(344 days)
Not Found
No
The description focuses on standard infrared temperature measurement technology and does not mention any AI or ML components or processes.
No
The device is used for the "intermittent measurement of temperature," indicating a diagnostic or monitoring function, not a therapeutic one. It does not provide treatment or therapy.
No
The device is an infrared thermometer, which measures body temperature. While temperature can be a symptom of various conditions, the device itself simply quantifies a physical parameter and does not diagnose a medical condition.
No
The device description explicitly lists hardware components such as infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, and battery. It also mentions focusing infrared via a Fresnel lens.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Infrared forehead thermometer measures body temperature by receiving infrared energy radiation from the surface of the forehead. This is a non-invasive measurement taken on the body, not a test performed on a sample taken from the body.
The description clearly indicates it's a device for measuring temperature directly from the forehead, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared forehead thermometer is a non-contact infrared thermometer (model BSX976) intended for the intermittent measurement of temperature from forehead at a distance of 1~3cm for people older than 2 years. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants.
Product codes
FLL
Device Description
BSX976 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, directly show on the LCD screen.
- The device is widely used for home healthcare, medical institutes, and many other occasions.
- The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc.
- It focuses the infrared from the human's forehead by the Fresnel lens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
older than 2 years
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
Electrical safety and electromagnetic compatibility (EMC): Complies with ANSI/AAMI ES60601-1 and IEC 60601-1-2.
Bench Testing: Complies with IEC 60601-1-11, ISO 80601-2-56 and ASTM E 1965-98.
Software Verification and Validation Testing: Considered "Moderate" level of concern.
Clinical data:
Clinical testing is conducted per ISO 80601-2-56 Clause 201.102, and 150 subjects were involved in the testing, 32 of which were febrile.
Summary:
Based on the non-clinical and clinical performance as documented in the device development, the subject devices were found to have a performance that is similar to the predicate device.
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.
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July 23, 2021
Shenzhen BSX Technology Electronics Co., Ltd. Lijuan Du RA Engineer Rm301.3F 8th Building, LiHao Industrial Area, No.78 AiNan Road Shenzhen, Guangdong 518116 China
Re: K202296
Trade/Device Name: Infrared Forehead Thermometer, Model BSX976 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 21, 2021 Received: June 21, 2021
Dear Lijuan Du:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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) K202296
Device Name
Infrared Forehead Thermometer(Model:BSX976)
Indications for Use (Describe)
The Infrared forehead thermometer is a non-contact infrared thermometer (model BSX976) intended for the internittent measurement of temperature from forehead at a distance of 1~3cm for people older than 2 years. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants.
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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e device is reusable
s/infants.
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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510(K) Summary - K202296
1. Submitter:
Table 1 Submitter (Owner) and Contact Information
| Company / Institution Name | |||
|---|---|---|---|
| Shenzhen BSX Technology Electronics Co., Ltd. | |||
| Phone Number (including area code) | FAX Number (including area code) | ||
| +86 0755 28719103 | +86 0755 28882567 | ||
| Street Address | |||
| Rm301.3F &4F 8th Building, LiHao Industrial Area, No.78 AiNan Road Longgang | |||
| City | State/Province | ZIP/Postal | |
| Code | Country | ||
| Shenzhen | Guangdong | 518116 | China |
| Contact Name | |||
| Yolanda L | |||
| Contact Title | Contact E-mail Address | ||
| Consultant | Yolanda.bleu@foxmail.com |
Date Prepared: 2021-05-08
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
2. Device Information:
Type of 510(k) submission: Traditional Trade Name: Infrared Forehead Thermometer Common Name: Clinical Electronic Thermometer Model: BSX976 Classification name: thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Device Class: II Requlation Number: 880.2910
3. Predicate device:
Sponsor: KAZ USA, Inc., A Helen of Troy Company Product Model: Forehead NTF3000 Thermometer Trade Name: Braun No Touch + Forehead NTF3000 Thermometer Classification name: thermometer, electronic, clinical Device Class: II Regulation Number: 880.2910 510(K) Number: K163516
4. Indications for Use
The Infrared forehead thermometer is a non-contact infrared thermometer (model BSX976) intended for the intermittent measurement of temperature from forehead at a
4
distance of 1~3cm for people older than 2 vears. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants
5. Basic principle
Any object in which temperature is higher than absolute zero degree will transmit some infrared radiation energy according to its own temperature. The radiation energy and its distribution per wavelength are closely associated with its surface temperature. Based on the principle, it is possible to measure the forehead temperature and then adjust the offset between forehead temperature and actual body temperature, which will result in the correct display of body temperature.
