(166 days)
The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the forehead. Microlife FR1MN1-1 especially enables the user to take measurements and be alerted for possible elevated temperature readings accordingly.
The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1, consists of mainly seven parts:
a) Thermopile Sensor
b) Application-Specific Intergrated Circuit
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Lens
e) LCD and Backlight
f) 2 Keys (Start key, O/I key)
g) 2 batteries AAA (LR03) 1.5V
The new Model FR1MN1-1 has the same intended use and temperature measurement fundamental algorithm as the 510(k) cleared devices.
Auto-Display memory The last reading is automatically displayed for 2 seconds when the unit is switched ON.
The provided document is a 510(k) premarket notification for a medical device, specifically the Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1. The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to detail comprehensive acceptance criteria and a deep dive into an "AI" algorithm's performance as would be expected for a novel AI/ML-based diagnostic device.
Therefore, the information available in this document is limited regarding the acceptance criteria and study details as they relate to AI/ML devices. The device described is a simple digital thermometer, not an AI-powered diagnostic tool. The "software algorithm" mentioned primarily refers to clinical offset tables for temperature conversion, not an AI model.
However, I will extract the relevant information as accurately as possible based on the provided text, interpreting "acceptance criteria" and "study" in the context of a thermometer's performance, particularly its accuracy.
Here's the breakdown:
Acceptance Criteria and Reported Device Performance
The core performance metric for a thermometer is its accuracy. The document refers to "Accuracy (Clinical Mode)" as a key characteristic.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a thermometer)
| Metric | Acceptance Criteria (from predicate) | Reported Device Performance (for FR1MN1-1) |
|---|---|---|
| Accuracy (Clinical Mode) | ±0.3 °C, 34.0 ~ 42.2 °C (±0.5 °F, 93.2 ~ 108.0 °F) (Predicate) | 0.4 °F, 96.8 ~ 102.2 °F (FR1MN1-1) |
| Clinical Bias | Not explicitly stated as a numerical criterion, but evaluated | Evaluated (details not in summary) |
| Clinical Uncertainty | Not explicitly stated as a numerical criterion, but evaluated | Evaluated (details not in summary) |
| Clinical Repeatability | Not explicitly stated as a numerical criterion, but evaluated | Evaluated (details not in summary) |
| Compliance with Standards (e.g., ASTM E 1965-98 (2009), IEC 80601-2-56) | Pass/Fail Criteria Outlined in Standard | Passed All Testing Requirements (Implicitly meets the standard's accuracy and other criteria) |
Note on Accuracy: The reported accuracy for the new device (0.4 °F) compared to the predicate (±0.5 °F) suggests an improvement or at least an equivalent level of performance within a specific range. However, the predicate's accuracy is given as a range (e.g., 34.0 ~ 42.2 °C), while the new device's accuracy is given as a single value (0.4 °F) for a specific range (96.8 ~ 102.2 °F). This difference in reporting style makes direct comparison of the exact numerical criteria challenging from this summary section alone. The "Passed All Testing Requirements" for ASTM E 1965-98 (2009) and IEC 80601-2-56 is the key here, as these standards define the specific accuracy acceptance criteria for clinical thermometers.
Study Details
2. Sample size used for the test set and the data provenance
- Sample Size: The document states that "Controlled human clinical studies were conducted," but it does NOT specify the exact sample size (number of subjects/patients) used for the clinical validation.
- Data Provenance: Not explicitly stated, but clinical studies are generally conducted in a prospective manner. The country of origin of the data is not specified. Given the submitter's identification (Microlife Intellectual Property GmbH, Switzerland), the studies could have been conducted in Europe or elsewhere. It is described as "Controlled human clinical studies," which implies prospective data collection for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of a thermometer. For a thermometer, "ground truth" for body temperature is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a calibrated rectal thermometer in a clinical setting), not by expert opinion. The "experts" would be the clinicians performing the comparative measurements, and their qualifications would be standard medical practice, not specialized expert consensus like for image interpretation.
4. Adjudication method for the test set
- This question is not applicable to a thermometer's performance evaluation. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in subjective tasks (e.g., image interpretation for AI ground truth). For a thermometer, comparative measurements against a reference standard are objective.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.
