(135 days)
The E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600, is an electronic clinical thermometer using an infrared sensor to detect body temperature from auditory canal for people of all ages in the home.
The E-Care Infrared Ear Thermometer, models LCT-300 and LCT-600 is a hand-held, battery-powered electronic thermometer which uses an infrared sensor (thermopile) to detect body temperature from auditory canal. Its operation is based on measuring infrared radiation from the tympanic membrane and the surrounding tissue. The signal of sensor is calculated and display by an ASIC controlled circuit. This device consists of a thermopile for the measuring sensor, an ASIC controlled circuit for calculating the electrical signal and an LCD to display the measured temperature.
By inserting the probe of this infrared ear thermometer into the outer canal, press the measurement button to start measurement. The electronic circuits amplify and calculate the signal of sensor, then display the temperature on LCD display. The total operation takes a few seconds.
The provided document describes the 510(k) summary for the E-Care Infrared Ear Thermometer (models LCT-300 and LCT-600) and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to the predicate device Braun Thermoscan Infrared Ear Thermometer model: IRT3520 (K983295), rather than setting explicit new acceptance criteria that the device must meet independently. However, the comparison table implicitly uses the predicate device's performance as the benchmark for acceptance.
| Feature / Acceptance Criteria (Implied by Predicate) | Predicate Device (IRT3520) Performance | Subject Device (LCT-300 & LCT-600) Performance |
|---|---|---|
| Displayed Temperature Range | 34 | 0 |
| Operating Ambient Temperature Range | 10-40°C (50-104°F) | 10-40°C (50-104°F) |
| Display Resolution | 0.1°C or °F | 0.1°C or °F |
| Sensor Type | Thermopile | Thermopile |
| Accuracy | ±0.2°C | ±0.2°C (0.4°F): 36 |
| Memory | 8 | 10 |
| Battery | 2 X CR2032 | 1 X CR2032 |
| Probe Cover | With | LCT-300: WithoutLCT-600: With |
Note on Accuracy: The accuracy specification for the subject devices is more detailed than the predicate, showing a slightly looser tolerance in the extreme ranges (±0.3°C vs ±0.2°C for the predicate). However, it matches in the core temperature range. The submission argues this difference does not affect safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "A clinical test report was conducted accord ASTM E1965." However, it does not specify the sample size used for this clinical test.
Regarding data provenance: The document does not explicitly state the country of origin. The submitter is E-Care Technology Co.,Ltd. based in Taiwan. It's safe to assume the testing was conducted in a location accessible to them, but this is not explicitly stated. The study is described as a "clinical test report," which implies a prospective study design to gather data on the device's accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical test.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method used for the clinical test data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study described is a comparison of the subject device against a predicate device, focusing on accuracy, not the improvement of human readers with AI assistance. This device is a thermometer, not an AI-assisted diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Yes, indirectly. The clinical test compares the E-Care Infrared Ear Thermometer (the "algorithm only," meaning the device's inherent measurement capability) against the predicate device. Since it's a standalone thermometer, its performance is its standalone performance without a human-in-the-loop directly interpreting the output beyond reading the temperature.
7. The Type of Ground Truth Used:
The ground truth used for these clinical tests would typically be a rectal thermometer or other highly accurate core body temperature measurement device as defined by the ASTM E1965 standard for infrared thermometers. The document does not explicitly state the specific ground truth method, but "clinical test report was conducted accord ASTM E1965" implies adherence to the methodology outlined in that standard for determining accuracy.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. Infrared ear thermometers (like the E-Care devices) are not typically "trained" in the machine learning sense. Their accuracy is based on their physical design, infrared sensor, and calibration, not on a training data set for an algorithm.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no "training set" in the context of this device's operation. Calibration would be performed against known temperature standards.
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Image /page/0/Picture/0 description: The image shows the word "Care" in a stylized font. The "C" is represented by a spiral shape, and the rest of the letters are connected with a horizontal line going through them. The font is bold and black, and the background is white.
ﻛﺘﺮ --
E-Care Technology Co.,Ltd
8F-11, NO.35, HSIN-TAI ROAD CHUBEI CITY, HSINCHU 302, TAIWAN TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw
MAR - 2 2012
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.
The assigned 510(k) number is:
- Submitter Contact Information: 1.
E-Care Technology Co.,Ltd.
8F-11, No.35, Hsin-Tai Road,
Chubei City, 302, Taiwan
Contact:
Mr. Kun-Yuan Ko Tel:886-3-5534996 Fax:886-3-5534980 e-mail:service@e-care.com.tw
-
Name of Device: 2.
E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600 -
- Predicate Device:
Braun Thermoscan Infrared Ear Thermometer model: IRT3520 (K983295)
- Predicate Device:
Device Description: 4.
4.1 General description:
The E-Care Infrared Ear Thermometer, models LCT-300 and LCT-600 is a hand-held. battery-powered electronic thermometer which uses an infrared sensor (thermopile) to detect body temperature from auditory canal. Its operation is based on measuring infrared radiation from the tympanic membrane and the surrounding tissue. The signal of sensor is calculated and display by an ASIC controlled circuit. This device consists of a thermopile for the measuring sensor, an ASIC controlled circuit for calculating the electrical signal and an LCD to display the measured temperature.
By inserting the probe of this infrared ear thermometer into the outer canal, press the measurement button to start measurement. The electronic circuits amplify and calculate the signal of sensor, then display the temperature on LCD display. The total operation takes a few seconds.
