(17 days)
K#020725
Not Found
No
The description focuses on standard infrared thermometry technology and does not mention any AI or ML components or capabilities.
No
The device is a thermometer used to detect body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
Explanation: The device is described as an electronic clinical thermometer used to detect body temperature, and its intended use is to measure natural thermal radiation. While temperature can be a diagnostic indicator, the device itself is a measurement tool, not a diagnostic device that interprets or diagnoses a condition.
No
The device description explicitly lists hardware components such as an IR Thermopile Sensor, ASIC, E2 PROM IC, LCD, Blacklight, Key, and Buzzer. This indicates it is a physical device with integrated 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 description clearly states the device is an electronic clinical thermometer that measures body temperature from the auditory canal using an infrared sensor. This is a direct measurement of a physiological parameter in vivo (within the living body), not a test performed on a sample in vitro (outside the living body).
- Intended Use: The intended use is to detect body temperature, which is a vital sign and not a diagnostic test performed on a sample.
Therefore, the Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Product codes
FLL
Device Description
The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.
The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:
- IR Thermopile Sensor a)
- b) ASIC
- E2 PROM IC C)
- LCD and Blacklight d)
- Key "2, Buzzer" 1 e)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal
Indicated Patient Age Range
neonatal, pediatric and adult population
Intended User / Care Setting
home setting
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)
Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer modified devices to validate the effectiveness of use without a probe cover.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#020725
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
JAN 1 5 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:_KO34073
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: December 23, 2003
Contact: Mr. Gerhard Frick
2. Name of the Device:
Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1
3. Information for the 510(k) Cleared Device (Predicate Device):
Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725
4. Device Description:
The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.
The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:
- IR Thermopile Sensor a)
- b) ASIC
- E2 PROM IC C)
1
- LCD and Blacklight d)
- Key "2, Buzzer" 1 e)
5. Intended Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
This device is used probe cover free.
Comparison to the 510(k) Cleared Device (Predicate Device): 6.
The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is substantially equivalent to the original Microlife Digital Infrared Ear Thermometer, Model IR1DE1.
The new model, IR1DE1-1, has the same intended use and is similar in design to the 510(k) cleared device.
The IR1DE1-1 is identical in functionality and performance, with the only difference being that the device is to be used probe cover free, and, the PCB layout of the device. The working environmental specification of 5-40 degree C, temperature measurements algorithm and its software codes of the modified devices remains unchanged.
The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device. The Microlife IR1DE1-1 device works with a only a 1-second called a "normal mode".
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E-1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements.
2
Guidance documents included the "FDA Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers", "Deciding When to Submit a 510(k) for a Change to An Existing Devices", and, "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
Discussion of Clinical Tests Performed: 8.
Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer modified devices to validate the effectiveness of use without a probe cover.
9. Conclusions:
The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 has the same intended use and technological characteristics as the unmodified model IR1DE1. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. These engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
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: K034023
Trade/Device Name: Digital Infrared Ear Thermometer, Model IR1DE1-1 Regulation Number: CFR 21 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 23, 2003 Received: December 29, 2003
Dear Ms. 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 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. 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. or the rice or ally i vith all the Act's requirements, including, but not limited to: registration 1 od intilet comply would and (21 CFR Part 801); good manufacturing practice and instills (21 OF real 807), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are quadion 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) rms retet 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you don't the Office of Compliance at (301) 594-4618. 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 maj con 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,
Chas. L. Dees
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
5
Exhibit B
Page 1 of 1
510(k) Number (if known): _ 034023
Device Name: Digital Infrared Ear Thermometer, Model IR1DE1-1
Indications For Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Qur
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number _ KO3 4023