(231 days)
Not Found
No
The summary describes a standard digital thermometer with wireless data transmission and does not mention any AI/ML capabilities or related performance metrics.
No
The device is described as a "thermometer intended for body temperature measurement," which is a diagnostic function, not a therapeutic one. It measures a condition but does not treat or alleviate it.
No
Explanation: The device is a thermometer used for measuring body temperature. While temperature measurement can be part of a diagnostic process, the device itself only measures a physiological parameter and does not interpret this measurement to diagnose a condition.
No
The device description explicitly states it is a "wrist band with sensors" and mentions hardware testing such as electrical safety, electromagnetic compatibility, shock, and biocompatibility, indicating it includes physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The TD-1035 Thermometer directly measures body temperature at the axillary site. It does not analyze any biological specimens.
- Intended Use: The intended use is for body temperature measurement, not for the analysis of in vitro samples.
The device is a medical device, specifically a thermometer, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TD-1035 Thermometer device is a thermometer intended for body temperature measurement at the axillary measurement site. The device is intended for measurement in patients 12 years and older in a home use environment.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The TD-1035 Thermometer is a wrist band with sensors, which are used to measure axillary temperature. The sensors are located on the inner edge of the wrist band, so when desired the band is removed from the wrist and held under the user's underarm with the sensors contacting the underarm skin directly.
The main function of TD-1035 Thermometer is to measurement the body temperature range easily and accurately. The TD-1035 Thermometer also has a wireless data transmission function which transmits the readings from the TD-1035 Thermometer to a personnel device, such as a smart phone, tablet PC, etc., via Bluetooth pairing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary (under arm)
Indicated Patient Age Range
12 years and older
Intended User / Care Setting
home use environment
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 accuracy study was performed to demonstrate the TD-1035 Thermometer meet the criteria of ISO 80601-2-56:2009. The evaluation study is in compliance with the international standard.
The laboratory testing of electrical safety, electromagnetic compatibility, and shock met the relevant requirements of the applicable recognized standard: IEC/EN 60601-1, IEC/EN 60601-1-11, IEC/EN 60601-1-2 and ISO 80601-2-56.
The software validation was performed to verify and validate the proposed device works functionally and is in compliance with FDA Guidance for the Content of the Premarket Submissions for Software Contained in Medical Devices.
Biocompatibility testing included cytotoxicity, sensitization and irritation studies completed in accordance with ISO 10993, Part 5: Tests for in vitro cytotoxicity, Part 10: Tests for skin irritation and skin sensitization, and Part 12: Sample preparation and reference materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
68.00°F to 94.98°F: ±0.18°F
95.00°F to 100.40°F: ±0.09°F
100.42°F to 113.00°F: ±0.18°F
(20.00°C to 34.99°C: ±0.10°C
35.00°C to 38.00°C: ±0.05°C
38.01°C to 45.00°C: ±0.10°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.
Not Found
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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
TaiDoc Technology Corporation Ms. Sharon Peng Regulatory Affairs Specialist 6f. No. 127. Wugong 2nd Rd Wugu District New Taipei City, 24888 TAIWAN
Re: K152680
Trade/Device Name: TD-1035 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 18, 2016 Received: March 24, 2016
Dear Ms. Peng:
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.
1
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 CFR Part 807); labeling (21 CFR 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 (OS) 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/ResourcesforYou/Industry/default.htm. 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
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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152680
Device Name TD-1035 Thermometer
Indications for Use (Describe)
The TD-1035 Thermometer device is a thermometer intended for body temperature measurement at the axillary measurement site. The device is intended for measurement in patients 12 years and older in a home use environment.
