(25 days)
Not Found
No
The device description explicitly states that the signal is calculated and displayed by an ASIC-controlled circuit, which is described as "hard-wire control instead of programmable control." There is no mention of AI, ML, or any software-based learning or decision-making processes.
No.
A device that merely measures a physiological parameter, like temperature, without contributing to the treatment, diagnosis, cure, or prevention of disease is a measurement device, not a therapeutic device. This device is an ear thermometer used for measurement only.
No
The device measures body temperature, which is a vital sign. While changes in body temperature can be indicators of illness, the device itself is not described as diagnosing a specific disease or condition, but rather providing a measurement.
No
The device description explicitly details hardware components such as an infrared sensor, electronic signal amplification, conditioning and digital LCD unit, thermopile, reference thermistor, buzzer, ASIC, and battery. It is a physical device that measures temperature.
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 provided description clearly states that the device measures body temperature from the auditory canal using an infrared sensor. This is a measurement taken directly from the body (in vivo).
- No Specimen Analysis: The device does not analyze any biological specimens. It directly measures a physical property (temperature) from the patient's body.
Therefore, based on the intended use and device description, this ear thermometer is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Mesure ear thermometer, models ST66, and ST67, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile 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 ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.
This system uses a 3.0 V 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 ST66 and ST67, they were designed and verified according to the US standard ASTM E 1965-00.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K080981 (P. 1 of 2)
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 quidance.
The assigned 510(k) number is:
Submitter's Identifications:
Company: Mesure Technology Co., Ltd.
Address: 7F, No. 86, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C. Contact person: John Chen / Ph. D.
-
- Name of the Device: Ear Thermometer / Models ST66 and ST67
- Information of the 510(k) Cleared Device (Predicate Device): 2. Ear Thermometer Model ST64 & ST65.(K040627)
ဒေ Device Description:
The Mesure ear thermometer, models ST66, and ST67, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile 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 ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.
This system uses a 3.0 V 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 ST66 and ST67, they were designed and verified according to the US standard ASTM E 1965-00.
4. Intended Use:
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification. conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
Comparison to the 510(k) Cleared Device (Predicate Device): 5.
Since the new models ST66 and ST67 were developed from the cleared device ST64 and ST5 through the design control procedures of Measure Technology Co., Ltd. with only the small change in dimension, device housing, and some non-performance and safety related features, the new device is substantial equivalence to that of device being modified. ST64 and ST65
-
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965: 2000, as well as EN 60601-1, and EN 60601-1-2 requirement.
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
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7. Conclusions
Kobo 981 (P.2052)
The Mesure ear thermometer thermometer, models ST66, and ST67 have the same intended use and technological characteristics as the cleared device of Measure's model ST64 and ST65. 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
John Chen, Ph.D. General Manager Mesure Technology Company, Limited 7F, No. 86 Sec. 1, Kwang Fu Road Sanchung City, Taipei Hsien, TAIWAN, R.O.C.
Re: K080981
Trade/Device Name: Ear Thermometer, Models ST66 and ST67 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 13, 2008 Received: April 7, 2008
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 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.
3
Page 2 - Dr. 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 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 (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,
Clive
Shin-Liang, 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
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Indications For Use
510(k) Number (if known): ЌФ§Ф98ј
Device Name: Ear Thermometer, Models ST66 and ST67.
Indications For Use:
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
| 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 I NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QL
Cathong to me
(Division Sign-Off) Division of Anesthesiology, General Hospital tion Control, Dental Devices
510(k) Number: K984978
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