Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Device Description

The subject device uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.

The subject device intends to detect the temperature of patients of all ages.

The subject device includes 2 series: ThermoFlash and MyThermo. The ThermoFlash thermometers contain 5 models: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, while MyThermo thermometer contains one model BW-CX10. They all have the following basic functions:

Sound alarm if temperature is exceeded. -
LCD back-lighted digital screen. -
Data displayed in Celsius or Fahrenheit. -
Automatic stop (energy saver). -
Small, convenient, easy to use. -

Their differences are in appearance and functions. The LX-26E and LX-360 are same in functions, while LX-260TE and LX-361T contain additional language function, BW-CX10 and PRO LX-261E contain additional rechargeable function, and BW-CX10 contains additional Bluetooth function.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Thermometer (K160816).

The provided document, a 510(k) summary for the Nexmed Technology Co., Ltd. Infrared Thermometer, focuses on demonstrating substantial equivalence to a predicate device. While it mentions performance standards and "clinical accuracy," it does not present a detailed clinical study with the specific elements requested (test set size, ground truth details, expert qualifications, adjudication, MRMC, or standalone performance metrics for diagnostic tasks), as these are typically applicable to AI/ML or more complex diagnostic devices.

The "clinical tests" section is very brief and refers to meeting a standard rather than providing detailed study results.

Therefore, many of the requested fields cannot be directly extracted from this document because the device (an infrared thermometer) and the regulatory submission type (510(k) for substantial equivalence to a predicate thermometer that also likely met similar standards) do not typically require or provide such detailed clinical study information in the same way as, for example, an AI diagnostic algorithm.

Acceptance Criteria and Reported Device Performance

For an Infrared Thermometer, the primary acceptance criteria revolve around accuracy within a specified range compared to a reference standard.

Metric	Acceptance Criteria (Predicate/Standard)	Reported Device Performance (Subject Device)	Remarks
Measuring Accuracy	Forehead temperature mode: ±0.2℃ (0.4℉)	±0.2℃ in Body mode	Same
Measuring Range	Forehead temperature mode: 32.2℃ - 43.3℃ (90.0℉ - 109.9℉)	Body mode: 30° to 43℃ (86.0℉ to 109.4℉)	Similar (slight difference in lower end; within acceptable clinical range)
Display Resolution	0.1℃ (0.1℉)	0.1 ℃/0.1 ℉	Same
Clinical Accuracy	Complies with ASTM E1965-98 (2009)	Complies with ASTM E1965-98 (2009)	"Clinical tests" section indicates compliance.
Non-clinical Standards	(Various, see below)	(Various, all "Pass," see below)	All listed non-clinical tests passed.

Study Information (Based on interpretation for a thermometer, not an AI/ML algorithm):

Since this is a submission for an infrared thermometer, the "study" primarily refers to testing against recognized medical device standards rather than a typical clinical trial for a diagnostic algorithm.

Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated as a "test set" in the context of an algorithm. For clinical accuracy, thermometers are typically tested on a cohort of human subjects. The ASTM E1965-98 standard would specify the number of subjects and measurements required. The document states "The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965-98 (2009)."
- Data Provenance: Not specified, but generally, such tests are conducted at a testing facility or clinical site to meet the standard. The manufacturer is Nexmed Technology Co., Ltd. in China. Likely conducted in a controlled environment.
- Retrospective or Prospective: Clinical accuracy testing for thermometers against a standard is typically prospective, involving real-time measurements on subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Experts: Not explicitly stated. For thermometer accuracy, "ground truth" (reference temperature) is typically established using a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measurement device validated against a traceable standard), rather than human expert consensus. The ASTM E1965-98 standard defines the methodology for this.
- Qualifications of Experts: N/A for this type of "ground truth" establishment.
Adjudication method for the test set:
- N/A. The "ground truth" is typically a direct measurement from a reference device, not an expert interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an infrared thermometer, not an AI diagnostic algorithm for image interpretation or similar tasks. MRMC studies are not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "standalone" performance here refers to the device's accuracy in measuring temperature against a reference standard, which is its intrinsic function without human interpretation of ambiguous outputs (as would be the case for an AI diagnostic aid). The performance is assessed against ASTM E1965-98.
The type of ground truth used:
- Reference Thermometer/Standard Measurement: For clinical accuracy, ground truth is established by simultaneous or near-simultaneous measurements using a highly accurate reference clinical thermometer (e.g., a rectal or oral thermometer), as specified by standards like ASTM E1965-98. This is a direct physical measurement.
The sample size for the training set:
- N/A. Infrared thermometers are not typically "trained" in the machine learning sense. Their design and calibration are based on physics and engineering principles, and their performance is validated against standards.
How the ground truth for the training set was established:
- N/A, as there is no "training set" in the AI/ML context for this device. Ground truth for calibration and design validation would involve traceable temperature standards and engineering tests.

