(286 days)
Infrared Thermometer (FT-F11) 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.
Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.
This infrared Ear Thermometer measure the temperature. It's from the ear canal which can be got more quickly and accurate the human body temperature.
This product has the following advantages:
1). Easy to Clean& Probe cover Free.
2). High speed & Accuracy scan the reading of temperature.
3). Conveniency, Only one key operation.
4). Automatic display last memorized measuring temperature. When do you turn on the power.
The provided text describes the substantial equivalence of the "Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)". The acceptance criteria, study details, and related information are extracted below:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for performance metrics like accuracy, but rather uses a comparison table to predicate devices. The implied acceptance criteria are that the new device's specifications are comparable to or within acceptable ranges of the predicate devices, and that testing confirms its safety and effectiveness.
| Feature | Predicate Device (K081788) (InnoTherm ICT-100, ICT-200) | Predicate Device (K101912) (THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301) | Subject Device (FT-F11, FT-F21, FT-F31, FT-F41) | Reported Device Performance (Implied) |
|---|---|---|---|---|
| Intended Use | Electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric, and adult populations. | Intermittent measurement of human body temperature in people of all ages. | FT-F11: Electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric, and adult populations. FT-F21, F31, F41: Intermittent measurement of human body temperature in people of all ages. | Matches intended use of predicate devices, with specialization for FT-F11. |
| Measurement temp range | 32.0 ~ 43.0 °C (89.6 ~ 109.4°F) | 34 ~ 42.5°C | 34°C - 43°C | Within or comparable to predicate ranges. |
| Ambient range | 16.0 ~ 40.0°C (93.2 ~ 108°F) | 15 ~ 40°C | 10.0°C-40.0°C | Within or comparable to predicate ranges. |
| Storage range | -10 ~ 41°C (14 ~ 105.8°F) | -20 ~ 50°C | -25.0°C-55.0°C | Within or comparable to predicate ranges. |
| Display type | LCD | LCD | LCD | Matches predicate device. |
| Activation | Scan button | Scan button | Scan button | Matches predicate device. |
| Battery type | CR2032 * 1 pcs | Two 1.5V AAA type batteries | Two 1.5V AAA type batteries | Comparable to predicate devices. |
| Classification | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | Matches predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size for the test set used in the clinical or bench tests. It also does not explicitly state the country of origin of the data or whether the study was 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 document. For a clinical thermometer, ground truth typically comes from highly accurate reference thermometers or other established temperature measurement methods, rather than expert interpretation of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for establishing ground truth for the test set.
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:
This device is an infrared thermometer, not an AI-assisted diagnostic tool for which MRMC studies involving human readers would typically be conducted. Therefore, no MRMC study or effect size related to human reader improvement with AI is mentioned or relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone electronic clinical thermometer. The clinical and bench tests assess the performance of the device on its own. The document states, "The clinical and bench tests demonstrated its accuracy and effectiveness." This implies standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a clinical thermometer, the ground truth for temperature measurement would typically be established using a highly accurate reference thermometer or other validated temperature measurement standard. This would be part of the "clinical and bench tests" conducted, specifically adhering to standards like ASTM E 1965. The document does not explicitly state the specific method used to establish ground truth beyond referencing standards.
8. The sample size for the training set:
This information is not applicable and not provided. As an infrared thermometer, this device is likely a hardware-based measurement system and does not typically involve "training sets" in the context of machine learning or AI algorithms. Its functionality is based on established physical principles of infrared detection.
9. How the ground truth for the training set was established:
This information is not applicable and not provided, as there is no mention of a "training set" for this type of device.
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K11703
MAR 2 9 2012
510(K) SUMMAKY
[as required by 807.92(c)]
-
- Identification of the Device:
-Proprietary-Trade Name: Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)" / Fudakang Industrial Co., Ltd. -Classification Name thermometer, electronic, clinical, Product Code: FLL,
- Identification of the Device:
-Common/Usual Name: Clinical Electronic Thermometer / Infrared Ear Thermometer
-
- Indications for Use (intended use):
Infrared Thermometer (FT-F11) 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.
- Indications for Use (intended use):
Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.
