Med-link Temperature Probes

{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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. June 18, 2019 Shenzhen Med-link Electronics Tech Co., Ltd. Baihan Feng Regulatory Affairs Specialist 4th Floor, Building A, Yingtailong Industrial Park Dalang South Road, Longhua District Shenzhen, Guangdong 518109 China Re: K182667 Trade/Device Name: Med-link Temperature Probes Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 14, 2019 Received: May 16, 2019 Dear Baihan Feng: 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 (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, For Tina Kiang, Ph.D 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182667 Device Name Med-link Temperature Probes ### Indications for Use (Describe) 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 Intelli Vue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL. These devices are used by qualified medical professional only. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Type of submission: Traditional The assigned 510(k) number is: K182667 #### 1. Submitter information Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th Fl, Bldg A, Yingtailong Industrial Park, Dalang South Road, Longhua District, Shenzhen, Guangdong, CHINA, 518109 Tel: 0086-755-61568825 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961 ## 2. Correspondent Baihan Feng (Regulatory Affairs Specialist, Primary Contact) E-mail: MDL001 @medlinket.com Liu Fei E-mail: USER22@med-linket.com - 3. Data of Preparation 14th, May 2019 ### 4. Identification of the Device Trade Name: Med-link Temperature Probes Common Name: Temperature Probe Classification Regulation: 21 CFR 880.2910 Classification Name: Clinical Electronic Thermometer Product Code: FLL Class: II Review Panel: General Hospital #### Identification of the Predicate Device 5. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MED Linket. The logo has the letters "MED" in red, with a blue swoosh underneath. To the right of the letters is a red circle, and the word "LINKET" in blue. There is a small "TM" symbol in the upper right corner of the word "LINKET". | No. | Device Name | Common<br>Name | Manufacture | Classifica<br>tion and<br>Code | Classific<br>ation<br>regulatio<br>n | 510(k)<br>number | |-----|-------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------|--------------------------------|--------------------------------------|------------------| | 1 | Unimed Temperature<br>Probe (Unimed Skin<br>Temperature Probe,<br>Unimed General<br>Purpose Temperature<br>Probe) | Temperature<br>Probe | Unimed<br>Medical<br>supplies Inc. | Class II,<br>FLL | 21 CFR<br>880.2910 | K121427 | ## Table 1 Predicate Device Information #### Indications for Use of the Subject device 6. 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 IntelliVue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL. These devices are used by qualified medical professional only. #### Device Description 7. The proposed devices are used for patient temperature measurement for multi-patient use. The temperature probes are reusable and 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. | No | Model | Description | Measurement<br>range | Accuracy | Compatible<br>monitors | |----|--------|----------------------------------------|----------------------|----------|----------------------------------| | 1 | W0003A | Adult Reusable Skin-surface Probe | 25-45°C | ±0.1 °C | Philips | | 2 | W0003B | Adult Reusable Esophageal/Rectal Probe | 25-45°C | ±0.1 °C | Intelli Vue<br>MP50<br>(K040304) | | 3 | W0001A | Adult Reusable Skin-surface Probe | 25-45°C | ±0.1°C | Mindray | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MedLinket. The logo features the letters "MED" in red, with a blue orbit-like design surrounding the letters. 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". | 4 | W0001B | Adult Reusable Esophageal/Rectal Probe | 25-45°C | ±0.1 °C | PM-9000<br>(K070791) | |----|--------|----------------------------------------|---------|---------|--------------------------------| | 5 | W0013A | Adult Reusable Skin-surface Probe | 25-45°C | ±0.1 °C | Mindray | | 6 | W0013B | Adult Reusable Esophageal/Rectal Probe | 25-45°C | ±0.1 °C | BeneVision<br>N12<br>(K182075) | | 7 | W0007A | Adult Reusable Skin-surface Probe | 25-45°C | ±0.1°C | Datex-Ohmeda | | 8 | W0007B | Adult Reusable Esophageal/Rectal Probe | 25-45°C | ±0.1 °C | Cardiocap II<br>(K912530) | | 9 | W0008A | Adult Reusable Skin-surface Probe | 25-45°C | ±0.1 °C | Drager Infinity | | 10 | W0008B | Adult Reusable Esophageal/Rectal Probe | 25-45°C | ±0.1 °C | Gamma XL<br>(K053484) | ## 8. 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 below were conducted in accordance with IEC 60601-1 Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance. 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. 