(158 days)
Not Found
No
The description focuses on standard infrared temperature measurement technology and does not mention any AI or ML components.
No.
The device is solely intended for measurement and monitoring of human body temperature, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is an infrared thermometer used to measure body temperature. While temperature can be an indicator of health, the device itself simply measures a physiological parameter and does not interpret results or provide a diagnosis of a condition or disease.
No
The device description explicitly lists hardware components such as infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, and batteries. It also mentions a Fresnel lens and ear cover. The performance studies include electrical safety, EMC testing, and bench testing, which are typical for hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- This Device's Function: The infrared thermometer measures body temperature by receiving infrared energy radiation directly from the human body (ear or forehead). This is a measurement taken on the body, not from a specimen taken from the body.
Therefore, based on the intended use and device description, this infrared thermometer is a medical device used for physiological measurement, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The infrared thermometer is intended for the measurement and monitoring of human body temperature by physician or lay person. The device is not intended for infants less than three months.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Breeze Infrared Thermometer measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.When measuring the ear temperature, the ear cover provided by the manufacturer must be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Forehead
Indicated Patient Age Range
The device is not intended for infants less than three months.
Intended User / Care Setting
physician or lay person. The device is intended to be used in the home setting and medical institutes.
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: Cytotoxicity, Skin Sensitization and Skin Irritation tests were conducted in accordance with ISO 10993-1.
- Reprocessing: Cleaning and Disinfection validation testing results are adequate and acceptable.
- Electrical safety and electromagnetic compatibility (EMC): Testing conducted on the Breeze Infrared thermometer device, complies with IEC60601-1: 2012, IEC 60601-1-11: 2015, and IEC 60601-1-2: 2014.
- Bench Testing: Conducted on the Breeze Infrared thermometer device, complies with ISO 80601-2-56: 2009 for performance effectiveness.
- Software Verification and Validation Testing: Provided in accordance with FDA Guidance for software with a moderate level of concern.
- Risk Analysis: Conducted in accordance with ISO 14971: 2007.
Clinical data:
- Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature.
- Study Type: Randomized, with a simple blind homologous control.
- Sample Size: A minimum of 144 subjects.
- Key results: Not explicitly stated, but the study intended to confirm performance for various age groups as referenced in Section 201.102 of ISO 80601-2-56.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.2℃(0.4℉)
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.
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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 & 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.
October 18, 2019
Suzhou Melodicare Medical Technology Co.,Ltd. Xiaoqian Zou General Manager Building Room 301, No 32 Hongxi Road, Suzhou High-Tech Zone Suzhou. 215163 China
Re: K191283
Trade/Device Name: Infrared Thermometer, Breeze model Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 11, 2019 Received: September 20, 2019
Dear Xiaoqian Zou:
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.
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
1
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 medical devices and radiation-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,
Geeta Pamidimukkala Acting 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
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Indications for Use
510(k) Number (if known) K191283
Device Name Infrared thermometer, model Breeze
Indications for Use (Describe)
The infrared thermometer is intended for the measurement and monitoring of human body temperature by physician or lay person. The device is not intended for infants less than three months.
| 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 in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Suzhou Melodicare Medical Technology Co., Ltd.
Building Room 301, no. 32 Hongxi road, Suzhou high-tech zone, Jiangsu province, China
Tel.: +86 -791-85216384 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Xiaoqian Zou |
| Prepare date: | October 17, 2019 |
| 2. Device name and classification: | Device Name: Infrared Thermometer
Models: Breeze
Classification Name:
21 CFR 880.2910
Clinical Electronic Thermometers
Product code: FLL
Regulatory Class: Class II |
| 3. Reason for Submission | New Application. |
| 4. Predicate Device(s): | Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer /K171214 |
| 5. Device Description: | Breeze Infrared Thermometer measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.When measuring the ear temperature, the ear cover provided by the manufacturer must be used. |
| 6. Indications for Use: | The infrared thermometer is intended for the measurement and monitoring of human body temperature by physician or lay person. The device is not intended for infants less than three months. |
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7. Predicate Device Comparison
In comparison to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.