6. Device Description
BSX976 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, directly show on the LCD screen.
- The device is widely used for home healthcare, medical institutes, and many other occasions.
- The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc.
- It focuses the infrared from the human's forehead by the Fresnel lens.
7. Performance Data
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the BSX976 Infrared Forehead thermometer device, consisting of all the modules and accessories in the system. The system complies with the ANSI/AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety 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 BSX976 Infrared Forehead thermometer device, consisting of all the accessories in the system. The system complies with the 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, ISO 80601-2-5 Medical electrical equipment — Part 2-56: Particular requirements for basic
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safety and essential performance of clinical thermometers for body temperature measurement and ASTM E 1965-98 Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature standards 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, "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, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Clinical testing is conducted per ISO 80601-2-56 Clause 201.102, and 150 subjects were involved in the testing, 32 of which were febrile.
Summary
Based on the non-clinical and clinical performance as documented in the device development, the subject devices were found to have a performance that is similar to the predicate device.
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8. Comparison to predicate device
| ITEM | Proposed Device | Predicate Device K163516 | Comparison Result |
|---|---|---|---|
| Manufacturer | Shenzhen BSX Technology Electronics Co., Ltd. | KAZ USA, Inc., A Helen of Troy Company | --- |
| Product name and Model | Infrared Forehead Thermometer BSX976 | Braun No Touch + Forehead NTF3000 Thermometer | --- |
| Indications for Use | The Infrared Forehead Thermometer is a non-contact infrared thermometer (model BSX976) intended for the intermittent measurement of temperature from forehead at a distance of 1~3cm for people older than 2 years. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants. | The Braun No Touch + Forehead NTF3000 Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the center of the forehead as the measurement site on people of all ages. | Different 1 |
| Measuring Site | Forehead | Forehead | Same |
| Measuring mode | Adjusted | Adjusted | Same |
| Detection method | Temperature is detected by thermistor and calculated. | Temperature is detected by thermistor and calculated. | Same |
| Design principle | Based on Infrared Sensor technology | Based on Infrared Sensor technology | Same |
| Measurement Range | $32.0℃~43.0℃$ | $34.4℃~42.2℃$ | Different 2 |
| Measurement Distance | 1~3 cm | 0~5 cm | |
| Measurement Accuracy | 32 °C to 43 °C: ±0.3 °C | 35 °C to 42 °C: ±0.2 °C | |
| 31 °C to 35 °C: ±0.3 °C | |||
| Above 42°C: ±0.3 °C | |||
| Resolution of Display | 0.1°C/°F | 0.1°C/°F | Same |
| Signal output and display | LCD, Buzzer | LCD, Buzzer | Same |
| Lens Filter | NO | NO | Same |
| Response time | within 3 seconds | within 2 seconds | Different 3 |
| signal processing | A/D signal processing mode | A/D signal processing mode | Same |
| sensor model | STP9CF55H | --- | |
| backlight feature | Green:34.0~37.5℃, | ||
| Yellow:37.6~38.0 ℃, | |||
| Red:38.1~42.9 ℃ | Green, > 35.7° – 37.4 °C | ||
| Yellow, > 37.4° – 38.5 °C | |||
| Red, > 38.5° – 42.2 °C | Different 3 | ||
| Integrated | |||
| circuitry model | MCU: HME055 | MCU: Weltrend WT5075F | Different 4 |
| Operating | |||
| Environment | 15°C to 40°C (59.0°F to 104.0°F) | ||
| ,20%~95%RH,70kPa to 106kPa | 15°C ~ 40°C | ||
| ≤85% moisture condensation | |||
| Storage | |||
| Environment | Temperature: -20 °C to 55 °C (-4 °F - 131 °F) | ||
| Humidity: 15-95% non- | |||
| condensing | -25°C~60°C | ||
| ≤95% moisture | |||
