(14 days)
No
The description details a standard infrared thermometer operation based on direct thermal radiation measurement and calculation, with no mention of AI/ML algorithms for data processing or interpretation.
No
The device is an electronic clinical thermometer used to detect body temperature, which is a diagnostic tool, not a therapeutic intervention.
No
The device measures body temperature, which is a vital sign, but it does not provide a diagnosis. Its function is to detect and display a physiological measurement.
No
The device description explicitly states it uses an infrared detector (thermopile detector) and has an LCD display, indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, 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 measures body temperature directly from the auditory canal using infrared technology. It does not analyze any biological specimens taken from the body.
Therefore, it falls under the category of a clinical thermometer used for measuring a physiological parameter (body temperature) directly from the patient.
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, Model TH01BN 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Radiant Innovation Infrared Ear Thermometer, Models TH5XY series (FDA#: K063185), TH00XY series (FDA#: K051269), THXXN series (FDA#: K040377), TH1 series (FDA#: K030324), TH88 series (FDA#: K020504) and TH8 series (FDA#: 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.
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Image /page/0/Picture/0 description: The image shows the word "RADIANT" in bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in a smaller font. Below the word "RADIANT" are four Chinese characters.
熱映光電股份有限公司
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:
1. Submitter's Identification:
APR 2 0 2007
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: Mar/23/2007
2. Name of the Modification Device:
Infrared Ear Thermometer TH01BN
3. Current Clearance Device:
Radiant Innovation Infrared Ear Thermometer, Models TH5XY series (FDA#: K063185), TH00XY series (FDA#: K051269), THXXN series (FDA#: K040377), TH1 series (FDA#: K030324), TH88 series (FDA#: K020504) and TH8 series (FDA#: K011059).
4. Device Description:
The Radiant Innovation Inc., Infrared Ear Thermometer, Model TH01BN 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.
1F, No.3, Industrial E. 9th Rd., Science-Based TEL: +886 3 5644185 Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 5644170
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Image /page/1/Picture/0 description: The image shows the word "RADIANT" in bold, black letters with the letter "A" replaced by an upside-down "V". Above the word "RADIANT" is the word "INNOVATION" in smaller, black letters. Below the word "RADIANT" are four Chinese characters.
熱映光電股份有限公司
47 4976 12.20P2
Intended Use: ട.
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.
Tests Performed for Determination of Substantial Equivalence are as follows: 6.
Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5:2003, 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) ", "Deciding When to Submit a 510(k) for a Change to an Existing Device".
7. Conclusions:
The RII Infrared Ear Thermometer TH01BN, have the same intended use and similar characteristics as the cleared device TH5XY series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH01BN do not raise any new questions of safety or effectiveness. Thus, the RII Infrared Ear Thermometer, Model TH01BN is substantially equivalent to the predicate device.
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1F, No.3, Industrial E. 9th Rd., Science-Based TEL:+886 3 5644185 Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 5644170
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2007
Mr. Frank Lin QA Department Manager Radiant Innovation Incorporated 1 F, No. 3 Industrial E. 9th Road, Science-Based Industrial Park, HsinChu TAIWAN
Re: K070976
Trade/Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH01BN Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 6, 2007 Received: April 6, 2007
Dear Mr. Lin:
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.
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Page 2 - Mr. Lin
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 your 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
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Image /page/4/Picture/0 description: The image shows the word "RADIANT" in bold, black letters with the letter "A" replaced by an upside-down "V". Above the word "RADIANT" is the word "INNOVATION" in smaller letters. Below the word "RADIANT" are four Chinese characters.
Image /page/4/Picture/1 description: The image shows the text "RADIANT INNOVATION Inc." in English, with the word "RADIANT" above "INNOVATION" and "Inc.". Above the English text is the same text in Chinese characters. The Chinese characters are arranged horizontally.
INDICATIONS FOR USE
EXHIBIT # B
510(k) Number (if known):
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH01BN
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.
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)
Anthony D. Orenstein
of the Massachusetts General Hospital,
Infusion Control, Cancer Devices
| 510(k) Number: | K074976 |
|---|---|
| ---------------- | --------- |
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300 新竹科學園區工業東九路 3 號 1 樓 1F, No.3, Industrial E. 9th Rd., Science-Based TEL:+886 3 5644185
Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 5644170