Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on basic temperature measurement technology (thermistor) and standard medical device testing (safety, performance, biocompatibility). There is no mention of AI or ML in the intended use, device description, or performance evaluation sections.

Therapeutic

No.
The device is used for monitoring temperature, not for treatment or therapy. It acts as a diagnostic or monitoring tool.

Diagnostic

No.
The device is used for monitoring temperature, which is a measurement function, not a diagnostic one that identifies or determines the nature of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states the probes consist of a connector and a thermistor, which are hardware components. The working principle is based on the resistance of a metal conductor, indicating a physical measurement process, not purely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "monitoring temperature for multi-patient use" or "monitoring temperature for single patient use." This is a direct measurement of a physiological parameter (body temperature) in vivo (within the living body), not an analysis of samples in vitro (outside the living body).
Device Description: The description clearly states the device is used for "patient temperature measurement" and describes a probe with a thermistor that is applied to the patient.
Working Principle: The working principle is based on the resistance of a metal conductor changing with temperature, which is a physical measurement, not a chemical or biological analysis of a sample.
Anatomical Site: The anatomical sites listed (Skin, Esophageal, and Rectal) are all locations within the patient's body.
Performance Studies: The performance studies focus on safety, essential performance (accuracy of temperature measurement), and biocompatibility, which are typical for devices that interact directly with the patient's body. There are no studies related to analyzing biological samples.

IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device directly measures a physiological parameter of the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Med-link Reusable Temperature Probes:

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.

Product codes

FLL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, Esophageal and Rectal

Indicated Patient Age Range

Adult /Pediatric

Intended User / Care Setting

Qualified medical professional only.
healthcare facilities like hospital.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: ±0.1°C

Predicate Device(s)

K121427, K181967

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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.

1

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

2

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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 | Common
Name | Manufacturer | Classification
and Code | Classification
regulation | 510(k)
number |
|-----|----------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------------------|----------------------------|------------------------------|------------------|
| 1 | Unimed Temperature Probe
(Unimed Skin Temperature
Probe, Unimed General
Purpose Temperature
Probe) | Temperature
Probe | Unimed
Medical
Supplies Inc. | Class II,
FLL | 21 CFR
880.2910 | K121427 |
| 2 | Disposable Temperature
Probe | Temperature
Probe | Shenzhen
Launch
Electrical Co.,
LTD | Class II,
FLL | 21 CFR
880.2910 | K181967 |

Table 1 Predicate Device Information

Indications for Use of the Subject Device 6.

Med-link Reusable Temperature Probes:

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.

7. 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.

5

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 | Measurement
range | Accuracy | Compatible
monitors |
|----|--------|--------------------------------------------------------|----------------------|-------------|-----------------------------------------|
| 1 | W0003D | Pediatric Reusable Esophageal/Rectal Probe | 25-45°C | $\pm$ 0.1°C | Philips
IntelliVue 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-surface
Probe | 25-45°C | $\pm$ 0.1°C | |
| 7 | W0001F | Adult /Pediatric Disposable Esophageal/Rectal
Probe | 25-45°C | $\pm$ 0.1°C | GE B20
(K122253) |
| 8 | W0099F | Adult /Pediatric Disposable Esophageal/Rectal
Probe | 25-45°C | $\pm$ 0.1°C | |
| 9 | W0003E | Adult /Pediatric Disposable Skin-surface
Probe | 25-45°C | $\pm$ 0.1°C | Philips
IntelliVue MP50 |
| 10 | W0003F | Adult /Pediatric Disposable Esophageal/Rectal
Probe | 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 Reusable
Temperature Probes,
Med-link Disposable
Temperature Probes	Unimed Temperature
Probe (Unimed Skin
Temperature Probe,
Unimed General Purpose
Temperature Probe)	Disposable Temperature
Probe	/
510(K) Submitter	Shenzhen Med-link
Electronics Tech Co., Ltd.	Unimed Medical supplies
Inc.	Shenzhen Launch
Electrical Co., LTD	/
510(K) Number	K193338	K121427	K181967	/
Classification
Regulation	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-link
Reusable
Temperature Probes:
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.	Unimed
Temperature
Probes are intended to be
used
for
monitoring
temperature.
The
temperature
probes
are
reusable and designed for
use with
monitors
of
Philips,
Marquette,
Mindray,
Spacelabs,
Siemens,
Artema/S&W
and
other
monitors
compatible with YSI 400
series temperature probes.
These
devices
are
indicated
for used
bv
qualified
medical
personnel only.	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.	Different
Note 1
Item	Proposed Device	Predicate Device	Predicate Device	Verdict
Operating
Principle	Resistance of thermistor
based on the metal
conductor increases with
temperature decrease, and
the linear changes to the
characteristics of the
temperature measurement.	Resistance of thermistor
based on the metal
conductor increases with
temperature decrease, and
the linear changes to the
characteristics of the
temperature measurement.	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.	Same
Note 2
Measurement Site	Skin, Esophageal and
Rectal	Skin, Esophageal and
Rectal	Skin (mainly axilla), oral,
rectal and nasopharyngeal
cavity	Different
Note 3
Usage	Reusable, disposable	Reusable	Disposable	Same
Measurement
Range	25-45°C	25-45°C	25-45°C	Same
Accuracy	±0.1°C	±0.1°C	±0.1°C	Same
Component	plug, cable and
temperature sensing probe	plug, cable and
temperature sensing probe	plug, cable and
temperature sensing probe	Same
Thermistor
resistance	2.25KΩ@25°C	2.252KΩ@25°C	Not-provided	Same as
the
K121427
predicate
device.
Material	Materials of reusable
probe:
Cable: TPU
Probe end: Epoxy, S304
Stainless Steel;
Materials of disposable
probe:
Cable: PVC
Probe end: Epoxy, PVC	Not-provided	Foam and PVC	Different
Note 4
Compatible	Reusable
temperature	Philips.Marquette.	Model C30 (Manufacturer:	Different
Item	Proposed Device	Predicate Device	Predicate Device	Verdict
Monitors	probes are compatible with
Philips Model IntelliVue
MP50, Mindray Model
PM-9000, Drager Model
Infinity Gamma XL, and
disposable temperature
probes are compatible with
GE Model B20 and Philips
Model IntelliVue MP50.	Mindray, Spacelabs,
Siemens, Artema/S&W
and other monitors
compatible with YSI 400
series temperature probes.	COMEN)	Note 1
Operation
Environment	Temperature:
+5 °C~+40 °C;
Atmospheric Pressure: 86
kPa to 106 kPa
Relative humidity
range:0 % to 80 %,
non-condensing (% RH)	Not-provided	Temperature:
+5 °C~+40 °C	Different
Note 5
Storage
Environment	Temperature: -10 °C to
+40 °C	Not-provided	Not-provided	Different
Note 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	Different
Note 6
Biocompatibility	All the patient-contacting
materials are evaluated by
the biocompatibility
standard ISO10993-5, ISO
10993-10.	All the patient-contacting
materials are evaluated by
the biocompatibility
standard ISO10993-5, ISO
10993-10.	Passed the tests as per ISO
10993-5 and ISO
10993-10 (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".

8

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

9

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 ●

10

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.