| condensation | Different 5 | ||
| Power supply | 2* 1.5 V AAA Batteries | Two (2) AA batteries | Different6 |
| Applicable | |||
| standards | ANSI AAMI ES60601-1, IEC | ||
| 60601-1-2, IEC 60601-1-11, and | |||
| ASTM E1965-98, ISO80601-2- | |||
| 56 | IEC 60601-1, IEC 60601-1-2, | ||
| IEC 60601-1-11, and ASTM | |||
| E1965-98, ISO80601-2-56 | Same | ||
| Memory Data | |||
| Limit | 20 sets | No | Different7 |
| 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 "°C" and | ||
| "°F" optional, and the two units | |||
| can convert by the conversion | |||
| key automatically | Dual temperature units "°C" | ||
| and "°F" optional and the two | |||
| units can convert by the | |||
| conversion key automatically | Same | ||
| physical | |||
| dimensions | |||
| (mmc) | 190×78×50mm | 200x60x134mm | Different8 |
| Weight | 82g (with batteries), 64g (w/o | ||
| batteries) | 99.5 g (with batteries), 77.1 g | ||
| (w/o batteries) |
Table 2 Similarity and difference analysis between Subject Device and Predicate Device
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Justification for the differences:
- Different Indications for Use
Both the candidate device and the predicate are used to measure the forehead temperature with non-contact mode, the difference is just different language description, no substantial difference, therefore, no safety or effectiveness questions will be raised.
- Different Measurement Range, Distance and Accuracy
The subject BSX976 shows minor different measurement range, measurement distance and accuracy from those of the predicate, but the verification and validation data demonstrated the compliance of requirements established in the Standard ASTM E1965-98 and ISO 80601-2-56. And the current measurement range can meet the clinical practice for operation. Hence, the minor difference will not cause any safety and effectiveness problems.
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The subject device shows different response time to predicate device passed ISO 80601-2-56 particular requirement test which would not raise safety and effectiveness concerns.
The subject device shows different backlight feature in different measurement range to
predicate device, but the subject device passed lEC 60601-2-56 safety and
particular re
- Different Integrated Circuitry Model
The subject device pass IEC 60601-1 and ISO 80601-2-56 test which can demonstrate the
safety and effectiveness of the device.
5)Different Operation & Storage Environment
Minor Operation & Storage Environment difference has also been verified during the design
process, and the international standards IEC 60601-1 and IEC 60601-1-11, do not rais concerns related to the device safety and effectiveness.
6)Different Power Supply
Minor different batteries would not raise concerns related to the device safety and effectiveness for the pass of IEC 60601-1 power safety test.
-
- Different Memory Function
The subject BSX976 can store memorize 20 measurements automatically while the predicate does not have the function, which is not the significant difference which will cause the safety and effectiveness, and this functionality has been well verified and can be found in the software submission documentation.
- Different Memory Function
- Different Dimension & Weight
The weight of BSX976 is less and dimension is smaller than the predicate device, but the physical characteristics difference will not raise any safety and effectiveness problem because it has been verified during the design and development.
As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, including the appearance, measurement range, measurement distance and accuracy, power supply, and operating environment which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical and clinical testing, the different technological characteristics do not affect the performance of the BSX976 Infrared Forehead Thermometer.
9. Conclusion
Based on the above considerations table, the Proposed Device, the BSX976 Infrared thermometer is substantially equivalent to the predicate device Braun No Touch + Forehead NTF3000 Thermometer (K163516).