(115 days)
No
The description focuses on standard infrared temperature measurement technology and does not mention any AI or ML components or processes.
No
The device is a thermometer used for measurement, not for treatment or therapy.
No
Explanation: The device is a thermometer used to measure body temperature, which is a measurement rather than a diagnostic interpretation of medical conditions.
No
The device description explicitly states it uses an infrared sensor (thermopile detector) and has an LCD display, indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device directly measures body temperature from the ear canal using infrared technology. It does not analyze any biological specimens taken from the body.
Therefore, based on the provided information, the Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series is a clinical thermometer, not an IVD.
N/A
Intended Use / Indications for Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature for all age population used in the home setting.
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature for all age population in the home setting.
Product codes
FLL
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are electronic thermometers using an infrared detector (thermopile detector) to detect electromagnetic energy from the tympanic membrane and the adjacent surfaces of the patient. The operation is based on measuring the body temperature from the auditory canal.
To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A Start button is pressed to start the measurement through the radiation exchanges. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane and the adjacent surfaces of the patient
Indicated Patient Age Range
all age 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)
Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601 -1 and EN 60601-1-2 requirements.
Guidance Documents included the FDA "Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers", "How to Prepare A Special 510(k)", and "Deciding When to Submit A 510(k) for A Change to an Existing Device".
The RII Infrared Ear Thermometer TH00XY series, have the same intended use and similar characteristics as the cleared device that THXXN series. Moreover, the bench testing contained in this submission supplied demonstrate that the modification of TH00XY do not raise any new questions of safety and effectiveness. The RII Infrared Ear Thermometer, Models TH00XY series is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K04037, K030324, K020504, K011059
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
SEP - 9 2005
EXHIBIT # 1
SPECIAL 510(K) SUMMARY
This summary of Special 510(k) safety and effectiveness information is being submitted in accordance of This summary of Special SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
Submitter's Identification: 1.
Radiant Innovation Inc., 1F, No.3 Industrial E. 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan
Contact:
Mr. Frank Lin QA Dept. Manager
Date Summary Prepared: May/12/2005
Name of the Modification Device: 2.
Infrared Ear Thermometer TH00XY series (TH005A/B, TH007A/B and TH008A/B)
Current Clearance Device: 3.
Radiant Innovation Infrared Ear Thermometer, Models THXXN series (FDA#: K04037), TH11 Radiant Innovation Intrared Ear Themienst, 1000504) and TH8 series (FDA#: K011059).
series (FDA#: K030324), TH88 series (FDA#: K020504) and TH8 series (FDA#: K011059).
Device Description: 4.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are I he Kadian Innovation mos, minantrared detector (thermopile detector) to detect electrome themionelers using an intrared at the operation is based on measuring the body temperature from the auditor from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, the ear thermometer is inserted into a patient's outcer can canal. A The to measure caremperature, the measurement through the radiation exchanges.
Start button is pressed to start the measurement through the rachanges. The start button 15 pressed to start the the circuit for amplification and calculation, The measured temperature then appears on a LCD display. The total operation takes a few seconds.
1
Intended Use: న.
The device is an electronic clinical thermometer using an infrated sensor to detect body The device is an electronic cinnear themneter ashing and adult population used in the home setting.
KOS 126 9
Tests Performed for Determination of Substantial Equivalence are as follows: 6.
Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601 -1 and EN 60601-1-2 requirements.
Guidance Documents included the FDA "Guidance On The Content of Premarket Notification Guidance Documents Included the TDA ronic The mometers", " "How to Prepare A Special
(510(k)) Submissions for Clinical Elect and Cleck on Casting Davica" (510(k)) Submissions Jor Cimical Electronic r a Change to an Existing Device" ..
9. Conclusions:
The RII Infrared Ear Thermometer TH00XY series, have the same untended use and similar The RII Infrared Ear Thermoneter THXXN series. More are bench testing contained in this characteristics as the cleared device that modification of TH00XY do not raise any new
submission supplicd demonstrate that the Stated For Thormamater Models TH00XY submission supplied demonstrate that the The RI Infrared Ear Thermometer, Models TH00X Y series is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures representing people. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2005
Mr. Frank Lin QA Dept. Manager Radiant Innovation, Incorporated 1F, No. 3, Industrial E. 9th Road Science-Based Industrial Park HsinChu, TAIWAN
Re: K051269
Trade/Device Name: Infrared Ear Thermometer TH00XY Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 5, 2005 Received: August 10, 2005
Dear Mr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your betermined the device is substantially equivalent (for the itelered above and not of attennelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to they been reclassified in accordance with the provisions of Americans, or to do rices that in tic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commay, therefore, market the device, subject to the general approvin application (11-2) The general controls provisions of the Act include controls providions of the restration, 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 (FMA), it may be subject to back adalaf Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Lin
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that IDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and regarments, including, but not limited to: registration You must comply with an the Fee b roquits (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 807), labeling (QS) regulation (21 CFR Pat 820); and if requirements as set form in the quality ajon 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) IThis letter will anow you to began mading of substantial equivalence of your device to a premiarket nonfication. - The FDA milling or 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), If you desire specific advice to: your as at (240) 276-0115. Also, please note the regulation i 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 obtain other general miseturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
4
Indications for Use
510(k) Number (if known):
K 05-1269
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH00XY series
Indications For Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body
the see l he device is an electronic cimical themionecer doing an innulation in the least in the home setting.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 807 Subpart C) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H. Murdich Jr. Anthony Watson GHDB 1/8/05
(Division Sign-Off)
sthesiology, General Hospital, ontrol, Dental Devices
510(k) Number
300 新竹科學園區工業東九路 3 號 1 樓 http://www.radiantek.com.tw
1F, No.3, Industrial E. 9" Rd., Science-Based TEL:+886 3 564418 n , No.J, Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 564417
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