(132 days)
No
The device is a disposable cable and leadwire set for ECG monitoring, which are passive components for signal transfer. The description focuses on materials, construction, and electrical safety standards, with no mention of data processing, analysis, or algorithmic capabilities.
No
The device is used to measure and transfer a patient's ECG signals for monitoring and diagnostic evaluation, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that the device is used "for general monitoring and/or diagnostic evaluation by heath care professional."
No
The device description explicitly states it consists of physical components like cables, connectors, and jackets, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure a patient's ECG for general monitoring and/or diagnostic evaluation." This involves measuring electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on cables and leadwires that transfer electrical signals from electrodes on the patient's chest to an ECG monitor. This is a direct connection to the patient, not a device that analyzes a sample in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device facilitates the measurement of a physiological signal directly from the patient.
N/A
Intended Use / Indications for Use
Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.
Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.
Product codes
DSA
Device Description
Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.
These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.
These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Attached to electrodes placed at standard specified locations on chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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
The safety performances of subject device are demonstrated by the Third party, CTI through testing following IEC 60601-1 General requirements for basic safety and essential performance and ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires.
The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.
Package integrity and functional performance testing were completed on the subject device following real time aging test to support the proposed shelf life.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
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June 28, 2022
Shenzhen Med-link Electronics Tech Co., Ltd. Yi Liu Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen, Guangdong 518109 China
Re: K220447
Trade/Device Name: Med-link Disposable ECG Cable and Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: April 29, 2022 Received: May 9, 2022
Dear Yi 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 (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.
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220447
Device Name Disposable ECG Cable and Leadwires
Indications for Use (Describe)
Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.
Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.
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) |
X 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/1 description: The image shows the logo for MedLinket. The logo is composed of the word "MedLinket" in a sans-serif font. The first letter, "M", is colored in orange, while the rest of the letters are in light blue.
Shenzhen Med-link Electronics Tech Co., Ltd.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| 1. Submitter information: | |
|---|---|
| Name and Address: | Shenzhen Med-link Electronics Tech Co., Ltd. |
| 4th and 5th Floor, Building Two, | |
| Hualian Industrial Zone, Xinshi Community, | |
| Dalang Street, Longhua District, Shenzhen, | |
| Guangdong 518109, | |
| People's Republic of China | |
| Primary Contact: | Yi Liu(Regulatory Affairs Specialist) |
| E-mail: user22@med-linket.com | |
| Tel: 0086-755-61568825 | |
| Fax: 0086-755-61120055 | |
| Data of Preparation: | 29, Apr. 2022 |
| 2. Device Information: | |
| Trade Name: | Disposable ECG Cable and Leadwires |
| Common Name: | Cable and Leadwires |
| Classification number: | 21 CFR 870.2900 |
| Classification name: | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Product Code: | DSA |
| Regulatory Class: | II |
| Review Panel: | Cardiovascular |
3. Identification of the Predicate Device:
| Device Name | Common Name | Manufacturer | 510(k)
number |
|--------------------------------------------------------------------|---------------------|-------------------------------------------------|------------------|
| Cable/ lead-wire (ECG,
EKG, SPO2 and invasive
blood pressure | Cable and Leadwires | Shenzhen Med-Link Electronics
Tech Co., Ltd. | K120010 |
4
Medlinket
Intended Use and Indications for Use of the Subject Device 4.
Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.
Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.
Device Description ട്.
Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.
These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.