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 FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling document issued on: March 17, 2015. #### 9. Comparison to the Predicate Device | Item | Proposed Device | Predicate Device | Verdict | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Trade name | Med-link Temperature Probes | Unimed Temperature Probe<br>(Unimed Skin Temperature Probe, Unimed General Purpose Temperature Probe) | / | | Item | Proposed Device | Predicate Device | Verdict | | 510(K) Submitter | Shenzhen Med-link Electronics<br>Tech Co., Ltd. | Unimed Medical supplies<br>Inc. | / | | 510(K) Number | K182667 | K121427 | / | | Classification<br>Regulation | 21CRF 880.2910 | 21CRF 880.2910 | SE | | Classification and<br>Code | Class II,<br>FLL | Class II,<br>FLL | SE | | Common name | Temperature Probe | Temperature Probe | SE | | Type of Use | Prescription | Prescription | SE | | Intended use | Med-link Temperature Probes are<br>intended to be used for<br>monitoring temperature for<br>multi-patient use. The temperature<br>probes are reusable and designed<br>for use with monitors of Philips<br>Model IntelliVue MP50, Mindray<br>Model PM-9000, Datex-Ohmeda<br>Model Cardiocap II, Drager<br>Model Infinity Gamma XL.<br>These devices are used by<br>qualified medical professional<br>only. | Unimed Temperature Probes<br>are intended to be used for<br>monitoring temperature. The<br>temperature probes are<br>reusable and designed for use<br>with monitors of Philips,<br>Marquette, Mindray,<br>Spacelabs, Siemens,<br>Artema/S&W and other<br>monitors compatible with<br>YSI 400 series temperature<br>probes.<br>These devices are indicated<br>for used by qualified medical<br>personnel only. | SE<br>Note 1 | | Operating<br>Principle | Resistance of thermistor based on<br>the metal conductor increases<br>with temperature decrease, and<br>the linear changes to the<br>characteristics of the temperature<br>measurement. | Resistance of thermistor<br>based on the metal conductor<br>increases with temperature<br>decrease, and the linear<br>changes to the characteristics<br>of the temperature<br>measurement. | SE | | Measurement Site | Skin, Esophageal and Rectal | Skin, Esophageal and Rectal | SE | | Measurement | 25-45°C | 25-45°C | SE | | Item | Proposed Device | Predicate Device | Verdict | | Range | | | | | Accuracy | ±0.1°C | ±0.1°C | SE | | Component | Reusable | Reusable | SE | | Thermistor<br>resistance | 2.25K@25°C | 2.252K@25°C | SE | | Material | Cable: PVC<br>Probe end: Epoxy, S304 Stainless<br>Steel | Not-provided | SE<br>Note 2 | | Compatible<br>Monitors | Philips Model IntelliVue MP50,<br>Mindray Model PM-9000,<br>Datex-Ohmeda Model Cardiocap<br>II, Drager Model Infinity Gamma<br>XL. | Philips,Marquette, Mindray,<br>Spacelabs, Siemens,<br>Artema/S&W and other<br>monitors compatible with<br>YSI 400 series temperature<br>probes. | SE<br>Note 1 | | Sterilization | Non-sterile | Non-sterile | SE | | Operation<br>Environment | Temperature: +5°C~+40°C;<br>Atmospheric Pressure: 86 kPa to<br>106 kPa<br>Relative humidity range:0 % to<br>80 %, non-condensing (% RH) | Not-provided | SE<br>Note 3 | | Storage<br>Environment | Temperature:<br>-10°C to +40°C | Not-provided | SE<br>Note 3 | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE | | Performance | ISO 80601-2-56 | EN 12470-4 | SE<br>Note 4 | | Biocompatibility<br>Evaluation | All the patient contracting<br>materials are evaluated by the<br>biocompatibility standard ISO<br>10993-5, ISO 10993-10. | All the patient contracting<br>materials are evaluated by the<br>biocompatibility standard<br>ISO 10993-5, ISO 10993-10. | SE | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for MED LINKET. The word "MED" is in red, and the word "LINKET" is in blue. There is a red circle between the two words. The letters are bold and easy to read. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for MEDLINKET. The logo features the letters "MED" in red, with a blue swoosh underneath. To the right of the letters is a red circle, and the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word "LINKET". ## Note 1 The compatible monitors of proposed devices are different from the predicate device. The core component of temperature probe in the subject device is Negative Temperature Coefficient (NTC) {8}------------------------------------------------ Image /page/8/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. The letters "TM" are in the upper right corner of the word "LINKET". which is identical to the NTC used in predicate device. The NTC determines the accuracy and range of temperature measurement. The performance bench testing in accordance with ISO 80601-2-56 for all models of the subject device with compatible monitors was conducted and the results met the requirements. Therefore, the intended use of proposed devices is the same as predicate device. This difference does not raise different questions of safety or effectiveness for the subject devices. Note 2 Although patient contact material are different for proposed device and predicate device, they are both complied with ISO 10993-5 and ISO 10993-10. The differences do not affect the safety and effectiveness. Note 3 Although some specifications of operating & storage conditions are different for proposed device and predicate device, they are both complied with IEC 60601-1 and ISO 80601-2-56. The differences do not affect the safety and effectiveness. Note 4 EN 12470-4 as old performance standard was replaced by new performance standard ISO 80601-2-56. Therefore, both of them met the applicable performance requirements. The differences do not affect the safety and effectiveness. ### 10. 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.