(92 days)
Not Found
No
The description details a standard electronic thermometer using a thermopile and a micro-controller for calculation and display. There is no mention of AI, ML, or any complex algorithms beyond basic signal processing for temperature conversion. The performance studies focus on meeting established standards for thermometers.
No
The device is an infrared ear thermometer, which is used for measuring body temperature. It is a diagnostic device for temperature measurement, not a therapeutic device designed to treat or prevent a condition.
No
This device is an infrared ear thermometer, which measures body temperature. While temperature can be an indicator of health status, the device itself simply measures a physiological parameter and does not diagnose a condition.
No
The device description explicitly details hardware components such as a thermopile, buzzer, Micro Controller, LCD display, batteries, base, wall mount, and power adapter. It is an electronic thermometer that uses a sensor to measure temperature.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Actherm Infrared Ear Thermometer measures body temperature from the auditory canal. This is a direct measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to "measure body temperature from auditory canal." This aligns with a general medical device for monitoring a vital sign, not an IVD.
Therefore, the description clearly indicates a device for in vivo measurement, not in vitro testing.
N/A
Intended Use / Indications for Use
Actherm Infrared Ear Thermometers ACT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover medACCU2010.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Actherm Infrared Ear Thermometers (Model ACT 8000R Series) are electronic thermometers using a thermopile as the temperature sensor. The sensor's electric signal is then calculated and displayed by a Micro-Controller. These thermometers display the temperature decimal. To compare with ACT 8000 Series, Model ACT 8000R Series has the same indication for use. ACT 8000R Series can be made with various functions, such as Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover, will be added following the model number.
The infrared ear thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally.
Actherm Infrared Ear Thermometers ACT 8000R Series can be combined with accessories, base, wall mount and power adapter. The base is a tray for holding probe cover box, power input, power/charge indicator, portable/ fixed probe-cover dispenser and the area for placing digital thermometer and its probe cover. For the wall mount, it can be fixed on the wall and the base can be put on this wall mount.
The system uses two 1.5V DC alkaline rechargeable batteries for the power supply and the battery power is automatically the Micro-Controller and displayed in LCD if the battery is exhausted. The batteries can be recharged only when the ear thermometer ACT8000R put on the base. ACT 8000R cannot be used when recharging.
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 age
Intended User / Care Setting
household and hospital 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)
Actherm Infrared Ear Thermometers ACT 8000R Series meets the ASTM Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1965-98: 2003), as well as EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC 60601-1-2), EN 12470-5 and ISO 10993-1, ISO 10993-5, ISO 10993-10 requirements. For all body contacting materials, the analysis has been made and the identical materials have been used in other legally marketed devices under the same use conditions.
Actherm Infrared Ear Thermometer ACT 8000 and ACT 8000R and Probe Cover medACCU 2010 fulfill the testing requirements of ASTM E 1965-98, EN 60601-1), EN 60601-1-2 (IEC 60601-1-2) and EN 12470-5. ACT 8000R just add the function of recharge, when recharging ACT 8000R, it must be put on the base and cannot take temperature. In addition, ACT 8000R Series also meets electrical Safety performed test such as EN 60601-1 (IEC 60601-1-2 (IEC 60601-1-2), so it is safe for human body. The clinical test results of Actherm Infrared Ear Thermometer ACT 8000 and Probe Cover medACCU 2010 conform to the requirements of ASTM E 1965-98 and EN 12470-5 that are the same performance for ACT 8000R Series. The product quality is standard-guaranteed. The compliance tests demonstrate precise measuring function and the clinical accuracy of the thermometer.
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
6F, No.18, Jhanye 2ndRd., Hsinchu Science Park, Hsinchu 30078, TAIWAN, R.O.C. e - mail: actherm@actherm.com.tw
율 886 36 66 95 96 @ 886 36 66 96 97
Image /page/0/Picture/3 description: The image shows a logo with the word "Aachen" written in a stylized font. Below the logo is a graphic element that resembles a stylized wing or swoosh. To the right of the wing, there is a certification mark with the letters "TUV" and "SOD" inside an octagon, and the letters "CE" followed by the number "0123" are present to the right of the certification mark.
