(132 days)
No
The device description explicitly states that the calculation and display are handled by an ASIC-controlled circuit, which is described as "hard-wire control instead of programmable control." This indicates a fixed, non-programmable logic, not AI or ML.
No.
The device's intended use is to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device is a thermometer used to measure body temperature, which is a physiological parameter, not for diagnosing a disease or condition. Its intended use is to provide a measurement, not an assessment for diagnosis.
No
The device descriptions clearly outline physical hardware components such as sensors (thermistor, thermopile), electronic signal processors, ASICs, LCD displays, buzzers, and batteries. These are not software-only components.
Based on the provided information, neither the ZSDT-XXX digital thermometer nor the ZSET-XXX infrared thermometer are IVDs (In Vitro Diagnostics).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Intended Use: The intended use of both thermometers is to measure body temperature directly from the patient (oral, rectal, armpit, or auditory canal). This is a direct measurement from the living body, not an examination of a specimen taken from the body.
- Device Description: The device descriptions detail sensors (thermistor and thermopile) that interact directly with the patient's body to measure temperature. There is no mention of analyzing biological specimens.
Therefore, these devices fall under the category of in vivo diagnostic devices (devices that measure parameters directly within the living body), not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages.
The clinical thermometer / model ZSET-XXX infrared thermometer 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
A> ZSDT-XXX Digital thermometer.
The digital clinical thermometer, models ZSDT-XXX Series, are the electronic thermometers by using a themistor 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 digital thermometer comprises of a thermistor for measuring sensor, measuring circuit for the measurement of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
This system uses a 1.5V/DC AG3 or SG3 Alkaline battery 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 ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00.
B> ZSET-XXX Infrared thermometer.
The infrared thermometer, models ZSET-XXX, are the handheld electronic thermometers 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 comprises of a thermopile for the measuring sensor, a reference thermistor 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 3.0 V DC battery(2xAAA 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 ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, rectal, or armpit (for ZSDT-XXX digital thermometer); auditory canal (for ZSET-XXX infrared thermometer)
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)
Compliance to applicable voluntary standards includes ASTM E1112: 2000, ASTM E1965: 2002, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement. All of the required conformity reports were included on the 510(k) submission documents.
The clinical report for the measurement accuracy comparison as required by ASTM E1965: 2002 is provided for ZSET-XXX and ST613C.
Verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared 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
JUL 1 1 2007
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's Identifications: Zen Strong Medical Technology Co., Ltd. 6F No. 88, Ning Jin St., Keelung, Taiwan, R.O.C.
Contact: Cheng Roei-Shenq Date of Summary Preparation: February 15, 2007
-
- Name of the Device: Clinical thermometer / Model ZSDT-XXX Digital thermometer and ZSET-XXX Infrared thermometer; where "XXX" means the designation of different device housing.
2. Device classification:
Trade/Device Name: Clinical thermometer / Model ZSDT-XXX Digital thermometer and ZSET-XXX Infrared thermometer; where "XXX" means the designation of different device housing. Requlation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II
3. Device Description:
Product Code: FLL
A> ZSDT-XXX Digital thermometer.
The digital clinical thermometer, models ZSDT-XXX Series, are the electronic thermometers by using a themistor 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 digital thermometer comprises of a thermistor for measuring sensor, measuring circuit for the measurement of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
This system uses a 1.5V/DC AG3 or SG3 Alkaline battery 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 ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00.
B> ZSET-XXX Infrared thermometer.
The infrared thermometer, models ZSET-XXX, are the handheld electronic thermometers 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 comprises of a thermopile for the measuring sensor, a reference thermistor 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.
1
This system uses a 3.0 V DC battery(2xAAA 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 ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002.
-
- Intended Use:
...
- Intended Use:
The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages.
The clinical thermometer / model ZSET-XXX infrared thermometer 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.
-
- Comparison to the 510(k) Cleared Device (Predicate Device):
-
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 2000, ASTM E1965: 2002, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement. All of the required conformity reports were included on the 510(k) submission documents.
-
- Discussion of clinical report for measurement accuracy: The clinical report for the measurement accuracy comparison as required by ASTM E1965: 2002 is provided for ZSET-XXX and ST613C.
-
- Conclusions
The Clinical thermometer / Model ZSDT-XXX Digital thermometer and ZSET-XXX Infrared thermometer has the same intended use and technological characteristics as the cleared device of Mesure model ST8A3C digital thermometer (K0402013) and ST613C ear thermometer (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.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device. Therefore, it is reasonable to conclude that Clinical thermometer / Model ZSDT-XXX Digital thermometer and ZSET-XXX Infrared thermometer one substantially requirement to the chosen predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
JUL 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Cheng Roei-Sheng Official Correspondent and President Zen Strong Medical Technology Company, Ltd. 6F No. 88, Ning Jing Street Keelung, R.O.C. TAIWAN
Re: K070578
Trade Name: Clinical Thermometer, Models ZSDE-XXX and ZSET-XXX Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 19, 2007 Received: June 19, 2007
Dear Mr. Roei-Sheng:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Roei-Sheng
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
ﺎﻧﻪ: ﻻﺗ
510(k) Number (if known):
Device Name: Clinical thermometer / Model ZSDT-XXX Digital thermometer and ZSET-XXX Infrared thermometer; where "XXX" means the designation of different housing ..
Indications For Use:
The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages.
The clinical thermometer / model ZSET-XXX infrared thermometer 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.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| 510(k) Number: | K070578 |
|---|---|
| ---------------- | --------- |
| fa Chula PD | |
|---|---|
| 7/11/07 |
| Page 1 of | 1 |
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