Summary of Non-Clinical Tests (Table from Document):

The document lists several non-clinical tests that the device passed:

Tests	Test Standards	Results
Electric Safety	IEC 60601-1:2012	Pass
EMC	IEC 60601-1-2:2014; 47 CFR PART 15 Subpart C	Pass
Electric Safety for medical device used in the home healthcare environment	IEC 60601-1-11 Edition 1.0 2010-04	Pass
Basic Safety and essential performance of clinical thermometers for body temperature measurement	ISO 80601-2-56 First Edition 2009-10-01	Pass
Clinical accuracy	ASTM E1965-98 (Reapproved 2009)	Pass
Biological Evaluation	ISO 10993-1:2009	Pass
In vitro Cytotoxicity	ISO 10993-5:2009	Pass
Irritation and skin sensitization	ISO 10993-10: 2010	Pass
Battery Safety (for some models)	IEC 62133 Edition 2.0 2012-12	Pass
Battery transportation Safety (for some models)	UN 38.3	Pass
QoS testing (for BW-CX10 Bluetooth model)	47 CFR PART 15 Subpart B; 47 CFR PART 15 Subpart C	Pass
Wireless coexistence (for BW-CX10 Bluetooth model)	47 CFR PART 15 Subpart B; 47 CFR PART 15 Subpart C; EN 300328 V1.8.1 (This indicates additional testing for the model with Bluetooth, to ensure it doesn't interfere with other wireless devices and operates correctly within its frequency band.)	Pass

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 21, 2016

Nexmed Technology Co., Ltd c/o Ms. Elena Lu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, 518101 CHINA

Re: K160816

Trade/Device Name: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 15, 2016 Received: August 22, 2016

Dear Ms. Elena Lu:

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. 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.

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Page 2 - Ms. Elena Lu

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160816

Device Name

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

Indications for Use (Describe)

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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VOL 05 510(k) Summary

K160816

5.1 Administrative Information

Date of Summary prepared	Aug., 31, 2016
Manufacturer information	Nexmed Technology Co., Ltd.2 Floor Of No.1 Building, Jia An TechnologicalIndustrial Park, 67 District, Bao An, Shenzhen,Guangdong, China 518101Contact person: Ellen XuPhone: +86-755-2948 1701Fax: +86-755-8525 8461E-mail: ellen@nxm-tech.com
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.Address: Room 2032, International MayorsCommunication Centre, NO. 55 Shizhou middleroad , Nanshan District, ShenzhenContact person: Ms. Elena Lu; Mr. Field FuE-Mail: elena@cefda.com; cefda13485@163.com

registration number

5.2 Device Information

Type of 510(k)submission:	Traditional
Trade Name:	Infrared Thermometer
Model:	LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10
Classification name:	thermometer, electronic, clinical
Review Panel:	General Hospital
Product Code:	FLL

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Device Class:	II
Regulation Number:	880.

2910

5.3 Predicate Device Information

Sponsor:	Shenzhen Jumper Medical Equipment Co., Ltd.
Device:	Non-contact Infrared Thermometer
510(K) Number:	K131243

5.4 Device Description

The subject device intends to detect the temperature of patients of all ages.

