(168 days)
Not Found
No
The description focuses on standard thermopile sensor technology and basic electronic components, with no mention of AI/ML terms or data processing beyond simple conversion and display.
No
The device is a thermometer, used for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device measures human body temperature, which is a physiological parameter. Measuring and providing a reading of a physiological parameter for the purpose of health monitoring or assessment falls under the definition of a diagnostic device. While it may not diagnose a specific disease, it provides information crucial for health assessment.
No
The device description explicitly states it is a handheld device composed of hardware components including a sensor, PCB, buttons, LCD display, and housing, powered by batteries. It is not solely software.
Based on the provided information, 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.
- Device Function: This device measures body temperature from the surface of the forehead using infrared thermal energy. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is to measure human body temperature, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, this forehead thermometer falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healthcare environments.
Product codes
FLL
Device Description
The Forehead thermometer is a handheld device, which can measure human body's temperature from the forehead for clinical or home use. The results can be displayed on LCD. The measurement is non-contact with a distance of 3-5 cm to measure the temperature. The thermometers are powered by AAA 1.5V×2 alkaline batteries, which can be used for people over one month. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface skin of the forehead, which is converted to a body temperature with the unit of °C or °F. The reference body site of the output temperature is oral. All the models share the similar design and the same critical components, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, voice mute/unmute and unit/mode switch, low battery detection and high temperature indicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
over one month
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)
Non-Clinical Data:
Biocompatibility testing
The biocompatibility evaluation for the thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered surface-contacting, limited exposure (-less than 24 hours). And the evaluation of testing is summarized as below.
Test name: In vitro Cytotoxicity; Test standard: ISO 10993-5; Evaluation endpoint: No potential cytotoxicity is allowed; Summary results: No potential cytotoxicity
Test name: Skin Sensitization; Test standard: ISO 10993-10; Evaluation endpoint: No sensitization should be observed; Summary results: No sensitization observed (test sample score 0)
Test name: Skin Irritation; Test standard: ISO 10993-10; Evaluation endpoint: No irritation should be observed; Summary results: Negligible (no observed primary irritation, test sample score 0).
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the thermometer device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 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, and the IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the thermometer device, consisting of all the accessories in the system. The system complies with the 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 for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Clinical data:
The clinical testing was conducted per Section 201.102 of ISO 80601-2-56 on the subject device. Clinical accuracy validation was carried out on people over one month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements.
Model AOJ-F101: Age group A1, A2, B, C; Subject number in total: 153
Model AOJ-F102: Age group A1, A2, B, C; Subject number in total: 142
Model AOJ-F103: Age group A1, A2, B, C; Subject number in total: 132
Age group is defined as below:
- A1 1 month up to 3 months
- A2 3 months up to one year
- B older than one and younger than five years
- C older than five years
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.
0
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October 7, 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: K221170
Trade/Device Name: Forehead Thermometer, models AOJ-F102, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 1, 2022 Received: September 6, 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
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.
Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221170
Device Name
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F105, AOJ-F105, AOJ-F106 and AOJ-F107
Indications for Use (Describe)
The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healtheare environments.
| 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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K221170
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: | September 14, 2022 |
| 2. Device name and classification: | Device Name: Forehead Thermometer Models: AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104, AOJ-F105, AOJ-F106 and AOJ-F107 Classification Name: 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe Product code: FLL Regulatory Class: Class II |
| 4. Predicate Device(s): | Shenzhen Changkun Technology Co., Ltd. CK-T1503 Infrared thermometer cleared under K193253. |
| 5. Device Description: | The Forehead thermometer is a handheld device, which can measure human body's temperature from the forehead for clinical or home use. The results can be displayed on LCD. The measurement is non-contact with a distance of 3-5 cm to measure the temperature. The thermometers are powered by AAA 1.5V×2 alkaline batteries, which can be used for people over one month. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface skin of the forehead, which is converted to a body temperature with the unit of °C or °F. The reference body site of the output temperature is oral. All the models share the similar design and the same critical components, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, voice mute/unmute and unit/mode switch, low battery detection and high temperature indicator. |
| 6. Indications for Use: | The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healthcare environments. |
7. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.
Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject
4
device. And no question is raised regarding to effectiveness and safety.
| ITEM | Proposed Device K221170
AOJ-F101/AOJ-F102/AOJ-F1
03/AOJ-F104/AOJ-F105/AOJ-
F106/AOJ-F107 | Predicate Device
CK-T1503/K193253 | Comparison
Result |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen AOJ Medical
Technology Co., Ltd. | Shenzhen Changkun Technology
Co., Ltd. | --- |
| Indications for
Use | The thermometer is intended to
measure human body
temperature of people over one
month from surface of forehead.
