(177 days)
Not Found
No
The summary describes a standard infrared thermometer and does not mention any AI or ML capabilities.
No
The device is an infrared thermometer intended for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
Explanation: The device is intended for the measurement of human body temperature, which is used to identify a fever, an indication of a potential medical condition. While it doesn't diagnose a specific disease, it provides data that can be used by a healthcare professional or an individual to inform diagnostic decisions or seek further medical attention.
No
The device description explicitly states it is a "hand-held, battery powered device" and measures temperature by detecting infrared radiation, indicating it is a physical hardware device, not software only.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an infrared thermometer that measures human body temperature from the forehead. It does not analyze any biological samples taken from the body. It directly measures a physical property (infrared radiation emitted by the skin) to infer body temperature.
Therefore, based on the provided information, this infrared thermometer falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared thermometer is non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use
Product codes
FLL
Device Description
The proposed device, infrared thermometer, is hand-held, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 1~5cm. The device is non-contacting infrared thermometer and intended for people of all age.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation detection
Anatomical Site
Forehead
Indicated Patient Age Range
people of all age
Intended User / Care Setting
home use and clinical use
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
A controlled human clinical study was conducted on proposed device by comparing against with predicate device in accordance with ASTM E1965-98 (2016). The test result demonstrated that accuracy and repeatability can meet the acceptance criteria. Therefore, it can be considered that the device conforms with ASTM E1965-98 (2016).
Key Metrics
Accuracy: ±0.2°C (0.4°F) at 35.0°C ~ 42.0°C (95.0°F ~ 107.6 °F) Others ±0.3°C (0.5 °F)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2021
Shandong Bittel Intelligent Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd Contact AddressP.O. Box 120-119 Shanghai. 200120 China
Re: K202368
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 14, 2021 Received: January 15, 2021
Dear Diana Hong:
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 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,
For Payal Patel 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202368
Device Name Infrared thermometer
Indications for Use (Describe)
The Infrared thermometer is non-contact infered thermometer intent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use
| 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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Exhibit # 2 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202368
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- Date of Preparation: 02/12/2021
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- Sponsor Identification
Shandong Bittel Intelligent Technology Co., Ltd. No.1 Rizhao North Road, Rizhao, Shandong China 276800
Establishment Registration Number: Not Registered yet
Contact Person: Cui Shi Position: Management Director Tel: +86-633-2212103 Fax: +86-633- 2212186 Email: sc@bittelgroup.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Infrared thermometer Common Name: Clinical electronic thermometer
Regulatory Information
Classification Name: Clinical electronic thermometer; Classification: II; Product Code: FLL; Regulation Number: 21CFR 880.2910 Review Panel: General Hospital;
Indication for Use Statement:
The Infrared thermometer is non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use
Device Description
The proposed device, infrared thermometer, is hand-held, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 1~5cm. The device is non-contacting infrared thermometer and intended for people of all age.
ર. Identification of Predicate Device
510(k) Number: K191251 Device Name: Infrared Thermometer Product Code: FLL; Regulation Number: 21CFR 880.2910
- Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test performed on the proposed device include
Biocompatibility testing
The biocompatibility test for the proposed device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing items include cytotoxicity, Sensitization and Irritation test, the test result demonstrated that there was no adverse
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effects, thereby, it can be determined that the device can comply with the following standards
-
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization
Electrical safety and EMC
Electrical safety and EMC testing were conducted on the proposed device and the test result demonstrated that the device can operate normally and did not raise any performance degradation and safety issue, thereby, it can be determined that the device can comply with the following standards
- A IEC 60601-1: 2005+CORR.1(2006)+CORR.2(2007)+AMI(2012) Medical electrical equipment-Part 1: general requirement for basic safety and essential performance
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IEC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests.
- A ISO 80601-2-56: 2017+A1: 2018 Medical Electrical Equipment- Part 1-2: Particular Requirements for Basic Safety And Essential Performance of Clinical thermometers for body temperature measurement
Software Verification and Validation Testing
Software verification and validation testing were conducted on the Infrared thermometer and 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 test result demonstrated that the software can achieve its performance.
- Clinical Test Conclusion 7.
A controlled human clinical study was conducted on proposed device by comparing against with predicate device in accordance with ASTM E1965-98 (2016). The test result demonstrated that accuracy and repeatability can meet the acceptance criteria. Therefore, it can be considered that the device conforms with ASTM E1965-98 (2016).
