TT1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

Device Description

The Digital Thermometer TT1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with disposable probe cover when taking temperature. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

AI/ML Overview

The KINGTECH Digital Thermometer, TT1001, is intended for measuring body temperature orally in clinical, hospital, and home environments for people of all ages.

The 510(k) submission for the KINGTECH Digital Thermometer, TT1001, primarily establishes substantial equivalence to a predicate device (TaiDoc Digital Thermometer, TD-1001, K122520) rather than presenting a de novo study with specific acceptance criteria and performance results directly from the TT1001 device. The submission states that the two devices have "entire identical specifications." Therefore, the "reported device performance" for the TT1001 is implicitly tied to the performance attributed to the predicate device and the general standards applied to digital thermometers.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the device's performance is demonstrated through adherence to recognized international and national standards for clinical thermometers. Since a direct performance study of the TT1001 with pass/fail criteria and specific results is not presented, the acceptance criteria are drawn from the cited standards, and the reported performance is the claim of compliance with these standards.

Acceptance Criteria (from cited standards)	Reported Device Performance (TT1001)
IEC 60601-1 (Medical electrical equipment - General requirements for safety)	Complies (Safety Test)
EN/IEC 60601-1-2 (Medical electrical equipment - Electromagnetic compatibility)	Complies (Electromagnetic Compatibility Test)
ISO 10993-5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)	Complies (Biocompatibility Test)
ISO 10993-10 (Biological evaluation of medical devices - Tests for in irritation and skin sensitization)	Complies (Biocompatibility Test)
EN12470 (Clinical thermometers - Oral)	Complies (Clinical Tests)
ASTM E1965-98 (Standard specification for infrared thermometers for intermittent determination of patient temperature)	Complies (Clinical Tests)
ASTM E1112-00 (Standard specification for electronic thermometers for intermittent determination of patient temperature)	Complies (Clinical Tests)

2. Sample Size and Data Provenance for Test Set

The provided 510(k) summary does not specify a distinct "test set" for the KINGTECH Digital Thermometer TT1001 for which a sample size or data provenance is detailed. The submission is a "change the application name" type, stating that the TT1001 has "entire identical specifications" to the predicate device (TaiDoc Digital Thermometer, TD-1001, K122520). The test reports and documentation for this submission were prepared by TaiDoc Technology Corporation and BioCare Co., Ltd. (a branch office of TaiDoc Technology Corporation).

Therefore, any performance data for the TT1001 is implicitly derived from the testing activities conducted for the predicate device, within the framework of the cited standards. The sample sizes and data provenance for those underlying studies for the predicate device are not explicitly provided in this document.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not applicable and not provided in the 510(k) summary. For a digital thermometer, "ground truth" typically refers to the accuracy of temperature measurement against a reference standard, not subjective expert assessment of an image or signal. The clinical performance testing would involve comparing the device's readings to a validated reference thermometer, rather than expert interpretation.

4. Adjudication Method for Test Set

This is not applicable and not provided. Performance testing of a digital thermometer involves objective measurement comparisons to standards, not human adjudication of ambiguous cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for a simple digital thermometer. These studies are typically employed for diagnostic imaging devices where human interpretation is a critical component influencing diagnostic accuracy, and AI assistance can potentially improve reader performance.

6. Standalone (Algorithm Only) Performance Study

No. While the thermometer uses an ASIC for calculation, the "device" is the complete physical product with its sensor, processing unit, and display. The performance studies cited (e.g., EN12470, ASTM E1112-00) evaluate the performance of the integrated device in measuring temperature, not a standalone algorithm in isolation from the hardware.

7. Type of Ground Truth Used

For the performance of the digital thermometer (implied by compliance with EN12470, ASTM E1965-98, and ASTM E1112-00), the ground truth for temperature measurement would be established by reference to a highly accurate and calibrated temperature standard (e.g., a laboratory reference thermometer or a temperature-controlled bath). The device's readings are compared against this known "true" temperature under specified conditions.

8. Sample Size for Training Set

This information is not applicable. The KINGTECH Digital Thermometer TT1001 is not an AI/ML-driven device that undergoes a "training" phase in the conventional sense of machine learning. Its operation is based on a fixed algorithm (ASIC) processing sensor input, validated against known physical principles and standards.

