K Number
K181089
Manufacturer
Date Cleared
2020-01-17

(632 days)

Product Code
Regulation Number
870.2900
Panel
CV
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SureLead Disposable Cable System is intended to be used with ECG monitoring devices. The SureLead Disposable Cable System is used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for generating monitoring and/or diagnostic evaluation by a health care professional.

Device Description

The SureLead Disposable Cable System 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. These cables are used to transfer the signals from the electrodes to the patient monitor. The SureLead Disposable Cable System uses the same type of construction and have the same technological characteristics as the predicate device. The SureLead Disposable Cable System is made of medical grade PVC and PP cable jacket with medical grade PVC and PP over molded connectors with integral relief.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (SureLead Disposable Cable System), seeking to prove substantial equivalence to a predicate device. It addresses the device's design, materials, and intended use, but it does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or complex clinical outcome data from a test set in the way you've described.

This document describes a medical device that is a physical patient accessory (cables), not an AI/software as a medical device (SaMD) or a diagnostic imaging system with an AI component. Therefore, the detailed questions about acceptance criteria for AI performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to the content of this document.

The "Performance Data" section (page 4) refers to non-clinical tests conducted to verify compliance with electrical safety, biocompatibility, and general medical device standards (e.g., ISO 10993, AAMI/ANSI EC53, IEC 60601-1). These are laboratory and bench testing standards, not clinical studies involving patient data read by experts for diagnostic or prognostic purposes, nor do they involve AI models.

Here's a breakdown of why your specific questions cannot be answered by this document:

  • 1. A table of acceptance criteria and the reported device performance: The document lists standards (e.g., ISO 10993, AAMI/ANSI EC53, IEC 60601-1) that the device complies with, implying these are the "acceptance criteria" for a physical device. However, it does not provide quantitative performance metrics against these criteria (e.g., specific impedance values, biocompatibility scores). It merely states that "The test results demonstrated that the proposed device complies with the following standards."
  • 2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical cables undergoing engineering and biocompatibility testing, not a dataset of patient images or clinical records.
  • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical cable involves engineering specifications and standard test methods (e.g., resistance, current leakage, material composition).
  • 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
  • 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an imaging or diagnostic device that relies on human interpretation aided by AI.
  • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm or AI component.
  • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be its physical and electrical properties conforming to established engineering and safety standards.
  • 8. The sample size for the training set: Not applicable. There is no AI model to train.
  • 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional medical device (patient cables) and its regulatory submission for substantial equivalence based on engineering and biocompatibility testing, not an AI-powered diagnostic device.

§ 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).