(70 days)
No
The description details standard infrared temperature measurement and signal processing by a microprocessor, with no mention of AI or ML algorithms for data analysis or interpretation.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a thermometer, which is used for monitoring, not therapy.
No
The device is described as an electronic clinical thermometer used for intermittent monitoring of human body temperature, which is a measurement tool, not a diagnostic one.
No
The device description explicitly states it uses an infrared detector (thermopile detector) and involves hardware amplification and processing by a microprocessor, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device measures body temperature in vivo (within the body) by detecting infrared radiation from the auditory canal. It does not analyze any biological specimens.
The description clearly states its function is to "detect body temperature from the auditory canal" and "for intermittent monitoring of human body temperature." This is a direct measurement of a physiological parameter within the living body, not an in vitro analysis of a specimen.
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 for intermittent monitoring of human body temperature in the home setting. The probe cover is intended as a disposable cover acting as a sanitary barrier between the thermometer and the ear canal.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiantion from the auditory canal. Its operation is based on measuring the natural infrared 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 amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
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)
The objective of this study was to compare the clinical accuracy of the THK09 Infrared Ear thermometer with that of two legally marketed thermometers in the US i) the MC 341 Omron Digital Thermometer (K091676) and ii) Braun IRT 3020 Ear Thermometer (K983295).
In accordance with ASTM E1965:2003, the clinical accuracy is characterized in terms of Bias, Standard Deviation or Limits of Agreement and Repeatability.
The summary results for bias, SD and Repeatability using the Omron MC 341 and the Braun IRT 3020 Ear thermometers as reference devices showed that the bias and repeatability was within the clinically relevant acceptance criteria of +/-0.2 deg C. The standard deviations were within 0.5 deg C.
The THK09 has a clinical accuracy comparable to the legally marketed MC 341 Omron Digital Thermometer (K091676) and ii) Brain IRT 3020 Ear Thermometer (K983295).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance Criteria: For bias and repeatability, a clinically acceptable value of +/- 0.2 deg C was used as the acceptance criteria.
Results: bias and repeatability was within the clinically relevant acceptance criteria of +/-0.2 deg C. The standard deviations were within 0.5 deg C.
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.
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.
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.
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SPECIAL 510(K) SUMMARY
DEC 2 9 2010
This 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 OA Department Manager Radiant Innovation Inc. TEL: +886 3 6111666 Ext. 100 FAX:+886 3 5644170 E-mail: jameshuang@radiantek.com.tw
Date Summary Prepared: Oct./12/2010
Name of the Device: 2.
Infrared Ear Thermometer THK09, IRT 3020 (Under brand name Braun IRT 3020 to be distributed by Kaz USA, Inc) Classification Name: Thermometer, Electronic, Clinical Regulation Number: 21 CFR 880.2910
3. Current Cleared Devices:
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, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect
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body temperature using infrared radiantion from the auditory canal. Its operation is based on measuring the natural infrared 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 amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
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 for intermittent monitoring of human body temperature in the home setting. The probe cover is intended as a disposable cover acting as a sanitary barrier between the thermometer and the ear canal.
6. Technological Characteristics and Substantial Equivalence:
Both the subject device (THK09, IRT 3020) and the predicate device (TH8 series) have the same intended use as well as same fundamental technology. The comparison table showing the differences between the subject device (THK09, IRT 3020) and the predicate device (TH8 series) is included in the 510(k) submission. The subject device (THK09, IRT 3020) is substantially equivalent to the predicate device (TH8 series) since the same intended use, indications for use and similar technological characteristics.
| Features | Predicate device(TH8 series) | Subject device (THK09, IRT 3020) |
|---|---|---|
| 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 | Start Button |
| Memory | 9 sets | 1 set |
| Sensor Type | Thermopile | |
| Case | ABS | |
| Weight | 70g | 60g |
| Dimension (LxWxH) | 143.83 cm | 13.16.23.2 cm |
| Battery | 3V Battery, CR2032 * 1 | |
| 2 Phase Battery Alarm | Yes |
The basic technological characteristics between subject device vs. predicate device.
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence 7.
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熱映光電股份有限公司
RADIANT INNOVATION Inc.
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".
8. Summary of Clinical Evaluation:
The objective of this study was to compare the clinical accuracy of the THK09 Infrared Ear thermometer with that of two legally marketed thermometers in the US i) the MC 341 Omron Digital Thermometer (K091676) and ii) Braun IRT 3020 Ear Thermometer (K983295).
In accordance with ASTM E1965:2003, the clinical accuracy is characterized in terms of Bias, Standard Deviation or Limits of Agreement and Repeatability.
Acceptance Criteria:
For bias and repeatability, a clinically acceptable value of +/- 0.2 deg C was used as the acceptance criteria.
Results
The summary results for bias, SD and Repeatability using the Omron MC 341 and the Braun IRT 3020 Ear thermometers as reference devices showed that the bias and repeatability was within the clinically relevant acceptance criteria of +/-0.2 deg C. The standard deviations were within 0.5 deg C.
Conclusion:
The THK09 has a clinical accuracy comparable to the legally marketed MC 341 Omron Digital Thermometer (K091676) and ii) Brain IRT 3020 Ear Thermometer (K983295).
9. Conclusions:
The RII Infrared Ear Thermometer (models THK09, IRT 3020) has the same intended use, indications for use and technological characteristics as the cleared device TH8 series device. The devices have minor differences of some additional features and corresponding hardware or software changes.
Bench testing contained in this submission supplied demonstrates these changes do not raise any new questions of safety or effectiveness. The materials used are identical to the ones used in the previously cleared devices. Clinical Evaluation of the THK09 shows that it is within the acceptance criteria of +/-0.2 deg C when compared to the legally marketed predicate reference devices when conducted in accordance with ASTM E1965:2003.
Thus, the RII Infrared Ear Thermometer, Models THK09, IRT 3020 are substantially equivalent to the predicate device.
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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 Innovations Incorporated 1F, No. 3 Industrial E. 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan 300
DEC 20 1000
Re: K103097
Trade/Device Name: Radiant Innovation Inc. Infrared Ear Thermometer THK09, IRT 3020 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 3, 2010 Received: December 6, 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/ReportalProblem/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,
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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103097 EXHIBIT # B
INDICATIONS FOR USE
DEC 2 9 2010
510(k) Number (if known):
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer THK09, IRT 3020
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 for intermittent monitoring of human body temperature in the home setting.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 807 Subpart C) Over-The-Counter Use ਨਿੱ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K103097 Page 1 of 1
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