Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model IntelliVueMP50, Mindray Model PM-9000 and Drager Model Infinity Gamma XL.

These devices are used by qualified medical professional only.

Med-link Disposable Temperature Probes:

Med-link 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 Model B20 and Philips Model IntelliVueMP50.

These devices are used by qualified medical professional only.

Device Description

The proposed devices are used for patient temperature measurement. The probes are reusable depending on models. 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 increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in healthcare facilities like hospital.

AI/ML Overview

The provided text describes the 510(k) summary for Med-link Reusable and Disposable Temperature Probes. While it outlines the device's characteristics and comparison to predicate devices, it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the context of AI/ML algorithm evaluation.

The document states:

"No clinical studies were performed to demonstrate substantial equivalence." (Section 10)
The non-clinical tests focused on safety, essential performance, and biocompatibility in accordance with relevant IEC and ISO standards for medical electrical equipment and biocompatibility. The performance standard cited is ISO 80601-2-56 for body temperature measurement.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML algorithm's performance, as this document is for a traditional medical device (temperature probes) and does not involve AI/ML.

However, I can extract the reported device performance and testing information that is present in the document for the temperature probes themselves, which is related to the accuracy of the temperature measurement.

Reported Device Performance (for the temperature probes, not an AI/ML algorithm):

Acceptance Criteria / Performance Metric	Reported Device Performance
Measurement Range	25-45°C
Accuracy	±0.1°C
Biocompatibility	Complies with ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization)
Electrical Safety	Complies with IEC 60601-1
Performance Standard	Complies with ISO 80601-2-56
Sterilization	Non-sterile
Operational Type	Continual

Regarding the other requested information for AI/ML algorithms:

Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML algorithm. Non-clinical tests were performed to assess safety and effectiveness against standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device calibration and accuracy testing typically refer to established laboratory methods and reference standards, rather than expert interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device itself is standalone in its function as a temperature probe; there is no AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For temperature accuracy, the ground truth would typically be established by calibrated reference thermometers in a controlled environment, adhering to the requirements of the relevant performance standards (e.g., ISO 80601-2-56).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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, 2020

Shenzhen Med-link Electronics Tech Co., Ltd. Fei Liu Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Shenzhen, 518109 China

Re: K193338

Trade/Device Name: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 16, 2020 Received: July 27, 2020

Dear Fei Liu:

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.

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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); 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 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.

for 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

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Image /page/3/Picture/0 description: The image shows the logo for MEDLINKET. The logo features the word "MED" in red, with a blue swoosh underneath. To the right of "MED" is a red circle, followed by the word "LINKET" in blue. There is a small "TM" symbol above and to the right of the word "LINKET".

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. Type of submission: Traditional The assigned 510(k) number is: K193338

1. Submitter information

Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-755-61568825 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961

2. Correspondent

Fei Liu (Regulatory Affairs Specialist, Primary Contact) E-mail: user22@med-linket.com

Jialing Zhang E-mail: user60@med-linket.com

3. Data of Preparation

16th, July. 2020

4. I Identification of the Device

Trade Name: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes Common Name: Temperature Probe Classification Regulation: 21 CFR 880.2910 Product Code: FLL Class: II Review Panel: General Hospital

5. Identification of the Predicate Devices

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Image /page/4/Picture/0 description: The image shows the logo for MEDLINKET. The logo consists of the letters "MED" in red, with a blue swoosh underneath. To the right of the letters is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".

No.	Device Name	CommonName	Manufacturer	Classificationand Code	Classificationregulation	510(k)number
1	Unimed Temperature Probe(Unimed Skin TemperatureProbe, Unimed GeneralPurpose TemperatureProbe)	TemperatureProbe	UnimedMedicalSupplies Inc.	Class II,FLL	21 CFR880.2910	K121427
2	Disposable TemperatureProbe	TemperatureProbe	ShenzhenLaunchElectrical Co.,LTD	Class II,FLL	21 CFR880.2910	K181967

Table 1 Predicate Device Information

Indications for Use of the Subject Device 6.

Med-link Reusable Temperature Probes:

These devices are used by qualified medical professional only.

Med-link Disposable Temperature Probes:

These devices are used by qualified medical professional only.

7. Device Description

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Image /page/5/Picture/0 description: The image shows the logo for MEDLINKET. The logo features the word "MED" in red, with the letters stacked on top of each other. To the right of "MED" is a red circle, followed by the word "LINKET" in blue. The letters in "LINKET" are connected to each other.

