(110 days)
Microlife Digital Underarm Thermometer MT18E1-2 is designed specifically for measuring underarm (axillary) temperatures in children ages infant to 6 years old.
Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the "hotspot" easily and comfortably every time. With its predictive technology, it would be able to speed up the measurement time. With these characteristics, this thermometer can provide both a very high clinical accuracy and quick measurement time.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.
The thermometer adds a fixed offset to match the actual underarm temperature.
Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Underarm Thermometer, Model MT18E1-2, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states compliance with ASTM E1112 and ASTM E1965. For electronic thermometers, these standards typically define accuracy requirements. Although specific numerical acceptance criteria (e.g., ± 0.1°C) and the exact reported device performance (e.g., mean bias, standard deviation of differences) are not detailed in this 510(k) summary, the summary states: "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline." The FDA's issuance of the 510(k) indicates that these criteria were met.
| Acceptance Criteria (Based on ASTM E1112 / E1965) | Reported Device Performance |
|---|---|
| Accuracy (e.g., Clinical Bias) | Evaluated and presented as per Microlife Clinical Test Protocol outline. (Specific numerical data not provided in summary, but implicitly met for 510(k) clearance.) |
| Clinical Uncertainty | Evaluated and presented as per Microlife Clinical Test Protocol outline. (Specific numerical data not provided in summary, but implicitly met for 510(k) clearance.) |
| Clinical Repeatability | Evaluated and presented as per Microlife Clinical Test Protocol outline. (Specific numerical data not provided in summary, but implicitly met for 510(k) clearance.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for the clinical tests. It only mentions "Controlled human clinical studies were conducted."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "Controlled human clinical studies." Given it's a 510(k) submission to the FDA, it's presumed to be a prospective clinical study, as typical for such submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. For thermometer studies, ground truth is typically established by highly accurate reference thermometers and not necessarily "experts" in the same way a diagnostic imaging study would use radiologists.
4. Adjudication Method for the Test Set:
Not applicable or not described in this context. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by multiple human readers, not for objective measurements by a thermometer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device for measuring temperature, not a diagnostic imaging AI algorithm that would typically involve human-in-the-loop performance measurement or MRMC studies. The device is standalone.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed. The device is a digital thermometer, which inherently functions as a standalone algorithm/device without human input on the measurement itself (beyond correct placement). The clinical studies evaluated the device's direct performance against a reference standard.
7. Type of Ground Truth Used:
The ground truth for thermometer studies is typically highly accurate reference temperature measurements (e.g., using a high-precision clinical reference thermometer or a standardized temperature bath) as defined by standards like ASTM E1112 and E1965. The document states studies were conducted "in accordance with ASTM E1965," which dictates methods for establishing reference temperatures.
8. Sample Size for the Training Set:
Not applicable. This device is a digital thermometer with a fixed algorithm for temperature conversion; it does not involve machine learning with a "training set" in the conventional sense. The "algorithm" refers to the conversion of thermistor resistance to temperature, which is a deterministic process.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this deterministic device. The algorithm's accuracy is ensured through calibration and design validation to meet the specified standards.
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103680
EXHIBIT #1a
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 5807.92.
The assigned 510(k) number is:_
- Submitter's Identification: 1.
Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: Sep 28, 2010
Vice President of Technical and Service Contact: Mr. Gerhard Frick e-mail: gerhard.frick@microlife.ch Tel: +41 79 216 0070
2. Name of the Device:
Microlife Digital Underarm Thermometer, Model MT18E1-2
3. Predicate Device Information:
Microlife Digital Underarm Thermometer, Model MT18E1, K#032364.
Device Description: র্ব
Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the "hotspot" easily and comfortably every time. With its predictive technology, it would be able to speed up the measurement time. With these characteristics, this thermometer can provide both a very high clinical accuracy and quick measurement time.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.
EXHIBIT #1a-1
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The thermometer adds a fixed offset to match the actual underarm temperature.
പ്പ് Intended Use:
Microlife Digital Underarm Thermometer MT18E1-2 is designed specifically for measuring underarm (axillary) temperatures in children ages infant to 6 years old.
Comparison to Predicate Devices: છે.
The Microlife Digital Underarm Thermometer, Model MT18E1-2 is substantially equivalent to Microlife Digital Underarm Thermometer, Model MT18E1, K#032364, which has the same intended use for human body temperature measurement but focus especially on underarm temperature and uses unique elbow sensor design.
The Microlife Digital Underarm Thermometer MT18E1-2 and the predicate device are identical in the temperature measurements algorithm and fundamental scientific technology, differing mostly by IC Model and measurement time.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers".
8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were conducted in accordance with ASTM . E1965 using the Microlife Digital Underarm Thermometer, Model MT18E1-2. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.
9. Software information:
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
10. Conclusions:
·
The Microlife Digital Underarm Thermometer, Model MT18E1-2 has the same intended use and technological characteristics as the Microlife Digital Underarm
EXHIBIT #1a-2
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Thermometer, Model MT18E1. Moreover, bench testing contained in this submission demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Underarm Thermometer, Model MT18E1-2 is substantially equivalent to the predicate device.
EXHIBIT #1a-3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Microlife Intellectual Property GmbH C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 10021
APR - 6 201
Re: K103680
Trade/Device Name: Microlife Digital Underarm Thermometer, Model MT18E1-2 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 15, 2011 Received: March 16, 2011
Dear Ms. Goldstein-Falk:
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. 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.
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Page 2 - Ms. Goldstein-Falk
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 on works mor of the Act or any Federal statutes and regulations administered by other Federal eqeincies. You must comply with all the Act's requirements, including, but not limited to: registeres: 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 potification" (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 from the 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,
Anthony 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
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Indications for Use
510(k) Number (if known): K しろしょ
Device Name: Microlife Digital Underarm Thermometer, Model MT18E1-2
Indications For Use:
Microlife Digital Underarm Thermometer MT18E1-2 is designed specifically for measuring underarm (axillary) temperatures in children ages infant to 6 years old.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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R.C. Chapa 4/6/11
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K103680
§ 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.