(158 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the Suzhou Melodicare Medical Technology Co., Ltd. Infrared Thermometer, Breeze model, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are derived from the referenced standards, primarily ASTM E 1965-98 and ISO 80601-2-56.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Breeze model) |
|---|---|
| Accuracy: ±0.2℃ (0.4℉) (ASTM E 1965-98, ISO 80601-2-56) | ±0.2℃ (0.4℉) |
| Measurement Range: Covers human body temperature range during intended application (implied by clinical testing per ASTM E 1965-98 and ISO 80601-2-56) | 34.0℃~42.4℃ (93.2℉~108.3℉) (Verified to meet accuracy requirements within this range) |
| Electrical Safety & EMC | System complies with IEC 60601-1: 2012, IEC 60601-1-11: 2015, and IEC 60601-1-2: 2014 |
| Biocompatibility | Cytotoxicity, Skin Sensitization, and Skin Irritation tests conducted per ISO 10993-1 |
| Reprocessing: Cleaning and Disinfection | Validation testing results for cleaning and disinfection are adequate and acceptable. |
| Software Verification & Validation | Documentation provided in accordance with FDA Guidance for software with a moderate level of concern. |
| Risk Analysis | Conducted in accordance with ISO 14971: 2007. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: A minimum of 144 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It describes the clinical study as "randomized, with a simple blind homologous control." It doesn't specify if it was retrospective or prospective, but clinical studies for device submissions are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For clinical thermometers, ground truth often refers to a reference thermometer reading taken by trained personnel (e.g., nurses or doctors) rather than an "expert concensus" in the diagnostic imaging sense.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. For simple clinical measurements like temperature, an adjudication process involving multiple experts for ground truth is generally not applicable in the same way it would be for complex image interpretation. The ground truth is typically a direct measurement from a reference device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure the effect size of AI on reader performance. This device is a direct measurement clinical thermometer.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done for the device's accuracy. The "Bench Testing" section confirms that the system complies with ISO 80601-2-56: 2009 for "performance effectiveness" and the "Clinical data" section states that "Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature." These standards directly evaluate the device's measurement accuracy against reference standards.
7. Type of Ground Truth Used
The ground truth used for the clinical study would be the measurements from a recognized reference thermometer or method as specified by the ASTM E 1965-98 standard. This standard outlines procedures for determining the accuracy of infrared thermometers against a reference temperature measurement in a clinical setting.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its size. Clinical thermometers, especially non-AI-driven ones, are typically calibrated during manufacturing and then validated for accuracy with a test set, rather than "trained" in the machine learning sense. If there are internal algorithms for temperature compensation or conversion, their development might involve internal data, but this is not typically disclosed or referred to as a "training set" in this context.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is described for this device, the establishment of ground truth for such a set is not applicable or detailed in the document. The device's performance relies on robust engineering, calibration against traceable standards, and validation of its accuracy.
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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
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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, ChinaTel.: +86 -791-85216384 |
|---|---|
| Contact Person: | Xiaoqian Zou |
| Prepare date: | October 17, 2019 |
| 2. Device name and classification: | Device Name: Infrared ThermometerModels: BreezeClassification Name:21 CFR 880.2910Clinical Electronic ThermometersProduct code: FLLRegulatory 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 DeviceBreeze | Predicate DeviceEFT-165/ K171214 | ComparisonResult |
|---|---|---|---|
| Manufacture | Suzhou Melodicare MedicalTechnology Co., Ltd. | Brav Electronic TechnologiesCo., Ltd. | --- |
| Indications forUse | The infrared thermometer isintended for the measurementand monitoring of human bodytemperature by physician orlay person. The device is notintended for infants less thanthree months. | The infrared thermometer isintended for the measurementand monitoring of human bodytemperature by doctor orcustomers in the hospital orhome. | Different¹ |
| Operational Specifications | |||
| OperationalPrinciple | Infrared radiation detection | Infrared radiation detection | Same |
| MeasuringMode | Forehead and ear | Forehead and ear | Same |
| MeasurementRange | 34.0℃~42.4℃(93.2℉~108.3℉) | 32.0℃~42.9℃(89.6℉~109.2℉) | Different ² |
| MeasurementDistance | 0 cm | 0 cm | Same |
| Accuracy | ±0.2℃(0.4℉) | ±0.2℃(0.4℉) | Same |
| Memory DataLimit | memorize 32 measurementsautomatically | memorize 20 measurementsautomatically | Same |
| Productconfiguration | It is mainly composed withinfrared sensor, signalreceiving processor, buttons,buzzer, LCD display, batteryand etc. | It is mainly composed withinfrared sensor, signalreceiving processor, buttons,buzzer, LCD display, batteryand etc. | Same |
| Temperatureunit andconversion | Dual temperature units "℃"and "℉" optional, and the twounits can convert by theconversion key automatically | Dual temperature units "℃"and "℉" optional, and the twounits can convert by theconversion key automatically | Same |
| BluetoothCompatible | NO | YES | Different 3 |
| ApplicableStandards | IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ASTME1965-98, ISO 10993-5, ISO10993-10, ISO 80601-2-56 | IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ASTME1965-98, ISO 10993-5, ISO10993-10, ISO 80601-2-56 | Same |
| Display | 0.1℃/℉ LCD | 0.1℃/℉ LCD | Same |
| OperatingEnvironment | 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 |
| StorageEnvironment | -20°C | -20°C | 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 | |||
| PatientContactingMaterials | ABS, PE | ABS, PE | Same |
| PatientContacting | 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.
§ 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.