(137 days)
The wireless temperature monitor, model ST323C, ST323F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement of the person of all age.
The ST323C and ST323F are the wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously. ST323C and ST323F is composed of two operational parts, the receiver and transmitter. The receiver is the main operation unit on which, the LCD display control circuit and the main operation keys are included. And the transmitter was constructed with the thermo sensor, measuring circuit, and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor. For the monitoring operation, both receiver and transmitter shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and transmitter. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 15 sec. 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. Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00.
The provided 510(k) summary describes a wireless temperature monitor (ST323C and ST323F). This device is a thermometer, not an AI/ML device, and therefore the majority of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, etc.) is not applicable.
However, I can extract and present the information that is relevant to the device's accuracy and the study conducted.
Here's the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to compliance with ASTM E1112: 2000 for performance verification. This standard is for electronic thermometers for intermittent determination of patient temperature. Specific acceptance criteria in terms of accuracy (e.g., ±0.1°C) and the device's reported performance against these numerical criteria are not explicitly stated in this 510(k) summary. However, the summary states: "Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00."
2. Sample Size Used for the Test Set and Data Provenance
A clinical report for measurement accuracy was conducted.
- Sample Size: Not explicitly stated in the document.
- Data Provenance: The measurement was taken from "children less than eight years old." The location of the study (country) is not specified, but the applicant company is based in Taiwan. The study appears to be prospective as it involves taking new measurements for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device measures a physical parameter (temperature). The "ground truth" is established by a reference thermometer, not by human expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" for temperature measurement is established by a reference thermometer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical measurement device, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The device's performance is inherently "standalone" in that it directly measures and displays temperature.
7. The Type of Ground Truth Used
The "ground truth" for the accuracy study was established by comparison with a "Mesure digital thermometer ST8A3C" which served as a reference. The method followed ASTM-E1965, which specifies standards for clinical thermometers.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a non-AI device.
Summary of Relevant Information from the provided text:
| Criteria/Study Aspect | Details from 510(k) Summary |
|---|---|
| Acceptance Criteria | Compliance with ASTM E1112: 2000 for performance. (Specific numerical accuracy criteria from the standard are not detailed in the summary). |
| Reported Device Performance | The clinical report indicates that "ST323C is suitable for the indication of intended use" based on comparison with a predicate digital thermometer. Specific numerical performance data (e.g., mean difference, standard deviation, or percentage within a certain error margin) are not provided in this summary. |
| Test Set Sample Size | Not explicitly stated. |
| Test Set Data Provenance | Measurements taken from "children less than eight years old." Prospective study. Country of origin not specified for the clinical study itself, though the manufacturer is Taiwanese. |
| Number of Experts for Ground Truth | Not applicable (physical measurement). |
| Qualifications of Experts | Not applicable (physical measurement). |
| Adjudication Method | Not applicable (physical measurement). |
| MRMC Comparative Effectiveness Study | Not applicable (non-AI device). |
| Standalone Performance Study | The device's direct measurement is its standalone performance. The clinical study evaluated its accuracy against a predicate. |
| Type of Ground Truth Used | Comparison with a "Mesure digital thermometer ST8A3C" which served as a reference, following the method recommended in ASTM-E1965. |
| Training Set Sample Size | Not applicable (non-AI device). |
| How Training Set Ground Truth Established | Not applicable (non-AI 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.
APR 1 0 2007
The assigned 510(k) number is:
Submitter's Identifications:
Mesure Technology Co., Ltd.
7F, No. 86, Sec. 1, Kwang Fu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C.
Contact: Ph. D. John, Chen / General Manager Date of Summary Preparation: October 20, 2006
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- Name of the Device:
Wireless temperature monitor, model ST323C and ST323F.
- Name of the Device:
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- Information of the 510(k) Cleared Device (Predicate Device):
Wireless thermometer monitor; model ST313C and ST313F (K023956).
- Information of the 510(k) Cleared Device (Predicate Device):
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- Device Description:
The ST323C and ST323F are the wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously.
- Device Description:
ST323C and ST323F is composed of two operational parts, the receiver and transmitter. The receiver is the main operation unit on which, the LCD display control circuit and the main operation keys are included. And the transmitter was constructed with the thermo sensor, measuring circuit, and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor.
For the monitoring operation, both receiver and transmitter shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and transmitter. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 15 sec.
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. Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00.
4. Intended Use:
The Wireless thermometer, model ST323C and ST323F is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement for the person of all age.
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- Comparison to the 510(k) Cleared Device (Predicate Device):
The Wireless thermometer, model ST323C and ST323F is substantially equivalent to the Mesure model ST313C and ST313F (K023956).
- Comparison to the 510(k) Cleared Device (Predicate Device):
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- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 2000, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
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- Discussion of clinical report for measurement accuracy:
Clinical test for the comparison of measurement accuracy between ST323C and Mesure digital thermometer ST8A3C are included. The measurement was taken by both ST323C and ST8A3C at armpit location for the children less than eight years old according to the method recommended in ASTM-E1965.
The result of clinical report indicates that ST323C is suitable for the indication of intended use.
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- Conclusions
The Mesure / Wireless thermometer, model ST323C and ST323F, has the same intended use and technological characteristics as the cleared device of Mesure model ST313F. 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 engineering 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Chen General Manager Mesure Technology Company Limited 7F, 86, Sec. 1, KwangFu Road Sanchung City, Taipei Hsien TAIWAN, R.O.C.
APR 1 0 2007
Re: K063542
Trade/Device Name: Wireless Temperature Monitor/Model: ST323C and ST323F Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 6, 2006 Received: March 19, 2007
Dear Mr. 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 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.
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Page 2 - Mr. 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 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 vour 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 Office of Compliance at (240) 276-0115. 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 Division of 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/industry/support/index.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):
Device Name: Wireless temperature monitor / Model: ST323C and ST323F.
Indications For Use:
The wireless temperature monitor, model ST323C, ST323F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement of the person of all age.
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)
for APW
on of Anesthesiology, General Hospital, on Control. Dental De
510(k) Number: K063542
Page 1 of
§ 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.