-
- Description of the device:
This infrared Ear Thermometer measure the temperature. It's from the ear canal which can be got more quickly and accurate the human body temperature.
- Description of the device:
This product has the following advantages:
- 1). Easy to Clean& Probe cover Free.
- 2). High speed & Accuracy scan the reading of temperature.
- 3). Conveniency, Only one key operation.
4). Automatic display last memorized measuring temperature. When do you turn on the power.
-
- Safety and Effectiveness, comparison to predicate device:
| Infrared Ear Thermometer(InnoTherm ICT-100,InnoTherm ICT-200)(K081788) | THE INFRAREDFOREHEADTHERMOMETER,MODEL FS- | Infrared Thermometer(FT-F11, FT-F21, FT-F31,FT-F41) |
|---|---|---|
| ------------------------------------------------------------------------------------ | ------------------------------------------------------- | ------------------------------------------------------------- |
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| 300&301(K101912) | |||
|---|---|---|---|
| Intended Use | The device is an electronicclinical thermometer usingan infrared sensor to detectbody temperature from theauditory canal in theneonatal, pediatric andadult population. | The InfraredForeheadThermometer, FS-300&301 is intendedfor intermittentmeasurement ofhuman bodytemperature inpeople of all ages. | Infrared Thermometer (FT-F11) is intended for anelectronic clinicalthermometer using aninfrared sensor to detectbody temperature from theauditory canal in theneonatal, pediatric andadult population.Infrared Thermometer,(FT-F21, FT-F31, FT-F41)is intended for intermittentmeasurement of humanbody temperature inpeople of all ages. |
| Measurementtemp range | 32.0 ~ 43.0 °C(89.6 ~ 109.4°F) | 34 ~ 42.5°C | 34°C - 43°C |
| Ambient range | 16.0 ~ 40.0°C(93.2 ~ 108°F) | 15 ~ 40°C | 10.0°C-40.0°C |
| Storage range | -10 ~ 41°C(14 ~ 105.8°F) | -20 ~ 50°C | -25.0°C-55.0°C |
| Display type | LCD | LCD | LCD |
| Activation | Scan button | Scan button | Scan button |
| Battery type | CR2032 * 1 pcs | Two 1.5V AAA typebatteries | Two 1.5V AAA typebatteries |
| Classification | thermometer, electronic,clinical (Class II), 21 CFR880.2910 | thermometer,electronic, clinical(Class II), 21 | thermometer, electronic,clinical (Class II), 21 CFR880.2910 |
-
- Testing information and Conclusion
In all material respects, the "Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)" is substantially equivalent to Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200) (K081788) INNOCHIPS TECHNOLOGY Co., Ltd. and THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301(K101912) / HUBDIC CO., LTD. Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent.
- Testing information and Conclusion
-
Contact person
NO.8 Yinhe Road ,Yuanjiangyuan Management one, Changping Town, Dongguan Guangdong, China. Tel: +86-769-81098181 Fax: +86-769-81098187 Contact person: Bob Yu / President
- Date Prepared: April 2011
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- Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence:
The safe and effective performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices. Infrared Thermometer (FT-F11, FT-F21, FT-F21, FT-F41) safety has been checked and validated by CHINA CEPREI (SICHUAN) LABORATORY. The clinical and bench tests* demonstrated its accuracy and effectiveness.
- Non clinical EN 60601-1:2006 on 26th July 2010 EN 60601-1-2:2007 on 21st July 2010 EN 12470-5:2003 on 27th July 2010 - Clinical ASTM E 1965 on 19th Sep 2010
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fudakang Industrial Company Limited C/O Mr. Daniel Nam General Manager PATS Corporation 205 South Broadway, Suite 718 Los Angeles, California 90012
MAR 2 9 2012
Re: K111703
Trade/Device Name: Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 15, 2012 Received: March 21, 2012
Dear Mr. Nam:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Nam
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. 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):
Device Name: Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)
Indications for use: Infrared Thermometer (FT-F11) 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.
Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.
Federal law restricts this device to sale on or by the order of a licensed practitioner.
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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhi C. Chay 3/29/11
(Division Sign-Off)
Page 1 of 1
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111703
§ 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.