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Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K202368 | K191251 | ||
| Product Code | FLL | FLL | Same |
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Indication for Use | The Infrared thermometer is | ||
| non-contact infrared | |||
| thermometer intended for the | |||
| intermittent measurement of | |||
| human body temperature from | |||
| forehead for people of all age. | |||
| The device is reusable for | |||
| home use and clinical use | The Infrared thermometer is | ||
| non-contact infrared | |||
| thermometer intended for the | |||
| intermittent measurement of | |||
| human body temperature from | |||
| forehead for people of all age. | |||
| The device is reusable for | |||
| home use and clinical use | Same | ||
| Measurement Method | Infrared radiation detection | Infrared radiation detection | Same |
| Components | Side button and main button | ||
| Left/Right shell | |||
| Spear shell | |||
| Display screen case | |||
| Battery cover | Button | ||
| Shell | |||
| LCD display case | |||
| Battery cover | Different 1 | ||
| Measurement Range | 32.5°C ~ 42.5°C | ||
| (90.5 ~ 108.5 °F) | 32.0°C ~ 42.5°C | ||
| (89.6 ~ 108.5 °F) | Different 2 | ||
| Accuracy | ±0.2°C (0.4°F) at 35.0°C ~ | ||
| 42.0°C (95.0°F ~ 107.6 °F) | |||
| Others ±0.3°C (0.5 °F) | ±0.2°C (0.4°F) at 35.0°C ~ | ||
| 42.0°C (95.0°F ~ 107.6 °F) | |||
| Others ±0.3°C (0.5 °F) | Same | ||
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Memory | NA | 60 sets | Different 3 |
| Measurement mode | Direct mode | Direct mode | Same |
| Display type | LCD | LCD | Same |
| Measurement Place | Forehead | Forehead | Same |
| Measurement | |||
| distance | 1~5cm | ≤3cm | Different 4 |
| Response time | 1s | 1s | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Scale Selection | °C/°F | °C/°F | Same |
| Auto power-off while | |||
| no operation | Yes | Yes | Same |
| Operation | 15°C ~ 40°C (59 ~ 104 °F) | 10°C ~ 40°C (50°F ~ 104 °F) | Different 5 |
| environment | 15%~85% RH | 15%~95% RH | |
| Storage environment | -25°C~+50°C (-13 ~ +122°F) | ||
| 15%~90% RH | -25°C~+55°C (-13~+131°F) | ||
| 15%~95% RH | |||
| Power requirements | Two pieces of 1.5V AAA batteries | Two pieces of 1.5V AAA batteries | Same |
| Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
| Performance | Complied with ISO 80601-2-56 | Complied with ISO 80601-2-56 | Same |
| Service life | 3 years | Unknown | Different 6 |
| Patient-contact Materials | ABS | ||
| PC | |||
| Silicone rubber | ABS | Different 7 | |
| Biocompatibility | No Cytotoxicity | ||
| No Sensitization | |||
| No Irritation | No Cytotoxicity | ||
| No Sensitization | |||
| No Irritation | Same |
Table 1 Comparison of Technology Characteristics
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Different 1 - Components
The components of the proposed device is different with the predicate device. However, the components don't affect the intended use. Therefore, the different will not affect the substantially equivalency.
Different 2 - Measurement Range
The measurement range of the proposed device is different with the predicate device, but the measurement range of the proposed device is within the measurement range of predicate device and the measurement range can meet the requirement of ISO 80601-2-56. In addition, the clinical investigation has been conducted on the proposed device and the test result demonstrated that the accuracy can meet the requirement. Therefore, this difference is not considered to affect the substantially equivalency.
Different 3 - Memory
The proposed device does not have the memory function. However, this function does not affect the intended use. Therefore, the different will not affect the substantially equivalency.
Different 4 - Measurement distance
The measurement distance of the proposed device is different from the predicate device. However, the clinical investigation has been conducted on the proposed device within the intended measurement range (1~5cm) and the test result demonstrated that the accuracy can meet the requirement. Therefore, this difference is not considered to affect the substantially equivalency.
Different 5 - Operation environment & Storage environment
The operation environment and storage environment of the proposed device is different with the
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predicate device. However, the operation environment and storage environment is similar with predicate device. Therefore, this difference is not considered to affect the substantially equivalency.
Different 6 - Service life
The service life for the predicate device is unknown. However, the service life test has been conducted on the proposed device and the results show that the proposed device can still maintain its function as intended at the end of the proposed service life. Therefore, this difference is not considered to affect the substantially equivalency.
Different 7 - Materials
The material of the proposed device is different with the predicate device, however, the biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effects. Therefore, this difference is not considered to affect the substantially equivalency.
Substantially Equivalent (SE) Conclusion 9.
From the bench test conducted on the proposed device provided in above, the test result showed that the proposed device can meet the requirements of related standards. Therefore, it can be determined that the proposed devices are Substantially Equivalent (SE) to the predicate device, K191251.