(98 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the ECT digital thermometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ECT digital thermometer are based on compliance with the ASTM E1112-00 (2006) standard specifications and other relevant IEC and ISO standards. The reported device performance is presented in comparison to predicate devices, demonstrating its substantial equivalence.
| Feature / Criterion | Acceptance Criteria (Implied by standard compliance and predicate comparison) | Reported Device Performance (ECT Digital Thermometer) |
|---|---|---|
| Accuracy | Should be within acceptable limits as per ASTM E1112-00 (e.g., ±0.1°C or ±0.2°F). | ±0.2 °F / ±0.1 °C |
| Measurement Range | Consistent with typical clinical thermometers. | 90.0 ~ 109.9 °F (32.0 ~ 42.9 °C) |
| Display Resolution | Clear and precise display for clinical use. | 0.1 °F/°C (3 1/2 digits, 0.1 increments) |
| Response Time | Timely temperature measurement for different sites. | Approx. 1 min (oral)Approx. 3 to 5 min (underarm)Approx. 1 min (rectal) |
| Operating Environment (Temperature) | Functional within typical clinical and home environments. | 41 ~ 104 °F (5 ~ 40 °C) |
| Operating Environment (Relative Humidity) | Functional within typical clinical and home environments. | 15 ~ 95% |
| Storage Environment (Temperature) | Withstand typical storage conditions. | -14 ~ 128 °F (-10 ~ 60 °C) |
| Storage Environment (Relative Humidity) | Withstand typical storage conditions. | ≤ 85 % |
| Automatic Shut-off | Energy saving feature. | YES / after about 10 min |
| Memory | Recall last temperature reading. | Recalls last temperature |
| Waterproof | For hygiene and durability. | YES |
| Materials | Biocompatible and durable. | Probe: 316 S.S., Case: ABS |
| Cleanability | Easily cleaned for reuse. | By 70% isopropyl alcohol or soap and water |
| Compliance | Adherence to relevant safety and performance standards. | ASTM E1112, IEC 60601-1, ISO 10993-5, ISO 10993-10 |
2. Sample Size for the Test Set and Data Provenance
The document states "Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability." However, it does not specify the sample size used for this bench testing.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned. Given it's basic bench testing for a physical device, it's highly likely to be prospective data generated in a lab setting, presumably by the manufacturer in China (Changshan Estar Electronics Co., LTD is located in China).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For a digital thermometer, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer in a controlled environment, not via expert consensus.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as experts were not used. The testing described is objective, comparing measurements against established, calibrated standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric. For a digital thermometer, the measurement output is objective.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done. The "Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability" directly pertains to the standalone performance of the device itself (its hardware and embedded software/ASIC for calculation). There is no "human-in-the-loop" aspect to the fundamental temperature measurement process of a digital thermometer that would require such a study distinction.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for testing an electronic thermometer is established by calibrated reference standards. This involves comparing the device's temperature readings to those of a highly accurate and traceable thermometer in controlled temperature environments.
8. The Sample Size for the Training Set
The document does not refer to a "training set" as this device does not use machine learning or AI algorithms that require training data in the conventional sense. Its functionality is based on direct physical measurement and pre-programmed algorithms.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of a digital thermometer, this question is not applicable. The device's internal algorithms for converting thermistor readings to temperature values are based on established thermodynamic principles and calibration, not machine learning model training.
{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. $< 90 °F (32°C)$ display for low (too low)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 LCDwith 3 1/2 digits (0.1 increments) | Reading value is displayed onLCD with 4 digits (0.01increments) | Reading value is displayed on LCDwith 4 digits (0.1 increments) |
| LCD Dimension | 33 x 23 mm | 15.5 x 6.5 mm | |
| Beep | When thermometer turn on andafter completion of measurement | Beeper sound at peak temperature | I beep when power on3 beeps after measurementcompleted |
| 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: 10min/day | Approx. 200 h for continuousoperation | Approx. 5,000 readings (if usedminutes 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% | < 80 % | 35 ~ 85% |
| Storage environment | |||
| Temperature | - 14 ~ 128 °F (- 10 ~ 60 °C) | 77 | 4 |
| Relative humidity | ≤ 85 % | < 80 % | 10 ~ 95% |
and the contraction of the comments of the comments of
:
၊
{4}------------------------------------------------
| (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) | |
| Automatic shut-off | YES/ After about 10 min | Approx. 30 minutes after use or 3minutes when not been used | |
| Memory | Recalls last temperature | ||
| Waterproof | YES | ||
| Materials | Probe: 316 S.S., Case: ABS | ||
| Clean | By 70% isopropyl alcohol or soapand water | ||
| Performance tested | ASTM E1112IEC 60601-1ISO 10993-5 /ISO 10993-10 |
·
·
.
.
.
End of summary
. . . . .
. .
.. . . . . . . .
:
{5}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jacob Chang Changshan Estar Electronics Company, Limited #462, Sec 2, Chongde Road, Beitun District Taichung China (Taiwan) 406
JUL 21 2010
Re: K101043
Trade/Device Name: ECT Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 23, 2010 Received: June 23, 2010
Dear Mr. Chang:
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 ffor 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. Chang
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.
Nh 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}------------------------------------------------
Indications for Use
510(k) Number (if known): K101043
Device Name: ECT digital thermometer
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.
Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (Part 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)
vi
p
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 1( 1(
Page 1 of 1
§ 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.