No	Model	Description	Measurementrange	Accuracy	Compatiblemonitors
1	W0003D	Pediatric Reusable Esophageal/Rectal Probe	25-45°C	$\pm$ 0.1°C	PhilipsIntelliVue MP50(K040304)
2	W0001C	Pediatric Reusable Skin-surface Probe	25-45°C	$\pm$ 0.1°C	Mindray
3	W0001D	Pediatric Reusable Esophageal/Rectal Probe	25-45°C	$\pm$ 0.1°C	PM-9000(K070791)
4	W0008C	Pediatric Reusable Skin-surface Probe	25-45°C	$\pm$ 0.1°C	Drager Infinity
5	W0008D	Pediatric Reusable Esophageal/Rectal Probe	25-45°C	$\pm$ 0.1°C	Gamma XL(K053484)
6	W0001E	Adult /Pediatric Disposable Skin-surfaceProbe	25-45°C	$\pm$ 0.1°C
7	W0001F	Adult /Pediatric Disposable Esophageal/RectalProbe	25-45°C	$\pm$ 0.1°C	GE B20(K122253)
8	W0099F	Adult /Pediatric Disposable Esophageal/RectalProbe	25-45°C	$\pm$ 0.1°C
9	W0003E	Adult /Pediatric Disposable Skin-surfaceProbe	25-45°C	$\pm$ 0.1°C	PhilipsIntelliVue MP50
10	W0003F	Adult /Pediatric Disposable Esophageal/RectalProbe	25-45°C	$\pm$ 0.1°C	(K040304)

8. Comparison to the Predicate Device

Item	Proposed Device	Predicate Device	Predicate Device	Verdict
Trade name	Med-link ReusableTemperature Probes,Med-link DisposableTemperature Probes	Unimed TemperatureProbe (Unimed SkinTemperature Probe,Unimed General PurposeTemperature Probe)	Disposable TemperatureProbe	/
510(K) Submitter	Shenzhen Med-linkElectronics Tech Co., Ltd.	Unimed Medical suppliesInc.	Shenzhen LaunchElectrical Co., LTD	/
510(K) Number	K193338	K121427	K181967	/
ClassificationRegulation	21CRF 880.2910	21CRF 880.2910	21 CRF 880.2910	Same
Classification and	Class II,	Class II,	Class II,	Same

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Image /page/6/Picture/0 description: The image shows the logo for MEDLINKET. The logo has the word "MED" in red, with a blue swoosh underneath. To the right of the swoosh is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".

Item	Proposed Device	Predicate Device	Predicate Device	Verdict
Code	FLL	FLL	FLL	FLL
Common name	Temperature Probe	Temperature Probe	Temperature Probe	Same
Type of Use	Prescription	Prescription	Prescription	Same
Indications for use	Med-linkReusableTemperature Probes:Med-linkTemperatureProbes are intended to beusedformonitoringtemperatureformulti-patientuse.Thetemperatureprobesarereusable and designed foruse withmonitorsofPhilipsModelIntelliVueMP50, MindrayModelPM-9000andDragerModelInfinityGamma XL.These devices are used byqualifiedmedicalprofessional only.Med-linkDisposableTemperature Probes:Med-linkDisposableTemperature Probes areintended to be used formonitoring temperature forsingle patient use. Thetemperature probes arenon-sterile and designedfor use with monitors ofGE Model B20 and PhilipsModel IntelliVueMP50.These devices are used byqualifiedmedicalprofessional only.	UnimedTemperatureProbes are intended to beusedformonitoringtemperature.Thetemperatureprobesarereusable and designed foruse withmonitorsofPhilips,Marquette,Mindray,Spacelabs,Siemens,Artema/S&Wandothermonitorscompatible with YSI 400series temperature probes.Thesedevicesareindicatedfor usedbvqualifiedmedicalpersonnel only.	TheDisposableTemperature Probe (bodysurface type) is to be usedwith a compatible medicalmonitorthathastemperature measurementfunction to continuouslymeasure the patient's skintemperature.TheDisposableTemperatureProbe(celomic type) is to beused with a compatiblemedical monitor that hastemperature measurementfunction to continuouslymeasure the patient's oral,rectal,nasopharyngealcavity temperature.	DifferentNote 1
Item	Proposed Device	Predicate Device	Predicate Device	Verdict
OperatingPrinciple	Resistance of thermistorbased on the metalconductor increases withtemperature decrease, andthe linear changes to thecharacteristics of thetemperature measurement.	Resistance of thermistorbased on the metalconductor increases withtemperature decrease, andthe linear changes to thecharacteristics of thetemperature measurement.	TheDisposableTemperature Probe obtainstemperature informationthrough the influencedegree that the thermalbalance has on theresistance value ofthermistor sensor after ithas contacted human body.	SameNote 2
Measurement Site	Skin, Esophageal andRectal	Skin, Esophageal andRectal	Skin (mainly axilla), oral,rectal and nasopharyngealcavity	DifferentNote 3
Usage	Reusable, disposable	Reusable	Disposable	Same
MeasurementRange	25-45°C	25-45°C	25-45°C	Same
Accuracy	±0.1°C	±0.1°C	±0.1°C	Same
Component	plug, cable andtemperature sensing probe	plug, cable andtemperature sensing probe	plug, cable andtemperature sensing probe	Same
Thermistorresistance	2.25KΩ@25°C	2.252KΩ@25°C	Not-provided	Same astheK121427predicatedevice.
Material	Materials of reusableprobe:Cable: TPUProbe end: Epoxy, S304Stainless Steel;Materials of disposableprobe:Cable: PVCProbe end: Epoxy, PVC	Not-provided	Foam and PVC	DifferentNote 4
Compatible	Reusabletemperature	Philips.Marquette.	Model C30 (Manufacturer:	Different
Item	Proposed Device	Predicate Device	Predicate Device	Verdict
Monitors	probes are compatible withPhilips Model IntelliVueMP50, Mindray ModelPM-9000, Drager ModelInfinity Gamma XL, anddisposable temperatureprobes are compatible withGE Model B20 and PhilipsModel IntelliVue MP50.	Mindray, Spacelabs,Siemens, Artema/S&Wand other monitorscompatible with YSI 400series temperature probes.	COMEN)	Note 1
OperationEnvironment	Temperature:+5 °C~+40 °C;Atmospheric Pressure: 86kPa to 106 kPaRelative humidityrange:0 % to 80 %,non-condensing (% RH)	Not-provided	Temperature:+5 °C~+40 °C	DifferentNote 5
StorageEnvironment	Temperature: -10 °C to+40 °C	Not-provided	Not-provided	DifferentNote 5
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
Performance	ISO 80601-2-56	EN 12470-4	ISO 80601-2-56	DifferentNote 6
Biocompatibility	All the patient-contactingmaterials are evaluated bythe biocompatibilitystandard ISO10993-5, ISO10993-10.	All the patient-contactingmaterials are evaluated bythe biocompatibilitystandard ISO10993-5, ISO10993-10.	Passed the tests as per ISO10993-5 and ISO10993-10 (Cytotoxicity,sensitization, irritation)	Same
Sterilization	Non-sterile	Non-sterile	Non-sterile	Same
Operational Type	Continual	Continual	Continual	Same

