(25 days)
Not Found
No
The device description explicitly states that an ASIC (Application Specific IC) is used for calculation, which is described as "hard-wire control instead of programmable control." There is no mention of AI, ML, or any software-based learning or adaptive algorithms.
No
The device is a digital thermometer used for measuring body temperature, which is a diagnostic function, not a therapeutic one.
No
This device is a digital thermometer used for measuring body temperature, which is a physiological parameter. It does not diagnose diseases or medical conditions.
No
The device description explicitly states it is a battery-operated electronic device comprising hardware components like a temperature sensor, ASIC, LCD, and battery. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device is a "Digital temperature monitor" intended for "measuring human body temperature precisely." It measures temperature directly from the body (oral, armpit, rectal).
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, based on the provided information, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
-
- Name of the Device: Digital temperature monitor, model GT-202/GT-203/GT-204/GT-205.
-
- Information of the 510(k) Cleared Device (Predicate Device): Digital clinical thermometer; model ST-813A (K962520).
3. 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.
-
- Intended Use:
ﺍﺳﺘﺨﺪﻣﺎ ..
- Intended Use:
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.
-
- 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).
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- 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.
1
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.
2
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
3
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 :
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.
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
OR
Over-The-Counter Use
(Optional Format 1-2-96)