(95 days)
K#091040, K#033820
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard electronic components and infrared sensing.
No
A thermometer is used for measurement and monitoring, not for treating or preventing disease.
Yes
The device is described as a thermometer intended for the "intermittent measurement and monitoring of human body temperatures." Temperature measurement is a diagnostic activity, as it provides information about a person's physiological state that can be used to identify health conditions.
No
The device description explicitly lists hardware components such as a thermopile sensor, ASIC, E2PROM IC, LCD, buttons, buzzer, and probe cap. This indicates it is a physical device with embedded software, not a software-only medical 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 Dual Mode Thermometer measures body temperature 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 temperatures," which is a direct measurement of a physiological parameter, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device, specifically a thermometer, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Microlife Dual Mode Thermometer IFR1MJ1 is intended for the intermittent measurement and monitoring of human body temperatures. The device is indicated for use by people above 12 years old to geriatric for ear mode and from newborn to geriatric for forehead mode in the home.
Product codes
FLL
Device Description
The Microlife Dual Mode Thermometer, Model IFR1MJ1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperatures from the forehead or auditory canal.
This Dual Mode Thermometer enables very safe and reliable measurements and with its technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of userfriendliness.
The Microlife Dual Mode Thermometer consists mainly of six parts:
- a) Thermopile Sensor
- b) ASIC
- c) E2PROM IC
- d) LCD and Backlight
- e) 2 Buttons, 1 Buzzer, Automatic switch
- f) Probe cap
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead or auditory canal
Indicated Patient Age Range
above 12 years old to geriatric for ear mode and from newborn to geriatric for forehead mode
Intended User / Care Setting
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:
Compliance to applicable voluntary standards includes ASTM E1965, as well as IEC60601-1and IEC60601-1-2 requirements.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers.
Clinical Tests:
Controlled human clinical studies were conducted in accordance with ASTM E1965, the bland-Altman plot was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per clinical validation for Microlife Dual Mode Thermometer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#091040, K#033820
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
JAN 2 7 2012
EXHIBIT#1a
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: K112) ゲイ
Submitter's Identification: 1.
-
- 1 - 1 /
Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: October 21, 2011
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 Dual Mode Thermometer, Model IFR1MJ1
3. Predicate Device Information:
Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1, K#091040
Microlife Digital Infrared Forehead Thermometer, Model FR1DM1, K#033820
Device Description: 4.
The Microlife Dual Mode Thermometer, Model IFR1MJ1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperatures from the forehead or auditory canal.
This Dual Mode Thermometer enables very safe and reliable measurements and with its technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of userfriendliness.
1
The Microlife Dual Mode Thermometer consists mainly of six parts:
- a) Thermopile Sensor
- b) ASIC
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
. -
- c) E2PROM IC
- d) LCD and Backlight
- e) 2 Buttons, 1 Buzzer, Automatic switch
- f) Probe cap
5. Intended Use:
The Microlife Dual Mode Thermometer IFR1MJ1 is intended for the intermittent measurement and monitoring of human body temperatures. The device is indicated for use by people above 12 years old to geriatric for ear mode and from newborn to geriatric for forehead mode in the home.
6. Comparison to Predicate Devices:
The Microlife Dual Mode Thermometer, Model IFR1MJ1 is substantially equivalent to Microlife Digital Infrared Ear Thermometer. Model IR1DV1-1. K#091040, and Microlife Digital Infrared Forehead Thermometer, Model FR1DM1, K#033820, which has the same intended use and is similar in design to the predicate devices.
The Microlife Dual Mode Thermometer IFR1MJ1 and the predicate devices are identical in the temperature measurements algorithm and fundamental scientific technology, Microlife IFR1MJ1 and IR1DV1-1 mainly differ by appearance, probe cap etc., Microlife IFR1MJ1 and FR1DM1 mainly differ by appearance, backlight, probe cap etc.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965, as well as IEC60601-1and 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 in accordance with ASTM E1965, the bland-Altman plot was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per clinical validation for Microlife Dual Mode Thermometer.
EXHIBIT #1a-2
2
9. Conclusions:
The Microlife Dual Mode Thermometer, Model IFR1MJ1 has the same intended use and technological characteristics as the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 and Microlife Digital Infrared Forehead Thermometer Model FR1DM1. 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 Dual Mode Thermometer IFR1MJ1 is substantially equivalent to the predicate devices IR1DV1-1 and FR1DM1.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned within a circle. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
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 10021
JAN 2 7 2012
Re: K113141
Trade/Device Name: Microlife Dual Mode Thermometer, Model IFR 1MJ I Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 29, 2011 Received: December 30, 2011
Dear Ms. Goldstein-Flak:
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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerelv vours.
for Anthony D. Watson.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5