- This question is not applicable. The device is a thermometer, not an AI-assisted diagnostic tool for human readers. There is no human-in-the-loop AI assistance scenario for a digital thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was implicitly done. The "software algorithm" refers to the thermometer's internal processing of infrared data into a temperature reading. The clinical study evaluated the direct output of the device (the algorithm's output) compared to reference methods. The study presented "clinical bias, clinical uncertainty and clinical repeatability per clinical validation for Microlife FR1MN1-1," which are direct measures of the device's accuracy and precision, independent of human interpretation of its output. The "algorithm" here is simply the conversion of raw sensor data to a temperature display.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for temperature measurement would be established by comparative measurements against a gold standard or reference thermometer, typically invasive methods like rectal temperature or highly accurate oral thermometers, in a controlled clinical setting. The document explicitly references "Controlled human clinical studies were conducted in accordance with ASTM E1965-98, IEC 80601-2-56 Test Report." These standards define the methodology for establishing accurate body temperature ground truth for thermometer validation.
8. The sample size for the training set
- The document implies that the "software algorithm" (specifically, the "clinical offset tables") was "adjusted to improve accuracy." While this hints at an iterative development process that might involve data, the document does NOT specify a distinct "training set" or its sample size. For a conventional device like this, the "training" might refer to engineers calibrating the offset tables based on empirical testing during development, rather than an explicit machine learning training process.
9. How the ground truth for the training set was established
- Given that the document does not mention a distinct "training set" in the machine learning sense, this question is not directly applicable. If "training" refers to the development and calibration of the offset tables, the ground truth would have been established through laboratory calibration and preliminary human clinical trials, similar to how the validation ground truth was established (i.e., comparison to reference thermometers).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2016
Microfile Intellectual Property GmbH c/o Ms. Susan Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K161728
Trade/Device Name: Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 2, 2016 Received: November 3, 2016
Dear Ms. Susan 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K161728
Device Name
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
Indications for Use (Describe)
The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
The assigned 510(k) number is: K161728
-
- Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland
- Submitter's Identification:
Date Summary Prepared: November 2, 2016
Contact: Mr. Gerhard Frick Vice President of Technical and Service Microlife Intellectual Property GmbH, Switzerland Tel: +41 79 216 0070 E-Mail: gerhard.frick@microlife.ch
2. Name of the Device:
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
Regulation Number: 21 CFR Part 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL
-
- Information for the 510(k) Cleared Device (Predicate Device):
Microlife Digital Infrared Forehead Thermometer, Model FR1DM1, K033820, Microlife Intellectual Property GmbH
- Information for the 510(k) Cleared Device (Predicate Device):
-
- Device Description:
The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the forehead. Microlife FR1MN1-1 especially enables the user to take measurements and be alerted for possible elevated temperature readings accordingly.
- Device Description:
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The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1, consists of mainly seven parts:
- a) Thermopile Sensor
- b) Application-Specific Intergrated Circuit
- c) Erasable Programmable Read-Only Memory Integrated Circuit
- d) Lens
- e) LCD and Backlight
- f) 2 Keys (Start key, O/I key)
- g) 2 batteries AAA (LR03) 1.5V
The new Model FR1MN1-1 has the same intended use and temperature measurement fundamental algorithm as the 510(k) cleared devices.
Auto-Display memory The last reading is automatically displayed for 2 seconds when the unit is switched ON.
న. Indications for Use:
The Microlife Digital Infrared Forehead Thermometer, Model FRIMN1-1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
| 6. | Comparison to the 510(k) Cleared Devices (Predicate Devices): | ||
|---|---|---|---|
| Item | Predicate device: MicrolifeDigital Infared ForeheadThermometer FR1DM1,Microlife Intellectual PropertyGmbH, K033820 | Modified device:Microlife Digital InfraredForehead Thermometer FR1MN1-1, Microlife Intellectual PropertyGmbH | Assessment ofDifferences |
| Thermometer type | Infrared thermometer | Infrared thermometer | same |
| Contact | Contact | same | |
| Intended use | Intended for the intermittentmeasurement and monitoring ofhuman body temperature in thehome, for use on people of allages. | Intended for the intermittentmeasurement and monitoring ofhuman body temperature. Thedevice is indicated for use bypeople of all ages in the home. | same |
| Device technology | Infrared | Infrared | same |
