(81 days)
Not Found
No
The summary describes a standard infrared thermometer and does not mention any AI or ML capabilities.
No.
The device is a thermometer used for temperature detection, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
This device is an ear thermometer used to detect body temperature, and while it provides information about a physiological state, it does not diagnose a disease or condition. It is used to measure a vital sign.
No
The device description explicitly states it uses an infrared sensor and infrared technology to measure temperature, indicating it is a hardware device.
Based on the provided information, the Fora ComfortScan Ear Thermometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fora ComfortScan Ear Thermometer measures body temperature by detecting infrared energy emitted from the ear canal or the surface of the skin. This is a direct measurement of a physical property of the body, not an analysis of a biological sample taken from the body.
- Intended Use: The intended use is to detect human body temperature and object surface temperature. This aligns with the function of a thermometer, not an IVD.
Therefore, the Fora ComfortScan Ear Thermometer falls under the category of a medical device, specifically a thermometer, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal, human skin (for object's surface temperature)
Indicated Patient Age Range
all ages
Intended User / Care Setting
Home
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
of 2
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 Ear | |
| Thermometer | ||
| Common Names | - Clinical electronic thermometer | |
| Classification Names | - Class II devices |
- 21 CFR 880.2910, FLL-clinical electronic
thermometer | |
| 3. Predicate Device | | |
| Trade/Proprietary Name: | Clever TD-1112 Ear/Skin/Surface IR
Thermometer | |
| Common/Usual Name: | - Clinical electronic thermometer | |
| Manufacturer | TaiDoc Technology Corporation | |
| 510 (k) Number | K061800 | |
. .
1
Page 2-of-2
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.
2
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.
3
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
4
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:
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
viii