(133 days)
Not Found
No
The description focuses solely on the physical transmission of ECG signals and does not mention any computational analysis or algorithms.
No.
The device is described as ECG cables and leadwires, which are used to transmit ECG signals for monitoring and diagnostic evaluation. It does not provide any therapeutic function.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used with ECG... for general monitoring and/or diagnostic evaluation by health care professional." The "Device Description" also mentions its use for "both diagnostic and monitoring purposes."
No
The device description explicitly states it is an "external device" used to transmit signals and describes physical components like cables, leadwires, and plugs, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ECG Cables and Leadwires are used to transmit electrical signals from electrodes placed on the patient's body to an ECG monitor. This is a direct measurement of physiological activity within the body (in vivo).
- Intended Use: The intended use is for general monitoring and/or diagnostic evaluation by connecting electrodes to the patient. This does not involve the analysis of specimens taken from the body.
The device is an external accessory used in conjunction with an ECG monitor for physiological monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The ECG Cables and Leadwire is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes, the other end is affixed/molded into one end of the trunk cable which are plug into an ECG monitor.
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 or extremities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device conforms to the following standards:
IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
AAMI / ANSI EC53:2013, ECG Trunk Cables and Patient Leadwires.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 01, 2020
Xinkang Medical Instrument Co., Ltd % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, GuangDong 518100 China
Re: K201359
Trade/Device Name: ECG Cables 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: August 25, 2020 Received: August 31, 2020
Dear Field Fu:
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
Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201359
Device Name ECG Cables and Leadwires
Indications for Use (Describe)
The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
| 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 G) |
|| | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
5.1 Administrative Information
| Date of Summary prepared | April 10, 2020 |
|---|---|
| Manufacturer information | Company: Xinkang Medical Instrument Co., Ltd. |
| Company address: | |
| 2 Floor, Puhua Science and Technology Park, | |
| Tongsheng Community Dalang Street, Longhua | |
| District, 518109 Shenzhen, People's Republic of | |
| China | |
| Contact person: Xu Changsheng | |
| Phone: +86-755-23776681 | |
| Fax: +86-755-23776861 | |
| E-mail: 751857289@qq.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: 1713A, 17th Floor, Block A, | |
| Zhongguan Times Square, Nanshan District, | |
| Shenzhen | |
| Contact person: James Tsai | |
| E-Mail: james_tsai@cefda.com, | |
| joyce@cefda.com, |
|
| Establishment registration number | |
| 5.2 Device Information | |
| Type of 510(k) submission: | Traditional |
| Trade Name: | ECG Cables and Leadwires |
| Model: | G2202B10A, E2101C5A,E2101C3A, E2101S3A
E2101S5A, G2202C10A, G2202S10A |
| Classification name: | Cable, Transducer And Electrode, Patient,
(Including Connector) |
| 510(K) No.: | K120010 |
| Common name: | ECG Cable / Leadwires |
| Classification name: | Cable, Transducer and Electrode, Patient, (Including Connector) |
| Production regulation: | 21 CFR § 870.2900 |
| Product code: | DSA |
| Panel: | Cardiovascular |
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Product: ECG Cables and Leadwires
Version: A/0
| Review Panel: | Cardiovascular |
|---|---|
| Product Code: | DSA |
| Device Class: | II |
| Regulation Number: | 870.2900 |
5.3 Predicate Device Information
Shenzhen Med-link Electronics Tech Co.,Ltd. Sponsor: Cable / Lead-wire Device: | K120010 510(K) Number:
5.4 Device Description
The ECG Cables and Leadwire is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes, the other end is affixed/molded into one end of the trunk cable which are plug into an ECG monitor.
5.5 Intended Use/ Indications for Use
The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
5.6 Technological characteristics of the subject device compared to the predicate device
Predicate Device Information:
Comparison to predicate device:
| Comparison
| item | Subject Device | Predicate Device (K120010) |
|---|---|---|
| Applicant | Xinkang Medical Instrument Co., | |
| Ltd. | Shenzhen Med-link Electronics Tech | |
| Co., Ltd. |
5
Xinkang Medical Instrument Co., Ltd. Product: ECG Cables and Leadwires
Version: A/0
| Product name | ECG Cables and Leadwires | ECG Cables /Leadwires |
|---|---|---|
| Product Code | DSA | DSA |
| Regulation | ||
| Number | 21CRF 870.2900 | 21CRF 870.2900 |
| Classification | Class II | Class II |
| Intended | ||
| use & | ||
| Indication | ||
| s for Use | The ECG Cables and Leadwires is | |
| intended to be used with ECG. The | ||
| ECG Cables and Leadwires is used | ||
| to connect electrodes placed at | ||
| appropriate sites on the patient to | ||
| ECG for general monitoring and/or | ||
| diagnostic evaluation by health | ||
| care professional. | Shenzhen Med-link Cable / lead-wire | |
| are intended to be used with ECG, | ||
| EKG, SpO2 and Invasive Blood | ||
| Pressure monitoring devices. The | ||
| Cable / leadwire are used to connect | ||
| electrodes, catheters, and/or sensors | ||
| placed at appropriate sites on the | ||
| patient to a monitoring device for | ||
| general monitoring and/or diagnostic | ||
| evaluation by heath care professional. | ||
| Usage | Reusable | Reusable |
| Anatomical | ||
| sites | Attached to electrodes placed at | |
| standard specified locations on | ||
| chest or extremities | Attached to electrodes placed at | |
| standard specified locations on chest | ||
| or extremities | ||
| Patient end | ||
| termination | Clip,Snap, Banana | Clip, Snap |
| Sterile | No | No |
| Leadwire | ||
| material | TPU | Shielded & Unshielded Copper with |
| PVC or TPU Jacket | ||
| Biocompatibility | Cytotoxicity | |
| Irritation | ||
| Sensitization | Cytotoxicity | |
| Irritation | ||
| Sensitization | ||
| Electrical | ||
| Performance | ||
| and Safety | Comply with AAMI/ANSI EC53: | |
| 2013 IEC 60601-1:2005+CORR.1: | ||
| 2006+CORR. 2:2007+AM1: 2012 | Comply with ANSI/AAMI EC | |
| 53:1995/(R)2001 IEC 60601-1:1998; | ||
| Am1: A2:1995 |
The subject device and the predicate device have the same intended use and similar technological characteristics; they both measure ECG signals for the patients. Thus the subject device is substantially equivalent to the predicate devices.
5.7 Brief discussion of the nonclinical tests
ECG Cables and Leadwires conforms to the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical
6
Xinkang Medical Instrument Co., Ltd.
Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
AAMI / ANSI EC53:2013, ECG Trunk Cables and Patient Leadwires.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
5.8 Brief discussion of clinical tests
N/A.
5.9 Other information (such as required by FDA guidance/Test)
N/A.
5.10 Conclusions
Based on the above information, the subject device and the predicate device have the same intended use and same technological characteristics; we conclude the subject device, ECG Cables and Leadwires, is substantially equivalent to the predicate device.