(568 days)
The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.
The Wireless temperature monitor, model ST-314C/F, are the electronic thermometers by using a thermistor 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, 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. This system uses a 3.0V DC 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. Reqarding the performance of ST-314C/F, it was designed and verified according to the US standard ASTM E1112-98.
The provided text describes the 510(k) summary for a Wireless temperature monitor, models ST-313C/F and ST-314C/F. The information related to acceptance criteria and the study proving device performance is extracted below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ASTM E1112:1998 for electronic thermometers. | Device was designed and verified according to ASTM E1112-98. "The result of clinical report indicates that ST313C is suitable for the indication of intended use." |
| Compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements (Electrical safety and EMC standards). | Device met these standards. |
| Measurement accuracy (relative to a predicate device, Funai RT-9101, for wrist and abdomen temperature measurements in children less than eight years old). | "The result of clinical report indicates that ST313C is suitable for the indication of intended use." (Specific numerical accuracy metrics are not provided in this summary, but a clinical test was performed to compare accuracy with the predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of subjects. The text mentions "clinical report for measurement accuracy" and "The measurement was taken by both ST313C and RT-9101 at wrist and abdomen location for the children less than eight years old."
- Data Provenance: The study was a "clinical report," suggesting prospective data collection. The location is not specified, but the submitter is based in Taiwan, R.O.C.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For a temperature monitor, the "ground truth" would likely be established by a reference thermometer or highly accurate direct measurement, rather than human experts.
4. Adjudication Method for the Test Set
This information is not provided in the given text. It is unlikely to be relevant for a device measuring a physical parameter directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
- MRMC Study: No, this was not an MRMC study. It was a comparison of device performance against a predicate device and standards, not a study evaluating human readers' effectiveness with or without AI assistance.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary evaluation appears to be a standalone performance assessment of the device. The "clinical report for measurement accuracy" compared the new device (ST313C) directly against a predicate device (Funai RT-9101). The device itself is an electronic thermometer, and its accuracy is assessed independently of human interpretation.
7. The Type of Ground Truth Used
The ground truth for accuracy was established by:
- Compliance with ASTM E1112:1998 standard for electronic thermometers.
- Comparison of measurements against a predicate device (Funai model RT-9101). The predicate device's measurements would serve as the "ground truth" for comparative accuracy.
8. The Sample Size for the Training Set
The provided text does not mention a training set as this device is a hardware electronic thermometer and not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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: (023956.
Submitter's Identifications: Mesure Technology Co., Ltd. 7F, No. 88, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C.
Contact: Ph. D. John, Chen / General Manager Date of Summary Preparation: June 6, 2003
- Name of the Device: Wireless temperature monitor, model ST-314C/F, ST313C/F.
-
- Information of the 510(k) Cleared Device (Predicate Device): Wireless thermometer monitor; model RT-9101 (K003326).
3. Device Description:
The Wireless temperature monitor, model ST-314C/F, are the electronic thermometers by using a thermistor 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, 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.
This system uses a 3.0V DC 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. Reqarding the performance of ST-314C/F, it was designed and verified according to the US standard ASTM E1112-98.
4. Intended Use:
The Wireless thermometer, model ST-314C/F, ST313C/F is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdomen and wrist/arm temperature measurement of a body less then eight ages old.
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Mesure Technology Co., Ltd.
5. Comparison to the 510(k) Cleared Device (Predicate Device):
The Wireless thermometer, model ST-314C/F, ST313C/F is substantially equivalent to the Funai model RT-9101 (K003326).
-
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
7. Discussion of clinical report for measurement accuracy:
Clinical test for the comparison of measurement accuracy between ST313C and Funai model RT-9101 are included. The measurement was taken by both ST313C and RT-9101 at wrist and abdomen location for the children less than eight years old according to the method recommended in ASTM-E1965.
The result of clinical report indicates that ST313C is suitable for the indication of intended use.
-
- Conclusions
The Mesure / Wireless thermometer, model ST-314C/F, ST313C/F, has the same intended use and technological characteristics as the cleared device of Funai model RT-910I. 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.
- Conclusions
In the other words, those enqineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health & Human Services, which is an eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Dr. John Chen General Manager Mesure Technology Company Limited 7F, 86, Sec. 1, KwangFu Road Sanchung City, Taipei Hsien, TAIWAN, R.O.C.
Re: K023956
Trade/Device Name: Wireless Temperature Monitor /Model: ST313C/F, ST314C/F Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 10, 2004 Received: May 17, 2004
Dear Dr. Chen:
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 Amerate ents, 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 approvisions 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 (1 Writ), it they of bude of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Dr. Chen
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 moun mat 7 Dr mar and regulations administered by other Federal agencies. or the For ar any 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 alle listing (21 et read 807), systems (QS) regulation (21 CFR Part 820); and if requirements as bet renis 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) I ma reter notification. The FDA finding of substantial equivalence of your device to a promarter learn and a cassification for your device and the 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), 11 you desire specific at .. Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. 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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Indications For Use
510(k) Number (if known): K023956
Device Name: Wireless temperature monitor / Model: ST313C/F, ST314C/F.
Indications For Use:
The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use V (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)
June Rerecce for Adwi 6/17/04
General Hospital. Infection Control, Der
510(k) Number:
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§ 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.