(54 days)
K#851146
Not Found
No
The device description and performance studies focus on hardware-based temperature measurement and a fixed clinical offset, with no mention of AI or ML algorithms.
No
The device is a thermometer used for measuring temperature, not for treating or diagnosing a disease or condition.
No.
The device is a thermometer used to measure body temperature, which is a vital sign, but it does not diagnose a medical condition.
No
The device description explicitly mentions hardware components like a thermistor, R-C oscillator circuit, and a fixed offset implemented in hardware. It is a physical thermometer, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Microlife Digital Underarm Thermometer MT18E1 V932 measures temperature directly from the body surface (underarm). It does not analyze samples taken from the body.
Therefore, it falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarm (axillary)
Indicated Patient Age Range
infant to 6 years old
Intended User / Care Setting
Not Found
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
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
Key Metrics
Not Found
Predicate Device(s)
K#851146
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
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.
1
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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
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.
3
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
4
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)