(235 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 form of programmable learning or adaptive algorithms.
No.
The device's intended use is solely for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
The device is an infrared ear thermometer that measures body temperature. While temperature can be a symptom, the device itself is not described as diagnosing a disease or condition, but rather as providing a physiological measurement.
No
The device description explicitly states it is a handheld electronic thermometer with hardware components including a thermopile sensor, reference thermometer, buzzer, 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 medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The KINGTECH Infrared Ear Thermometer measures body temperature directly from the auditory canal using an infrared sensor. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to measure body temperature, which is a physiological measurement, not an analysis of a biological sample.
Therefore, based on the provided information, this device falls under the category of a general medical device for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Ear Thermometer model TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820 are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use on people at all ages.
Product codes
FLL
Device Description
The Infrared Ear Thermometer, models TM810B, TM810B, TM817, TM818, TM818A, TM819 and TM820 is a handheld electronic thermometer 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 comprised of a thermopile for the measuring sensor, a reference thermometer 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 3.0V DC battery (2*AAA batteries) 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 TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, they were designed and verified according to the US standard ASTM E 1965-2003.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
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)
A Clinical Test Report conducted according to ASTM E1965:2003 performed by the manufacturer was included as part of ASTM E1965 conformity test report. This report was carried out in such a way that compared the accuracy performance between models TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, as well as TM818A and the predicate device according to the method recommended in ASTM E1965 standard.
The results of the clinical Test Report could positively support the claim of Substantial Equivalence for TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, against the chosen 510k predicate 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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990and 21 CFR 807.92 at September 20, 2010.
The assigned 510(k) number is _K102935
- Submitter's contact Information: Kingtech Enterprises Limited. FDA registration number: 3008808166 Farm village, DaLingShan Town, DonGuan Phone: (86)769-8563-6260 Fax: (86)769-8563-6234 Official correspondent i.e. 510k contact person: Dr. Jen, Ke-Min Phone: (886)3-5208829 Fax: (886)3-5209783 E-mail: ceirs.jen@msa.hinet.net
-
- Name of Device:
Infrared Ear Thermometer, Models TM810A, TM817, TM818, TM818, TM818A, TM819 and TM820
- Name of Device:
-
- Information of the 510(k) Cleared Device (Predicate Device): Measure Technology, models: ST613C and ST614F (K011254)
-
- Device Description:
The Infrared Ear Thermometer, models TM810B, TM810B, TM817, TM818, TM818A, TM819 and TM820 is a handheld electronic thermometer 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 comprised of a thermopile for the measuring sensor, a reference thermometer 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 3.0V DC battery (2*AAA batteries) 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 TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, they were designed and verified according to the US standard ASTM E 1965-2003.
1
-
- Intended Use:
The Infrared Ear Thermometer model TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820 are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use on people at all ages.
- Intended Use:
-
- Comparison to the 510(k)Cleared device (Predicate Device): The Infrared Ear Thermometer, models TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820 are substantially equivalent to the Measure Technology, models: ST613C and ST613F (K011254).
-
- Discussion of Non-Clinical Tests Verification Activities Performed to Determine the
- Safety and Performance of IR-04MT are as the followings:
- 1> Performance Compliance Test according to ASTM E1965:2003 conducted by manufacturer
- 2> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory.
- 3> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
- 4> Biocompatibility Compliance Test according to ISO 10993-5 & ISO 10993-10 by accredited laboratory
-
- Discussion of Clinical Tests Verification Activities Performed to Determine the
Effectiveness of Device are as the followings:
A Clinical Test Report conducted according to ASTM E1965:2003 performed by the manufacturer was included as part of ASTM E1965 conformity test report. This report was carried out in such a way that compared the accuracy performance between models TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, as well as TM818A and the predicate device according to the method recommended in ASTM E1965 standard.
The results of the clinical Test Report could positively support the claim of Substantial Equivalence for TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, against the chosen 510k predicate device.
-
- Conclusions:
The Infrared Ear Thermometer, models TM810B, TM810B, TM817, TM818, TM818A, TM819 and TM820, have the same intended use and technological characteristics as the cleared device of Measure Technology, models: ST613C and ST613F (K011254). 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.
- Conclusions:
In the other words, those engineering difference do not: (1) affect the intended use of ; and (2) alter the fundamental scientific technology of the device. Thus there are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Ke-Min Jen Kingtech Enterprises, Limited Farm Village Da Ling Shan Town Dong Guan, Guangdong China
MAY 2-7 2011
Re: K102935
Trade/Device Name: Infrared Ear Thermometer / Models TM810A, TM810B, TM817, TM818, TM818A TM819, and TM820 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 30. 2011 Received: May 9, 2011
Dear Dr. Jen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Jen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony U.m
Anthony D. Watson, B.S., M.S., M.B.A. 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
K102935 ______________________________________________________________________________________________________________________________________________________________________ 510(k) Number:
Device Name: Kingtech Enterprises Limited KINGTECH Infrared Ear Thermometers Models: TM810A, TM810B, TM817, TM818A, TM818A, TM819, TM820
· Indications for use:
The KINGTECH Infrared Ear Thermometer, models: TM810B, TM810B, TM817, TM818, TM818A, TM819, and TM820 are battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The devices are reusable and intended for home use on people at all ages.
Prescription Use - -
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102935
Page l of of 1
Page 3 of 3