(98 days)
Not Found
No
The description details a standard digital thermometer using a thermistor and ASIC for calculation, with no mention of AI or ML terms, training data, or complex algorithms beyond basic temperature conversion.
No
Explanation: A therapeutic device is used to treat or cure a medical condition. This device is a thermometer, used only for measuring body temperature (a diagnostic function), not for treatment.
No
A diagnostic device identifies or characterizes a disease or condition. This device, a digital thermometer, measures body temperature, which is a vital sign, but it does not diagnose a specific disease or condition on its own. While temperature can be an indicator of illness, the thermometer itself isn't performing the diagnosis.
No
The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, ASIC, LCD, and battery, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ECT digital thermometer measures human body temperature directly, not through the analysis of a sample taken from the body.
- Intended Use: The intended use is to measure body temperature orally, rectally, or underarm, which are direct measurements on the body.
Therefore, the function and intended use of this digital thermometer do not align with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The ECT digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
This thermometer uses a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' ▼' in LCD display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or underarm
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
clinical or 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)
The ECT digital thermometer complied with the requirements of ASTM E1112-00 (2006) standard specifications, as well as IEC 60601-1(2005), ISO 10993-5(2009) and ISO 10993-10(2002) requirements. Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability. For all body contacting materials, analysis is made that the identical materials have been used in other legally marketed devices under the same use conditions.
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
JUL 21 2010
Changshan Estar Electronics Co., LTD
Xindu Industry Zone, Changshan County, Zhejiang Province, 324200, China Tel: +86-570-5110468 Fax: +86-570-5110374
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: June 12, 2010
Device
Trade name: ECT digital thermometer
Common/Usual name: Digital thermometer
Classification name: Clinical electronic thermometer
Medical specialty (Panel): General Hospital
Regulation number: 880.2910
Product Code: FLL
Classification: Class II
Predicate devices
Omrom MC-245 (K091676), Omron Healthcare Incorporated
Basic Digital Thermometer, model DT-02 (K041694), Hangzhou Hua'an Medical & Health Instrument Co. Ltd.
Indication for Use
ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.
Device description:
The ECT digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
This thermometer uses a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' ▼' in LCD display.
1
Changshan Estar Electronics Co., LTD.
Xindu Industry Zone, Changshan County, Zhejiang Province, 324200, China Tel: +86-570-5110468 Fax: +86-570-5110374
Statement of substantial equivalence
The ECT digital thermometer is similar in design and intended use to the MC-245 and DT-02, differing only in physical dimensions, display resolution, battery replacement method. They use a thermistor to measure temperature and comprise 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.
While there are minor differences in performance specifications of the thermometers, these differences do not alter the intended use function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, ESTAR believes that the ECT digital thermometer is substantially equivalent to legally marketed devices currently in commercial distribution.
Summary of Non-Clinical Testing
The ECT digital thermometer complied with the requirements of ASTM E1112-00 (2006) standard specifications, as well as IEC 60601-1(2005), ISO 10993-5(2009) and ISO 10993-10(2002) requirements. Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability. For all body contacting materials, analysis is made that the identical materials have been used in other legally marketed devices under the same use conditions.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Changshan Estar Electronics Co., Ltd. concludes that, ECT Digital thermometer is substantially equivalent to predicate devices as described herein.
2
| ECT digital thermometer | DT-02(K041694) | MC-245(K091676) | |
|---|---|---|---|
| Intend use | To measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use people of all ages. | To measure the body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on either oral, axillaries (under arm) | To measure the body temperature on either oral, axillaries (under arm) and rectal |
| Measurement method | Human temperature is detected by thermistor and calculated | ||
| Measurement area | Oral, rectum, underarm | ||
| Probe tip | Rigid | ||
| Measurement range | $90.0 ~ 109.9°F$ | ||
| $32.0~42.9°C$ | $89.6 ~ 109.4°F$ | ||
| $32.0 ~ 43.0°C$ | $89.6 ~ 107.6 °F$ , | ||
| $32.0 ~ 42.0 C$ | |||
| Display resolution | $0.1°F/°C$ | $0.01°F/°C$ | 4 digits( $0.1°F/°C$ increments) |
| Accuracy | $\pm0.2 °F/\pm0.1 °C$ | $\pm0.05°C$ | $\pm0.2 °F/\pm0.1 °C$ |
| Over measurement range | Temp. $ $109.9 °F (42.9°C)$ display for high (too high) | ||
| Response time | Approx. 1 min (oral) | ||
| Approx. 3 to 5 min (underarm) | |||
| Approx. 1 min (rectal) | Approx. 1 min. (oral) | ||
| Approx. 100 sec. (underarm) | |||
| Approx. 1 min (rectal) | Approx. 80 sec (oral) | ||
| Approx. 2 min (underarm) | |||
| Approx. 1 min (rectal) |
The SE comparison of the ECT digital thermometer. DT-02 (K041694) and MC-245 (K021676)
.
.
.
.
3
| (Continuous) | The SE comparison of the ECT digital thermometer, DT-02 (K041694) and MC-245 (K091676) | ||
|---|---|---|---|
| ECT digital thermometer | DT-02(K041694) | MC-245(K091676) | |
| Display | Reading value is displayed on LCD | ||
| with 3 1/2 digits (0.1 increments) | Reading value is displayed on | ||
| LCD with 4 digits (0.01 | |||
| increments) | Reading value is displayed on LCD | ||
| with 4 digits (0.1 increments) | |||
| LCD Dimension | 33 x 23 mm | 15.5 x 6.5 mm | |
| Beep | When thermometer turn on and | ||
| after completion of measurement | Beeper sound at peak temperature | I beep when power on | |
| 3 beeps after measurement | |||
| completed | |||
| Power source | Alkaline-Magnesium button battery, DC 1.5V/1.55V(LR41) | ||
| Power consumption | 0.15 mW | 0.1 mW | |
| Battery life | Approx. 1 year( using time: 10 | ||
| min/day | Approx. 200 h for continuous | ||
| operation | Approx. 5,000 readings (if used | ||
| minutes per day) | |||
| Weight (with battery) | Approx 1/3 oz(10.5g) | Approx 1/3 oz(10.5g) | Approx 1/3 oz(11g) |
| Dimension | 10(H) x 13(W) x 128 (L) mm | 10(H) x 18(W) x 127(L) mm | 19.4(W) x 132.5 (L) x 10.0 (D) mm |
| Operating environment | |||
| Temperature | 41~104 °F (5 ~ 40 °C) | 41 ~ 113 °F (5 ~ 45 °C) | 50 |
| Relative humidity | 15 ~ 95% |