The Digital temperature monitor, model GT-202, GT-204, and GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.

Device Description

The Digital temperature monitor, model GT-202/GT-204/GT-205, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. 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. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Temperature Monitor, models GT-202, GT-204, GT-205:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states that the device was designed and verified according to the US standard ASTM E1112-98. As the document does not provide specific numerical acceptance criteria from ASTM E1112-98 or detailed performance results, the table below reflects what is stated in the document.

Acceptance Criterion (Based on ASTM E1112-98)	Reported Device Performance
Compliance with ASTM E1112-98	"designed and verified according to the US standard ASTM E1112-98"
Not explicitly stated in the document	Not explicitly stated in the document

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device was "designed and verified according to the US standard ASTM E1112-98" and that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be related to engineering verification against a standard rather than clinical expert evaluation for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. The validation appears to be against a technical standard (ASTM E1112-98) rather than an expert-adjudicated clinical dataset.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a standalone temperature monitor, and the evaluation focuses on its technical performance against a standard, not on assisting human interpretation.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states: "Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98." This indicates that the device's accuracy and performance were evaluated according to this standard.

7. Type of Ground Truth Used

The ground truth used for the standalone performance study was based on the standards and specifications outlined in ASTM E1112-98. This standard would define the acceptable accuracy limits and test methodologies for digital clinical thermometers. It's an engineering and performance standard rather than a clinical ground truth like pathology or expert consensus on a medical image.

8. Sample Size for the Training Set

The document does not mention any training set size. This device (a digital thermometer) is a hard-wired control system (ASIC-controlled circuit) rather than a software-based AI system that would typically require a training set. The performance is determined by its hardware design and implementation to meet specific accuracy standards.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set, there is no information on how its ground truth was established. This type of device does not involve machine learning or AI that would typically use a training set with established ground truth.

Summary

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OCT 2 4 2003

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Ko33069 . Submitter's Identifications: TENGHI CO., LTD. 112, YI-CHUNG EAST ROAD, TAIPING, TAICHUNG, TAIWAN, R.O.C..

Contact: Mr. Lin Heiao-Feng / Manager Date of Summary Preparation: September 15, 2003

1. Name of the Device: Digital temperature monitor, model GT-202/GT-203/GT-204/GT-205.
1. Information of the 510(k) Cleared Device (Predicate Device): Digital clinical thermometer; model ST-813A (K962520).

3. Device Description:

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.

This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98.

1. Intended Use:
  ﺍﺳﺘﺨﺪﻣﺎ ..

The Digital temperature monitor, model GT-202/GT-204/GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.

1. Comparison to the 510(k) Cleared Device (Predicate Device): The Digital temperature monitor, model GT-202/GT-205 is substantially equivalent to the Measure model ST-813A (K962520).
1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

7. Conclusions

The Tenghi digital temperature monitor, model GT-202/GT-204/GT-205, has the same intended use and technological characteristics as the cleared device of Measure model ST-813A. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2003

Mr. Lin Heiao-Feng Marking Manager 112, YI-Chung East Road, Taiping, TAICHUNG, TAIWAN, R.O.C

Re: K033069

Trade/Device Name: Digital Themperature Monitor, Model GT-2002, GT-2004 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 18, 2003 Received: September 29, 2003

Dear Mr. Heiao-Feng:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Heiao-Feng

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runyon

Chiu Lin, Ph.D. & Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _ Digital temperature monitor / Model: GT-202, GT-204, GT-205.

Indications For Use :

Patara Cuscenti

livision Sinn-( on of Anesthesiology, General Hospital, n Control. Dental Dev

510(k) Number: K933069

(Please: Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

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.