(106 days)
Not Found
No
The description details a standard infrared thermometer using a thermopile sensor and signal processing, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an infrared thermometer used to measure body temperature, which is a diagnostic function, not a therapeutic one. Therapeutic devices are designed for treatment or therapy.
No
Explanation: A diagnostic device is used to identify or determine the presence of a disease or condition. This device measures body temperature, which is a vital sign but does not independently diagnose a disease. While temperature can be an indicator, the device itself does not provide a diagnosis.
No
The device description explicitly states it is a handheld instrument mainly composed of hardware components such as an infrared sensor, signal receiving processor, buttons, buzzer, LCD display, and battery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The infrared thermometer described measures body temperature by detecting infrared radiation emitted from the eardrum or forehead. This is a measurement taken directly from the living body (in vivo).
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures a physical property (temperature) from the body surface.
Therefore, based on the intended use and device description, this infrared thermometer falls under the category of a general medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Infrared thermometers (AOJ-20A and AOJ-20B) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The infrared thermometers (AOJ-20A and AOJ-20B) are handheld instruments, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The intended patient population is all age groups except for babies under three months. The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of °C or °F.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation detection
Anatomical Site
eardrum or forehead
Indicated Patient Age Range
all age groups except for babies under three months
Intended User / Care Setting
professional use and home use
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)
Non-Clinical Data:
Performance Testing Information:
- (1) ISO 10993-5 Biological evaluation for medical device Part 5 Test for In Vitro Cytotoxicity
- (2) ISO 10993-10 Biological evaluation for medical device Part 10 Test for irritation and skin sensitization
- (3) AAMI TIR12:2004 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, Approved 23 December 2004.
Bench Testing Information:
- (1) ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009((R)2012 and A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- (2) IEC 60601-1-11: 2010 MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- (3) IEC 60601-1-11: 2010 MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- (4) IEC 60601-1-2: 2014 Medical electrical equipment =Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- (5) ISO 80601-2-56: 2009 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement for performance effectiveness.
- (6) Software verification and validation testing per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Clinical Data:
Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 90 subjects, of which 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.). with no single measurement error exceeding the allowable limit, provides a 99% confidence. A reference device is introduced as required by the standard, and the acceptance criteria is that clinical accuracy of the subject device is at least the same as that of the reference, and the accuracy is ±0.2℃ during the claimed measurement range 32℃ - 42.9℃.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.2°C(0.4°F) for measurement range 32℃ - 42.9℃.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EFT-165 Infrared Thermometer/K171214
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2018
Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao General Manager Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming District, Shenzhen Guangdong, 518105 China
Re: K182133
Trade/Device Name: Infrared Thermometer, models AOJ-20A and AOJ-20B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 12, 2018 Received: October 22, 2018
Dear Oihuan Zhao:
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182133
Device Name
Infrared thermometer, models AOJ-20A and AOJ-20B
Indications for Use (Describe)
The Infrared thermometers (AOJ-20A and AOJ-20B) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K182133
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd. |
|---|---|
| Room 202, HaoGu industry park, 2037 Guanguang road, Guangming district, | |
| 518105, Shenzhen, P.R. China | |
| Tel.: +86 18603031299 | |
| Contact Person: | Qihuan Zhao |
| Prepare date: | 2018-11-15 |
| 2. Device name | |
| and classification: | Device Name: Infrared Thermometer |
| Models: AOJ-20A, AOJ-20B | |
| Regulation Number: 21 CFR 880.2910 | |
| Regulation Name: Clinical Electronic Thermometer | |
| Product code: FLL | |
| Regulatory Class: Class II | |
| 3. Predicate | |
| Device(s): | Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer |
| /K171214 | |
| 4. Device | |
| Description: | The infrared thermometers (AOJ-20A and AOJ-20B) are handheld instruments, |
| which can measure human body's temperature either via the eardrum or the | |
| forehead for clinical or home use. The intended patient population is all age | |
| groups except for babies under three months. | |
| The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results | |
| can be displayed on LCD. | |
| A thermopile sensor is employed to detect or monitor the infrared thermal energy | |
| emitted from the eardrum or the surface of the skin of the forehead, which is | |
| converted into temperature measurement with the unit of °C or °F. | |
| 5. Indications for | |
| Use: | The Infrared thermometers (AOJ-20Aand AOJ-20B) take human body temperature |
| via the eardrum or forehead. They apply to all age groups except for babies under | |
| three months. Both devices apply to both professional use and home use. |
4
6.Predicate Device Comparison
| ITEM | Proposed Device
AOJ-20A&AOJ-20B | Predicate Device
EFT-165/K171214 | Comparison
Result |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen AOJ Medical
Technology Co., Ltd. | Brav Electronic Technologies
Co., Ltd. | --- |
| Indications for
Use | The Infrared thermometers
(AOJ-20Aand AOJ-20B) take
human body temperature via the
eardrum or forehead. They apply
to all age groups except for
babies under three months. Both
devices apply to both
professional use and home use. | The infrared thermometer is
intended for the measurement
and monitoring of human body
temperature by doctor or
customers in the hospital or
home. | Different 1 |
| Operational Specifications | | | |
| Operational
Principle | Infrared radiation detection | Infrared radiation detection | Same |
| Measuring Mode | Forehead and ear | Forehead and ear | Same |
| Measurement
Range | 32.0°C42.9°C109.2°F) | 32.0°C
(89.6°F42.9°C109.2°F) | Same |
(89.6°F
| Measurement
Distance | 0 cm | 0 cm | Same |
| Accuracy | ±0.2°C(0.4°F) | ±0.2°C(0.4°F) | Same |
| Memory Data
Limit | memorize 20 measurements
automatically | memorize 20 measurements
automatically | Same |
| Product
configuration | It is mainly composed with
infrared sensor, signal receiving
processor, buttons, buzzer, LCD
display, battery and etc. | It is mainly composed with
infrared sensor, signal receiving
processor, buttons, buzzer, LCD
display, battery and etc. | Same |
| Temperature unit
and conversion | Dual temperature units “°C” and
“°F” optional, and the two units
can convert by the conversion
key automatically | Dual temperature units “°C” and
“°F” optional, and the two units
can convert by the conversion
key automatically | Same |
| Applicable
Standards | IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11, and ASTM
E1965-98 | AAMI ANSI ES60601-1, IEC
60601-1-2, IEC 60601-1-11, and
ASTM E1965-98 | Same |
| Display | 0.1°C/°F, LCD | 0.1°C/°F, LCD | Same |
| Operating
Environment | Temperature: 10°C~40°C
(50°F-104°F)
Humidity: 15%-95% RH,
non-condensing
Atmospheric pressure: 70–106
kPa | 15°C ~ 35°C (59°F to 95 °F)