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K Number
K191428
Device Name
ECG Cable
Manufacturer
Shenzhen Changke Connect Electronics Co., Ltd.
Date Cleared
2019-11-27

(182 days)

Product Code
DSA
Regulation Number
870.2900
Type
Traditional
Panel
CV
Reference & Predicate Devices
K120010
Predicate For
K200026
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

The ECG Cable 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.

AI/ML Overview

The provided text is a 510(k) summary for an ECG Cable and does not contain information about an AI-powered device or software. Therefore, I cannot extract acceptance criteria, study details, or ground truth information relevant to AI/ML device performance.

The document primarily focuses on demonstrating substantial equivalence of the ECG Cable to a predicate device based on:

  • Intended Use/Indications for Use: The ECG Cable connects electrodes to an ECG for monitoring/diagnostic evaluation by healthcare professionals.
  • Technological Characteristics: Comparison of features like reusability, anatomical sites, patient end termination, material, electrical safety, and biocompatibility.
  • Performance Data:
    • Biocompatibility testing: Cytotoxicity, Sensitization, and Irritation tests conducted in accordance with ISO 10993-1.
    • Non-clinical data: Compliance with IEC 60601-1 and ANSI/AAMI EC53 standards for electrical safety.
    • Clinical data: No clinical study was included as performance was demonstrated through non-clinical and biocompatibility testing.

Since this submission is for a physical medical device (an ECG cable) and not an AI/ML diagnostic or measurement software, the concepts of "acceptance criteria for AI performance," "test set sample size," "expert ground truth," "adjudication," "MRMC study," or "standalone algorithm performance" are not applicable here.

§ 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).