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Image /page/7/Picture/0 description: The image shows the logo for MEDLINKET. The logo features the word "MED" in red, with the letters stacked on top of each other. To the right of "MED" is a red circle, followed by the word "LINKET" in blue. The letters in "LINKET" are connected to each other. The letters "TM" are in the upper right corner of the word "LINKET".

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Image /page/8/Picture/0 description: The image is a logo for MEDLINKET. The logo is composed of the word "MED" in red, with the letters stacked on top of each other. The word "LINKET" is in blue, with a red circle in the middle of the word. There is a blue curved line that goes from the bottom of the "M" in "MED" to the bottom of the "T" in "LINKET".

Note 1

The compatible monitors of proposed devices are different from those of the predicate devices. The core component of temperature probes in the subject devices is Negative Temperature Coefficient (NTC) which is identical to the NTC used in the predicate devices. The performance bench testing in accordance with ISO 80601-2-56 for all models of the subject devices with compatible monitors were conducted and the requirements. The NTC determines the accuracy and range of temperature measurement. The difference does not raise new questions of safety and

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Image /page/9/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath. To the right of the word "MED" is a red circle, followed by the word "LINKET" in blue, with the letters "TM" in a smaller font above the "ET".

effectiveness.

Note 2

Both the subject device and the K181967 predicate device measure differences in resistance and equate that to changes in temperature. Therefore, the operating principles are actually the same.

Note 3

Although nasopharyngeal as a measurement site is excluded in the sites of proposed devices, our disposable temperature probes have been compared with the predicate disposable temperature probes in intended use, working principle, construct, material, safety and performance standard, etc., such a removal of measurement site doesn't affect the substantial equivalence among other items, nor does it affect the equivalent comparison between proposed device and predicate device in measurement sites including skin, esophageal and rectal. The difference does not raise new questions of safety and effectiveness.

Note 4

Although patient-contacting materials are different for proposed devices and predicate devices, all of them are complied with ISO 10993-5 and ISO 10993-10. The differences do not raise new questions of safety and effectiveness.

Note 5

Although some specifications of operating & storage conditions are different for proposed devices and predicate devices, they are all complied with IEC 60601-1 and ISO 80601-2-56. The differences do not raise new questions of safety and effectiveness.

Note 6

EN 12470-4 as old performance standard was replaced by new performance standard ISO 80601-2-56. Therefore, all of them met the applicable performance requirements. The differences do not raise new questions of safety and effectiveness.

9. Non-clinical Test

A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Temperature Probes. The tests listed above were conducted in accordance with IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance, Compatibility testing with monitors, ISO 80601-2-56 Medical equipment-Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

ISO 10993-5 Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization

Cytotoxicity Test
Irritation Test ●
Sensitization Test ●

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Image /page/10/Picture/0 description: The image shows the logo for MEDLINKET. The logo is composed of the word "MED" in red, followed by a red circle, and then the word "LINKET" in blue. A blue swoosh underlines the logo.

FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling document issued on: March 17, 2015.

In addition, shelf life testing was conducted to ensure the temperature probes meet the requirements of the expected life of the probe.

10. Clinical performance data

No clinical studies were performed to demonstrate substantial equivalence.

11. Conclusion

Based on the comparison and analysis in this submission, it can be concluded that: Med-link Temperature Probes are substantially equivalent 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.