(13 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 TH88 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 total operation takes a few seconds. The measured temperature then appears on a LCD display.
The provided text describes a Special 510(k) submission for the Radiant Innovation Inc. Infrared Ear Thermometer, Models TH88 series. This submission focuses on demonstrating substantial equivalence to a previously cleared device (Models TH8 series) based on minor modifications (outer appearance and probe cover installation instructions). As such, the submission primarily relies on compliance with voluntary standards rather than a detailed performance study with acceptance criteria and statistical analysis of device performance against a ground truth.
Therefore, many of the requested details about acceptance criteria and a comprehensive study showing the device meets them cannot be extracted directly from this document. The document states that the modifications "will not significantly change the safety and effectiveness" and that "bench testing contained in this submission supplied demonstrate that the modification of TH88 do not Thus, the RII Infrared Ear raise any new questions of safety or effectiveness."
However, I can extract information related to the standards the device complies with, which implicitly define performance expectations.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document explicitly states compliance with ASTM E1965 for clinical electronic thermometers. This standard defines performance requirements (e.g., accuracy, precision, stability).
- Reported Device Performance: The document does not provide specific performance metrics (e.g., mean bias, standard deviation of differences) for the TH88 series. It only states that the device complies with ASTM E1965, implying its performance meets the requirements of that standard.
Table of Acceptance Criteria (from ASTM E1965 compliance) and Reported Device Performance (implied):
| Acceptance Criteria (from ASTM E1965) | Reported Device Performance |
|---|---|
| Specific performance metrics as defined by ASTM E1965 (e.g., accuracy, precision, repeatability, stability under various conditions) | Device is compliant with ASTM E1965, implying it meets the performance requirements of this standard. Specific numerical performance data for the TH88 series is not provided in this document. |
| Safety requirements as per IEC 60601-1 and IEC 60601-1-2 | Device is compliant with IEC 60601-1 and IEC 60601-1-2, implying it meets the safety and EMC requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. The document refers to "bench testing," which typically occurs in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a clinical study where ground truth would be established by experts. Performance is assessed against a standard (ASTM E1965), which would involve calibrating the device against known temperature references.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No human adjudication described for performance testing of a thermometer.
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:
- Not applicable. This is a simple electronic thermometer, not an AI-powered diagnostic device requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the thermometer operates "standalone" in function, the document does not describe a standalone algorithm performance study in the context of AI/software. Its performance is measured directly as a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for evaluating thermometer accuracy generally involves known, precisely controlled temperature references (e.g., a calibrated blackbody radiator or temperature bath) as specified by standards like ASTM E1965. The document implies this by stating compliance with ASTM E1965.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/machine learning model that would require a "training set."
In summary, the document is a Special 510(k) for minor device modifications, and as such, it defers to compliance with established voluntary standards (primarily ASTM E1965) for demonstrating safety and effectiveness rather than presenting a novel, detailed performance study with clinical ground truth and expert adjudication.
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EXHIBIT#1
FEB 2 8 2002
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:
Submitter's Identification: 1.
Radiant Innovation Inc., No. 40, Lane 19, Bade Road Hsin-Chu City Taiwan, R.O.C.
Contact:
Mr. Charles Chang Eng. Dep. Manager
Date Summary Prepared: Feb/07/2002
Name of the Modification Device: 2.
Infrared Ear Thermometer, Models TH88 series
3. Current Clearance Device:
Radiant Innovation Infrared Ear Thermometer, Models TH8 series. ( FDA# K011059)
Device Description: 4.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH88 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 The total The measured temperature then appears on a LCD display. calculation. operation takes a few seconds.
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Image /page/1/Picture/0 description: The image shows the logo for RADIANT INNOVATION Inc. The logo is in black and white and features the company name in both English and Chinese. The English name is in a bold, sans-serif font, while the Chinese name is in a traditional, serif font. The logo also includes a small graphic of a lightbulb.
Intended Use: 5.
The device is an electronic clinical thermometer using an infrared sensor to detect body The device is an crocronic childed in the neonatal, pediatric and adult population used in the home setting.
Comparison to the Cleared Devices: 6.
The RII Infrared Ear Thermometer, Models TH88 series are substantially equivalent to THE CHI Intrared Dar Internice Ear Thermometer, Models TH8 series, on the principle of operation, scientific technology with the same intended use, technological characteristics and specifications.
The only differences between TH8 and TH88 series Infrared Ear Thermometer are the outer appearance and addition operation procedures for probe cover installation on the user's manual which will not significantly change the safety and effectiveness .
Tests Performed for Determination of Substantial Equivalence are as follows: 7.
Compliance to applicable voluntary standards includes ASTM E1965, as well as IEC 60601 -1 and IEC 60601-1-2 requirements.
Guidance Documents included the FDA "Guidance On The Content of Premarket Satuation (51 0(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, Models TH88 series, have the same intended use and similar characteristics as the cleared device, Model TH8 series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH88 do not Thus, the RII Infrared Ear raise any new questions of safety or effectiveness. Thermometer, Models TH88 series is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.
FEB 2 8 2002
Radiant Innovation, Incorporated C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K020504
Trade/Device Name: Infrared Ear Thermometer, Models TH88 Series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 13, 2002 Received: February 15, 2002
Dear Ms. Falk:
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.
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.
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Page 2 - Ms. Falk
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Part 800); and i and listing (21 CFK Part 807), laboling (21 CFR Pat 820); and if (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 This letter will anow you to begin manoung your substantial equivalence of your device to 510(K) premiarket notification. The I Drivinalig as ification 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 II you desire specific ad rior for your for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 607.10 Ios in 100 milly, for questions on the promotion and
Office of Compliance at (301) 594-4618. Additionally, for questions on 1 (301) 504-4 Office of Comphance at (301) 591-1610. The Office of Compliance at (301) 594-4639. advertising of your ar agulation entitled, "Misbranding by reference to premarket Also, prease note the regulation on other general information on your responsibilities under nothication (ZTCPN Part 007.97). Oaks gold Manufacturers, International and the Act may be obtained from all Drivision of 2011 or (301) 443-6597 or at its
Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#EXHIBIT B
Indications for Use Statement
Special 510(k) Number (if known):
Device Name: Radiant Innovation Inc. Infrared Ear Thermometer, Models TH88 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cucurete
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F10(k) Number __ 020504
PrescriptionUse (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Page 12
§ 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.