(166 days)
No
The description focuses on standard infrared thermometry technology and does not mention any AI or ML components or algorithms. The device description lists basic electronic components and a fundamental temperature measurement algorithm, which is stated to be the same as the predicate device.
No
The device is intended for the intermittent measurement and monitoring of human body temperature, not for treatment or therapy.
No
The device is a thermometer, used for measuring body temperature, which is a physiological parameter. While an elevated temperature might be a symptom of a condition, the device itself does not provide a diagnosis of a disease or condition; it only provides a measurement.
No
The device description explicitly lists multiple hardware components including a thermopile sensor, integrated circuits, lens, LCD, keys, and batteries.
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 Infrared Forehead Thermometer measures body temperature directly from the forehead using infrared technology. 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 measurement, not an in vitro test.
Therefore, this device falls under the category of a medical device, specifically a thermometer, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
people of all ages in the home.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: 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. The testing was conducted to demonstrate performance as well as substantial equivalence to the predicate devices. The device passed all testing requirements as outlined in the listed national and international standards.
Clinical Tests: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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.
1
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
2
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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3
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:
4
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: Microlife | ||
| Digital Infared Forehead | |||
| Thermometer FR1DM1, | |||
| Microlife Intellectual Property | |||
| GmbH, K033820 | Modified device: | ||
| Microlife Digital Infrared | |||
| Forehead Thermometer FR1MN1- | |||
| 1, Microlife Intellectual Property | |||
| GmbH | Assessment of | ||
| Differences | |||
| Thermometer type | Infrared thermometer | Infrared thermometer | same |
| Contact | Contact | same | |
| Intended use | Intended for the intermittent | ||
| measurement and monitoring of | |||
| human body temperature in the | |||
| home, for use on people of all | |||
| ages. | 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. | same | ||
| Device technology | Infrared | Infrared | same |
| Item | Predicate device: Microlife | ||
| Digital Infared Forehead | |||
| Thermometer FR1DM1, | |||
| Microlife Intellectual Property | |||
| GmbH, K033820 | Modified device: | ||
| Microlife Digital Infrared | |||
| Forehead Thermometer FR1MN1- | |||
| 1, Microlife Intellectual Property | |||
| GmbH | Assessment of | ||
| Differences | |||
| 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 ~42.2°C | ||
| (93.2~108.0°F) | 34°C ~42.2°C | ||
| (93.2~108.0°F) | 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 |
| Operating | |||
| temperature | |||
| (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: Microlife | ||
| Digital Infared Forehead | |||
| Thermometer FR1DM1, | |||
| Microlife Intellectual Property | |||
| GmbH, K033820 | Modified device: | ||
| Microlife Digital Infrared | |||
| Forehead Thermometer FR1MN1 - | |||
| 1, Microlife Intellectual Property | |||
| GmbH | Assessment of | ||
| Differences | |||
| Power auto off | Approx. 1 minute after the last | ||
| measurement has been taken | Approx. 20 seconds, after the last | ||
| measurement 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 backlight | |
| according to the measured | |||
| temperature | 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 system | ||
| has a malfunction. | Display "Err" when the system has | ||
| a 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 |
5
6
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.
7
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 this | |
| Standard | Passed All | ||
| Testing | |||
| Requirements | |||
| 2 | AAMI/IEC 60601-1:2005/(R) | ||
| 2012 And | |||
| A1:2012,C1:2009/(R)2012 And | |||
| A2:2010/(R)2012 | Pass/Fail Criteria is Outlined in this | ||
| Standard | Passed All | ||
| Testing | |||
| Requirements | |||
| 3 | IEC 60601-1-2:2007 | Pass/Fail Criteria is Outlined in this | |
| Standard | Passed All | ||
| Testing | |||
| Requirements | |||
| 4 | ASTM E 1965-98 (2009) | Pass/Fail Criteria is Outlined in this | |
| Standard | Passed All | ||
| Testing | |||
| Requirements | |||
| 5 | ISO 14971:2007 | Pass/Fail Criteria is Outlined in this | |
| Standard | Passed All | ||
| Testing | |||
| Requirements | |||
| 6 | AAMI/ANSI/ISO 10993-1:2010 | Pass/Fail Criteria is Outlined in this | |
| Standard | Passed All | ||
| Testing | |||
| Requirements | |||
| 7 | AAMI/ANSI/ISO 10993-5:2009 | Pass/Fail Criteria is Outlined in this | |
| Standard | Passed All | ||
| Testing | |||
| Requirements |
8
| 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.