(29 days)
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.
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.
The Microlife Instant Digital Electronic Thermometer, Model MT1811, was studied to demonstrate its substantial equivalence to a predicate device (Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958). The study focused on clinical accuracy, repeatability, and bias.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states compliance with standards and outlines clinical evaluations but does not explicitly list quantitative acceptance criteria tables or specific numerical performance metrics for clinical bias, uncertainty, or repeatability from the clinical study itself. It only states that these were "evaluated per the Microlife Clinical Test Protocol outline."
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Bias | Not explicitly stated in the provided document. Typically, this would involve a defined maximum allowable difference between the device's reading and a reference standard (e.g., central body temperature). Compliance with "ASTM E1112" likely implies certain accuracy requirements. | Reported as "evaluated," but specific numerical results for clinical bias are not provided in this summary. |
| Clinical Uncertainty | Not explicitly stated in the provided document. This would typically be a statistical measure of the variability of the device's readings. Compliance with "ASTM E1112" likely implies certain precision requirements. | Reported as "evaluated," but specific numerical results for clinical uncertainty are not provided in this summary. |
| Clinical Repeatability | Not explicitly stated in the provided document. This would typically be a statistical measure of the consistency of measurements when taken multiple times under the same conditions. | Reported as "evaluated," but specific numerical results for clinical repeatability are not provided in this summary. |
| Compliance to Standards | ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | The device "complian[ed] to applicable voluntary standards includes ASTM E1112." |
| IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | The device "complian[ed] to applicable voluntary standards includes...IEC60601-1." | |
| IEC 60601-1-2 (Medical electrical equipment: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The device "complian[ed] to applicable voluntary standards includes...IEC60601-1-2." |
Note: The document references compliance with ASTM E1112, which specifies performance requirements for clinical electronic thermometers, including accuracy and precision. The detailed acceptance criteria would be defined within that standard and the "Microlife Clinical Test Protocol outline" which is not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Controlled human clinical studies were conducted," but does not specify the sample size (number of subjects) used for these studies.
- Data Provenance: Not explicitly stated. The submission is from Microlife Intellectual Property GmbH, Switzerland, but the location of the clinical studies (e.g., country of origin for the data) is not mentioned. The studies were "clinical" and "human," indicating prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts or their qualifications used to establish ground truth. For thermometer validation, ground truth is typically established by highly accurate reference thermometers or invasive temperature monitoring (e.g., pulmonary artery catheter for core temperature).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given the nature of a thermometer study, "adjudication" in the traditional sense (e.g., for subjective image interpretation) is generally not applicable. Instead, the comparison is typically made against a physical reference standard measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically relevant for diagnostic imaging interpretation where multiple human readers assess cases. This submission is for a digital electronic thermometer, which is a direct measurement device rather than an interpretive one.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study was implicitly done. The device itself is an algorithm-driven electronic thermometer designed to provide a direct temperature reading. The clinical studies evaluated the performance of this device in "intermittent measurement and monitoring of human body temperature," which is its standalone function. There is no "human-in-the-loop" component for its primary function of temperature measurement.
7. The Type of Ground Truth Used
The document indicates that clinical bias, uncertainty, and repeatability were evaluated. For electronic thermometers, the ground truth is typically established using:
- Reference standard thermometers: Highly accurate and calibrated thermometers (e.g., mercury-in-glass or electronic readouts traceable to national standards).
- Invasive temperature measurements: For core body temperature, this might involve measurements from pulmonary artery catheters or esophageal probes, especially in hospital settings to validate different body sites (oral, rectal, axillary).
The specific nature of the reference standard used for ground truth is not explicitly detailed in the provided summary.
8. The Sample Size for the Training Set
The document does not specify a separate training set sample size. The "well established physical model" mentioned for predictive temperature calculation suggests that a model was developed, likely using clinical data, but the details of this development/training set are not provided in this 510(k) summary. For predictive algorithms, a training set is used to "learn" the relationship, and a separate test set (the "controlled human clinical studies") is used for validation.
9. How the Ground Truth for the Training Set Was Established
The document states that the device uses "temperature detected in the first few seconds to predict body temp using a well established physical model." It does not explicitly describe how the ground truth for the training set (or the development of this physical model) was established. It can be inferred that earlier clinical data or physiological models would have been used to establish the "well-established physical model" and its ground truth, but the details are absent from this summary.
{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
§ 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.