(266 days)
Not Found
No
The device description and performance studies focus on basic temperature sensing technology and standard medical device testing, with no mention of AI or ML.
No.
The device is used for monitoring temperature, not for treatment or therapy.
No
The device is intended for monitoring temperature, not for diagnosing a medical condition.
No
The device description explicitly states the device consists of a connector and a thermistor, which are hardware components. The performance studies also include hardware-specific testing like biocompatibility and electrical safety.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Med-link Temperature Probes are used for monitoring temperature directly on or within the patient's body (skin, esophageal, rectal). This is a direct physiological measurement, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states "monitoring temperature for multi-patient use," not analyzing biological samples.
- Device Description: The description focuses on the physical components and working principle of a temperature sensor, not on reagents or methods for analyzing biological samples.
Therefore, based on the provided information, the Med-link Temperature Probes are medical devices used for direct patient monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
Device Description
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.
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
Not Found
Intended User / Care Setting
qualified medical professional only.
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 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.
The core component of temperature probe in the subject device is Negative Temperature Coefficient (NTC) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.1°C
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for MED-LINKET. The logo has the word "MED" in red, with a blue swoosh underneath. There is a red circle in the middle of the swoosh. To the right of the circle is the word "LINKET" in blue, with a small "TM" symbol in the upper right corner.
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: 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
-
- Data of Preparation
14th, May 2019
- Data of Preparation
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.
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| No. | Device Name | Common
Name | Manufacture | Classifica
tion and
Code | Classific
ation
regulatio
n | 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 |
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
range | Accuracy | Compatible
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
MP50
(K040304) |
| 3 | W0001A | Adult Reusable Skin-surface Probe | 25-45°C | ±0.1°C | Mindray |
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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
(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
N12
(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
(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
(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 | |
| (Unimed Skin Temperature Probe, Unimed General Purpose Temperature Probe) | / | ||
| Item | Proposed Device | Predicate Device | Verdict |
| 510(K) Submitter | Shenzhen Med-link Electronics | ||
| Tech Co., Ltd. | Unimed Medical supplies | ||
| Inc. | / | ||
| 510(K) Number | K182667 | K121427 | / |
| Classification | |||
| Regulation | 21CRF 880.2910 | 21CRF 880.2910 | SE |
| Classification and | |||
| Code | Class II, | ||
| FLL | Class II, | ||
| FLL | SE | ||
| Common name | Temperature Probe | Temperature Probe | SE |
| Type of Use | Prescription | Prescription | SE |
| Intended use | 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. | 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 by qualified medical | |||
| personnel only. | SE | ||
| Note 1 | |||
| 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. | 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 | |||
| resistance | 2.25K@25°C | 2.252K@25°C | SE |
| Material | Cable: PVC | ||
| Probe end: Epoxy, S304 Stainless | |||
| Steel | Not-provided | SE | |
| Note 2 | |||
| Compatible | |||
| Monitors | Philips Model IntelliVue MP50, | ||
| Mindray Model PM-9000, | |||
| Datex-Ohmeda Model Cardiocap | |||
| II, Drager Model Infinity Gamma | |||
| XL. | Philips,Marquette, Mindray, | ||
| Spacelabs, Siemens, | |||
| Artema/S&W and other | |||
| monitors compatible with | |||
| YSI 400 series temperature | |||
| probes. | SE | ||
| Note 1 | |||
| Sterilization | Non-sterile | Non-sterile | SE |
| 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 | SE | |
| Note 3 | |||
| Storage | |||
| Environment | Temperature: | ||
| -10°C to +40°C | Not-provided | SE | |
| Note 3 | |||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| Performance | ISO 80601-2-56 | EN 12470-4 | SE |
| Note 4 | |||
| Biocompatibility | |||
| Evaluation | All the patient contracting | ||
| materials are evaluated by the | |||
| biocompatibility standard ISO | |||
| 10993-5, ISO 10993-10. | All the patient contracting | ||
| materials are evaluated by the | |||
| biocompatibility standard | |||
| ISO 10993-5, ISO 10993-10. | SE |
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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)
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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.