(81 days)
The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
The Fora ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.
The provided 510(k) summary for the Fora ComfortScan Ear Thermometer offers limited detail regarding specific acceptance criteria and the comprehensive study design. However, based on the available information, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The submission states compliance with voluntary standards, which inherently include acceptance criteria for accuracy and performance. Without the full standard documents, specific numerical criteria are not explicitly given in this summary. However, we can infer some general performance reporting.
| Acceptance Criteria (Inferred from standards and predicate) | Reported Device Performance (as stated in the summary) |
|---|---|
| Compliance with ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) | "The results were compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements." |
| Clinical acceptability of temperature differences and repeatability | "For clinical results, differences were within clinical acceptability and repeatability was statistically and clinically acceptable." |
| Accuracy within specified ranges (typically ±0.2°C or ±0.4°F for clinical thermometers within a certain range) | "differences were within clinical acceptability" and "repeatability was statistically and clinically acceptable." (Specific numerical values for accuracy and repeatability are not provided in this summary.) |
| Electrical safety and electromagnetic compatibility (EMC) requirements as per IEC standards | "compliance to applicable voluntary standards includes... IEC 60601-1 and IEC 60601-1-2 requirements." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The summary only mentions "clinical and non-clinical studies."
- Data Provenance: Not explicitly stated. Given the manufacturer's location (Taiwan), it's plausible the studies were conducted there, but this is an assumption. The summary does not specify if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the summary. For a clinical thermometer, "ground truth" for temperature is typically established using a reference thermometer (e.g., a mercury-in-glass thermometer or a highly accurate electronic thermometer calibrated to national standards), not human experts in the way medical image analysis might.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for subjective assessments, such as interpreting medical images. For a device measuring a quantitative physical parameter like temperature, adjudication by multiple experts isn't usually applicable for establishing the ground truth measurements. The "ground truth" would be the reading from a calibrated reference 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
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and the impact of AI assistance. A clinical thermometer measures a direct physiological parameter and does not involve human "readers" or AI assistance in its primary function for interpretation.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies performed (clinical and non-clinical) were inherently standalone in nature for the thermometer. The device itself measures temperature, and its performance is evaluated based on the accuracy and repeatability of those measurements compared to a reference standard, without human interpretation of its internal "algorithm." The results "were compliance to applicable voluntary standards" and "differences were within clinical acceptability and repeatability was statistically and clinically acceptable," indicating standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for temperature measurement would be established by comparison to a calibrated reference thermometer. While not explicitly stated, this is the standard practice for evaluating the accuracy of clinical thermometers, as dictated by standards like ASTM E1965-98. The summary refers to "clinical acceptability," which implies a comparison to a known, accurate temperature.
8. The sample size for the training set
This information is not applicable and therefore not provided. Clinical thermometers are typically hardware-based devices with firmware that executes a measurement algorithm. They don't typically undergo a "training" phase in the machine learning sense with a "training set." Performance is validated through testing on actual measurements.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of this device.
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510 (k) Summary
| AUG 11 2008 | Page 1-of-2 | |
|---|---|---|
| 1. Submitter Information | ||
| Company name | TaiDoc Technology Corporation | |
| Contact person | Yuhua Chen | |
| Address | 6F, No.127, Wugong 2nd Rd.,Wugu Township, Taipei County,248, Taiwan | |
| Phone | (886-2) 6625-8188 | |
| FAX | (886-2) 6625-0288 | |
| yuhua.chen@taidoc.com | ||
| 2. Name of Device | ||
| Trade Names | - Fora ComfortScan EarThermometer | |
| Common Names | - Clinical electronic thermometer | |
| Classification Names | - Class II devices- 21 CFR 880.2910, FLL-clinical electronicthermometer | |
| 3. Predicate Device | ||
| Trade/Proprietary Name: | Clever TD-1112 Ear/Skin/Surface IRThermometer | |
| Common/Usual Name: | - Clinical electronic thermometer | |
| Manufacturer | TaiDoc Technology Corporation | |
| 510 (k) Number | K061800 |
. .
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4. Device Description
The Fora ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.
5. Intended Use
The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal in the home. It is also available to detect object's surface temperature including human skin temperature.
6. Comparison to Predicate Device
Fora ComfortScan Ear Thermometer has equivalent technological characteristics and intended use as the Clever TD-1112 Ear/Skin/Surface IR Thermometer (K061800).
7. Performance Studies
The clinical and non-clinical studies were conducted to validate the effectiveness of use. The results were compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements. For clinical results, differences were within clinical acceptability and repeatability was statistically and clinically acceptable.
8. Conclusion
Fora ComfortScan Ear Thermometer demonstrates satisfactory performance and are suitable for their intended use.
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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 caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2008
Mr. Yuhua Chen Regulatory Affairs Specialist TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County 248, TAIWAN
Re: K081445
Trade/Device Name: Fora ComfortScan Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 19, 2008 Received: May 22, 2008
Dear Mr. Chen:
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. Chen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 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
Enclosure
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Indications for Use
510(k) Number:
Device Name: Fora ComfortScan Ear Thermometer
Indications for Use:
The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use __ X . (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Liana-Ai for ADW
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Kostinat 510(k) Number:
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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.