(127 days)
Not Found
No
The description focuses on the physical transmission of ECG signals and does not mention any computational analysis or interpretation of the data using AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is described as an ECG cable used to transmit signals for monitoring and diagnostic evaluation, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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." 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 from electrodes via leadwires and a trunk cable, which are physical components. It also mentions biocompatibility testing, which is relevant to physical contact with the body, not software.
Based on the provided information, 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 to examine these samples outside of the body.
- Device Function: The description clearly states that this device is an external cable used to transmit electrical signals (ECG) from electrodes placed on the patient's body to an ECG monitor. It is not analyzing samples taken from the body.
- Intended Use: The intended use is for connecting electrodes to an ECG for monitoring and diagnostic evaluation of the patient's electrical heart activity, not for analyzing biological samples.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The disposable ECG cable is intended to be used with ECG. The device 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 device 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. The proposed device is disposable.
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the Changke ECG Cables was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation. The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days.
Non-clinical data: The Changke ECG Cables have been tested according to the following standards: IEC 60601-1: 2005+CORR.1: 2006+CORR.2: 2007+A1: 2012, Medical Electrical Equipment-. Part 1: General requirements for basic safety and essential performance and ANSI/AAMI EC53: 2013 ECG Trunk Cables and Patient Leadwires. The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data: No clinical study is included in this submission.
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
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May 12, 2020
Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, 518067. China
Re: K200026
Trade/Device Name: Disposable ECG Cable Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: April 2, 2020 Received: April 8, 2020
Dear Kevin Wang:
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.
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
1
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 mediation-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 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
2
Indications for Use
510(k) Number (if known) K200026
Device Name Disposable ECG Cable
Indications for Use (Describe)
The disposable ECG cable is intended to be used with ECG. The device 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2020/01/02
1. Submission sponsor
Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, P.R. China Contact person: Yahui Zhou Title: General Manager E-mail: zhouyahui@szcklt.com Tel: +86 136 1301 2560
Submission correspondent 2.
Name: Chonconn Medical Device Consulting Co., Ltd. Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Disposable ECG Cable |
|---|---|
| Common Name | ECG Wire |
| Classification Name | Cable, Transducer and Electrode, Patient |
| Classification | Class II |
| Regulation Number | 870.2900 |
| Product Code | DSA |
| Review Panel | Cardiovascular |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd. Device: ECG Cable K#: K191428
5. Device Description
The device 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
4
monitor. The proposed device is disposable.
Intended use & Indication for use 6.
The disposable ECG cable is intended to be used with ECG. The device 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.
| Features | Subject Device
Changke Disposable ECG
Cables | Predicate Device
K191428 | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Applicant | Shenzhen Changke Connect
Electronics Co., Ltd. | Shenzhen Changke Connect
Electronics Co., Ltd. | Same |
| Classification
Regulation | 21CRF 870.2900 | 21CRF 870.2900 | Same |
| Classification
and Code | Class II, DSA | Class II, DSA | Same |
| Intended use | The disposable ECG cable is
intended to be used with ECG.
The device 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. | The ECG Cable is intended to be
used with ECG. The ECG Cable
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. | Same |
| Usage | Disposable | Reusable | Different 1) |
| 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 | Same |
| Patient end
termination | Clip | Banana, Snap | Different 2) |
| Sterile | No | No | Same |
| Leadwire
material | TPU, Gold plated brass | TPU, PET, Nickel plated brass | Different 3) |
| Electrical
Safety | Complied with IEC 60601-1 and
EC53 | Complied with IEC 60601-1 and
EC53 | Same |
| Biocompatibility | | | |
| Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same |
| Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
| Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
7. Comparison to the Predicate Device
5
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.
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.
Different (3): The material is different. The proposed device was tested according to ISO 10993-5 and ISO 10993-10. Therefore, this difference does not raise new questions of safety and effectiveness for subject device.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Changke ECG Cables was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity
- . Sensitization
- Irritation •
The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days.
Non-clinical data
The Changke ECG Cables have been tested according to the following standards:
- IEC 60601-1: 2005+CORR.1: 2006+CORR.2: 2007+A1: 2012, Medical Electrical Equipment-. Part 1: General requirements for basic safety and essential performance
- ANSI/AAMI EC53: 2013 ECG Trunk Cables and Patient Leadwires. .
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data
No clinical study is included in this submission.
9. Conclusion
The intended use and technological features of the proposed subject device do not substantially differ from the legally marketed predicate device. Disposable ECG cable and the predicate device have substantially equivalent intended uses and methods of operation.