(29 days)
QT1JA1
Not Found
No
The description mentions "predictive technology" and a "well established physical model" to predict temperature based on early readings, but it does not mention AI, ML, or any related terms. The mechanism described appears to be based on a traditional physical model rather than a learned algorithm.
No
The device is a thermometer used for measuring and monitoring body temperature, which is a diagnostic tool rather than a therapeutic one. It does not actively treat or alleviate a medical condition.
No
Explanation: The device measures body temperature, which is a symptom, but it does not diagnose a disease or condition based on that measurement.
No
The device description explicitly states it is a "digital electronic thermometer" and mentions a "fast probe," indicating it is a physical hardware device with embedded software, not a standalone software application.
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 MT 1811 Instant Digital Thermometer measures human body temperature directly from the body (orally, rectally, under the arm). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "intermittent measurement and monitoring of human body temperature," which is a direct physiological measurement, not an in vitro test.
Therefore, this device falls under the category of a general medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Microlife MT18I1 Instant Digital Electronic Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.
Product codes
FLL
Device Description
This predictive (instant) digital electronic thermometer enables very fast and reliable measurements. With its predictive technology, this thermometer offers very high clinical accuracy and, has been designed to provide maximum userfriendliness.
With Microlife patented fast probe, others being equal, temperature curve of sensor varies with sites ( oral, underarm, rectal ) , this thermometer can use of temperature detected in the first few seconds to predict body temp using a well established physical model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally and under the arm.
Indicated Patient Age Range
adult and pediatric population
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
Controlled human clinical studies were conducted using the Microlife Instant Digital Electronic Thermometer, Model MT1811. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Controlled human clinical studies were conducted using the Microlife Instant Digital Electronic Thermometer, Model MT1811. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958,
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
DEC - 9 2004
Exhibit #1
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: Kot 3 // O
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: November 5th, 2004
2. Name of the Device:
Microlife Instant Digital Electronic Thermometer, Model MT1811
3. Predicate Device Information:
Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958,
4. Device Description:
This predictive (instant) digital electronic thermometer enables very fast and reliable measurements. With its predictive technology, this thermometer offers very high clinical accuracy and, has been designed to provide maximum userfriendliness.
With Microlife patented fast probe, others being equal, temperature curve of sensor varies with sites ( oral, underarm, rectal ) , this thermometer can use of temperature detected in the first few seconds to predict body temp using a well established physical model.
5. Intended Use:
Microlife MT18I1 Instant Digital Electronic Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.
1
6. Comparison to Predicate Devices:
The Microlife Instant Digital Electronic Thermometer, Model MT1811 is similar in design to the Microlife Instant Thermometer, Model QT1JA1, K#031958, differing mostly in response time, physical dimensions, power requirements, memory, waterproof, PCB layout, case material.
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.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers.
Discussion of Clinical Tests Performed: 8.
Controlled human clinical studies were conducted using the Microlife Instant Digital Electronic Thermometer, Model MT1811. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.
9. Conclusions:
The Microlife Instant Digital Electronic Thermometer, Model MT1811 has the same intended use and similar technological characteristics as the Microlife Instant Thermometer, Model QT1JA1. Moreover, bench testing contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Instant Digital Electronic Thermometer, Model MT1811 is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K043110
Trade/Device Name: Microlife MT1811 Instant Digital Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 5, 2004 Received: November 10, 2004
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 vour 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.
DEC - 9 2004
3
Page 2 - Ms. Goldstein-Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease of act result a made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the riot of arry I outs 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 and fibing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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), 11 you acontact 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/dsma/dsmamain.html
Sincerely yours,
Shao-Rune
fo 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
4
Exhibit B
Page _ 1
510(k) Number (if known): KO 273 11 (
Microlife MT18I1 Instant Digital Thermometer Device Name:
Indications For Use:
The Microlife MT 1811 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use _ X (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tim Vints
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: k(a 43)/10