4.2 Difference between LCT-300 and LCT-600:
LCT-300 and LCT-600 use the same electronic components and software (firmware). Basically, their operation is the same, but there are some differences between them:
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Image /page/1/Picture/0 description: The image shows a logo with a stylized spiral on the left, followed by the word "Care" in a bold, slightly distorted font. The spiral is thick and black, resembling a coil. The word "Care" has a horizontal line running through the middle of the letters, creating a fragmented effect. The overall design is simple yet eye-catching, with a focus on the unique typography and the spiral element.
E-Care Technology Co.,Ltd. 8F-11, NO.35, HSIN-TAI ROAD CHUBEI CITY, HSINCHU 302, TAIWAN TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw
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- Different shape (outlooking).
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- LCT-300 does not use probe cover and LCT-600 uses probe cover. During the calibration process in factory, LCT-300 does not have a probe cover on it and LCT-600 does. So LCT-300 (without using probe cover) and LCT-600 (with probe cover) can have the same measurement accuracy after calibration. In their individual user manual, there is different description of usage methods to ensure correct measurement.
5. Intend for Use:
The E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600, is an electronic clinical thermometer using an infrared sensor to detect body temperature from auditory canal for people of all ages at the home.
6. Comparison to Predicate Device:
Both the subject devices (LCT-300 and LCT-600) and predicate device (Braun Thermoscan Infrared Ear Thermometer model: IRT3520 (K983295)) use the same fundamental technology and have the same intended use. The following is the comparison table between the subject devices (LCT-300 and LCT-600) and predicate device (Braun IRT3520):
| Features | Predicate Device(IRT3520) | Subject Device(LCT-300) | Subject Device(LCT-600) |
|---|---|---|---|
| 510 (k) # | K983295 | K | K |
| *DisplayedTemperatureRange | 34 | 0 | 0 |
| OperatingAmbientTemperatureRange | 10-40°C(50-104°F) | 10-40°C (50-104°F) | 10-40°C (50-104°F) |
| DisplayResolution | 0.1°C or °F | 0.1°C or °F | 0.1°C or °F |
| Sensor Type | Thermopile | Thermopile | Thermopile |
| *Accuracy | ±0.2°C | ±0.2°C (0.4°F): 36 | ±0.2°C (0.4°F):36 |
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Image /page/2/Picture/0 description: The image shows a logo with the word "Care" written in a stylized font. The "C" is represented by a spiral shape, and the rest of the letters are in a bold, blocky font. A horizontal line runs through the middle of the word, adding a unique design element to the logo. The overall design is simple yet eye-catching.
E-Care Technology Co.,Ltd. 8F-11, NO.35, HSIN-TAI ROAD CHUBEI CITY, HSINCHU 302, TAIWAN TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw
| 102.2~109.4°F | 102.2~109.4°F | ||
|---|---|---|---|
| *Memory | 8 | 10 | 10 |
| *Battery | 2 X CR2032 | 1 X CR2032 | 1 X CR2032 |
| *Probe Cover | With | Without | With |
※ The subject device and predicate device are different for these features with "**".
The difference in these features does not affect the intend use and alter the fundamental scientific technology of these devices. Moreover these verification and validation test contained in this submission demonstrate the difference in subject devices could maintain the same safety and effectiveness as predicate device. Thus, the E-Care Infrared Ear Thermometer, model LCT-300 and LCT-600 is substantially equivalent to the Braun Thermoscan Infrared Ear Thermometer model: IRT3520 (K983295).
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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence 7. are as following:
Compliance to applicable voluntary standards includes ASTM E1965 as well as IEC 60601-1 and IEC 60601-1-2. -
Discussion of Clinical Tests Performed for Determination of Substantial Equivalence: 8. A clinical test report was conducted accord ASTM E1965 . This report was carried out in such a way that compared the accuracy performance between the E-Care Infrared Ear Thermometer, models LCT-300 and LCT-600, and the predicate device. The results of this clinical test reports positively support the claim of Substantially Equivalence for LCT-300 and LCT-600 against the chosen 510k predicate device.
9. Conclusions:
The E-Care Infrared Ear Thermometer, Models LCT-300 and LCT-600 have the same intended use and similar characteristics as the cleared device Braun Thermoscan infrared ear thermometer model: IRT3520 (K983295). Moreover, clinical testing contained in this submission demonstrates that any difference in their technological characteristics do not raise any question of safety or effectiveness. Thus, the E-Care Infrared Ear Thermometer, Models LCT-300 and LCT-600 are substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kun-Yuan Ko General Manager E-Care Technology Company, Limited 8F-11, NO.35, Hsin-Tai Road Chubei City TAIWAN 30252
MAR - 2 2012
Re: K113095
Trade/Device Name: E-Care Infrared Ear Thermometers Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 6, 2012 Received: February 13, 2012
Dear Mr. Ko:
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.
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Page 2 - Mr. Ko
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 vours.
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
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Image /page/5/Picture/0 description: The image shows a logo with the word "Care" written in a stylized font. The "C" is formed by a spiral shape, and the rest of the letters are connected with a horizontal line going through them. The logo is in black and white.
E-Care Technology Co.,Ltd.
8F-11, NO.35, HSIN-TAI ROAD CHUBEI CITY, HSINCHU 302, TAIWAN TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw
Indications for Use:
510(k) Number (if known): Device Name: E-Care Infrared Ear Thermometers Models: LCT-300 & LCT-600
● Indications for use:
The E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600, is an electronic clinical thermometer using an infrared sensor to detect body temperature from auditory canal for people of all ages in the home.
Prescription use _ (21CFR 801 Subpart D) and / or
Over-The- Counter Use V (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
3/1/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113095
§ 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.