1093795
MAR 1 2 2010
510(k) Summary
Submitter's Identification
Actherm Inc. 6F, No.18, Jhanye 2nd Rd., Hsinchu Science Park, Hsinchu 30078, Taiwan, R.O.C. +886 3 666 9596 Tel : Fax: +886 3 666 9697
Contact Person : Richard Hsieh Date the summary was prepared : December 04, 2009
Name of the device
Trade Name – Actherm Infrared Ear Thermometer ACT 8000R Series and Its Probe Cover medACCU 2010 Common Name - Infrared Ear Thermometer Classification name - Clinical Electronic Thermometer (21CFR 880.2910, Product FLL)
Predicate Device Information
Actherm Infrared Ear Thermometer ACT 8000 Series and Its Probe Cover medACCU 2010 510 (k) number : K090031.
ન્દ્ર
1
6F, No.18, Jhanye 2nd Rd., Hsinchu Science Park, Hsinchu 30078, TAIWAN, R.O.C. e - mail: actherm@actherm.com.tw
Aetherium
Device Description
Actherm Infrared Ear Thermometers (Model ACT 8000R Series) are electronic thermometers using a thermopile as the temperature sensor. The sensor's electric signal is then calculated and displayed by a Micro-Controller. These thermometers display the temperature decimal. To compare with ACT 8000 Series, Model ACT 8000R Series has the same indication for use. ACT 8000R Series can be made with various functions, such as Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover, will be added following the model number.
8 886 36 66 95 96
886 36 66 96 97
The infrared ear thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally.
Actherm Infrared Ear Thermometers ACT 8000R Series can be combined with accessories, base, wall mount and power adapter. The base is a tray for holding probe cover box, power input, power/charge indicator, portable/ fixed probe-cover dispenser and the area for placing digital thermometer and its probe cover. For the wall mount, it can be fixed on the wall and the base can be put on this wall mount.
The system uses two 1.5V DC alkaline rechargeable batteries for the power supply and the battery power is automatically the Micro-Controller and displayed in LCD if the battery is exhausted. The batteries can be recharged only when the ear thermometer ACT8000R put on the base. ACT 8000R cannot be used when recharging.
(Labeling please see Attachment 1)
Intended Use
Actherm Infrared Ear Thermometers ACT 8000R Series have the same intended use as the predicate device. They are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover.
2
6F, No.18, Jhanye 2nd Rd., Hsinchu Science Park, Hsinchu 30078, TAIWAN. R.O.C. e - mail: actherm@actherm.com.tw
Image /page/2/Picture/2 description: The image shows two phone numbers: 886 36 66 95 96 and 886 36 66 96 97. There is a phone icon next to the first number and a document icon next to the second number. The image also contains a logo and a certification mark.
Technological Characteristics
Actherm Infrared Ear Thermometers ACT 8000R Series have the same mode of operation, design principle, and biological specifications as the predicate device. ACT 8000R Series can be made with various functions, such as Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover, will be added following the model number.
Comparison to 510(k) Predicate Devices
The Actherm Infrared Ear Thermometers, the ACT 8000R Series are substantially equivalent to the following digital thermometers: Infrared Ear Thermometer Model ACT 8000 Series. Its 510(k) number is K090031.
To compare with ACT 8000 Series, the Actherm Infrared Ear Thermometers ACT 8000R Series are similar in design and intended use to the predicates differing only in supplied batteries.
The ACT8000 Series use two 1.5V DC alkaline batteries and the ACT 8000R Series use two 1.5V alkaline rechargeable batteries that can be recharged only when the infrared ear thermometer ACT 8000R is put on the base. ACT 8000R cannot be used when recharging.
All products use the same temperature sensing element - a thermopile, an LCD display, Micro-Controller and a buzzer.
Substantial Equivalence
Infrared Ear Thermometers ACT 8000R Series, and the claimed device are the same in intended use, essential component; sensor, power requirement, PCB circuit, software program, biological specification, performances, design principle, dimension of probe cover, and are also close in electrical safety, and materials, etc. However, in these characters, the slight difference of measuring range, battery type, labeling, won't affect product safety and effectiveness.
3
r
6F, No.18, Jhanye 2nd Rd., Hsinchu Science Park, Hsinchu 30078, TAIWAN. R.O.C. e - mail: actherm@actherm.com.tw
会 886 36 66 95 96 图 886 36 66 96 97
The change is in power supply. The ACT 8000 Series use two 1.5V DC alkaline batteries and the ACT 8000R Series use two 1.5V alkaline rechargeable batteries that can be recharged only when the infrared ear thermometer ACT 8000R is put on the base is a tray for holding probe cover box, power input, power/charge indicator, portable/ fixed probe-cover dispenser and the area for placing digital thermometer and its probe cover. ACT 8000R cannot be used when recharging. It has passed electrical safety performed test, therefore, it is safe for human body.
