(176 days)
Not Found
No
The summary describes a standard infrared ear thermometer and does not mention any AI or ML components or capabilities.
No.
The device is described as an infrared ear thermometer for detecting body temperature, which is a diagnostic tool, not a therapeutic one.
No
This device is an infrared ear thermometer used to measure body temperature, which is a vital sign, not to diagnose a disease or condition. While temperature can be an indicator of illness, the device itself performs a measurement function, not a diagnostic one.
No
The device description explicitly states it uses an "infrared sensor" to detect temperature, indicating a hardware component is essential for its function.
No, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infrared Ear Thermometer measures body temperature directly from the auditory canal using an infrared sensor. It does not analyze a sample taken from the body.
- Intended Use: The intended use is to detect body temperature, which is a physiological measurement, not an analysis of a biological sample.
Therefore, based on the provided information, the Infrared Ear Thermometer is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Product codes
FLL
Device Description
Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal
Indicated Patient Age Range
neonatal, pediatric and adult population
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed according to 'Harmonized Standard and ASTM'. Test results support the conclusion that actual device performance satisfies the design intent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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K081788 pg 1 of 2
510(K) SUMMARY
[as required by 807.92(c)]
OEC 1 7 2008
-
- Identification of the Device:
-Proprietary-Trade Name: "Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200)" INNOCHIPS TECHNOLOGY Co., Ltd. -Classification Name thermometer, electronic, clinical, Product Code: FLL -Common/Usual Name: Clinical Electronic Thermometer / Infrared Ear Thermometer
- Identification of the Device:
-
- Equivalent legally marketed device:
This product is similar in design and identical in function to the K011059 / INFARED EAR THERMOMETER, MODEL TH8 SERIES / RADIANT INNOVATION, INC.
- Equivalent legally marketed device:
-
- Indications for Use (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.
- Indications for Use (intended use):
-
- Description of the device:
Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.
- Description of the device:
| Intended Use | |
|---|---|
| Infrared Ear Thermometer | |
| (InnoTherm ICT-100, InnoTherm ICT- |
-
| RII INFRARED EAR
THERMOMETER, MODELS TH8
SERIES (K011059) |
| 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. | 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. |
-
- Safety and Effectiveness, comparison to predicate device:
1
202
| Measurement
temp range | 32.0 ~ 43.0 ℃
(89.6 ~ 109.4 °F) | 34.0 ~ 42.2 ℃
(93.2 ~ 108 °F) |
|---------------------------|------------------------------------------------------------------|------------------------------------------------------------------|
| Ambient range | 16.0 ~ 40.0 ℃
(93.2 ~ 108 °F) | 10 ~ 40 ℃
(50 ~ 104 °F) |
| Storage range | -10 ~ 41 ℃
(14 ~ 105.8 °F) | -20 ~ 50 ℃
(-4 ~ 122 °F) |
| Display type | LCD | LCD |
| Activation | Scan button | Scan button |
| Battery type | CR2032 * 1 pcs | CR2032 * 1 pcs |
| Classification | thermometer, electronic, clinical
(Class II), 21 CFR 880.2910 | thermometer, electronic, clinical
(Class II), 21 CFR 880.2910 |
6. Testing information and Conclusion
In all material respects, the "Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200)" is substantially equivalent to RII INFRARED EAR THERMOMETER, MODELS TH8 SERIES (K011059) RADIANT INNOVATION, INC. Testing was performed according to 'Harmonized Standard and ASTM'. Test results support the conclusion that actual device performance satisfies the design intent.
2
Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innochips Technology Company, Limited C/O Mr. Brandon Choi General Manager PATS Corporation 49 Candlewood Way Buena Park, California 90621
DEC 1 7 2008
Re: K081788
Trade/Device Name: Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 21, 2008 Received: November 21, 2008
Dear Mr. Choi:
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. Choi
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,
Clint S. Liz, Ph.D.
Chiu S. Lin, Ph. D Division 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 (if known):
Device Name: Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200)
Indications for use:
Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Anten Om
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________