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)
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary
This is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(K) number is: K152680
1. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Sharon Peng |
| Title: | Regulatory Affairs Specialist |
| Address: | 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, |
| 24888, Taiwan | |
| Phone: | +886-2-6625-8188 # 1176 |
| Fax: | +886-2-6625-0288 |
| E-mail: | sharon_peng@taidoc.com.tw |
| Prepared Date: | May 05, 2016 |
2. Device name:
| Proprietary Name: | TD-1035 Thermometer | |
|---|---|---|
| Common Name: | Electronic Thermometer | |
| Product Code: | FLL | |
| Review Panel: | General Hospital | |
| Device Class: | Class II | |
| Regulation Number: | 21 CFR §880.2910 | |
3. Predicate Device:
| Proprietary Name: | Omron MC-246 |
|---|---|
| 510(K) Number: | K091676 |
4
4. Intended Use:
The TD-1035 Thermometer device is a thermometer intended for body temperature measurement at axillary temperature measurement site. The device is intended for measurement in patients 12 years and older in a home use environment.
5. Device Description:
The TD-1035 Thermometer is a wrist band with sensors, which are used to measure axillary temperature. The sensors are located on the inner edge of the wrist band, so when desired the band is removed from the wrist and held under the user's underarm with the sensors contacting the underarm skin directly.
The main function of TD-1035 Thermometer is to measurement the body temperature range easily and accurately. The TD-1035 Thermometer also has a wireless data transmission function which transmits the readings from the TD-1035 Thermometer to a personnel device, such as a smart phone, tablet PC, etc., via Bluetooth pairing.
6. Test Principle:
The TD-1035 Thermometer detects the temperature by thermistor, which provides signals to the microcontroller where the signals are converted into a digital temperature value that is displayed on the LCD screen.
7. Substantial Equivalence Information:
The technological characteristics of the proposed device, TD-1035 Thermometer, are compared to the predicate device (K091676) and summarized in the following table.
| Item | Predicate device | Proposed device | Comments |
|---|---|---|---|
| Classification | Class II | Class II | Same |
| Product Code | FLL | FLL | Same |
| Item | Predicate device | Proposed device | Comments |
| Indications | The Omron electronic | The TD-1035 Thermometer | Similar, the subject |
| for use | thermometer Models MC-246 | device is a thermometer | device is confined to |
| is intended to measure the | intended for body temperature | home use, and axillary | |
| body temperature either oral, | measurement at axillary | contact which is within | |
| axillaries (under arm) and | temperature measurement site. | the intended use | |
| rectal and to be used by | The device is intended for | boundary set forth by | |
| medical professionals in | measurement in patients 12 | the predicate. Safety | |
| clinical and hospital | years and older in a home use | and effectiveness is not | |
| environments and consumers | environment. | affected because the | |
| in a home environment. It is | intended use is limited | ||
| intended for use on people of | to boundaries with no | ||
| all ages. | new potential hazards. | ||
| Environment | Home and professional use | Home use | Similar, the subject |
| device is confined to | |||
| home use which is | |||
| within the intended use | |||
| boundary by the | |||
| predicate. Safety and | |||
| effectiveness is not | |||
| affected because the | |||
| use environment is | |||
| limited to boundaries | |||
| with no new potential | |||
| hazards. | |||
| Thermometer | |||
| Detection | Temperature is detected by | Temperature is detected by | Same |
| method | thermistor and calculated. | thermistor and calculated. | |
| Accuracy | 89.6°F to 107.6°F: ±0.2°F | 68.00°F to 94.98°F: ±0.18°F | Similar, the claimed |
| (32.0℃ to 42.0℃: ±0.1℃) | 95.00°F to 100.40°F: ±0.09°F | accuracy is with the | |
| 100.42°F to 113.00°F: ±0.18°F | predicate device | ||
| (20.00°C to 34.99°C: ±0.10°C | accuracy tolerance, and | ||
| 35.00°C to 38.00°C: ±0.05°C | is verified per ISO | ||