According to the description above, the two devices are substantial equivalent.
Performance Data
Actherm Infrared Ear Thermometers ACT 8000R Series meets the ASTM Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1965-98: 2003), as well as EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC 60601-1-2), EN 12470-5 and ISO 10993-1, ISO 10993-5, ISO 10993-10 requirements. For all body contacting materials, the analysis has been made and the identical materials have been used in other legally marketed devices under the same use conditions.
Safety and Effectiveness
Actherm Infrared Ear Thermometer ACT 8000 and ACT 8000R and Probe Cover medACCU 2010 fulfill the testing requirements of ASTM E 1965-98, EN 60601-1), EN 60601-1-2 (IEC 60601-1-2) and EN 12470-5. ACT 8000R just add the function of recharge, when recharging ACT 8000R, it must be put on the base and cannot take temperature. In addition, ACT 8000R Series also meets electrical Safety performed test such as EN 60601-1 (IEC 60601-1-2 (IEC 60601-1-2), so it is safe for human body. Moreover, Infrared Ear Thermometers ACT 8000R Series, and the claimed device are the same in intended use, essential component, sensor, power requirement, PCB circuit, Software program, biological specification, performances, design principle, dimension of probe and probe cover, and also close in electrical safety, and materials, etc. The clinical test results of Actherm Infrared Ear Thermometer ACT 8000 and Probe Cover medACCU 2010 conform to the requirements of ASTM E 1965-98 and EN 12470-5 that are the same performance for ACT 8000R Series. The product quality is standard-guaranteed. The compliance tests demonstrate precise measuring function and the clinical accuracy of the thermometer. Therefore, these thermometers are safety and effectiveness.
4
4
ACTIFICI
6F, No.18, Jhanye 2ndRd., Hsinchu Science Park, Hsinchu 30078, TAIWAN, R.O.C. e - mail: actherm@actherm.com.tw
Image /page/4/Picture/3 description: The image shows a logo with the word "Acaborn" written in a stylized font. Below the word is a horizontal line. To the right of the line is a certification mark with the letters "TUV" inside of an octagon. Next to the certification mark is the text "CE0123".
Conclusion
ﺮ ﮐ
Actherm Infrared Ear Thermometers ACT 8000R Series have intended use, principles of operation, and similar technological characteristics as predicate devices. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Actherm Infrared Ear Thermometers ACT 8000R Series are substantially equivalent to the predicate devices.
5
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Richard Hsieh General Manager Actherm, Incorporated 6F, No. 18 Jhanye 2nd Road Hsinchu Science Park Hsinchu China Taiwan 30078
MAR ] 2 2010
Re: K093795
Trade/Device Name: Actherm Infrared Ear Thermometer ACT 8000R Series and Its Probe Cover medACCU2010 Regulation Number: 21CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 4, 2010 Received: February 16, 2010
Dear Mr. Hsieh:
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.
6
Page 2- Mr. Hsieh
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/ ucm 1.5809.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.
for
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
7
ACTHERM Inc.
6F, No.18, Jhanye 2nd Rd., Hsinchu Science Park, Hsinchu 30078, TAIWAN, R.O.C. e - mail: actherm@actherm.com.tw
☎ 886 36 66 95 96 B 886 36 66 96 97
Image /page/7/Picture/3 description: The image shows a logo with the word "Aetherium" in a stylized font. Below the word is a graphic element that appears to be a stylized representation of a bird or wing. To the right of the graphic element are two certification marks: a TÜV SÜD octagon logo and a CE mark followed by the number 0123.
Indication for Use
510(k) Number (if known) : K093795
Device Name : Actherm Infrared Ear Thermometer ACT 8000R Series and Its Probe Cover medACCU2010
Indication For Use :
Actherm Infrared Ear Thermometers ACT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on pcople of all age, and is used with or without probe cover medACCU2010.
Prescription Use Over-The-Counrter Use ____x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Th
(Division Sign-Q (Offision of Anesthesiology. General Hospital Infection Control, Dental Devices
Page 1 of 1
16 093 510(k) Number: