(54 days)
Microlife Digital Underarm Thermometer MT18E1 V932 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. In addition, to speed up the measurement time, we have added the fixed offset into this thermometer which is fulfilled by the hardware. 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 uses a clinical offset of 1.5°F to match the actual underarm temperature.
The provided text describes the 510(k) summary for the Microlife Digital Underarm Electronic Thermometer, Model MT18E1 (V932). However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Here's an breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions compliance with ASTM E1112 as an applicable voluntary standard. This standard would contain the acceptance criteria for electronic thermometers. However, the specific criteria (e.g., accuracy range, measurement time) and the device's reported performance against those specific criteria are not explicitly stated in the provided text. It only generally states that clinical data was presented evaluating "clinical bias, clinical uncertainty, clinical repeatability and clinical offset."
| Acceptance Criteria (from ASTM E1112 - not explicitly stated in document, inferred) | Reported Device Performance (as stated or inferred) |
|---|---|
| (Specific accuracy limits, e.g., ±X°F for Y temperature range) | "very high clinical accuracy" (general statement) |
| (Specific measurement time limits) | "quick measurement time" (general statement) |
| (Clinical bias, uncertainty, repeatability limits) | Clinical data presented evaluating clinical bias, clinical uncertainty, clinical repeatability, and clinical offset. (Specific values not provided) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Controlled human clinical studies were conducted," but the number of subjects or measurements is not provided.
- Data Provenance: The studies were "Controlled human clinical studies" but the geographic location (e.g., country of origin) and whether they were retrospective or prospective are not specified. Given the nature of clinical trials for device approval, they are typically prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not specified. The document mentions "Controlled human clinical studies" and that clinical data was presented, but it does not detail how ground truth temperatures were established, nor the involvement or qualifications of experts.
4. Adjudication Method for the Test Set:
Not specified. The document does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable/Not done. This type of study (MRMC) is typically used for imaging modalities or diagnostics where multiple human readers interpret cases. A digital thermometer measures a physiological parameter directly, so an MRMC study comparing human "reading" of the thermometer with and without AI assistance is not relevant to this device. The device itself is the "reader."
6. Standalone Performance Study (Algorithm only without human-in-the-loop):
Yes, implicitly. The clinical studies conducted evaluate the performance of the "Microlife Digital Underarm thermometer MT18E1 V932" as a standalone device. Its output (temperature reading) is the direct result of the device's algorithm and hardware, without requiring human interpretation or intervention in the measurement process itself. The "clinical bias, clinical uncertainty, clinical repeatability and clinical offset" are all measures of standalone performance.
7. Type of Ground Truth Used:
Inferred to be reference temperature measurement. For a thermometer, the "ground truth" would typically be established by a highly accurate reference thermometer or method (e.g., rectal temperature using a laboratory-grade precision thermometer, or core body temperature measured invasively if ethical and feasible). The document does not explicitly state the method, but for evaluating "clinical bias, clinical uncertainty, clinical repeatability and clinical offset," a reference standard is used for comparison.
8. Sample Size for the Training Set:
Not applicable/Not specified. This device is a digital thermometer, not an AI/ML model that requires a "training set" in the conventional sense of machine learning for image classification or prediction tasks. While the device's offset of 1.5°F is "fixed" and integrated into the hardware, this would have been determined through empirical testing and calibration, not through a "training set" like an AI algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable/Not specified. As noted above, there's no "training set" in the AI/ML sense. The "fixed offset into this thermometer which is fulfilled by the hardware" implies that the 1.5°F offset was determined through prior empirical testing and comparison to reference temperatures to align underarm readings with actual core or reference body temperatures. The document does not detail how that 1.5°F offset was established or the ground truth used for that determination.
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SEP 2 3 2003
Exhibit #1
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 §807.92.
The assigned 510(k) number is: 19032364 ,
1. Submitter's Identification:
Microlife Intellectual Property Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Prepared: July 30, 2003
2. Name of the Device:
Microlife Digital Underarm Electronic Thermometer, Model MT18E1 (V932)
3. Predicate Device Information:
Micro Idea Instrument Digital Thermometer, Model MT 3001/5001, K#851146, Microlife Corporation
4. Device Description:
Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the " hotspot" easily and comfortably every time. In addition, to speed up the measurement time, we have added the fixed offset into this thermometer which is fulfilled by the hardware. 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 uses a clinical offset of 1.5°F to match the actual underarm temperature.
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5. Intended Use:
Microlife Digital Underarm Thermometer MT18E1 V932 is designed specifically for measuring underarm (axillary) temperatures in children ages infant to 6 years old.
6. Comparison to Predicate Devices:
The Microlife Intellectual Property' s digital underarm thermometer, Model MT18E1DV932 is substantially equivalent to the Micro Idea Instrument Digital Thermometer, Model MT3001/5001 K#851146.
The new model MT18E1 V932 has the same intended use for human body temperature measurement but focuses especially on underarm temperature and is similar in design to the 510(k) cleared device except for the unique elbow sensor design.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements and well as ISO 10993 biocompatibility testing.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification
8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were conducted using the Microlife Digital Underarm thermometer MT18E1 V932 . Clinical data was presented evaluating clinical bias, clinical uncertainty, clinical repeatability and clinical offset per Microlife clinical test protocol for Digital Underarm thermometer
9. Conclusions:
The Microlife Digital Underarm Thermometer has the same intended use and similar technological characteristics as the Micro Idea Instrument Digital Thermometer. DModel MT3001/5001). Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Underarm Thermometer is substantially equivalent to the predicate device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2003
Microlife Intellectual Property Gmbh C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K032364
Trade/Device Name: Microlife Digital Electronic Thermometer, Model MT18E1 (V932) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 30, 2003 Received: August 7, 2003
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.
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 - 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 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 Office of 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 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/dsma/dsmamain.html
Sincerely yours,
Susan Russoor
Susan Runner, DDS, MA Interim 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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Exhibit B
Page __ 1 of of the 1
510(k) Number (if known): K032664
Device Name
Indications For Use:
Microlife Digital Underarm Thermometer MT18E1 (V932) is designed specifically for measuring underarm (axillary) temperatures in children ages infant to 6 years old.
Patricio Lucenite
ivision Sion-Off) ivision of Anesthesiology. General Hospital. Infection Control, Dental Devices
510(k) Number: K032364
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.