It is a non-sterile, reusable,
non-contact and hand-held
device. It is indicated to be used
in homecare and healthcare
environments. | Infrared Thermometer (model:
CK-T1501, CK-T1502,
CK-T1503) is a non-sterile,
reusable, non-contact and
handheld device. It can be used
by consumers in homecare
environment and doctors in
clinic as reference. It is intended
for measuring human body
temperature of people over one
month old by detecting infrared
heat from the forehead. | Different 1 |
| Operational Specifications | | | |
| Operational
Principle | Infrared radiation detection | Infrared radiation detection | Same |
| Measuring Mode | Forehead | Forehead | Same |
| Measurement
Distance | 35 cm for forehead mode | 35 cm for forehead mode | 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 |
| Measurement
Range | 32.0°C42.9°C | 32.0°C42.5°C | Different 2 |
| Accuracy | ±0.2°C | 32°C34.9°C: ± 0.3°C42°C: ±0.2°C
35°C
42.1°C42.5°C: ±0.3°C | Different 3 | 40°C
| Memory Data
Limit | 40 values | 32 values | Different 3 |
| Temperature unit
and conversion | YES, °C/°F switchable | YES, °C/°F switchable | Same |
| Applicable
Standards | IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11, and ISO
80601-2-56 | IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11, and ISO
80601-2-56 | Same |
| Display | 0.1°C/°F, LCD | 0.1°C/°F, LCD | Same |
| Operating
Environments | Temperature: 15°C
Humidity: 10% - 85%
(Non-Condensing)
Atmospheric pressure: 70–106
kPa | Temperature: 10°C~ 40°C
Humidity: 15%-85%
(Non-Condensing)
Atmospheric pressure: 80-106
kPa | Different 4 |
| Transport and
Storage
Environments | Temperature: 0°C~ 40°C
Humidity: no more than 90%
(Non-Condensing) | Temperature: 0°C~ 50°C
Humidity: ≤90%
(Non-Condensing) | Same |
| | Atmospheric pressure: 70-106 kPa | Atmospheric pressure: 80-106 kPa | |
| Power supply | 2 X 1.5V AAA Alkaline battery | 2 X 1.5V AAA Alkaline battery | Same |
| Physical Specifications | | | |
| Weight | AOJ-F101: 100 g (W/O battery)
AOJ-F102: 100 g (W/O battery)
AOJ-F103: 102 g (W/O battery)
AOJ-F104/AOJ-F105/
AOJ-F106 /AOJ-F107: 100 g
(W/O battery) | 172 g (battery included) | Different 5 |
| Dimensions
(mm×mm×mm) | AOJ-F101: 158×102×41
AOJ-F102: 158×83×45
AOJ-F103: 158×95×43
AOJ-F104/AOJ-F105/
AOJ-F106 /AOJ-F107:
158×83×45 | 149×77×43 | |
| Biological Specifications | | | |
| Patient
Contacting
Materials | ABS, PC | ABS | Different 6 |
| Patient
Contacting | Surface-contacting,
Less than 24 h | Surface-contacting,
Less than 24 h | Same |
| Biocompatibility
Standard | ISO 10993-5,
ISO 10993-10 | ISO 10993-5,
ISO 10993-10 | Same |
| Biocompatibility
Testing Items | In vitro Cytotoxicity
Skin Sensitization
Irritation | In vitro Cytotoxicity
Skin Sensitization
Irritation | Same |
Table 1 Comparison between the predicate CK-T1503 and the subject devices
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Justification for the differences:
-
- Different Indications for Use
As indicated in the comparison table, the application scenario of the subject device and the predicate device can be used both in hospital and home, they have same intended use, they are just some language description differences. The difference does not raise new safety and effectiveness issues.
- Different Indications for Use
-
- Different measurement range and accuracy
The measurement range and accuracy of subject device have minor difference from that of the predicate device, which are software-controlled function, and the measurement range and accuracy has been evaluated per the internal standards ISO 80601-2-56. The test results met the requirements.
- Different measurement range and accuracy
The differences do not raise new safety and effectiveness issues.
-
- Different memory capacity
The predicate device can store up to 32 values, while the subject device has the capacity to store 40 memories, this memory function has been verified during the design and development process. The test results met the requirements.
- Different memory capacity
The differences do not raise new safety and effectiveness issues.
-
- Different Operation Environments
Minor difference to operation environments between the subject device and the predicate device, but the system has been proved to be safe and effective since the performance testing was conducted under the suggested environment and the results met the requirements. The difference does not raise
- Different Operation Environments
6
new safety and effectiveness issues.
-
- Different Physical Specifications
The weight and size of the subject device and predicate are different. The performance testing was conducted in accordance with standards. The test results met requirements. The differences do not raise new safety and effectiveness issues.
- Different Physical Specifications
-
- Different Patient Contacting Materials
Different materials used in the subject device and the predicate.
- Different Patient Contacting Materials
Biocompatibility testing was conducted for the subject device. The test results demonstrate the subject device comply with standard ISO 10993-5 and ISO 10993-10. The difference does not raise any new safety and effective issues.
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
Biocompatibility testing
The biocompatibility evaluation for the thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered surface-contacting, limited exposure (-less than 24 hours). And the evaluation of testing is summarized as below.
| Test name | Test standard | Evaluation endpoint | Summary results |
|---|---|---|---|
| In vitro | |||
| Cytotoxicity | ISO 10993-5 | No potential | |
| cytotoxicity is allowed | No potential cytotoxicity | ||
| Skin Sensitization | ISO 10993-10 | No sensitization | |
| should be observed | No sensitization observed (test sample | ||
| score 0) | |||
| Skin Irritation | ISO 10993-10 | No irritation should | |
| be observed | Negligible (no observed primary | ||
| irritation, test sample score 0). |
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the thermometer device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 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, and the IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the thermometer device, consisting of all the accessories in the system. The system complies with the 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 for performance effectiveness.
Software Verification and Validation Testing
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Software verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Clinical data:
The clinical testing was conducted per Section 201.102 of ISO 80601-2-56 on the subject device. Clinical accuracy validation was carried out on people over one month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements. The specific number of tested subjects, age groups and test results are described as below.
| Item | | Age group | Subject number
in total |
|----------|--|--------------|----------------------------|
| Model | | | |
| AOJ-F101 | | A1, A2, B, C | 153 |
| AOJ-F102 | | A1, A2, B, C | 142 |
| AOJ-F103 | | A1, A2, B, C | 132 |
Age group is defined as below:
- A1 1 month up to 3 months l
- -A2 3 months up to one year
- -B older than one and younger than five years
- C older than five years -
9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. Based on the performance testing, comparison and analysis above, the subject AOJ Forehead Thermometer is substantially equivalent to the predicate device.