K Number
K041692
Device Name
INFRARED EAR THERMOMETER, ET-100 SERIES
Date Cleared
2004-09-13

(83 days)

Product Code
Regulation Number
880.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.
Device Description
Infrared Ear Thermometer Model ET-100 Series
More Information

Not Found

Not Found

No
The summary describes a standard infrared ear thermometer and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance metrics typically associated with AI/ML devices.

No.
The device is an infrared ear thermometer intended for intermittent measurement and monitoring of human body temperature, not for treatment or therapy.

Yes
The device is intended for "intermittent measurement and monitoring of human body temperature," which is a measurement used to assess a physiological state, a key characteristic of a diagnostic device.

No

The device description explicitly states it is an "Infrared Ear Thermometer Model ET-100 Series," which is a hardware device. The summary does not mention any software component as the primary or sole function.

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 ET-100 series Infrared Ear Thermometer measures body temperature directly from the auditory canal. This is a direct measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
  • Intended Use: The intended use clearly states "intermittent measurement and monitoring of human body temperature from the auditory canal". This aligns with a general medical device for physiological measurement, not an IVD.

Therefore, the ET-100 series Infrared Ear Thermometer falls under the category of a general medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.

Product codes

FLL

Device Description

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Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

auditory canal

Indicated Patient Age Range

all ages

Intended User / Care Setting

consumers in the home.

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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 eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2004

Mr. JI Bo General Manager General Mua'an Medical & Health Instrument Company Limited Building 2, Baimiao Industrial Park, Economic Development Zone Wuchang Hangzhou Zhejiang 310023 P.R. CHINA

K041692 Re:

Trade/Device Name: Infrared Ear Thermometer Model ET-100 Series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 7, 2004 Received: September 7, 2004

Dear Mr. Bo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nated 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 t), it may of cashes of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Page 2 - Mr. Bo

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast that FDA has made a determination that your device complies with other requirements moan that 1 Dr mai may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outstal button and including, but not limited to: registration r ou into comply was a 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 et read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betternic product radiation 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) This letter wification. The FDA finding of substantial equivalence of your device to a premained total our redicate 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), rr you decire 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 may overn 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 vours,

ClsL
Chiu Lin, Ph.D.

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

2

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

f

Device Name:_Infrared Ear Thermometer Model ET-100 Series

Indications For Use:

.

.

The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: koy /642

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