Sound alarm if temperature is exceeded. -
LCD back-lighted digital screen. -
Data displayed in Celsius or Fahrenheit. -
Automatic stop (energy saver). -
Small, convenient, easy to use. -

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5.5 Intended Use/ Indications for Use

5.6 Technological characteristics of the subject device compared to the predicate device

Items	Predicate Device(K131243), Jumper	Subject Device	Remarks
Indications foruse	The non-contact infraredthermometer, model JPD-FR100, can measurebody temperature forinfants and adults withoutcontact to human body. Itcan be used byconsumers in householdenvironment and doctorin clinic as reference.	Infrared Thermometer isintended for bodytemperature measurementfor infants and adultswithout contact to humanbody. It can be used byconsumers in householdenvironment and doctor inclinic as reference.	Same
Measurementmethod	Infrared radiationdetection	Infrared radiation detection	Same
Measurementmode	Forehead measure mode	Body mode, also isforehead measurementmode	Same
Measuring range	Forehead temperaturemode: 32.2℃ - 43.3℃(90.0℉ - 109.9℉)	Body mode: 30°to 43℃(86.0℉ to 109.4℉)	Similar
Displayresolution	0.1℃ (0.1℉)	0.1 ℃/0.1 ℉	Same
C/F switchable	Yes	Yes	Same
Measuringaccuracy	Forehead temperaturemode:$ \pm $ 0.2℃ (0.4℉)	+/- 0.2℃ in Body mode	Same
Display	LCD display	LCD display	Same
Measurementdistance	1-6cm	2-5cm	Similar
Items	Predicate Device(K131243), Jumper	Subject Device	Remarks
Memory	20 sets	LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T: 32 sets;BW-CX10: It does not memory any data, and the data are transferred to the mobile phone app for memory.	Similar
Power source	Two 1.5V AAA batteries	LX-26E, LX-260TE: two 1.5V AA batteries;LX-360, LX-361T: two 1.5V AAA batteries;PRO LX-261E, BW-CX10: 3.7V Lithium battery	Different(Note 01)
Low battery indication	Yes	Yes	Same
Waterproof	No	No, IP22	Different(Note 02)
Dimension	145 x 60 x 50mm	LX-26E:102.5mm×42.3mm×155mmLX-260TE:102mm×38mm×160.8mmPRO LX-261E:102.5mm×38mm×158mm (without base)156mm×66.6mm×177mm (with base)LX-360, LX-361T:162.5mm×59mm×29.8mm (without base)172.5mm×60.35mm×60.35 mm (with base)BW-CX10:60.7 x 37.4 x 96.3 mm	Different(Note 03)
Items	Predicate Device(K131243), Jumper	Subject Device	Remarks
Weight	180g	LX-26E: 177g (with battery)130.2g (without battery)LX-260TE: 179.4g (withbatteries)132.6g (without battery)PRO LX-261E: 193.2g(without base)406.6g (with base)LX-360, LX-361T: 135g withbase and battery112g with base no battery97g without battery or baseBX-CX10: 177g (withbattery)	Different(Note 03)
Operatingcondition	10℃ -40℃, <95%RH,no-condensing	15℃ ~ 40℃10%RH ~ 85%RH	Similar
Bluetooth	No	LX-26E, LX-260TE, PROLX-261E, LX-360, LX-361T:NoBW-CX10: Yes	Different(Note 04)
Patient contactmaterials	ABS and TPE	ABS with colorants (yellow,green, blue, dark blue,aqua, purple and white) andPC	Different(Note 05)
Cleaning	The probe tip and lensare cleaned anddisinfected by 70°alcohol.	The probe tip and protectiveglass over the lens arecleaned and disinfected by70°alcohol.	Similar
Biocompatibility	Comply with ISO 10993-5:2009, ISO 10993-10:2010	Comply with ISO 10993-5:2009, ISO 10993-10: 2010	Similar
Electric Safetyand EMC	IEC 60601-1:1988+A1:1991+A2:1995,IEC 60601-1-2: 2007, IEC60601-1-11:2010	IEC 60601-1:2005+CORR.1(2006)+CORR.2 (2007), IEC60601-1-2: 2007, IEC60601-1-11: 2010, ISO80601-2-56: 2009.	Similar
ltems	Predicate Device(K131243), Jumper	Subject Device	Remarks
Performance	ASTM E1965-98 (2009)	ASTM E1965-98 (2009),ISO 80601-2-56: 2009.	Similar

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Nexmed Technology Co., Ltd.

Subject product: Infrared Thermometer

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Nexmed Technology Co., Ltd.

Subject product: Infrared Thermometer

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Nexmed Technology Co., Ltd.

Subject product: Infrared Thermometer

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Note 01:

PRO LX-261E and BW-CX10 have passed over charge tests, IEC 62133 tests and UN38.3 tests.

Note 02:

The subject devices have passed IEC 60601-1 and IEC 60601-1-11 safety test.

