(293 days)
No
The description mentions a "proprietary algorithm" for temperature conversion, but this appears to be a standard calibration and conversion algorithm based on the sensor's properties, not AI/ML. There are no mentions of AI, DNN, ML, training sets, or test sets.
No.
The device's intended use is to measure human body temperature, which is a diagnostic function, not a therapeutic one. It provides information about the body's state but does not treat or alleviate a medical condition.
No
The device is a thermometer used for measuring human body temperature, which is generally considered a monitoring device rather than a diagnostic device. Its intended use is to precisely measure temperature, not to diagnose a condition.
No
The device description explicitly states it is a "battery-operated electronic device" consisting of a temperature sensor, microprocessor, BLE radio transmitter, and batteries, all integrated into a physical patch. This clearly indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "measuring human body temperature precisely." This is a measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a temperature sensor, microprocessor, and radio transmitter. These components are used for direct measurement of temperature, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or analysis of biological specimens, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wireless thermometer measures a physical property of the body itself.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Armpit
Indicated Patient Age Range
all age
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safe and effective performance of the TempTraq™ System has been clearly demonstrated by bench tests:
- System Verification
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +0.1°C between 30°C ~ 42.4°C
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
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
1
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
2
Digital Signature Concurrence Table | |
---|---|
Reviewer Sign-Off | |
William M. Burdick | |
Branch Chief Sign-Off | |
Richard Chapman | |
Division Sign-Off | |
Erin Keith |
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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 -
5
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 -
6
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
Device
TempTraqT
M, Model
TT-100
(TT-100)
Blue Spark
Technologies | Primary
Predicate
Wireless
Thermometer
(ST323C/F)
Mesure
Technology
Co., Ltd. | Reference
Predicate
iThermonitor
(WT701)
Raiing
Medical
Company | Discussion |
|------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------|
| 510(k)
Number | N/A | K063542 | K132761 | N/A |
| Product Code | FLL | FLL | FLL | Identical |
| Regulation # | 21CFR880.29
10 | 21CFR880.291
0 | 21CFR880.29
10 | Identical |
| Class | Clinical
electronic
thermometers | Clinical
electronic
thermometers | Clinical
electronic
thermometers | Identical |
Table 5-1: Substantial Equivalence Table
7
| Intended Use | The Wireless
thermometer, | The Wireless
thermometer, | The Wireless
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
reusable and
intended for
armpit
monitoring
for persons
over two
years old. | | |
| Display Use
Specification | iOS device
display
and Android
device display | Custom receiver | iOS device
display | Equivalent | |
| Working
Voltage | 3.0V DC | 3.0V DC | 3.0V DC | Identical | |
| Battery | Two (2) Blue
Spark 1.5 V
batteries (103-
UT1) | 3V x 1
(CR2032) | The button
battery 3.0 V,
210mAh | Equivalent | |
| Measurement
Range | 30 ~ 42.4 C | 10.0°C ~
43.0°C
(50.0°F~
109.4°F) | 25 ~ 45° C | Equivalent | |
| Accuracy | +0.1°C
between 30°C
~ 42.4°C | 0.1°C / 0.2°F
between 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 | |
| Temperature
Unit | °C or °F | °C or °F | °C or °F | Identical | |
| Signal
Transmission | Wireless 2.4G
Bluetooth
BLE | Wireless | Wireless 2.4G
Bluetooth
BLE | Identical | |
| Receiver | Wireless 2.4G
Bluetooth
BLE enabled
smart devices
running Apple
operating
system iOS
7.1 through | Custom receiver | Wireless 2.4G
Bluetooth
BLE enabled
smart devices
running Apple
operating
system iPhone
4S, iPhone 5, | Equivalent | |
| | 8.1 or Android
operating
system 4.3
through 4.4.4 | | | iPad (3rd
generation),
iPad (4th
generation),
iPad mini,
iPod (5th
generation) | |
| Valid
Transmission | Up to 40 feet | 160 feet
distance
(approx.50M)
in an open
space. If there
are objects in
that space, the
transmission
distance will be
affected | Up to 5
meters | Equivalent | |
| Operating
Temperature | 16°C ~ 40°C | N/A | 5°C ~ 40 °C | Identical/
Equivalent | |
| Operating
Humidity | 15% - 95% RH | 15% - 95% RH | 15-85% | Equivalent | |
| Anatomical
Application | Armpit
peel-and-stick
contact
thermometer
sensor | Armpit
wearable w/out
adhesive | Armpit
peel-and-stick
contact
thermometer
sensor | Identical/
Equivalent | |
| Patient Usage | Single-use | reusable | reusable | Equivalent | |
| Temperature
Measurement
Interval : | Continuous -
transmitter
measures body
temperature
every 10
seconds | Continuous -
transmitter
measures body
temperature
once every 15
seconds | Continuous -
transmitter
measures
body
temperature
every 4
seconds | Equivalent | |
| Memory
Function : | Can store up
to 24 hours of
readings | 200 sets | can store up
to 72 hours of
readings | Equivalent | |
| Storage: | Data back-up | Data back-up | Cloud Storage | Equivalent | |
8
Blue Spark Technologies TempTraq™ – Traditional 510(k)
510(k) Summary - Section 5-5 of 7 -
9
Summary of technological characteristics / performance data:
10
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 ●
11
-
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.