The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

Device Description

The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all been tested and evaluated for biocompatibility.

AI/ML Overview

The provided text describes the acceptance criteria and the study that demonstrates the performance of the Disposable Temperature Probe.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Temperature Range	25°C-45°C	25°C-45°C (Same)
Accuracy	±0.1°C (25°C - 45°C)	±0.1°C (25°C - 45°C) (Same)
Biocompatibility	Complies with ISO 10993-5 and ISO 10993-10	Passed the tests as per ISO 10993-5 and ISO 10993-10 (Cytotoxicity, sensitization, irritation)
Electrical Safety	Complies with IEC 60601-1	Passed the test as per IEC 60601-1
EMC	Complies with IEC 60601-1-2	Passed the test as per IEC 60601-1-2
Ambient Temperature Operation	Covers 15°C to 35°C (as per ISO 80601-2-56)	Functions well under specified ambient temperature environment (including 15°C to 35°C)

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test sets (e.g., for accuracy, biocompatibility, electrical safety, or EMC). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It generally states that "Non-clinical testings have been conducted" and refers to compliance with international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document refers to compliance with international standards for performance and safety tests, which typically involve laboratory testing rather than expert-established ground truth for a clinical dataset.

4. Adjudication method for the test set

This information is not provided in the document. As mentioned above, the tests described are primarily engineering and laboratory-based, not clinical studies requiring adjudications.

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

An MRMC comparative effectiveness study was not conducted. This device is a disposable temperature probe, which is a physical measurement device, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.

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

This concept is not applicable to this device. The Disposable Temperature Probe is a sensor; it does not contain an algorithm in the sense of AI or image analysis. Its performance is evaluated through direct physical measurements against established standards.

7. The type of ground truth used

For accuracy, the ground truth would be precise temperature measurements from calibrated reference instruments or environments during laboratory testing. For biocompatibility, the ground truth is established by the accepted biological responses to materials as defined by ISO 10993 standards. For electrical safety and EMC, the ground truth is compliance with the limits and conditions specified in the respective IEC standards.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this information is not applicable.

9. How the ground truth for the training set was established

As there is no training set for this device, this information is not applicable.

Summary

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December 10, 2018

Shenzhen Launch Electrical Co., LTD % Tracy Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No. 22 Guimiao Road Shenzhen, Guangdong, 518000 China

Re: K181967

Trade/Device Name: Disposable Temperature Probe. Model: TAS03-14. TAS03-15. TAS03-16. TAS03-17 (body surface type); TAE03-09S, TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 8, 2018 Received: November 13, 2018

Dear Tracy Che:

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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sapana Patel -S

For 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) K181967

Device Name

Disposable Temperature Probe/ Model: TAS03-14, TAS03-16, TAS03-17 (body surface type); TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type)

Indications for Use (Describe)

The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary

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

K181967

(1) Applicant information

510 (k) owner's name:	SHENZHEN LAUNCH ELECTRICAL CO., LTD
-----------------------	-------------------------------------

Address:	NO. F Building, Zhonggangxing Industrial Estate, ZhanggeCommunity, Guanlan Street, Longhua New District, Shenzhen,China
Contact person:	Jiaan Huang
Phone number:	+86-755-29532401
Fax number:	+86-755-29532483
Email:	yuanhe@cnlaunch.com
Date of summary prepared:	2018.12.07

(2) Proprietary name of the device

Trade name/Model:	Disposable Temperature Probe/ Model: TAS03-14, TAS03-15,TAS03-16, TAS03-17 (body surface type); TAE03-09S,TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S,TAE03-15S, TAE03-16S (celomic type)
Regulation name:	Clinical electronic thermometer
Regulation number:	21 CFR 880.2910
Product code	FLL
Review panel:	General hospital
Regulation class:	Class II

(3) Predicate and reference device

彩 Predicate device

Sponsor	Dräger Medical GmbH
Device Name and Model	Temperature Probes (General purpose/ Skin)
510(k) Number	K121999
Product Code	FLL
Regulation Number	21 CFR 880.2910
Regulation Class	II

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Sponsor	Starboard Medical, LLC	Welch Allyn, Incorporated
Device Name and Model	Esophageal/RectalTemperature Probe	SureTemp® Plus
510(k) Number	K140134	K030580
Product Code	BZT, FLL	FLL
Regulation Number	21 CFR 868.192021 CFR 880.2910	21 CFR 880. 2910
Regulation Class	II	II

Reference device જુન

(4) Description/ Design of device

(5) Indications for use

been tested and evaluated for biocompatibility.

The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

Component ofDevice RequiringBiocompatibility	Material ofComponent	Body Contact Category(ISO 10993-1)	Contact Duration(ISO 10993-1)
------------------------------------------------------	--------------------------	----------------------------------------	-----------------------------------

(6) Materials

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Sticker	Foam	Surface-contacting device:Intact skin	< 24hours
Probe	PVC	Surface-contacting device:Mucosal membrane	< 24hours

The body-contacting material used in Disposable Temperature Probe have all passed biocompatibility test.

(7) Technological characteristics and substantial equivalence

Item	Targeteddevice	Predicate device	Referencedevice	Referencedevice	Remark
Trade name	DisposableTemperatureProbe/Model:TAS03-14,TAS03-15,TAS03-16,TAS03-17(body surfacetype);TAE03-09S,TAE03-10S,TAE03-11S,TAE03-12S,TAE03-13S,TAE03-14S,TAE03-15S,TAE03-16S(celomictype)	TemperatureProbes (Generalpurpose/ Skin)	Esophageal/RectalTemperatureProbe	SureTemp® Plus	/
510 (k) number	K181967	K121999	K140134	K030580	/
Regulationnumber	21 CFR880.2910	21 CFR880.2910	21 CFR868.192021 CFR880.2910	21 CFR 880.2910	Same
Product code	FLL	FLL	BZT, FLL	FLL	Same
Class	II	II	II	II	Same
Indications foruse/ Intendeduse	The DisposableTemperatureProbe (bodysurface type) isto be used witha compatible	GeneralPurposeTemperatureProbesDrägerdisposable	TheEsophageal/RectalTemperatureProbe isindicated for	The Welch AllynSureTemp® Plusis intended to beused byhealthcareprofessionals to	SimilarNote 5
	medical	general purpose	continuous	provide an
	monitor that	temperature	monitoring of	accurate
	has temperature	probes are	esophageal,	prediction of
	measurement	intended for	rectal, and	patient
	function to	patient core	nasopharyngeal	temperature
	continuously	body	temperatures.	using the oral,
	measure the	temperature		axillary or rectal
	patient's skin	measurement in		body sites in 4 to
	temperature.	combination		15 seconds or to
	The Disposable	with Dräger and		provide an
	Temperature	Siemens patient		actual
	Probe (celomic	monitoring		temperature
	type) is to be	systems. The		reading in the
	used with a	probes are		continuous
	compatible	inserted into the		monitor mode in
	medical	oesophagus or		about 3 minutes.
	monitor that	the rectum.
	has temperature	Skin
	measurement	Temperature
	function to	Probes
	continuously	Dräger
	measure the	disposable skin
	patient's oral,	temperature
	rectal,	probes are
	nasopharyngeal	intended for
	cavity	patient skin
	temperature.	temperature
		measurement incombination

		with Dräger and
		Siemens patient
		monitoring
		systems. The
		probes are
		affixed on the
		patient's skin
		with an adhesive
		cover.
Suitable for the	Adult and	Adult, pediatric	/	/	Same
crowd	pediatric	and neonatal
	patient	patient
Thermometer	Skin(mainly	Skin, oesophagus	Esophageal,	Oral, axillary or	Similar
type	axilla),oral,	or the rectum.	rectaland	rectal body sites
	rectaland		nasopharyngeal
	nasopharyngealcavity
PrescriptionorOTC	Prescription	Prescription	/	/	Same
Single use	Yes	Yes	/	/	Same
Components	DisposableTemperatureProbe iscomposed ofplug, cable andtemperaturesensing probe.	Mainlycomposed of aplug connectedto a patientmonitor and athermistor on thepatient end.	/	/	Similar
Sensor	Thermistorwhich issensitive totemperaturechange.	Thermistorwhich issensitive totemperaturechange.	/	/	Same
MonitoringSystemCompatibility	Model C30(Manufacturer:COMEN)	Dräger andSiemens patientmonitoringsystems.	/	/	DifferentNote 1
Principleofoperation	The DisposableTemperatureProbe obtainstemperatureinformationthrough theinfluencedegree that thethermal balancehas on theresistance valueof thermistorsensor after ithas contactedhuman body.	The thermistorconsists of aresistor which issensitive totemperaturechanges.	/	/	Similar
Devicespecifications	750±50mm or750±20mm8.9g (Bodysurface type),13.1g (Celomictype)	/	/	/	DifferentNote 2
Temperaturerange	25°C-45°C	25°C-45°C	/	/	Same
Accuracy	±0.1°C (25°C - 45°C)	±0.1°C (25°C - 45°C)	/	/	Same
Ambienttemperatureenvironment	5°C-40°C	Not specified.	/	/	SimilarNote 3
Materials	Foam and PVC	Stainless steel, /thermoplasticelastomers,thermoplasticPolyolefin.	/	/	DifferentNote 4
Biocompatibility	Passed the testsas per ISO10993-5 andISO 10993-10(Cytotoxicity,sensitization,irritation)	Passed the tests /as per ISO10993-5 and ISO10993-10	/	/	Same
Electrical safety	Passed the testas per IEC60601-1	Passed the test as /per IEC 60601-1	/	/	Same
EMC	Passed the testas per IEC60601-1-2	Passed the test as /per IEC60601-1-2	/	/	Same
Sterility	Non-sterile	Non-sterile	/	/	Same

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SHENZHEN LAUNCH ELECTRICAL CO., LTD 510(k)s - Section 7. 510 (k) Summary

A Note 1:

Although compared with the predicate device, the subject device may be used with different monitors, all related safety and performance tests have been conducted and met requirements, so this difference does not raise any device performance issues.

A Note 2:

Although the device specifications may be different from that of the predicates, this difference does not raise any product problems.

A Note 3:

The ambient temperature environment of the predicate device are not specified or not exactly the same. According to ISO 80601-2-56, a clinical thermometer shall operate in normal use over the ranges of an ambient temperature operating range from 15℃ to 35℃. The ambient temperature of the subject device covers this range, our company has also tested the subject device according to ISO 80601-2-56, which has proved that the subject device functions well under specified ambient temperature environment.

A Note 4:

The materials used in the subject device are different from that of the predicate device. But regarding biocompatibility, our company has authorized a qualified third-party lab to conduct tests according to ISO 10993-5 and ISO 10993-10, which has proved that the materials used in the subject device are biologically safe.

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Note 5:

Although the predicate device is intended for patient skin temperature measurement, the reference devices are intended for temperature measurement via nasopharynx and oral route. The method of measurement do not raise new or different questions of safety or effectiveness.

(8) Non-clinical studies and tests performed

Non-clinical testings have been conducted to verify that the Disposable Temperature Probe meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the targeted device complies with the following standards:

A IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
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
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. (General Plastic Surgery/General Hospital)

The body-contacting components of this device are sticker and probe which have been demonstrated conformance to the following standards.

ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
A ISO 10993-10. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Cleaning validation and disinfection validation have been conducted based on the following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

(9) Conclusion

Based on the above analysis and tests performed, it can be concluded that the performance and function of Disposable Temperature Probe is Substantially Equivalent (SE) 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.