(43 days)
Not Found
No
The device description explicitly states that the control circuit is an ASIC (Application Specific IC) and is considered hard-wire control instead of programmable control, which is not indicative of AI/ML. There are no mentions of AI, DNN, or ML, nor any descriptions of training or test sets typically associated with AI/ML development.
No
The device measures a physiological parameter (temperature) but does not provide treatment or alleviate symptoms. It is a diagnostic device for measurement.
No
The device measures body temperature, which is a physiological parameter. While variations in body temperature can be symptoms of disease, the device itself simply measures a physical quantity and does not diagnose a specific disease or condition.
No
The device description explicitly details hardware components like 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 done outside of the body (in vitro).
- Device Function: The description clearly states that this device measures body temperature by means of a sensor applied directly to the patient's body (oral, axillary, or rectal). This is a measurement taken on the body (in vivo).
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
Therefore, based on the provided information, this digital clinical thermometer is a medical device used for in vivo measurement, not 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 (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Product codes
FLL
Device Description
The digital clinical thermometer, models ST-8A3C, and ST-8A3F, 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 ST-8A3C, and ST-8A3F, it was designed and verified according to the US standard ASTM E 1112-98.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, axillary or rectal
Indicated Patient Age Range
Not Found
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)
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.
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
lesure Technology Co., Ltd.
510(K) SUMMARY
SEP = 8 2004
his summary of 510(k) safety and effectiveness information is being submitted in accordance with the movements of SMDA 1990 and 21 CFR 807.92, and the relevant 510(K) submission guidance.
Ko42013 he assigned 510(k) number is: __
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.
Name of the Device:
Digital Clinical Thermometer, model ST-8A3C, and ST-8A3F.
Information of the 510(k) Cleared Device (Predicate Device): Digital Clinical Thermometer, model ST-833A, and ST-834A (K981337).
Device Description:
The digital clinical thermometer, models ST-8A3C, and ST-8A3F, 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 ST-8A3C, and ST-8A3F, it was designed and verified according to the US standard ASTM E 1112-98.
Intended 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 LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Comparison to the 510(k) Cleared Device (Predicate Device):
Since the new models ST-8A3C, and ST-8A3F were developed from the cleared device ST-833A, and ST-834A through the design control procedures of Measure Technology Co., Ltd. with only the small change in dimension and device housing, the new device is substantial equivalence to that of device being modified, ST-833A, and ST-834A.
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.
Conclusions
The Mesure digital clinical thermometer, models ST-8A3C, and ST-8A3F have the same intended use and technological characteristics as the cleared device of Measure's model ST-833A, and ST-834A. 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.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract emblem featuring a stylized caduceus, a symbol often associated with healthcare. The emblem is composed of three curved lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Dr. John Chen Official Correspondent Mesure Technology Company Limited 7F, No. 88, Sec. 1, KwangFu Road Sanchung City Taipei Hsien, Taiwan, REPUBLIC OF CHINA
Re: K042013
Trade/Device Name: Digital Clinical Thermometer, Models ST-8A3C, and ST-8A3F Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 27, 2004 Received: August 30, 2004
Dear Dr. 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 Intersule conmisers prives that have been reclassified in accordance with the provisions of Amendinone, or to act rood Cosmetic Act (Act) that do not require approval of a premarket the Federal I ood, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of 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 (1 Wry, it may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be rouslish further announcements concerning your device in the Federal Register.
2
Page 2 - Dr. Chen
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease oc auvrsou that I Da determination that your device complies with other requirements mean that i DX nas made a decessand regulations administered by other Federal agencies. of the Act of ally reachards are squirements, including, but not limited to: registration 1 out must comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CFR Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in as at 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) This letter will and w yourse of a finding of substantial equivalence of your device to a premitset notification. The PDF misults 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), If you desire specific acriter 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 may obtain 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,
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
510(k) Number (if known):
Device Name: Digital Clinical Thermometer, Models ST-8A3C, and ST-8A3F.
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 LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Criterium Viheme
nesthesiology, General Hospital ontrol, Dental Device
510(k) Number:
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