(17 days)
Not Found
No
The device description explicitly states that the signal is calculated and displayed by an ASIC (Application Specific IC) which is described as "hard-wire control instead of programmable control," indicating a lack of software-based AI/ML.
No
The device is a digital thermometer used to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device measures body temperature, which is a vital sign, but it does not diagnose a specific condition or disease. It provides data that a healthcare professional might use as part of a diagnostic process, but the device itself does not perform diagnosis.
No
The device description explicitly details hardware components such as a thermistor, reference resistor, buzzer, ASIC, LCD, and battery, indicating it is a physical device with embedded electronics, not software only.
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 about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The described device is a digital thermometer that measures body temperature directly from the patient's body (oral, axillary, or rectal). This is an in vivo measurement, meaning it's taken within the living body.
The device's function is to measure a physiological parameter (body temperature) directly from the patient, not to analyze a sample taken from the patient. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axially or rectal temperature measurements for home use on people of all ages.
Product codes
FLL
Device Description
The 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X, are the electronic thermometers by using a thermistor as 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 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X it was designed and verified according to the US standard ASTM E 1112-00.
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
home use
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)
Not Found
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
Mesure Technalpgy J ి గ్రామాల
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, and the relevant 510(k) submission ouidance.
The assigned 510(k) number is: ಗಡಿಸಿ 0 3ರ 3 Submitter's Identifications: Company: Mesure Technology Co., Ltd. Address: 7F, No. 88, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C. Contact person: John Chen / Ph. D.
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- Name of the Device: 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X.
3. Device Description:
The 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X, are the electronic thermometers by using a thermistor as 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 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X it was designed and verified according to the US standard ASTM E 1112-00.
4. Intended Use:
The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axially or rectal temperature measurements for home use on people of all ages.
5. Comparison to the 510(k) Cleared Device (Predicate Device):
Since the new models 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X were developed from the cleared device ST8631 through the design control procedures of Measure Technology Co., Ltd. with only the small change in sensor wire material and wiring construction so as to shorten the measuring time, the new device is substantial equivalence to that of device being modified, ST8631(K021048) and 10-second Digital Thermometer, model ST87, ST89, ST89, and ST8B.(K040156).
1
Mesure Technology Co., Ltd.
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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: 2000, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
7 Conclusions
The Mesure 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X have the same intended use and technological characteristics as the cleared device of Measure's model ST8631. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate 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 ST8631 (K021048) and 10-second Digital Thermometer, model ST87, ST89, ST80, and ST8B (K040156).
2
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and two curved lines representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Mr. John Chen Mesure Technology Company Limited 7F, No. 86/88 Sec 1, Kwang Fu Road Sanchung City, Taipei Hsien, TAIWAN
Re: K050303 Trade/Device Name: 5 Sec Digital Clinical Thermometer / Models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST840X, and ST8B30X/ST8B40X. Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 5, 2005 Received: February 8, 2005
Dear Mr. Chen:
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 vour 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.
3
Page 2 - Mr. Chen
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 vour 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
4
Indications For Use
14050303 510(k) Number (if known):
Device Name: 5 Sec Digital Clinical Thermometer / Models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X.
Indications For Use:
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital 1.CD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cim
Seneral Hospital.
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