(76 days)
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 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 FR1DM1 is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. The Microlife Digital Infrared Forehead Thermometer, consists mainly of five parts: a) IR Thermopile Sensor, b) ASIC, c) E2PROM IC, d) LCD and Blacklight, e) Kev2, Buzzer1
The provided 510(k) summary for the Microlife Digital Infrared Forehead Thermometer, Model FR1DM1, mentions clinical studies but does not detail the acceptance criteria or reported device performance in a table format. It also lacks specific details on sample sizes, ground truth establishment, or expert qualifications beyond a high-level statement that "Controlled human clinical studies were conducted using the Microlife Infrared forehead thermometer FR1DM1. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per Microlife clinical test protocol for infrared forehead thermometer."
Therefore, I cannot provide a table of acceptance criteria or many of the requested details based solely on the provided text. However, I can extract the information that is present and indicate where details are missing.
Here's a breakdown of the available information and what is not provided:
Acceptance Criteria and Device Performance:
The document explicitly states that the device complies with ASTM E1965-98. This standard defines requirements for infrared thermometers and would include accuracy specifications. While the specific numerical acceptance criteria (e.g., maximum bias, uncertainty, and repeatability) from ASTM E1965-98 are not explicitly stated in this document, the submission implies adherence to them.
The document reports that clinical data "evaluating clinical bias, clinical uncertainty and clinical repeatability per Microlife clinical test protocol for infrared forehead thermometer" was presented. However, the actual values for these performance metrics are not included in this summary.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (from ASTM E1965-98, implied) | Reported Device Performance (not provided in this summary) |
|---|---|---|
| Clinical Bias | (Defined by ASTM E1965-98) | Not provided |
| Clinical Uncertainty | (Defined by ASTM E1965-98) | Not provided |
| Clinical Repeatability | (Defined by ASTM E1965-98) | Not provided |
Other Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only states "Controlled human clinical studies were conducted."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For a thermometer, "ground truth" typically involves a reference thermometer (e.g., a rectal thermometer) rather than expert interpretation of images. The document refers to "clinical test protocol," which would describe the methodology for establishing a reference temperature, but the details are absent here.
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Adjudication method for the test set:
- Not applicable or not specified. For a thermometer, adjudication in the sense of multiple expert reviews of a complex finding (like an image) is generally not relevant. The "ground truth" (reference temperature) is established through standardized measurement.
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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:
- Not applicable. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers or interpretation of complex cases.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is a digital infrared thermometer that outputs a temperature reading directly. Its performance evaluation (clinical bias, uncertainty, repeatability) inherently assesses its standalone algorithmic performance in converting infrared radiation to a temperature display. There is no human interpretation component in its fundamental operation or evaluation as described.
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The type of ground truth used:
- Implied Reference Standard (likely another thermometer): For a thermometer, ground truth is typically established by simultaneously measuring body temperature using a highly accurate, accepted reference method (e.g., a rectal thermometer, an oral thermometer, or potentially another validated infrared thermometer) for comparison. The document mentions "clinical test protocol for infrared forehead thermometer," which would define this reference method.
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The sample size for the training set:
- Not applicable/Not provided. The document describes clinical validation studies in item 8. It does not explicitly mention a separate "training set" in the machine learning sense for the device's core temperature measurement algorithm, as the technology relies on established physical principles (infrared thermometry) and calibration, rather than deep learning requiring large training datasets in the same way. Development would involve calibration and testing, but not necessarily a "training set" as defined for AI models.
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How the ground truth for the training set was established:
- Not applicable/Not provided, as there's no explicit mention of a training set as would be found in AI/ML development. Calibration and engineering validation would have occurred during device development using precise temperature standards and reference measurements.
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FEB 2 3 2004
Exhibit #1
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:________________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: December 8, 2003
Contact: Mr. Gerhard Frick
2. Name of the Device:
Microlife Digital Infrared Forehead Thermometer, Model FR1DM1
Predicate Device Information: 3.
Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725
Device Description: 4.
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is an ectronic thermometer using an infrared sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD.
Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces.
The Microlife Digital Infrared Forehead Thermometer, consists mainly of five parts:
- a) IR Thermopile Sensor
- b) ASIC
- c) E2PROM IC
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- d) LCD and Blacklight
- e) Kev2, Buzzer1
5. Intended Use:
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 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.
Comparison to Predicate Devices: 6.
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is substantially equivalent to the original Microlife Digital Ear Thermometer, Model IR1DE1 in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc.,
The major difference between the Microlife Infrared Forehead Thermometer and the predicate device is the measuring site. The predicate device is measuring ear temperature while the subject device is measuring forehead temperature.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965-98, 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 Infrared forehead thermometer FR1DM1. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per Microlife clinical test protocol for infrared forehead thermometer.
9. Conclusions:
The Microlife Infrared Forehead Thermometer, Model FR1DM1, has the same intended use and similar technological characteristics as the Microlife Infrared Ear thermometer Model IR1DE1. Moreover, bench testing contained in this
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submission supplied demonstrate that any differences in their characteristics do submission suppliod aomenstate of safety or effectiveness. Thus, the Microlife not raise any new questions of our oneously of onvolvalentially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 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: K033820
Trade/Device Name: Microlife Digital Infrared Forchead Thermometer, Model FR1DM1 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 8, 2003 Received: December 9, 2003
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 Amendinents, or to act result Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 wr ), it nay of be actions in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and regarents, including, but not limited to: registration You must comply with an the Act 3 requirements art 801); good manufacturing practice and ifsing (21 CFR Fall 807), laboring (21 CFR Particles), 1
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bjocchs (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) This letter will anow your of other of substantial equivalence of your device to a premarket notification. The I Dr Intention or cassification 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), If you desire specific auvice for your de 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 may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Small Manufacturer (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carl
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
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Exhibit B
Page ___ 1 __ of ___ 1 __
KO33820 510(k) Number (if known):
Device Name: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1
Indications For Use:
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is The Microllie Digital mirarou Forencement and monitoring of human body Intended for the mermikont model of or use by people of all ages in the home.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K033820 |
| Prescription Use(Per 21 CFR 801.109) | Over-The Counter Use(Optional Format 1-2-96) |
|---|---|
| ------------------------------------------ | -------------------------------------------------- |
OR
§ 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.