Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.

Device Description

The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures. The proposed device is available in two models, which are WT1 and WT2. Similarities between models: a. Both of them incorporate a temperature sensitive sensor b. Both of them can measure and monitor human body temperature under arm; C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature; Differences between models: a. WT1 has an automatic power on/off feature; b. WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for measuring and monitoring; c. WT2 can be used with a designated probe cover; d. WT2 can be used for measurement of oral temperature.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Electronic Thermometer (Models WT1 and WT2), formatted as requested.

Electronic Thermometer (Models WT1 and WT2)

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria are generally established by compliance with recognized standards and the reported performance is directly stated in the comparison table.

Acceptance Criteria Category	Specific Acceptance Criteria (from standards or implied)	Reported Device Performance (from comparison table)	Meets Criteria?
Accuracy	Not explicitly stated as a separate acceptance criterion, but implied by comparison to predicate. The standard ISO 80601-2-56 sets specific requirements for accuracy. The predicate device claims ±0.1°C within its operational range.	±0.1°C (25.00°C~~34.99°C and 38.51°C~~45.00°C) ±0.05°C (35.00°C~38.50°C)	YES, claims higher accuracy in certain ranges than the predicate. Implied compliance with ISO 80601-2-56 suggests meeting its accuracy requirements.
Precision	Not explicitly stated, but common for medical thermometers.	4 numeric digits displayed in 0.01 degree increments	YES (Matches predicate)
Response Time	Not explicitly stated as an acceptance criterion other than being "acceptable" and communicated in the user manual. The predicate device has a much faster response time.	5 minutes	YES (Stated as acceptable, though slower than predicate)
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10.	No Cytotoxicity, No Sensitization, Irritation-negligible	YES
Electrical Safety	Compliance with IEC 60601-1.	Complied with IEC 60601-1	YES
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	Complied with IEC 60601-1-2	YES
Range	Consistent with clinical thermometer use.	25.00°C~45.00°C	YES (Wider than predicate)

Notes on Acceptance Criteria: The document primarily relies on non-clinical testing against recognized national and international standards (ISO, IEC) to demonstrate substantial equivalence. The detailed accuracy claims are a performance specification that needs to be verified by testing.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information about:

Sample size used for the test set.
Data provenance (e.g., country of origin, retrospective or prospective).

The "test set" in this context refers to non-clinical tests (e.g., biocompatibility testing, electrical safety testing, EMC testing), which are performed on device samples, not human participants or clinical data. The precise number of device units or samples used for each non-clinical test (e.g., for biocompatibility or electrical safety) is not specified in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable as no clinical studies were performed, and thus no clinical ground truth was established by experts for a test set. Non-clinical tests establish "ground truth" based on standard protocols, calibrated equipment, and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were performed. Adjudication methods are typically employed in clinical trials or studies where human readers/experts independently assess cases, and a process is needed to resolve discrepancies.

5. 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

Not applicable. This device is an electronic thermometer, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images/data. Therefore, an MRMC study is not relevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a standalone electronic thermometer. The performance described (accuracy, precision, response time) is for the device operating independently to measure temperature. There isn't an "algorithm" in the sense of AI or image processing, but the device's measurement functionality itself operates in a standalone manner to generate a temperature reading. The companion mobile application "Temp Sitter" serves for display and potentially trend monitoring, but the temperature measurement occurs directly by the physical device. The compliance with standards like ISO 80601-2-56 reflects this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests that were performed:

Accuracy and Response Time: Ground truth would be established using calibrated reference thermometers and temperature sources as per the methodologies outlined in ISO 80601-2-56 or similar standards.
Biocompatibility: Ground truth is established by laboratory testing results (e.g., cell viability assays for cytotoxicity, skin patch tests for sensitization, observation of tissue reactions for irritation) against specified limits.
Electrical Safety and EMC: Ground truth is established by laboratory measurements taken by specialized equipment as per the IEC standards.

8. The Sample Size for the Training Set

Not applicable as no AI or machine learning algorithm requiring a "training set" is mentioned or implied for this device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set was used.