9. How Ground Truth for Training Set was Established

This information is not applicable, as there is no "training set" or AI/ML model for this device.

Summary

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KINGTECH ENTERPRISES LIMITED

ROOM 2016. 20F , BLOCK B, REGE:NT CENTER. 70 TA CHUEN PING ST., KWAI CHUNG, N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939

510(K) SUMMARY for KINGTECH Digital Thermometer, TT1001

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(K) number is:__K_133111

Submission Date:	September 21, 2013
Submitter:	Kingtech Enterprises LimitedRoom 2016, 20/F., Block B, Regent Center 70 Ta Chunen PingStreet, Kwai Chung, New Territories, HKTel: +852-24810188 Fax:+852-2423939
Manufacturer:	Kingtech (Dong Guan) Enterprises LimitedFarm Village, Da Ling Shan Town, DongGuan, ChinaTel: +86-76985636260 Fax:+86-76985636350
EstablishmentRegistration No.:	3008808166
Official Contact:	Dr. Jen, Ke-MinTel: +886-3-5208829 Fax:+886-3-5209783Email: ceirs.jen@msa.hinet.net
Common /Usual Name:	Digital Thermometer
Trade Name:	KINGTECH Digital Thermometer, TT1001
ClassificationCode:	FLL, Class II, 21 CFR 880.2910
Intended Use:	TT1001 Digital Thermometer is intended to measure the bodytemperature orally and to be used by medical professionals inclinical and hospital environments and consumers in a homeenvironment. It is intended for use on people of all ages.
PredicatedDevices:	K122520, TaiDoc Digital Thermometer, TD-1001TaiDoc Technology Corporation
Device Description:	The Digital Thermometer TT1001 enables easy and accuratereadings over the body temperature range. It must be used inconjunction with disposable probe cover when taking temperature.From the construction point of view, the digital thermometercomprises of a thermistor for measuring sensor, a reference resistorfor comparison of temperature, a buzzer for sounding effect, anASIC for calculating, and LCD for displaying the measuringtemperature digitally for which the thermistor contacts.

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KINGTECH ENTERPRISES LIMITED

ROOM 2016, 20/F, BLOCK B, REGENT CENTER, 70 TA CHUEN PING ST., KWAI CHUNG, N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939

Test Principle:	The Digital thermometer TT1001 is the electronic thermometeroperated by a thermistor as the temperature sensor and an ASIC(Application Specified IC) for signal processing. The basicoperation principle is that a change of thermistor, caused bychanges of temperature, provide signal to ASIC. ASIC gets thesensor's signal then processes the signal and calculates the result,after that displays the temperature result by a LCD.
Performance Tests:	Safety Test:• IEC 60601-1 - Medical electrical equipment Part 1. Generalrequirements for safety, 2005.Electromagnetic Compatibility Test:• EN/IEC 60601-1-2 - Medical electrical equipment, Part 2.Electromagnetic compatibility - Requirements and tests, 2007.Biocompatibility Tests:• ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.• ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for in irritation and skin sensitization.
Clinical Tests:	In accordance with:EN12470, ASTM E 1965-98, and ASTM E1112-00
Comparison andConclusion:	This 510k submission only need change the application name ofthe predicate K122520 from "TaiDoc Digital Thermometer,TD-1001" to "KINGTECH Digital Thermometer, TT1001"; thereis the entire identical specifications and only need to separate intodifferent 510k. And all of the test reports and documentation forthis 510k submission were prepared by TaiDoc TechnologyCorporation and BioCare Co., Ltd. who is a branch office ofTaiDoc Technology Corporation.Thus the new device is substantially equivalent to the predicatedevices in this aspect.

. .

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

December 26, 2013

Kingtech Enterprises Limited C/O Dr. Ke-Min Jen Official Correspondent Room 2016, 20/F., Block B, Regent Center 70 Ta Chunen Ping Street Kwai Chung, New Territories HONG KONG

Re: K133111

Trade/Device Name: KINGTECH Digital Thermometer TT1001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL Dated: September 21, 2013 Received: September 30, 2013

Dear Dr. Jen:

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.

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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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

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for

Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133111

Device Name

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KINGTECH Digital Thermometer, TT1001

Indications for Use (Describe)

TT.1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Digitally signed by Richard C. Chapman Date: 2013.12.26 11:36:46 -05'00'

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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.