Please refer to the following table that notes 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 device. No new questions are raised regarding effectiveness and safety.
| ITEM | Proposed Device
Breeze | Predicate Device
EFT-165/ K171214 | Comparison
Result |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Suzhou Melodicare Medical
Technology Co., Ltd. | Brav Electronic Technologies
Co., Ltd. | --- |
| Indications for
Use | The infrared thermometer is
intended for the measurement
and monitoring of human body
temperature by physician or
lay person. The device is not
intended for infants less than
three months. | The infrared thermometer is
intended for the measurement
and monitoring of human body
temperature by doctor or
customers in the hospital or
home. | Different¹ |
| Operational Specifications | | | |
| Operational
Principle | Infrared radiation detection | Infrared radiation detection | Same |
| Measuring
Mode | Forehead and ear | Forehead and ear | Same |
| Measurement
Range | 34.0℃42.4℃131°F)
(93.2℉108.3℉) | 32.0℃55°C (-4°F42.9℃131°F)
(89.6℉109.2℉) | Different ² |55°C (-4°F
| Measurement
Distance | 0 cm | 0 cm | Same |
| Accuracy | ±0.2℃(0.4℉) | ±0.2℃(0.4℉) | Same |
| Memory Data
Limit | memorize 32 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 "℃"
and "℉" optional, and the two
units can convert by the
conversion key automatically | Dual temperature units "℃"
and "℉" optional, and the two
units can convert by the
conversion key automatically | Same |
| Bluetooth
Compatible | NO | YES | Different 3 |
| Applicable
Standards | IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11, and ASTM
E1965-98, ISO 10993-5, ISO
10993-10, ISO 80601-2-56 | IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11, and ASTM
E1965-98, ISO 10993-5, ISO
10993-10, ISO 80601-2-56 | Same |
| Display | 0.1℃/℉ LCD | 0.1℃/℉ LCD | Same |
| Operating
Environment | 15°C ~ 35°C ( 59°F to 95 °F)
≤85% moisture condensation | 15°C ~ 35°C ( 59°F to 95 °F)
≤85% moisture condensation | Same |
| Storage
Environment | -20°C
≤90% moisture condensation | -20°C
≤90% moisture condensation | Same |
| Power supply | 2 X 1.5V AAA | 2 X 1.5V AAA | Same |
| Physical Specifications | | | |
| Weight | 62 g (without battery) | 72 g (without battery) | Different 4 |
| Dimensions
(length x width x height) | 161.5mm *35.8mm *55.9mm | 152mm * 44 mm *30mm | |
| Biological Specifications | | | |
| Patient
Contacting
Materials | ABS, PE | ABS, PE | Same |
| Patient
Contacting | Surface-contacting, less than 24 h | Surface-contacting, less than 24 h | Same |
Table 1 Comparison between the main predicate device EFT-165 and the subject device
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Justification for the differences:
-
- Different Indications for Use
As indicated in the comparison table, the subject device can be used both in hospital and home, which the predicate can be used in both scenarios. The difference is just the different language, so the different will not introduce any new questions of safety and effectiveness. The age range of the patients for the subject device is based on the conducted clinical testing.
- Different Indications for Use
-
- Different Measurement Range
The measurement range of the subject device is 34.0℃~42.4℃, minor different from that of the predicate device 32.0℃~42.9℃. The difference will not affect the clinical safety and effectiveness since the range can cover the temperature range during intended application scenarios, and the subject device has been verified to meet the accuracy requirements defined in the standards ASTM E 1965-98 and ISO 80601-2-56.
- Different Measurement Range
-
- Different Bluetooth function
The subject device is not equipped with the Bluetooth function while the predicate does, but absence of this function will not raise new safety and effectiveness.
- Different Bluetooth function
-
- Different Physical Specifications
The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor different ill not raise any safety and effectiveness questions.
- Different Physical Specifications
As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The only differences between the subject and predicate devices are the indications for use (which link specific age groups with specific modes of temperature reading) and the appearance and operating/storage environment, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical and clinical testing, the different indications and technological characteristics do not affect the safety and effectiveness of the Breeze Infrared thermometer system.
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8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data". Summary of the data provided is below:
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testinq
The biocompatibility evaluation for the Breeze Infrared thermometer was 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 tissue-contacting for a duration of less than 24 hours. And Cytotoxicity, Skin Sensitization and Skin Irritation tests were conducted.
Reprocessing: Cleaning and Disinfection
The sterilization and shelf life information provided are acceptable because the subject devices are non-sterile devices. The validation testing results for cleaning and disinfection of the subject devices are adequate and acceptable.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Breeze Infrared thermometer device. consisting of all the modules and accessories in the system complies with IEC60601-1: 2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11: 2015 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment, and the 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 standard for EMC.
Bench Testing
Bench testing was conducted on the Breeze Infrared thermometer device, consisting of all the accessories in the system. The system complies with 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.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
Risk Analysis
A risk analysis was conducted in accordance with ISO 14971: 2007 – Medical devices - Application of risk management to medical devices.
Clinical data:
Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature. This clinical study was randomized, with a simple blind homologous control, which consisted of a minimum of 144 subjects with the various age groups as referenced in Section 201.102 of ISO 80601-2-56.
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9. Substantial Equivalence Conclusion:
Differences between the indications for use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing, and risk management activities. The Suzhou Melodical Technology Co., Ltd. Breeze Infrared Thermometer is Substantially Equivalent (SE) to the Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer, cleared under K171214.