| Item | Predicate device: MicrolifeDigital Infared ForeheadThermometer FR1DM1,Microlife Intellectual PropertyGmbH, K033820 | Modified device:Microlife Digital InfraredForehead Thermometer FR1MN1-1, Microlife Intellectual PropertyGmbH | Assessment ofDifferences |
| Measurement target | Human | Human | same |
| Measuring location | Forehead | Forehead | same |
| Appearance(ID design) | Image: Forehead Thermometer | different shape | |
| Physical dimension | (141.0±0.5)mm (L)(26.0±0.5)mm (W)(20.0±0.5)mm (D) | (157.0+0.5)mm (L)(53.0±0.5)mm (W)(36.0+0.5)mm (D) | different |
| Power supply | 1 battery CR2032 3.0V | 2 batteries AAA (LR03) 1.5V | different |
| Measuring range(Body Mode) | 34°C | 34°C | same |
| Measuring range(Non-clinical mode/laboratory) | 32 | 80.6 | different |
| Accuracy(Clinical Mode) | ±0.3 °C, 34.0 ~ 42.2 °C(±0.5 °F, 93.2 ~ 108.0 °F) | 0.4 °F, 96.8 ~ 102.2 °F | different |
| Display resolution | 0.1°C or 0.1 °F | 0.1°C or 0.1°F | same |
| Operatingtemperature(Body Mode) | 16.0°C-40°C (60.8°F~104.0°F) | 16.0°C-40°C (60.8°F~104.0°F) | same |
| Storage conditions | -25°C | -25°C | same |
| Display type | LCD | LCD | same |
| Memory | 12 set, last measurement | last measurement | different |
| Item | Predicate device: MicrolifeDigital Infared ForeheadThermometer FR1DM1,Microlife Intellectual PropertyGmbH, K033820 | Modified device:Microlife Digital InfraredForehead Thermometer FR1MN1 -1, Microlife Intellectual PropertyGmbH | Assessment ofDifferences |
| Power auto off | Approx. 1 minute after the lastmeasurement has been taken | Approx. 20 seconds, after the lastmeasurement has been taken | different |
| Low/dead | Low battery at 2.7V | Low battery at 2.6V | different |
| battery indications | Dead battery at 2.55V | Dead battery at 2.5V | different |
| Backlight | Single backlight | Green, yellow and red backlightaccording to the measuredtemperature | different |
| Reference site | No | No | same |
| Beeper indication | Yes | Yes | same |
| Sensor type | Same | Same | same |
| Lens | Yes | Yes | same |
| Labeling | Microlife | Microlife | same |
| Error | Display "Err" when the systemhas a malfunction. | Display "Err" when the system hasa malfunction. | same |
| IC | Same | Same | same |
| Sensor | OTP-668D2 | OTP-668D2 | same |
| Software algorithm | FW table "xyz" rev.1 | FW table "xyz" rev. 1.1 | different |
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The subject FR1MN1-1 device uses the same infrared technology, measures and monitor body temperature at the forehead site as the predicate Microlife FR1DM1.
The major differences are as below:
- Power supply, memory sets, low/dead battery indications, backlight, etc. These are mainly a) user- friendly features.
- b) Software Algorithm
The modified device uses slightly adjusted clinical offset tables for additional improved accuracy. Our algorithm was adjusted to improve accuracy. A clinical study was performed to validate this.
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Based upon the aforementioned information, the two devices are substantially equivalent.
-
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating performance of the Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 in the intended environment of use is supported by testing that was conducted in accordance with Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following testing was conducted to demonstrate performance as well as substantial equivalence to the predicate devices:
The following National and International Standards were utilized for testing the subject device:
| Item | Test name | Pass/Fail Criteria | Results |
|---|---|---|---|
| 1. | IEC 60601-1:2005+A1:2012 | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
| 2 | AAMI/IEC 60601-1:2005/(R)2012 AndA1:2012,C1:2009/(R)2012 AndA2:2010/(R)2012 | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
| 3 | IEC 60601-1-2:2007 | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
| 4 | ASTM E 1965-98 (2009) | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
| 5 | ISO 14971:2007 | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
| 6 | AAMI/ANSI/ISO 10993-1:2010 | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
| 7 | AAMI/ANSI/ISO 10993-5:2009 | Pass/Fail Criteria is Outlined in thisStandard | Passed AllTestingRequirements |
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| 8 | AAMI/ANSI/ISO 10993-10:2010 | Pass/Fail Criteria is Outlined in this Standard | Passed All Testing Requirements |
|---|---|---|---|
| 9 | AAMI/ANSI/ISO 10993-12:2012 | Pass/Fail Criteria is Outlined in this Standard | Passed All Testing Requirements |
| 10 | AAMI/ANSI/ISO 80601-2-56:2009 | Pass/Fail Criteria is Outlined in this Standard | Passed All Testing Requirements |
| 11 | IEC 60601-1-11:2010 | Pass/Fail Criteria is Outlined in this Standard | Passed All Testing Requirements |
It was our conclusion that Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 tested meets all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were conducted in accordance with ASTM E1965-98, IEC 80601-2-56 Test Report using the Microlife Digital Infrared Forehead Thermometer Model FR1MN1-1. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per clinical validation for Microlife FR1MN1-1.
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:
Conclusions drawn from the non-clinical and clinical tests demonstrate that the subject device is substantially equivalent to the predicate device.
§ 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.