TempTraq TT-100

K143267 · Blue Spark Technologies, Inc. · FLL · Sep 2, 2015 · General Hospital

Device Facts

• Record ID: K143267
• Device Name: TempTraq TT-100
• Applicant: Blue Spark Technologies, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Sep 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

TempTraq Model TT-100 is a single-use, wearable, battery-operated electronic patch; contains temperature sensor IC, microprocessor, and Bluetooth Low Energy (BLE) transmitter. Sensor uses diode technology where voltage varies with temperature; factory-calibrated to convert voltage to temperature. Device adheres to skin under armpit via biocompatible adhesive. Continuously measures body temperature every 10 seconds; transmits data wirelessly to mobile app on iOS or Android smart devices. Used by patients of all ages; provides continuous monitoring; enables remote temperature tracking via app. Benefits include continuous, non-invasive temperature monitoring without manual intervention.

Clinical Evidence

Bench testing only. No clinical data required. Evidence includes system verification, software validation, and compliance with standards: ES60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, ISO 10993-1, and ASTM E1112-00.

Technological Characteristics

Flexible printed circuit board; temperature sensor IC using diode technology; two 1.5V flexible batteries (3.0V DC total). Connectivity: Bluetooth Low Energy (BLE). Form factor: wearable patch with biocompatible adhesive. Standards: ASTM E1112-00, IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for human body temperature measurement in the armpit for persons of all ages.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Wireless Thermometer (ST323C/F) (K063542)

Reference Devices

• iThermonitor (K132761)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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## 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: [phone] Fax: [phone] 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.: [phone] Email: [e-mail]

#### 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 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.

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 | Proposed<br>Device<br>TempTraqT<br>M, Model<br>TT-100<br>(TT-100)<br>Blue Spark<br>Technologies | Primary<br>Predicate<br>Wireless<br>Thermometer<br>(ST323C/F)<br>Mesure<br>Technology<br>Co., Ltd. | Reference<br>Predicate<br>iThermonitor<br>(WT701)<br>Raiing<br>Medical<br>Company | Discussion |
|------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------|
| 510(k)<br>Number | N/A | K063542 | K132761 | N/A |
| Product Code | FLL | FLL | FLL | Identical |
| Regulation # | 21CFR880.29<br>10 | 21CFR880.291<br>0 | 21CFR880.29<br>10 | Identical |
| Class | Clinical<br>electronic<br>thermometers | Clinical<br>electronic<br>thermometers | Clinical<br>electronic<br>thermometers | Identical |

## Table 5-1: Substantial Equivalence Table

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| Intended Use | The Wireless<br>thermometer, | The Wireless<br>thermometer, | The Wireless<br>Thermometer | 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 is<br>reusable and<br>intended for<br>armpit<br>monitoring<br>for persons<br>over two<br>years old. | | |
| Display Use<br>Specification | iOS device<br>display<br>and Android<br>device display | Custom receiver | iOS device<br>display | Equivalent | |
| Working<br>Voltage | 3.0V DC | 3.0V DC | 3.0V DC | Identical | |
| Battery | Two (2) Blue<br>Spark 1.5 V<br>batteries (103-<br>UT1) | 3V x 1<br>(CR2032) | The button<br>battery 3.0 V,<br>210mAh | Equivalent | |
| Measurement<br>Range | 30 ~ 42.4 C | 10.0°C ~<br>43.0°C<br>(50.0°F~<br>109.4°F) | 25 ~ 45° C | Equivalent | |
| Accuracy | +0.1°C<br>between 30°C<br>~ 42.4°C | 0.1°C / 0.2°F<br>between 32°C ~<br>43.0°C (89.6°F<br>~ 109.4°F) | =0.05° C (35-<br>38.5° C);<br>+0.1° C (25-<br>34.99° C);<br>+0.1°C<br>(38.51-45°C) | Equivalent | |
| Temperature<br>Unit | °C or °F | °C or °F | °C or °F | Identical | |
| Signal<br>Transmission | Wireless 2.4G<br>Bluetooth<br>BLE | Wireless | Wireless 2.4G<br>Bluetooth<br>BLE | Identical | |
| Receiver | Wireless 2.4G<br>Bluetooth<br>BLE enabled<br>smart devices<br>running Apple<br>operating<br>system iOS<br>7.1 through | Custom receiver | Wireless 2.4G<br>Bluetooth<br>BLE enabled<br>smart devices<br>running Apple<br>operating<br>system iPhone<br>4S, iPhone 5, | Equivalent | |
| | 8.1 or Android<br>operating<br>system 4.3<br>through 4.4.4 | | | iPad (3rd<br>generation),<br>iPad (4th<br>generation),<br>iPad mini,<br>iPod (5th<br>generation) | |
| Valid<br>Transmission | Up to 40 feet | 160 feet<br>distance<br>(approx.50M)<br>in an open<br>space. If there<br>are objects in<br>that space, the<br>transmission<br>distance will be<br>affected | Up to 5<br>meters | Equivalent | |
| Operating<br>Temperature | 16°C ~ 40°C | N/A | 5°C ~ 40 °C | Identical/<br>Equivalent | |
| Operating<br>Humidity | 15% - 95% RH | 15% - 95% RH | 15-85% | Equivalent | |
| Anatomical<br>Application | Armpit<br>peel-and-stick<br>contact<br>thermometer<br>sensor | Armpit<br>wearable w/out<br>adhesive | Armpit<br>peel-and-stick<br>contact<br>thermometer<br>sensor | Identical/<br>Equivalent | |
| Patient Usage | Single-use | reusable | reusable | Equivalent | |
| Temperature<br>Measurement<br>Interval : | Continuous -<br>transmitter<br>measures body<br>temperature<br>every 10<br>seconds | Continuous -<br>transmitter<br>measures body<br>temperature<br>once every 15<br>seconds | Continuous -<br>transmitter<br>measures<br>body<br>temperature<br>every 4<br>seconds | Equivalent | |
| Memory<br>Function : | Can store up<br>to 24 hours of<br>readings | 200 sets | can store up<br>to 72 hours of<br>readings | 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.