(27 days)
Not Found
No
The description details a standard infrared thermometer operation based on direct radiation measurement and calculation, with no mention of AI/ML algorithms for data processing or interpretation.
No.
The device is used for measurement and diagnosis, not for treatment or therapy.
No
The device measures body temperature, which is a vital sign, but it does not diagnose a medical condition or disease.
No
The device description explicitly mentions hardware components such as an infrared sensor, thermopile detector, circuit for amplification and calculation, and an LCD display. It is a physical device that uses software to process the data from its hardware sensors.
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 body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The device described is an infrared ear thermometer. It measures body temperature by detecting thermal radiation from within the body (specifically, the auditory canal). This is a direct measurement of a physiological parameter, not an analysis of a specimen taken from the body.
Therefore, based on the provided information, this device falls under the category of a non-IVD medical 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 Radiant Innovation Inc., Infrared Ear Thermometer, Models TH1 series are electronic thermometers using an infrared detector (thermopile detector) 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 of the patient.
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 electrical signal read out from the detector is fed to the circuit for amplification and calculation. 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
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)
Bench testing contained in this submission supplied demonstrate that the modification of TH1 do not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the word "RADIANT" in large, bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in smaller, black letters. Below the word "RADIANT" are four Chinese characters in black ink.
Image /page/0/Picture/1 description: The image contains a line of traditional Chinese characters. The characters read from left to right as: 熱映光電股份有限公司. This translates to something similar to "Hot Light Optoelectronics Co., Ltd." in English. The characters are written in a clear, bold font.
O N N O
KUBO2224 EXHIBIT#1
Special 510(K) SUMMARY
This summary of Special 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:
FEB 2 7 2003
1. Submitter's Identification:
Radiant Innovation Inc., No. 40, Lane 19, Bade Road Hsin-Chu City Taiwan, R.O.C.
Contact:
Mr. Charles Chang Eng. Dep. Manager
Date Summary Prepared: Jan 24, 2003
2. Name of the Modification Device:
Infrared Ear Thermometer, Models TH1 series
3. Current Clearance Device:
Radiant Innovation Infrared Ear Thermometer, Models TH8 series. ( FDA# K011059)
4. Device Description:
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH1 series are electronic thermometers using an infrared detector (thermopile detector) 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 of the patient.
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 electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
1
Image /page/1/Picture/0 description: The image shows the logo for Radiant Innovation Inc. The logo is divided into two parts, with the left side featuring the word "RADIANT" in bold, stylized letters, and the word "INNOVATION" above it in smaller letters. Below "RADIANT" are the Chinese characters for "Radiant". The right side of the logo features the company's name in Chinese characters, followed by "RADIANT INNOVATION Inc.," in English.
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.
6. Comparison to the Cleared Devices:
The RII Infrared Ear Thermometer, Models TH1 series are substantially equivalent to RII's current clearance device: Infrared Ear Thermometer, Models TH8 series, on the principle of operation, scientific technology with the same intended use, technological characteristics and specifications.
The only differences between TH8 and TH1 series Infrared Ear Thermometer are the outer appearance and the user's manual which will not significantly change the safety and effectiveness .
7. Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965, as well as IEC 60601 -1 and IEC 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) ", "Deciding When to Submit a 510(k) for a Change to an Existing Device" ..
8. Conclusions:
The RII Infrared Ear Thermometer, Models TH1 series, have the same intended use and similar characteristics as the cleared device, Model TH8 series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH1 do not raise any new questions of safety or effectiveness. Thus, the RII Infrared Ear Thermometer, Models TH1 series is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2003
Mr. Charles Chang Eng. Department Manaager Radiant Innovations Incorporated No. 40, Lane 19, Bade Road Hsin-Chu City TAIWAN, R.O.C.
Re: K030324
Trade/Device Name: Radiant Innovations Inc. Infrared Ear Thermometer, Model TH1 series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 29, 2003 Received: January 31, 2003
Dear Mr. Charles Chang:
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.
3
Page 2 - Mr. Chang
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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact 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 Division 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.
Suzer Runoes
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Radiant Innovation Inc. The logo is split into two parts, with the left side showing the word "RADIANT" in bold, stylized letters, with the word "INNOVATION" above it in smaller letters. Below the word "RADIANT" are four Chinese characters. The right side of the logo shows the Chinese characters for "Radiant Innovation Inc.", with the English translation below it.
#EXHIBIT B
Indications for Use Statement
Special 510(k) Number (if known):
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 series
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)
Valerie Mura - PXC
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030324
PrescriptionUse (Per 21 CFR 801.109)
OR
Over-The-Counter Use 1 (Optional Format 1-2-96)