Summary

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

February 9, 2016

Guangdong Biolight Meditech Co., Ltd % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152739

Trade/Device Name: Electronic Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 25, 2016 Received: February 1, 2016

Dear Ms. 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. 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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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 and Part 809), 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

for Erin I. Keith, M.S. 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) K152739

Device Name

Electronic Thermometer, Model WT1 and WT2

Indications for Use (Describe)

Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.

Type of Use (Select one or both, as applicable)	Research Use Only (21 CFR 201.3 Subject to Transition) For In-Vitro Diagnostic Use (21 CFR 809 Subject to Transition)
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__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K152739

1. Date of Preparation: 1/25/2016
1. Sponsor Identification

Guangdong Biolight Meditech Co., Ltd

Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Ms. Liang, Jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang j@blt.com.cn

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Electronic Thermometer Common Name: Clinical electronic thermometer Model(s): WT1, WT2

Regulatory Information

Classification Name: Clinical electronic thermometer Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital

Intended Use Statement:

Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.

Device Description

The proposed device is available in two models, which are WT1 and WT2.

Similarities between models:

a. Both of them incorporate a temperature sensitive sensor
Both of them can measure and monitor human body temperature under arm; b.
C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature;

Differences between models:

WT1 has an automatic power on/off feature; a.
WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for b. measuring and monitoring;
WT2 can be used with a designated probe cover; c.
WT2 can be used for measurement of oral temperature. d.

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1. Identification of Predicate Device(s)
  510(k) Number: K132514 Product Name: Kinsa Smart Thermometer
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 results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009/(R) 2014, 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 Sensitization.
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
ISO 80601-2-56 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison
  Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Predicate Device
Product Code	FLL	FLL
Regulation Number	21 CFR 880.2910	21 CFR 880.2910
Intended Use	Electronic Thermometer isintended for measuring andmonitoring human bodytemperature orally and/or underarm for adult, pediatric and infant.It can be used in healthcarefacility and home.	The Kinso Smart Thermometer isintended to measure the human bodytemperature orally, rectally, or underthe arm, and the devices are reusablefor clinical or home use on people ofall ages
Measurement Site	orally and/or under arm	orally, rectally, or under the arm
Feature	Compatible with iOS MobileDevice via	Compatible with iOS Mobile Devicevia

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	wireless connection	wire connection
	Display in mobile application, nodisplay on device	Display in mobile application, nodisplay on device
Component	Temperature Sensitive Sensor	Temperature Sensitive Sensor
	Plastic Housing	Plastic Housing
	Circuit Board	Circuit Board
	No Cable	Cable
	Battery (button cell)	Mobile Device Power Supply
Accessories	Adhesive tape (WT1)	No
	Container (WT1)	No
	Probe cover (WT2)	No
Range	$25.00°C~45.00°C$	$35.00°C~42.00°C$
Accuracy	$±0.1°C$ $25.00°C~34.99°C$	Not Claimed
	$±0.05°C$ $35.00°C~38.50°C$	$±0.1°C$ $35.00°C~42.00°C$
	$±0.1°C$ $38.51°C~45.00°C$
Precision	4 numeric digits displayed in 0.01degree increments	4 numeric digits displayed in 0.01degree increments
Response Time	5 minutes	15 seconds
Unit	°C and °F	°C and °F
Patient contactmaterials	Stainless Steel, S216Polycarbonate (PC), 2458Silicone, TPENon-Woven ClothMedical Melt Adhesive	Stainless SteelThermoplastic rubberAcrylonitrile butadiene styrene
Biocompatibility	No CytotoxicityNo SensitizationIrritation-negligible	Comply with ISO 10993-5 and ISO10993-10
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2

Discussion of Main Differences:

The proposed device can only measure orally and/or under arm, however, the predicate device can additionally measure rectal temperature. The intended sites have been communicated in the user manual, and this will not affect the intended use of the device; the proposed device connects with the iOS device through wireless method, however, the predicate device connects the iOS device through cable. Risk analysis and associated verification has been performed that the wireless feature is acceptable; In addition, the proposed device has a longer response time, however, this time is still acceptable and communicated in the User Manual.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.