(28 days)
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.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH5XY 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 1.CD display. The total operation takes a few sconds.
The provided text is a 510(k) summary for the Radiant Innovation Inc. Infrared Ear Thermometer TH5XY series. The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and characteristics, and compliance with applicable voluntary standards. It does not present a study with specific acceptance criteria and detailed device performance data in the format requested.
Therefore, many of the requested fields cannot be directly extracted from the provided text. However, I can infer some information based on the type of document.
Here's the breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document mentions "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." These standards define the performance and safety requirements for clinical electronic thermometers, and adherence to them would constitute the acceptance criteria. Specific numerical values for criteria (e.g., accuracy +/- X degrees) are not explicitly stated in this summary document.
- Reported Device Performance: The document only states that "bench testing contained in this submission supplied demonstrate that the modification of TH5XY do not raise any new questions of safety or effectiveness." It does not provide the specific results of these bench tests or how they directly compare to the numerical acceptance criteria of the standards.
Without the specific numerical criteria from ASTM E1965-98 or EN12470-5:2003, and the corresponding performance data from the "bench testing," a table as requested cannot be constructed.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The document refers to "bench testing," which typically means testing conducted in a laboratory environment, not necessarily involving human subjects from a specific country or in a retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the text describes "bench testing" against standards, not a clinical study involving expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the text describes "bench testing" against standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this device is an Infrared Ear Thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device functions in a "standalone" manner (it takes a temperature reading without a human interpreting an algorithm's output), the document does not describe "standalone algorithm performance" in the context of typical AI/software device evaluations. The "bench testing" would assess the device's accuracy and adherence to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a thermometer, the "ground truth" for accuracy would typically be a highly accurate reference thermometer or temperature standard used during bench testing. This is not explicitly stated but implied by compliance to accuracy standards (e.g., ASTM E1965-98).
8. The sample size for the training set:
- Not applicable. This is a hardware device, and the summary does not indicate any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
Summary of available information:
| Information Category | Details |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Acceptance Criteria: Compliance to ASTM E1965-98, EN12470-5:2003, IEC 60601-1, and EN 60601-1-2. (Specific numerical criteria for accuracy, precision, etc., as defined by these standards, are not explicitly detailed in the summary document.) Reported Device Performance: "bench testing contained in this submission supplied demonstrate that the modification of TH5XY do not raise any new questions of safety or effectiveness." (Specific numerical performance results are not provided in this summary document.) |
| 2. Sample size used for the test set and data provenance | Sample Size: Not specified.Data Provenance: "bench testing" (implies laboratory setting, no specific country or retrospective/prospective human data mentioned). |
| 3. Number of experts and qualifications for ground truth (test set) | Not applicable (bench testing against standards, not clinical study with expert ground truth). |
| 4. Adjudication method (test set) | Not applicable (bench testing against standards). |
| 5. MRMC comparative effectiveness study and effect size | No (device is an infrared ear thermometer, not an AI-assisted diagnostic tool). |
| 6. Standalone (algorithm only) performance study | The device functions in a standalone manner, but the document describes "bench testing" for performance against standards, not a specific "standalone algorithm performance" study as typically understood for AI/software devices. |
| 7. Type of ground truth used | Implied to be reference temperature standards or highly accurate reference thermometers used during bench testing to verify compliance with specified accuracy ranges in the mentioned voluntary standards (e.g., ASTM E1965-98), although not explicitly stated. |
| 8. Sample size for the training set | Not applicable (device does not appear to use machine learning/AI). |
| 9. How ground truth for the training set was established | Not applicable (device does not appear to use machine learning/AI). |
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Image /page/0/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 letters, with the word "INNOVATION" above it in smaller letters. The right side of the logo shows the company name in Chinese characters, followed by "RADIANT INNOVATION Inc."
SPECIAL 510(K) SUMMARY
NOV 17 2006
This summary of Special 510(k) safety and effectivencss 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. Frank Lin QA Dept. Manager
Date Summary Prepared: Sep/27/2006
2. Name of the Modification Device:
Infrared Ear Thermometer TH5XY series (TH500/50Z, TH520 and TH560/56Z)
3. Current Clearance Device:
Radiant Innovation Infrared Ear Thermometer, Models 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, Models TH5XY 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 1.CD display. The total operation takes a few sconds.
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Image /page/1/Picture/0 description: The image shows a company logo with both English and Chinese text. On the left, the word "RADIANT" is prominently displayed above the words "
熱 映 光 電". To the right of that is the Chinese text "熱映光電股份有限公司". Below that is the text "RADIANT INNOVATION Inc."
ડા 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. Tests Performed for Determination of Substantial Equivalence are as follows:
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" ..
9. Conclusions:
The RII Infrared Ear Thermometer TH5XY series, have the same intended use and similar characteristics as the cleared device TH00XY series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH5XY do not raise any new questions of safety or effectivencss. Thus, the RII Infrared Ear Thermometer, Models TH5XY series is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Lin Quality Assurance Department Manager Radiant Innovation, Incorporated 1F, No. 3, Industrial East 9th Road Science-Based Industrial Park HsinChu, Taiwan 300 Republic of China
NOV 1 7 2006
Re: K063185
Trade/Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH5XY Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 26, 2006 Received: October 20, 2006
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 Incan that I DA mas made a aves and regulations administered by other Federal agencies. or the Act of any I ouchar the Act's requirements, including, but not limited to: registration 1 od inust compry with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quality tion 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) I mis letter will and wyour to began finding of substantial equivalence of your device to a premarket notification. - The Pre 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), rryou donto specific at no room innee 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 may overnit oner gater gaternational 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/industry/support/index.html.
Sincerely yours,
Sujata Y. Michaud DMD
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 logo for Radiant Innovation Inc. The logo is split into two parts, with the English version on the left and the Chinese version on the right. The English version of the logo is "RADIANT INNOVATION", with "INNOVATION" in a smaller font above "RADIANT". The Chinese version of the logo is arranged in two lines, with the first line in traditional Chinese characters and the second line being "RADIANT INNOVATION Inc."
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH5XY 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 807 Subpart C) Over-The-Counter Use _ 网
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| Number: | K063185 |
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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 http://www.radiantek.com.tw
§ 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.