(127 days)
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 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.
The provided text describes a 510(k) premarket notification for a "Disposable ECG Cable" (K200026) and a comparison with a predicate device. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets acceptance criteria in the way this request envisions (e.g., performance metrics like sensitivity/specificity for an AI algorithm).
Medical devices like ECG cables are typically evaluated against established technical standards and for safety and effectiveness, rather than having acceptance criteria and performance reported in terms of diagnostic accuracy metrics.
Therefore, many of the requested points are not applicable to this type of device submission. However, I can extract the relevant information.
Acceptance Criteria and Device Performance for Disposable ECG Cable (K200026)
Based on the provided document, the "acceptance criteria" are derived from compliance with recognized international and national standards for medical electrical equipment and biocompatibility. The "reported device performance" is demonstrated through successful adherence to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Standard Complied With) | Reported Device Performance (Compliance Statement) |
|---|---|---|
| Electrical Safety | 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) | Complied with IEC 60601-1 |
| ANSI/AAMI EC53: 2013 (ECG Trunk Cables and Patient Leadwires) | Complied with EC53 | |
| Biocompatibility | ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity evaluation conducted) |
| ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) | Complied with ISO 10993-10 (Sensitization and Irritation evaluation conducted) | |
| FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | Biocompatibility evaluation conducted in accordance with FDA Guidance for ISO 10993-1 | |
| Intended Use | Substantial equivalence in intended use to predicate device, connecting electrodes to ECG for monitoring/diagnostic evaluation. | "The intended use and technological features of the proposed subject device do not substantially differ from the legally marketed predicate device." |
| Materials | No new questions of safety and effectiveness raised by differing materials (TPU, Gold plated brass vs. TPU, PET, Nickel plated brass) | Tested according to ISO 10993-5 and ISO 10993-10 to ensure safety. "Therefore, this difference does not raise new questions of safety and effectiveness for subject device." |
| Usage (Disposable) | No new questions of safety and effectiveness raised by disposable vs. reusable usage. | Tested according to IEC 60601-1 and EC53. "Therefore, this difference does not raise new questions of safety and effectiveness for subject device." |
| Patient End Termination | No new questions of safety and effectiveness raised by differing termination type (Clip vs. Banana, Snap). | Tested according to IEC 60601-1 and EC53. "Therefore, this difference does not raise new questions of safety and effectiveness for subject device." |
Study Details:
For a device like an ECG cable, the "study" is typically a series of non-clinical bench tests and biocompatibility assessments demonstrating compliance with the aforementioned standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in terms of distinct units. The testing is performed on samples of the device as required by the standards (e.g., number of units necessary to perform electrical safety tests, or for biocompatibility tests).
- Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. It indicates the manufacturer is in Shenzhen, China. The studies are prospective (tests performed specifically for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is Not Applicable (N/A) for this type of device. There's no "ground truth" to be established by clinical experts in this context. The performance is determined by meeting engineering and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No adjudication method is used as there is no subjective assessment of clinical data or diagnoses involved. Compliance is determined by objective measurements against standard requirements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A: This is not an AI-enabled diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A: This is not an algorithm-based device. No standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: For this device, "ground truth" is established by the specifications and measurable parameters defined in the referenced industry standards (e.g., electrical resistance limits, insulation integrity, biological response to materials).
8. The sample size for the training set
- N/A: This device does not involve machine learning or AI algorithms requiring a training set.
9. How the ground truth for the training set was established
- N/A: This device does not involve machine learning or AI algorithms.
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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
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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
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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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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
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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 DeviceChangke Disposable ECGCables | Predicate DeviceK191428 | Comparison |
|---|---|---|---|
| Applicant | Shenzhen Changke ConnectElectronics Co., Ltd. | Shenzhen Changke ConnectElectronics Co., Ltd. | Same |
| ClassificationRegulation | 21CRF 870.2900 | 21CRF 870.2900 | Same |
| Classificationand Code | Class II, DSA | Class II, DSA | Same |
| Intended use | The disposable ECG cable isintended to be used with ECG.The device is used to connectelectrodes placed at appropriatesites on the patient to ECG forgeneral monitoring and/ordiagnostic evaluation by healthcare professional. | The ECG Cable is intended to beused with ECG. The ECG Cableis used to connect electrodesplaced at appropriate sites on thepatient to ECG for generalmonitoring and/or diagnosticevaluation by health careprofessional. | Same |
| Usage | Disposable | Reusable | Different 1) |
| Anatomicalsites | Attached to electrodes placed atstandard specified locations onchest or extremities | Attached to electrodes placed atstandard specified locations onchest or extremities | Same |
| Patient endtermination | Clip | Banana, Snap | Different 2) |
| Sterile | No | No | Same |
| Leadwirematerial | TPU, Gold plated brass | TPU, PET, Nickel plated brass | Different 3) |
| ElectricalSafety | Complied with IEC 60601-1 andEC53 | Complied with IEC 60601-1 andEC53 | 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
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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.
§ 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).