These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Comparison | Disposable | ||
| ECG Cable and Leadwires | Shenzhen Med-link | ||
| Cable/lead-wire | / | ||
| 510k number | K220447 | K120010 | / |
| 510(K) Submitter | Shenzhen Med-link | ||
| Electronics Tech Co., Ltd. | Shenzhen Med-link | ||
| Electronics Tech Co., Ltd. | / | ||
| Intended use | |||
| &Indications | |||
| for Use | Disposable ECG Cable and | ||
| Leadwires are intended to be used | |||
| with ECG monitoring devices to | |||
| measure a patient ' s ECG for | |||
| general monitoring and/or | |||
| diagnostic evaluation by heath | |||
| care professional. | |||
| Disposable ECG Cable and | Shenzhen Med-link | ||
| Cable/lead-wire is intended to be | |||
| used with ECG, EKG, SpO2 and | |||
| invasive Blood Pressure | |||
| monitoring devices. The | |||
| Cable/lead-wire are used to | |||
| connect electrodes, catheters, | |||
| and/or sensors placed at | SE | ||
| Leadwires meets the requirements | |||
| of the standard ANSI/AAMI | |||
| EC53, ECG TRUNK CABLES | |||
| and PATIENT LEADWIRES. | |||
| This leadwire set is intended for | |||
| single-patient use. | appropriate sites on the patient to a | ||
| monitoring device for general | |||
| monitoring and/or diagnost ic | |||
| evaluation by health care | |||
| professional. | |||
| Device description | Disposable ECG Cable and | ||
| Leadwires with specific various | |||
| lengths are the replacements for | |||
| similar cables manufactured by | |||
| Original Equipment | |||
| Manufacturers (OEM) and other | |||
| third party after market | |||
| manufacturers for their respective | |||
| monitors. | |||
| These devices consist of | |||
| connectors on each cable end and | |||
| a shielded bulk cable. The cables | |||
| are used to transfer the signals | |||
| from the electrodes to the patient | |||
| monitor. | Med-link Cable / Lead-wire with | ||
| specific various lengths are the | |||
| replacements for similar cables | |||
| manufactured by Original | |||
| Equipment Manufacturers (OEM) | |||
| and other third party after market | |||
| manufacturers for their respective | |||
| monitors. | |||
| These cables consist of connectors | |||
| on each cable end and a shielded | |||
| bulk cable. The cables are used to | |||
| transfer the signals from the | |||
| electrodes to the patient monitor. | SE | ||
| Anatomical | |||
| Sites | Attached to electrodes placed at | ||
| standard specified locations on | |||
| chest wall | Attached to electrodes placed at | ||
| standard specified locations on | |||
| chest wall | SE | ||
| Design | |||
| /Appearance | ECG and EKG Cables | ||
| with various connectors (monitor | ECG and EKG Cables | ||
| with various connectors (monitor | SE | ||
| trunk / lead wire,electrode grabber | |||
| & snapper) | trunk / lead wire,electrode grabber | ||
| & snapper) | |||
| Sterility | Non sterile | Non sterile | SE |
| Usage | Disposable | Reusable | Different1) |
| Patient end | |||
| termination | Clip | Clip, Snap | Different2) |
| Material | PVC | Shielded & Unshielded Copper | |
| with PVC or TPU Jacket | Different3) | ||
| Cable Length | Various specified | ||
| standard lengths | Various specified | ||
| standard lengths | SE | ||
| Electrical Safety | Complied with IEC 60601-1 and | ||
| EC53 | Complied with IEC 60601-1 and | ||
| EC53 | SE | ||
| Biocompatibility | Complied with ISO 10993-1, ISO | ||
| 10993-5, ISO 10993-10 | Complied with ISO 10993-1, ISO | ||
| 10993-5, ISO 10993-10 | SE |
8. Comparison to the Predicate Device
5
Tedli ket
6
Shenzhen Med-link Electronics Tech Co., Ltd.
Justifications for differences between proposed device and the predicate device are shown as below:
Different (1): The proposed device is disposable and the predicate device is reusable. The proposed device was tested according to IEC 60601-1 and EC53. Therefore, this difference does not raise new questions of safety and effectiveness for subject device as compared to the predicate device.
Different (2): The patient end termination is different. This end is intended to connect the electrodes. The proposed device was tested according to IEC 60601-1 and EC53. Therefore, this difference does not raise new questions of safety and effectiveness for subject device as compared to the predicate device.
Different (3): The material is different. The proposed device was tested according to ISO 10993-10. Therefore, this difference does not raise new questions of safety and effectiveness for subject device as compared to the predicate device.
9. Non-clinical Test
Compare to predicate product specified in K120010, our device and the predicate device are same in Essential Components, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated.
7
MedLinket
The safety performances of subject device are demonstrated by the Third party, CTI through testing following IEC 60601-1 General requirements for basic safety and essential performance and ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires.
The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.
Package integrity and functional performance testing were completed on the subject device following real time aging test to support the proposed shelf life.
11. Conclusion
Based on the comparison and analysis in this submission, it can be concluded that: Disposable ECG Cable and Leadwires is substantially equivalent to the predicate device.