 Ed. 2 Medical Devices-Application of Risk Management to Medical Devices
IEC 62304:2006 Ed. 1 Medical Device Software Software lifecycle Processes
ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process
E1112-00 (Reapproved 2011), standard specification for electronic thermometer for intermittent determination of patient temperature. (General Plastic Surgery/General Hospital)

Clinical testing was not required to establish equivalency of the device.

The comparison of technological characteristics, non-clinical performance data and software validation, demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.

Conclusion:

Blue Spark Technologies concludes that the device is substantially equivalent to the currently legally marketed predicate devices. The TempTrag™, Model TT-100 has equivalent indications for use or intended use, has identical or equivalent technological characteristics, and does not introduce new potential hazards or safety risks. The device is as safe and effective as 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.