(89 days)
No
The summary describes a standard infrared thermometer and does not mention any AI or ML capabilities.
No
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
Explanation: The device is an infrared thermometer intended to measure human body temperature. While temperature can be an indicator for health, the device itself is described for measurement, not for providing a diagnosis or interpreting the temperature data for a diagnosis. It assists in gathering information, but does not perform a diagnostic function.
No
The device description explicitly states it is a "handheld device" and mentions "product enclosure, PCB layout and button designs," which are hardware components. While it can transmit data to a non-device app, the core temperature measurement function is performed by the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures body temperature directly from the eardrum or forehead. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to measure human body temperature, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, based on the provided information, the Infrared thermometer described is a medical device, but it falls under a different category than In Vitro Diagnostics.
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.
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 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 and can also be transmitted to a non-device APP to record and display through Bluetooth.
There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eardrum or forehead
Indicated Patient Age Range
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)
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance data were referenced in support of the substantial equivalence determination. 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 contacting, limited exposure (-less than 24 hours). And the evaluation of testing includes the following tests:
- · Cytotoxicity
- · Skin Sensitization
- · Skin Irritation
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 themometer device, consisting of all 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 documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software for this device was considered as a "Basic" Documentation level.
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.
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.
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October 14, 2023
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 District Shenzhen, Guangdong 518126 China
Re: K232128
Trade/Device Name: Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 13, 2023 Received: July 17, 2023
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Daniel Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors
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OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Infrared Thermometer (AOJ-20A); Infrared Thermometer (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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | Prepared on: 2023-07-17 | |||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Shenzhen AOJ Medical Technology Co., Ltd | |||
| Applicant Address | Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park, | |||
| Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, Shenzhen | ||||
| Guangdong 518126 China | ||||
| Applicant Contact Telephone | 86 755-27786026 | |||
| Applicant Contact | Mr. Jack Wang | |||
| Applicant Contact Email | regulation@aojmedical.com | |||
| Device Name | ||||
| 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Infrared Thermometer (AOJ-20A); | |||
| Infrared Thermometer (AOJ-20Y) | ||||
| Common Name | Clinical electronic thermometer | |||
| Classification Name | Thermometer, Electronic, Clinical | |||
| Regulation Number | 880.2910 | |||
| Product Code | FLL | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20Y | FLL | ||
| K220276 | Infrared Thermometer TET-351 (Reference Device) | FLL | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The 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 and can also be transmitted to a non-device APP to record and display through Bluetooth. | ||||
| There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs. | ||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |||
| 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. | ||||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |||
| The indication for use of the subject device is the same as the predicate devices. | ||||
| Technological Comparison | 21 CFR 807.92(a)(6) |
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The subject device is a modification device to the device cleared by K221039.The only modification is software change to allow Bluetooth communication to a non-device APP. K220276 was used as a reference device to support the evaluation of the Bluetooth feature.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance data were referenced in support of the substantial equivalence determination. 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 contacting, limited exposure (-less than 24 hours). And the evaluation of testing includes the following tests:
- · Cytotoxicity
- · Skin Sensitization
- · Skin Irritation
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 themometer device, consisting of all 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 documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software for this device was considered as a "Basic" Documentation level.
Not Applicable.
Based on the non-clinical performance data as document, the subject devices were found to be as safe, as effective, and perform as well as the legally marketed devices identified above.