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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a non-contact infrared forehead thermometer (Model BSX976). It outlines the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The device's performance is primarily assessed against recognized international standards for medical electrical equipment and clinical thermometers. The acceptance criteria are implicitly defined by compliance with these standards, particularly regarding accuracy and safety.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (Summary)	Relevant Standard
Electrical Safety	Complies with ANSI/AAMI ES60601-1 and IEC 60601-1-2	ANSI/AAMI ES60601-1, IEC 60601-1-2
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2	IEC 60601-1-2
Basic Safety & Essential Performance (Home Healthcare)	Complies with IEC 60601-1-11	IEC 60601-1-11
Clinical Thermometer Performance (Accuracy, etc.)	Complies with ISO 80601-2-56 and ASTM E 1965-98	ISO 80601-2-56, ASTM E 1965-98
Software Verification & Validation	Testing conducted as per FDA guidance, "Moderate" level of concern addressed	FDA Guidance for Software in Medical Devices
Measurement Accuracy (Specific Range)	32 °C to 43 °C: ±0.3 °C (This is the reported performance for the subject device, which aligns with the standard's allowances for non-contact infrared thermometers)	ISO 80601-2-56, ASTM E 1965-98
Response Time	Within 3 seconds (Passed ISO 80601-2-56 particular requirement test)	ISO 80601-2-56
Operating Environment	Verified during design process, compliance with IEC 60601-1 and IEC 60601-1-11	IEC 60601-1, IEC 60601-1-11
Storage Environment	Verified during design process, compliance with IEC 60601-1 and IEC 60601-1-11	IEC 60601-1, IEC 60601-1-11
Power Safety	Power safety test passed (implying compliance with IEC 60601-1)	IEC 60601-1

Study Details Proving Device Meets Acceptance Criteria

The document describes both non-clinical (bench) data and clinical data collected to demonstrate product performance.

Sample sizes used for the test set and data provenance:
- Clinical Data (Test Set): 150 subjects were involved in the clinical testing. 32 of these subjects were febrile.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the submitter's location (Shenzhen, China) and the nature of a 510(k) submission, it is highly probable the clinical study was conducted prospectively, but this is not explicitly confirmed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. The clinical testing was conducted "per ISO 80601-2-56 Clause 201.102," which is a standard for clinical thermometers. This standard itself outlines methods for clinical evaluation, including comparison to reference thermometers, but the specific details of the human expertise involved in the ground truth establishment for this specific study are not described in the provided summary.
Adjudication method for the test set:
- The document does not specify an adjudication method. For a clinical thermometer study, ground truth is typically established by simultaneous measurement with a highly accurate reference thermometer (e.g., a rectal thermometer) under controlled conditions, rather than by human adjudication of readings.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a review of a basic medical device (a thermometer), not an AI-assisted diagnostic imaging device. Therefore, an MRMC study with human readers and AI assistance is not relevant and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly. The "Clinical data" and "Bench Testing" sections describe the device's performance in isolation. The compliance with ISO 80601-2-56 and ASTM E 1965-98 specifically evaluates the thermometer's direct measurement accuracy, which is its standalone performance. This device is not an algorithm in the sense of AI; it is a physical device that performs a measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical data (temperature measurement) is established by comparison to a reference temperature measurement method as defined by the standard ISO 80601-2-56. This standard typically involves using a highly accurate alternative method (e.g., a calibrated contact thermometer, such as a rectal or oral thermometer, serving as the "true" body temperature) against which the infrared thermometer's readings are compared. The summary does not explicitly state the exact reference method used, but compliance with the standard implies such a comparison.
The sample size for the training set:
- This device is a physical thermometer, not a traditional machine learning model that undergoes a "training set" process in the AI sense. Therefore, there is no specific training set sample size as would be described for an AI/ML algorithm. Its "training" is in its design, calibration, and manufacturing processes, guided by engineering principles and adherence to standards.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML context, this question is not applicable. The device's calibration and design are based on established physics principles of infrared thermometry and validated against recognized metrology standards for temperature measurement.

Summary

{0}------------------------------------------------

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 and 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.

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

e device is reusable
s/infants.

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

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/PostalCode	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

{5}------------------------------------------------

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.

{6}------------------------------------------------

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 °C31 °C to 35 °C: ±0.3 °CAbove 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 °CYellow, > 37.4° – 38.5 °CRed, > 38.5° – 42.2 °C	Different 3
Integratedcircuitry model	MCU: HME055	MCU: Weltrend WT5075F	Different 4
OperatingEnvironment	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
StorageEnvironment	Temperature: -20 °C to 55 °C (-4 °F - 131 °F)Humidity: 15-95% non-condensing	-25°C~60°C≤95% moisturecondensation	Different 5
Power supply	2* 1.5 V AAA Batteries	Two (2) AA batteries	Different6
Applicablestandards	ANSI AAMI ES60601-1, IEC60601-1-2, IEC 60601-1-11, andASTM E1965-98, ISO80601-2-56	IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ASTME1965-98, ISO80601-2-56	Same
Memory DataLimit	20 sets	No	Different7
Productconfiguration	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc.	It is mainly composed withinfrared sensor, signalreceiving processor, buttons,buzzer, LCD display, batteryand etc.	Same
Temperatureunit andconversion	Dual temperature units "°C" and"°F" optional, and the two unitscan convert by the conversionkey automatically	Dual temperature units "°C"and "°F" optional and the twounits can convert by theconversion key automatically	Same
physicaldimensions(mmc)	190×78×50mm	200x60x134mm	Different8
Weight	82g (with batteries), 64g (w/obatteries)	99.5 g (with batteries), 77.1 g(w/o batteries)

Table 2 Similarity and difference analysis between Subject Device and Predicate Device

{7}------------------------------------------------

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.

{8}------------------------------------------------

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.

1. 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 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).

Regulation Number and Section

§ 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.