What is the regulatory pathway for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Unimed Temperature Probe (K121427); Disposable Temperature Probe (K181967).

Who can help prepare an FDA 510(k) submission like Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

Q: Who is the manufacturer of Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Shenzhen Med-Link Electronics Tech Co., Ltd. filed the 510(k) submission for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (K193338).

Q: What is the FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

K193338 · Shenzhen Med-Link Electronics Tech Co., Ltd. · FLL · Aug 25, 2020 · General Hospital

Device Facts

Record ID	K193338
Device Name	Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
Applicant	Shenzhen Med-Link Electronics Tech Co., Ltd.
Product Code	FLL · General Hospital
Decision Date	Aug 25, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2

Intended 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.

Device Story

Device consists of temperature probes with a connector on the monitor end and a thermistor on the patient end. Operates via resistance-based sensing where thermistor resistance changes linearly with temperature. Used in healthcare facilities by qualified medical professionals to monitor patient temperature. Input is thermal energy from the patient; output is an electrical signal processed by compatible patient monitors (Philips, Mindray, Drager, GE) to display temperature values. Aids clinicians in continuous patient temperature monitoring. Reusable models (TPU cable, stainless steel/epoxy probe) and disposable models (PVC cable/probe) available.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), performance testing (ISO 80601-2-56), biocompatibility (ISO 10993-5, ISO 10993-10), and monitor compatibility testing.

Technological Characteristics

NTC thermistor-based temperature sensing. Reusable probes: TPU cable, S304 stainless steel/epoxy probe end. Disposable probes: PVC cable/epoxy probe end. Measurement range 25-45°C, accuracy ±0.1°C. Non-sterile. Complies with IEC 60601-1 and ISO 80601-2-56. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for monitoring patient body temperature in healthcare facilities. Reusable probes for multi-patient use; disposable probes for single-patient use. Compatible with specific Philips, Mindray, Drager, and GE monitors. For use by qualified medical professionals only.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

Unimed Temperature Probe (K121427)
Disposable Temperature Probe (K181967)

Reference Devices

Philips IntelliVue MP50 (K040304)
Mindray PM-9000 (K070791)
Drager Infinity Gamma XL (K053484)
GE B20 (K122253)

Related Devices

K223807 — Reusable Temperature Probe, Disposable Temperature Probe · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 25, 2023
K121427 — UNIMED TEMPERATURE PROBE · Unimed Medical Supplies, Inc. · May 29, 2012
K173194 — Temperature Probe · Orantech, Inc. · Oct 10, 2018
K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG · Jkh USA, LLC · Aug 31, 2021
K182667 — Med-link Temperature Probes · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jun 18, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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}------------------------------------------------ {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 | {6}------------------------------------------------ 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 | {7}------------------------------------------------ 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.