(129 days)
No
The description details a standard infrared thermometer operation based on thermal radiation measurement and basic circuit amplification and calculation, with no mention of AI or ML terms or concepts.
No
The device is a diagnostic tool used to measure body temperature, not to treat or alleviate a medical condition.
No
Explanation: The device is an electronic clinical thermometer used to detect body temperature. While temperature can be a symptom, the device itself provides a measurement, not a diagnosis of a medical condition. Its intended use is for temperature detection, which is a measurement, not a diagnostic determination.
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 software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device measures body temperature directly from the auditory canal using infrared technology. This is a measurement taken on the body, not from a specimen taken from the body.
Therefore, based on the provided information, the Radiant Innovation Inc., Infrared Ear Thermometer, Model TH709L(E) is a medical device, but it is not an In Vitro Diagnostic 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, Model TH709L(E) is electronic thermometer 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)
Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5;2003, as well as EN 60601-1 (IEC 60601-1) and EN 60601-1-2 (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".
bench testing contained in this submission supplied demonstrate that the modification of TH709L(E) 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)
K101253, K070976, K063185, K051269, K040377, K030324, K020504, K011059
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 smaller letters. Below the word "RADIANT" are four Chinese characters. The characters are arranged horizontally.
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Image /page/0/Picture/1 description: The image shows a company name in Chinese characters. The characters read "熱映光電股份有限公司". This translates to "Ray Shine Optronics Corporation". The text is in a bold, sans-serif font.
SPECIAL 510(K) SUMMARY
DEC 1 0 2010
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:
Submitter's Identification: ، 1.
Radiant Innovation Inc., 1F, No.3 Industrial E. 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan
Contact:
Mr. James Huang QA Department Manager Radiant Innovation Inc. TEL: +886 3 6111666 Ext. 100 FAX:+886 3 5644170 E-mail: jameshuang@radiantek.com.tw
Date Summary Prepared: July/26/2010
2. Name of the Device:
Infrared Ear Thermometer TH709L(E) Classification Name: Thermometer, Electronic, Clinical Regulation Number: 21 CFR 880.2910
Current Clearance Device: 3.
Radiant Innovation Infrared Ear Thermometer, Models TH60N (510(k)#: K101253), TH01BN (510(k)#: K070976), TH5XY series (510(k)#: K063185), TH00XY series (510(k)#: K051269), THXXN series (510(k)#: K040377), TH1 series (510(k)#: K030324), TH88 series (510(k)#: K020504) and TH8 series (510(k)#: K011059).
Device Description: 4.
The Radiant Innovation Inc., Infrared Ear Thermometer, Model TH709L(E) is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the
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Image /page/1/Picture/0 description: The image shows the word "RADIANT" in large, bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in smaller letters. Below the word "RADIANT" are four Chinese characters.
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.
Intended Use: న్.
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.
Technological Characteristics and Substantial Equivalence: 6.
Radiant Infrared Ear Thermometer TH709L(E) is an ear thermometer with probe cover and some sub-functions such as: temperature unit switchable, recall memory, last reading display, ambient temperature, and backlight.
And, the model number will indicate backlight is with or not.
Both the subject device (TH709L(E)) and predicate device (TH8 series) have the same intended use and fundamental technology. The comparison table of subject device (TH709L(E)) and predicate device (TH8 series) is included in the 510(k) submission. The subject device (TH709L(E)) is substantially equivalence to the technological features as the predicate device (TH8 series).
The basic technological characteristics between subject device vs. predicate device
| Features | Predicate device(TH8 series) | Subject device (TH709L(E)) |
|---|---|---|
| 510(k)# | K011059 | K |
| Accuracy | 35.5 | other +/-0.3°C (0.5°F). |
| Temp. Range | 34.0-42.2°C | |
| Ambient Range | 10-40°C | |
| Response Time | 1 sec | |
| Read modes | Ear (Oral) | |
| Scale Selection | °C/°F | |
| Display Type | LCD | |
| Probe Cover | With | |
| Activation | Scan Button | |
| Memory | 9 sets | 25 sets |
| SENSOR TYPE | Thermopile | |
| Case | ABS | |
| Weight | 70g | 57.7g |
| Dimension (LxWxH) | 143.83 cm | 123.84 cm |
| Battery | 3V Battery, CR2032 * 1 | |
| Backlight Source | EL (Optional) | LED (Optional) |
| 2 Phase Battery Alarm | Yes |
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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플를 검색
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence 7. are as follows:
Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5;2003, as well as EN 60601-1 (IEC 60601-1) and EN 60601-1-2 (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" ..
Conclusions: 8.
ﺗ
The RII Infrared Ear Thermometer TH709L(E), have the same intended use and similar characteristics as the cleared device TH8 series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH709L(E) do not raise any new questions of safety or effectiveness. Thus, the RII Infrared Ear Thermometer, Model TH709L(E) is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged vertically along the left side, with a dotted line separating the text from a stylized symbol on the right. The symbol consists of three curved lines that resemble a person embracing another person.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James Huang Quality Assurance Department Manager Radiant Innovation, Incorporated 1F, Number 3, Industrial E. 9th Rd Science- Based Industrial Park Hsinchu China (Taiwan) 300
DEC 1 0 2010
Re: K102187
Trade/Device Name: RII Infrared Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 9, 2010 Received: November 10, 2010
Dear Mr. Huang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Huang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
James D. Ratcliff
for
Anthony D. Watson, B.S., M.S., M.B.A. 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/5/Picture/0 description: The image shows the word "RADIANT" in large, bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in smaller, bold, black letters. Below the word "RADIANT" are four Chinese characters in black.
K102187
EXHIBIT # B
INDICATIONS FOR USE
DEC 1 0 2010
510(k) Number (if known):
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH709L(E)
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 区
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
R.C.A. 12/10/60
Concurrence of CDRH, Office of Delforderien (ODE)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Page 1 of 1
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