(115 days)
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature. The device is intended for use on the pediatric and adult population used in the home setting.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are electronic clinical thermometers using an infrared detector (thermopile detector) to detect electromagnetic radiation. The operation is based on measuring the body temperature from the auditory canal 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 measured temperature then appears on a LCD display. The total operation takes a few seconds.
The provided text describes a Special 510(k) Summary for a Radiant Innovation Inc. Infrared Ear Thermometer TH00XY series. This is a submission to the FDA for a modification to an existing, previously cleared device. Therefore, the "study" referred to is primarily focused on demonstrating substantial equivalence to the predicate device and compliance with established standards, rather than a de novo clinical trial with new acceptance criteria.
The document does not contain a detailed study report with specific acceptance criteria beyond compliance with standard performance metrics for thermometers, nor does it explicitly state performance metrics in a summarized table format with reported values. It primarily references compliance with existing standards.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table with specific acceptance criteria and reported device performance. Instead, it states compliance with recognized standards.
| Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|
| ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) | The device complies with this standard. (Specific performance values like accuracy, repeatability, etc., are implied by compliance but not explicitly stated in this summary.) |
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) | The device complies with this standard. |
| EN 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The device complies with this standard. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in terms of patient data. The tests conducted appear to be bench testing as stated: "More are bench testing contained in this submission supplicd demonstrate that the modification of TH00XY do not raise any new [questions]."
- Data Provenance: The document does not refer to clinical data or patient data with provenance information (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes bench testing and compliance with standards, not a clinical study involving expert-established ground truth for patient data.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes bench testing and compliance with standards, not a clinical study requiring adjudication of patient cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not done. The submission is for an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would typically involve human readers.
- Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study or AI assistance is described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in essence, the bench testing and compliance with ASTM E1965-98 can be considered a standalone performance assessment of the device (algorithm/hardware combination) without human intervention in the measurement process beyond operation. The thermometer itself provides a direct reading.
7. Type of Ground Truth Used
The ground truth for the performance claims is based on standardized measurement references and methodologies mandated by the cited standards (e.g., ASTM E1965-98). This involves calibrated heat sources and precision measurement techniques to assess accuracy, repeatability, and other performance characteristics. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. Infrared ear thermometers rely on physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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SEP - 9 2005
EXHIBIT # 1
SPECIAL 510(K) SUMMARY
This summary of Special 510(k) safety and effectiveness information is being submitted in accordance of This summary of Special 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: May/12/2005
Name of the Modification Device: 2.
Infrared Ear Thermometer TH00XY series (TH005A/B, TH007A/B and TH008A/B)
Current Clearance Device: 3.
Radiant Innovation Infrared Ear Thermometer, Models THXXN series (FDA#: K04037), TH11 Radiant Innovation Intrared Ear Themienst, 1000504) and TH8 series (FDA#: K011059).
series (FDA#: K030324), TH88 series (FDA#: K020504) and TH8 series (FDA#: K011059).
Device Description: 4.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are I he Kadian Innovation mos, minantrared detector (thermopile detector) to detect electrome themionelers using an intrared at the operation is based on measuring the body temperature from the auditor from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, the ear thermometer is inserted into a patient's outcer can canal. A The to measure caremperature, the measurement through the radiation exchanges.
Start button is pressed to start the measurement through the rachanges. The start button 15 pressed to start the the circuit for amplification and calculation, The measured temperature then appears on a LCD display. The total operation takes a few seconds.
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Intended Use: న.
The device is an electronic clinical thermometer using an infrated sensor to detect body The device is an electronic cinnear themneter ashing and adult population used in the home setting.
KOS 126 9
Tests Performed for Determination of Substantial Equivalence are as follows: 6.
Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601 -1 and EN 60601-1-2 requirements.
Guidance Documents included the FDA "Guidance On The Content of Premarket Notification Guidance Documents Included the TDA ronic The mometers", " "How to Prepare A Special
(510(k)) Submissions for Clinical Elect and Cleck on Casting Davica" (510(k)) Submissions Jor Cimical Electronic r a Change to an Existing Device" ..
9. Conclusions:
The RII Infrared Ear Thermometer TH00XY series, have the same untended use and similar The RII Infrared Ear Thermoneter THXXN series. More are bench testing contained in this characteristics as the cleared device that modification of TH00XY do not raise any new
submission supplicd demonstrate that the Stated For Thormamater Models TH00XY submission supplied demonstrate that the The RI Infrared Ear Thermometer, Models TH00X Y 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 United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures representing people. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2005
Mr. Frank Lin QA Dept. Manager Radiant Innovation, Incorporated 1F, No. 3, Industrial E. 9th Road Science-Based Industrial Park HsinChu, TAIWAN
Re: K051269
Trade/Device Name: Infrared Ear Thermometer TH00XY Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 5, 2005 Received: August 10, 2005
Dear Mr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your betermined the device is substantially equivalent (for the itelered above and not of attennelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to they been reclassified in accordance with the provisions of Americans, or to do rices that in tic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commay, therefore, market the device, subject to the general approvin application (11-2) The general controls provisions of the Act include controls providions of the restration, 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 (FMA), it may be subject to back adalaf 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 Please be advised that I DA 3 issualled on that your device complies with other requirements mean that IDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and regarments, including, but not limited to: registration You must comply with an the Fee b roquits (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 807), labeling (QS) regulation (21 CFR Pat 820); and if requirements as set form in the quality ajon 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) IThis letter will anow you to began mading of substantial equivalence of your device to a premiarket nonfication. - The FDA milling or 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), If you desire specific advice to: your as at (240) 276-0115. Also, please note the regulation i 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 obtain other general miseturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
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Indications for Use
510(k) Number (if known):
K 05-1269
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH00XY series
Indications For Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body
the see l he device is an electronic cimical themionecer doing an innulation in the least 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)
Shule H. Murdich Jr. Anthony Watson GHDB 1/8/05
(Division Sign-Off)
sthesiology, General Hospital, ontrol, Dental Devices
510(k) Number
300 新竹科學園區工業東九路 3 號 1 樓 http://www.radiantek.com.tw
1F, No.3, Industrial E. 9" Rd., Science-Based TEL:+886 3 564418 n , No.J, Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 564417
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§ 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.