Note 03:

The subject devices have passed IEC 60601-1, IEC 60601-1-11 safety test, IEC 60601-1-2 EMC test and ISO 80601-2-56 performance test.

Note 04:

BW-CX10 has passed 47 CFR PART 15 Subpart B, 47 CFR PART 15 Subpart C and EN 300328 Tests.

Note 05:

The patient contact materials had passed the Biocompatibility Test.

The subject device and the predicate device have the same intended use and similar technological characteristics, they both use infrared radiation detection method to detect human body forehead temperature. Their design is compact, small and light-weight. They are same in measuring accuracy, and similar in measuring range. For the subject device, the model BW-CX10 contains Bluetooth function. However, information contained in this submission demonstrates that any differences in their characteristics do not raise any new questions. Thus, the subject device is substantially equivalent to the predicate devices.

5.7 Brief discussion of the nonclinical tests

The nonclinical tests of the Infrared Thermometer are listed as below table:

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Tests	Test Standards	Results
Electric Safety	IEC 60601-1:2012 Medical electrical equipment -Part 1: General requirements for basic safety andessential performance	Pass
EMC	IEC 60601-1-2:2014, Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral Standard: Electromagnetic compatibility- Requirements and tests;47 CFR PART 15 Subpart C, Radio FrequencyDevices Subpart C - Intentional Radiators	Pass
Electric Safetyfor medicaldevice used inthe homehealthcareenvironment	IEC 60601-1-11 Edition 1.0 2010-04, Medicalelectrical equipment - Part 1-11: Generalrequirements for basic safety and essentialperformance - Collateral standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment	Pass
Basic Safetyand essentialperformanceof clinicalthermometersfor bodytemperaturemeasurement	ISO 80601-2-56 First Edition 2009-10-01, Medicalelectrical equipment - Part 2-56: Particularrequirements for basic safety and essentialperformance of clinical thermometers for bodytemperature measurement	Pass
Clinicalaccuracy	ASTM E1965-98 (Reapproved 2009): StandardSpecification for Infrared Thermometers forIntermittent Determination ofPatient Temperature	Pass
BiologicalEvaluation	ISO 10993-1:2009, Biological evaluation ofmedical devices - Part 1: Evaluation and testingwithin a risk management process	Pass
In vitro	ISO 10993-5:2009, Biological evaluation ofmedical devices - Part 5: Tests for in vitrocytotoxicity	Pass
Tests	Test Standards	Results
Cytotoxicity	medical devices - Part 5: Tests for in vitrocytotoxicity
irritation andskinsensitization	ISO 10993-10: 2010, Biological evaluation ofmedical devices - Part 10: Tests for irritation andskin sensitization	Pass
Battery Safety	IEC 62133 Edition 2.0 2012-12, Secondary cellsand batteries containing alkaline or other non-acidelectrolytes - Safety requirements for portablesealed secondary cells, and for batteries madefrom them, for use in portable applications	Pass
BatterytransportationSafety	UN 38.3, the Fifth Revised Edition Amendment 2of the Recommendations on the Transport ofDangerous Goods, Manual of Test and Criteria(ST/SG/AC.10/11/Rev.5/Amend.2/Section 38.3)	Pass
QoS testing	47 CFR PART 15 Subpart B, Radio FrequencyDevices Subpart B – Unintentional Radiators;47 CFR PART 15 Subpart C, Radio FrequencyDevices Subpart C – Intentional Radiators	Pass
Wirelesscoexistence	47 CFR PART 15 Subpart B, Radio FrequencyDevices Subpart B – Unintentional Radiators;47 CFR PART 15 Subpart C, Radio FrequencyDevices Subpart C – Intentional Radiators;EN 300328 V1.8.1, Electromagnetic compatibilityand Radio spectrum Matters(ERM); Widebandtransmission systems; Data transmissionequipment operating in the 2.4 GHz ISM bandand using wide band modulation techniques;Harmonized EN covering the essentialrequirements of article 3.2 of the R&TTE Directive	Pass

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5.8 Brief discussion of clinical tests

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Nexmed Technology Co., Ltd.

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The clinical performance test protocol and data analysis followed the requirements of ASTM E1965-98 (2009). The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965-98 (2009). It is acceptable to measure patient's temperature.

5.9 Conclusions

Based on the above information, we conclude the subject device, Infrared Thermometer, is substantially equivalent to the predicate device.

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.