(257 days)
Not Found
No
The description focuses on standard infrared thermometry technology and does not mention AI, ML, or related concepts. The performance studies described are standard clinical accuracy validations.
No.
The device is intended to measure human body temperature, which is a diagnostic function, not a therapeutic one. It does not provide treatment or alleviate symptoms.
Yes
Explanation: The device measures human body temperature, which is a physiological parameter used to assess health status and can inform diagnosis (e.g., presence of fever indicating infection or illness).
No
The device description explicitly states it is a "handheld device" and mentions hardware components like an LCD, batteries, and a thermopile sensor. It also details mechanical changes and hardware adjustments for different models.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures human body temperature directly from the eardrum or forehead. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is to measure body temperature, which is a physiological measurement, not an in vitro diagnostic test.
Therefore, while it is a medical device used for health assessment, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
eardrum or forehead
Indicated Patient Age Range
people over three months old
Intended User / Care Setting
homecare and healthcare environments.
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)
Performance data includes "Non-Clinical Data" and "Clinical Data".
Non-Clinical Data:
Biocompatibility testing: Conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10. Results: No potential cytotoxicity, No sensitization observed (test sample score 0), Negligible (no observed primary irritation, test sample score 0).
Electrical safety and electromagnetic compatibility (EMC) testing: Complies with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.
Bench Testing: Complies with ISO 80601-2-56 for performance effectiveness.
Software Verification and Validation Testing: Test results demonstrated the software function met the requirements. Software was considered "moderate" level of concern.
Clinical data:
Clinical accuracy validation was carried out on people over three month indicated in the instructions for use, per Section 201.102 of ISO 80601-2-56. The number of subjects in each age group met the minimum number requirements.
Sample Sizes for Ear mode from model AOJ-20A to AOJ-20Y: 138, 136, 137, 138, 137, 137, 135, 137, 137, 137, 137 respectively.
Sample Sizes for Forehead mode from model AOJ-20A to AOJ-20Y: 138, 136, 137, 138, 137, 137, 135, 137, 137, 137, 137 respectively.
Age groups: A1 1 month up to 3 months (Not applicable for this device as it's for people older than 3 months), A2 3 months up to one year, B older than one and younger than five years, C older than five years, C1 older than five and younger than six years, C2 older than six and younger than 12 years, C3 older than 12 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2022
Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301&4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China
Re: K221039
Trade/Device Name: Infrared Thermometer, models AOJ-20A, AOJ-20C, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 17, 2022 Received: November 28, 2022
Dear Jack Wang:
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 aware 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
ce determination does not mean that FDA
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Joyce M. Whang -S
Joyce M. Whang, Ph.D. Deputy Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221039
Device Name
Infrared Thermometer, models AOJ-20A. AOJ-20C. AOJ-20C. AOJ-20E. AOJ-20F. AOJ-20F. AOJ-20M. AOJ-20M. AOJ-20T. AOJ-20R and AOJ-20Y
Indications for Use (Describe)
The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, 518126, Shenzhen, China TEL: 86 755-27786026 |
|---|---|
| Contact Person: | Jack Wang |
| Prepare date: | December 20, 2022 |
| 2. Device name and classification: | Device Name: Infrared Thermometer Models: AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y Classification Name: 21 CFR 880.2910 Clinical Electronic Thermometers Product code: FLL Regulatory Class: Class II |
| 3. Predicate Device: | Shenzhen AOJ Medical Technology Co., Ltd. AOJ-20A cleared under K182133. The predicate has not been subject to any recall. |
| 4. Device Description: | The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E. |
| 6. Indications for Use: | The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments. |
4
7. Predicate Device Comparison
| ITEM | Proposed Device
AOJ-20 series/K221039 | Predicate Device
AOJ-20A/K182133 | Comparison
Result |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen AOJ Medical
Technology Co., Ltd. | Shenzhen AOJ Medical
Technology Co., Ltd. | Same |
| Indications for
Use | The Infrared thermometer is
intended to measure human
body temperature of people over
three months old from the
eardrum or forehead. It is
indicated to be used in homecare
and healthcare environments. | 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. | 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 for ear mode
03 cm for forehead mode | 0 cm for ear mode3 cm for forehead mode | Same |
0
| Accuracy | ±0.2°C(0.4°F) | ±0.2°C(0.4°F) | Same |
| Memory Data
Limit | The last 40 values (except
AOJ-20A is 10 values) | The last 20 values | Different 2 |
| 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 |
| Operation Mode | Adjusted Mode | Adjusted Mode | Same |
| Age toggle
switch | Used for sub-mode switch for
children forehead measurement,
available for AOJ-20B and
AOJ-20E only | Not available | Different 3 |
| Sub-mode
selection | Button for sub-mode selection
of children forehead
measurement, available for
AOJ-20M only | Not available | Different 3 |
| Toggle Switch
for unit switch | Available for all models except
AOJ-20Y, switch the unit by
toggle switch | Not available, unit switch is
realized by button operation | Different 4 |
| Touch function | Realize the mode switch by
touching, available for AOJ-20Y
only | Not available | Different 5 |
| Temperature unit
and conversion | Dual temperature units "°C" and
"°F" optional, and the two units
can convert by the conversion | Dual temperature units "°C" and
"°F" optional, and the two units
can convert by the conversion | Same |
| Display | 0.1°C/°F, LCD(except AOJ-20Y) | 0.1°C/°F, LCD | Same |
| Operating
Environment | Temperature: 5°C40°C40°C
(50°F-104°F)
Humidity: 15%-95% RH,
non-condensing
Atmospheric pressure: 70-106
kPa | Temperature: 10°C
(50°F-104°F)
Humidity: 15%-95% RH,
non-condensing
Atmospheric pressure: 70–106
kPa | Different 6 |
| Storage
Environment | Ambient Temperature: -20°C to
55°C (-4°F-131°F)
Relative Humidity: