Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Disposable Temperature Probes:

Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Device Description

The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (Reusable and Disposable Temperature Probes) and its substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria through detailed performance metrics and a comparison to a defined ground truth.

Therefore, many of the requested details about acceptance criteria, specific study design elements (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are not present in the provided document.

However, I can extract the following information that is available:

1. A table of acceptance criteria and the reported device performance:

The document mentions compliance with standards which inherently include performance criteria. Specifically, the "Accuracy" is listed.

Acceptance Criteria	Reported Device Performance
Accuracy	±0.1°C
Measurement Range	25-45°C
Measurement Time	60s
Biocompatibility	Complied with ISO 10993-1, ISO 10993-5, and ISO 10993-10
Electrical Safety	Complied with IEC 60601-1
Performance Standard	Complied with ISO 80601-2-56
Electromagnetic Compatibility	Complied with IEC 60601-1-2

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

Sample Size for Test Set: Not specified. The document states "Non-clinical testing has been conducted to verify that the subject devices meet all design specifications." The exact number of units or measurements in these tests is not provided.
Data Provenance: The tests are non-clinical, conducted by the manufacturer, Shenzhen SINO-K Medical Technology Co., Ltd., which is based in Shenzhen, Guangdong, China. The testing confirms compliance with international standards (IEC, ISO, ASTM).

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

Number of Experts: Not applicable/not specified. The testing described is non-clinical performance testing against established international standards, not expert evaluation of medical images or diagnostic outputs.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. This document describes objective performance testing against engineering standards, not a diagnostic study requiring expert adjudication.

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:

MRMC Study: No. This device is a temperature probe, not an AI-assisted diagnostic tool.

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

Standalone Performance: Yes, in the sense that the device's inherent performance (e.g., accuracy, measurement range) was demonstrated through non-clinical testing against standards (e.g., ISO 80601-2-56) without human interpretation of results beyond reading the device's output.

7. The type of ground truth used:

Ground Truth Type: International standards (ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2), and established biocompatibility standards (ISO 10993 series). These specify acceptable ranges and methodologies for determining performance, forming the "ground truth" for compliance.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device is a hardware temperature probe, not a machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2023

Shenzhen SINO-K Medical Technology Co., Ltd. % Kevin Wang Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K223807

Trade/Device Name: Reusable Temperature Probe, Disposable Temperature Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 25, 2023 Received: July 26, 2023

Dear Kevin Wang:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223807

Device Name

Reusable Temperature Probe, Disposable Temperature Probe

Indications for Use (Describe)

Reusable Temperature Probes:

Disposable Temperature Probes:

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary - K223807

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: August 25, 2023

1. Submission sponsor

Name: Shenzhen SINO-K Medical Technology Co., Ltd. Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, Guangdong, China Contact person: Lao Chengxin Title: General Manager E-mail: boss(@sino-k.com Tel: +86 137 15333326

Submission correspondent 2.

Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160

3. Subject Device Information

Trade/Device Name	Reusable Temperature Probe, Disposable Temperature Probe
Regulatory Class	Class II
Regulation Number	21CFR 880.2910
Regulation/CommonName	Clinical Electronic Thermometer
Product Code	FLL
Submission type	Traditional 510(K)

Predicate Device 4.

Manufacturer Name	Shenzhen Med-link Electronics Tech Co., Ltd.
510(k) Number	K193338
Trade/Device Name	Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
Regulatory Class	Class II
Regulation Number	21CFR 880.2910
Regulation/Common Name	Clinical Electronic Thermometer
Product Code	FLL
Submission type	Traditional 510(K)

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5. Device Description

No.	Model	Description
1	ST1304	Skin contact Temperature Probe, adult, reusable
2	ST2304	Body cavity Temperature Probe, Esophageal, adult, reusable
3	ST3304	Skin contact Temperature Probe, pediatric, reusable
4	ST4304	Body cavity Temperature Probe, Esophageal, pediatric, reusable
5	ST5105A	Skin contact Temperature Probe, adult, disposable
6	ST6105A	Body cavity Temperature Probe, Esophageal, adult, disposable

6. Indication for use

Reusable Temperature Probes:

Reusable Temperature Probes are intended to be used for monitoring temperature for multipatient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000.

These devices are used by qualified medical professionals only.

Disposable Temperature Probes:

Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use.

The temperature probes are non-sterile and designed for use with monitors of GE-Marquette Model DASH3000.

These devices are used by qualified medical professionals only.

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Item	Subject Device,K223807	Predicate Device,K193338	Comparison
Trade name	Reusable TemperatureProbe, DisposableTemperature Probe	Med-link ReusableTemperature Probes,Med-link DisposableTemperature Probes	/
510(k) submitter	Shenzhen SINO-KMedical TechnologyCo., Ltd.	Shenzhen Med-linkElectronics Tech Co.,Ltd.	/
510(k) Number	K223807	K193338	/
Models	Reusableadult/pediatricmodels: ST1304,ST2304, ST3304,ST4304Disposableadult/pediatricmodels:ST5105A, ST6105A	Reusable pediatricmodels:W0003D,W0001C,W0001D,W00008C,W00008DDisposableadult/pediatric models:W0001E, W0001F,W0099F, W0003E,W0003F	SENote 1
Type of use	Prescription/Rx	Prescription/Rx	Same
Indication forUse	Reusable TemperatureProbes:Reusable TemperatureProbes are intended tobe used for monitoringtemperature for multi-patient use. Thetemperature probes arereusable and designedfor use with monitor ofGE-Marquette ModelDASH3000.These devices are usedby qualified	Med-link ReusableTemperature Probes:Med-link TemperatureProbes are intended to beused for monitoringtemperature for multi-patient use. Thetemperature probes arereusable and designed foruse with monitors ofPhilips ModelIntelliVueMP50,Mindray Model PM-9000and Drager Model	SENote 1
Item	Subject Device,K223807	Predicate Device,K193338	Comparison
	professional only.DisposableTemperature Probes:DisposableTemperature Probesare intended to be usedfor monitoringtemperature for singlepatient use. Thetemperature probes arenon-sterile anddesigned for use withmonitors of GE-Marquette ModelDASH3000.These devices are usedby qualified medicalprofessional only.	These devices are usedby qualified medicalprofessional only.Med-link DisposableTemperature Probes:Med-link DisposableTemperature Probes areintended to be used formonitoring temperaturefor single patient use.The temperature probesarenon-sterile and designedfor use with monitors ofGE Model B20 andPhilips ModelIntelliVueMP50.These devices are usedby qualified medicalprofessional only.
OperatingPrinciple	Resistance ofthermistor based onthe metal conductorincreases withtemperature decrease,and the linear changesto the characteristicsof the temperaturemeasurement.	Resistance of thermistorbased on the metalconductor increases withtemperature decrease,and the linear changes tothe characteristics of thetemperaturemeasurement.	Same
Measure site	Skin, Esophagus	Skin, Esophageal andRectal	SENote 2
Usage	Reusable, Disposable	Reusable, Disposable	Same
MeasurementRange	25-45°C	25-45°C	Same
MeasurementTime	60s	180s	SE Note 3
Accuracy	±0.1°C	±0.1°C	Same
Components	plug, cable andtemperature sensing	plug, cable andtemperature sensing	Same
Item	Subject Device,K223807	Predicate Device,K193338	Comparison
	probe	probe
Thermistorresistance	2.25KΩ@25°C	2.25KΩ@25°C	Same
DeviceDimension	Reusable models:3mDisposable models:0.8m	Unknown	SENote 4
Material	Materials of reusableprobe:Cable: PVCProbe end: Steel,Epoxy, PA66Materials ofdisposable probe:Cable: PVCProbe end: Epoxy,Medical pressure-sensitive adhesive	Materials of reusableprobe:Cable: TPUProbe end: Epoxy,S304 Stainless Steel;Materials of disposableprobe:Cable: PVCProbe end: Epoxy, PVC	SENote 5
CompatibleMonitors	GE-Marquette ModelDASH3000	Reusable temperatureprobes are compatiblewith Philips ModelIntelliVue MP50,Mindray Model PM-9000, Drager ModelInfinity Gamma XL, anddisposable temperatureprobes are compatiblewith GE Model B20 andPhilips Model IntelliVueMP50.	SENote 1
OperatingEnvironment	Temperature: +5to+40°CHumidity: ≤80%(non-condensing)Atmospheric pressure: 86kPa ~106kPa	Temperature:+5°C~+40°C;Atmospheric Pressure: 86kPa to 106 kPaRelative humidityrange:0 % to 80 %,non-condensing (% RH)	Same
StorageEnvironment	Temperature: -10°C to+40°C	Temperature: -10°C to+40°C	Same
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
Performance	ISO 80601-2-56	ISO 80601-2-56	Same
Biocompatibility	All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-1	All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-5, ISO 10993-10.	Same
Sterilization	Non-sterile	Non-sterile	Same
Operational Type	Continual	Continual	Same
Shelf life	2 years	Unknown	SENote 6

7. Comparison to the Predicate Device

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Note 1
The subject device is compatible with a different monitor than the predicate device. In addition, the intended patient population of both the subject device and the predicate device include adult and pediatric patient populations with the only difference being that The core component of the temperature probes in the subject devices is Negative Temperature Coefficient (NTC) which is identical to the NTC used in the predicate devices. The NTC determines the accuracy and range of temperature measurement. The subject device performance was tested in accordance with ISO 80601-2-56 for all models, using the compatible monitor. All results met the requirements. Therefore, the differences do not raise new questions of safety and effectiveness.

Note 2

The subject device measurement sites are a subset of the predic sites. The subject device performance and biocompatibility was tested in accordance to ISO 80601-2-56 and ISO10993-1, respectively. Therefore, the difference does not raise new questions of safety and effectiveness.

Note 3

The meas ne of the subject device is 60 seconds; he time of the predicate device is 180 seconds. The subject device's measurement time is le than that of the predicate and the device performance of all models have been tested to ISO80601-2-56. Therefore, the differences do not raise new or different questions of safet and effectiveness.

Note 4

ns of the predicate device are unknown. The ide flexibility for clinical use. The length e of the subject devices. The performance o

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been verified with ISO 80601-2-56; the difference does not raise new questions of safety and effectiveness.

Note 5

Although patient-contacting materials are different between the subject devices and predicate devices, all of the subject device models were tested in accordance to and complied with ISO 10993-5 and ISO 10993-10. Therefore, the differences do not raise new questions of safety and effectiveness.

Note 6

The shelf life of the subject device is 2 years; however, the shelf life of the predicate device is unknown. The performance of the subject device has been verified for the claimed shelf life. Therefore, the difference does not raise new questions of safety and effectiveness.

8. Non- Clinical Testing

The following testing was conducted to demonstrate substantial equivalence.

Biocompatibility testing

The biocompatibility evaluation for the subject devices were conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:

Cytotoxicity
- o ISO10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. Sensitization
- ISO10993-10 Third Edition 2010-08-01 Biological evaluation of medical 0 devices - Part 10: Tests for irritation and skin sensitization
Irritation .
- ISO10993-10 Third Edition 2010-08-01 Biological evaluation of medical O devices - Part 10: Tests for irritation and skin sensitization
Oral mucosa Irritation (Body cavity Temperature Probe only)

Performance Testing

Non-clinical testing has been conducted to verify that the subject devices meet all design specifications which support 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:

IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical

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Equipment- Part 1: General requirements for basic safety and essential performance

. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems

9. Clinical Testing

No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

10. Conclusion

It can be concluded that the differences between the subject devices, Reusable Temperature Probe, Disposable Temperature Probe and predicate devices do not raise new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device. Med-link Reusable Temperature Probes, Med- link Disposable Temperature Probes, cleared under K193338.

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.