| 38.01°C to 45.00°C: ±0.10°C) | 80601-2-56:2009 | ||
| requirements. | |||
| Item | Predicate device | Proposed device | Comments |
| Measurement range | 89.6°F to 107.6°F | ||
| (32.0°C to 42.0°C) | 68.00°F to 113.00°F | ||
| (20.00°C to 45.00°C) | Similar, the claimed measurement range includes the range specified by the predicate and is verified per ISO 80601-2-56:2009 requirements. | ||
| Resolution | 0.1°C / 0.1°F | 0.01°C / 0.01°F | Same |
| Measurement area | Oral, rectum, armpit | armpit | Similar, the measurement area is the same as one area measurable using the predicate device. |
| Measurement units | °C or °F | °C or °F | Same |
| General | |||
| Power source | one LR42 battery (DC 1.5V) | one 3V CR2032 lithium battery | Similar, electrical safety is verified per recognized standards noted below. |
| Battery life | Approx. 2 years | ||
| (3 times measurements / day) | Approx. 25 days | ||
| (1 time measurement / day) | Different | ||
| Beeper | Yes | None | Different, the absence of this function is validated as acceptable via human factors testing. |
| Operating condition | 50°F to 104°F (10°C to 40°C); | ||
| 30% to 85% R.H. | 41°F to 104°F (5°C to 40°C); | ||
| 15% to 93% R.H. | Similar, this function is verified per ISO 80601-2-56:2009 requirements | ||
| Item | Predicate device | Proposed device | Comments |
| Storage | |||
| condition | 4°F to 140°F (-20°C to 60°C); | ||
| 10% to 95% R.H. | -13°F to 158°F (-25°C to | ||
| 70°C); | |||
| 10% to 95% R.H. | Similar, this function is | ||
| verified per ISO | |||
| 80601-2-56:2009 | |||
| requirements | |||
| Data | |||
| transmission | None | Bluetooth | Different, this function |
| is verified per IEC | |||
| 62304 requirements. | |||
| Appearance | |||
| Dimensions: | 132.5 mm (L) x 19.4mm (W) | ||
| x 10mm (H) | 40.5mm (L) x 27.5mm (W) x | ||
| 11.7mm (H) | Different, the physical | ||
| features of the device | |||
| are validated per IEC | |||
| 60601-1:2012 | |||
| requirement. | |||
| Weight (g) | 11g | 18g | Different |
| Outer casing | On/off button, LCD display, | ||
| protective case, probe cover | On/off button, LCD display, | ||
| armband | Different | ||
| Appearance | Image: Thermometer | Image: Wristband | Different |
| Conformance | |||
| Standard | • Safety: EN 60601-1 | ||
| • EMC: IEC 60601-1-2 | |||
| • Biocompatibility: ISO10993 | |||
| • Performance: EN 12470-3 | • Safety: EN 60601-1 | ||
| • EMC: IEC 60601-1-2 | |||
| • Biocompatibility: ISO10993 | |||
| • Performance: ISO | |||
| 80601-2-56 | Similar, ISO | ||
| 80601-2-56 is | |||
| recognized by the FDA |
5
CONFIDENTIAL
6
7
A comparison table that described similarities and modifications is briefly provided and demonstrates that the modified TD-1035 Thermometer is substantially equivalent to the Omron MC-246 (K091676) and does not raise new questions of safety and effectiveness.
CONFIDENTIAL
8
8. Performance Data:
The submission included the following performance data for the TD-1035 Thermometer device.
The accuracy study was performed to demonstrate the TD-1035 Thermometer meet the criteria of ISO 80601-2-56:2009. The evaluation study is in compliance with the international standard.
The laboratory testing of electrical safety, electromagnetic compatibility, and shock met the relevant requirements of the applicable recognized standard: IEC/EN 60601-1, IEC/EN 60601-1-11, IEC/EN 60601-1-2 and ISO 80601-2-56.
The software validation was performed to verify and validate the proposed device works functionally and is in compliance with FDA Guidance for the Content of the Premarket Submissions for Software Contained in Medical Devices.
Biocompatibility testing included cytotoxicity, sensitization and irritation studies completed in accordance with ISO 10993, Part 5: Tests for in vitro cytotoxicity, Part 10: Tests for skin irritation and skin sensitization, and Part 12: Sample preparation and reference materials.
9. Conclusion:
The proposed devise of TD-1035 Thermometer has the same classification information, same intended use, same test principle and similar product design and specifications with the predicate device. Based on the information provided in this submission, the TD-1035 Thermometer is substantially equivalent to the predicated Digital Thermometer, model Omron MC-246 (K091676).