(83 days)
Medline Patient Cables and Lead Wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. Additionally, the use of Medline Patient Cables and Lead Wires is limited by the indications for use of the ECG monitoring or diagnostic equipment it is connected to. Medline Patient Cables and Lead Wires are intended for Prescription Use only.
Medline Patient Cables and Lead Wires are used to transmit signals from patient surface electrodes to various electrocardiograph (ECG) recorders/monitors for diagnostic and/or monitoring purposes. Medline Patient Cables and Lead Wires are not stand-alone devices, but are accessories to legallymarketed ECG monitors and patient electrodes, ultimately acting as a conduit between the two to transmit signals from the patient to the monitor.
The proposed device consists of two distinct parts – reusable trunk cables and disposable lead wires – which are used as a system to transfer signals originating from skin-mounted EGG electrodes (distal end) to an ECG monitoring device (proximal end). All designs of Medline Trunk Cables feature a monitor connector at one end, which mates with a designated OEM monitor, and a yoke connector at the other end, which provides the connection point from the trunk cable to the lead wires. Similarly, all designs of Medline Lead Wires feature a lead connector at one end, which mates with the yoke end of the trunk cable, and an electrode connector at the other end, which attaches to patient electrodes. It is this system's cabling that facilitates the conduction of signals from the electrodes to the ECG monitoring device.
The document provided is a 510(k) summary for the Medline Patient Cables and Lead Wires, stating its substantial equivalence to a predicate device (Curbell Patient Monitoring Cables and Lead Wires, K081762). As such, it focuses on demonstrating that the new device is as safe and effective as the predicate, rather than establishing novel acceptance criteria or conducting a study to prove new performance claims typical of an AI/ML device.
Therefore, the requested information regarding acceptance criteria and a study to prove device performance as typically understood for an AI/ML device (e.g., diagnostic accuracy, reader studies, etc.) is not applicable to this submission. The document primarily describes non-clinical performance and biocompatibility testing to ensure the device meets established standards for patient cables and lead wires. Here's a breakdown of the relevant information provided:
1. Table of acceptance criteria and reported device performance:
The document lists performance testing against standards, rather than specific acceptance criteria with numerical targets and reported performance values. The summary states that functional performance testing was conducted to demonstrate the device meets the "standard specifications" of the listed standards. It does not provide a table of measured performance against specific pre-defined acceptance values.
| Standard / Test Category | Description of Performance Test / Standard Met | Device Performance (as reported) |
|---|---|---|
| Biocompatibility | Conducted per FDA guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" and ISO 10993-1. For direct skin contact (> 24 hours to 30 days): |
- Cytotoxicity MEM Elution (ISO 10993-5:2009)
- Buehler Dermal Sensitization - Repeated Patch (GLP-2 Extracts) (ISO 10993-10:2010)
- Irritation - Primary Skin Irritation (ISO 10993-10:2010) | Tests performed and concluded favorably (implied by 510(k) clearance, specific results not provided in summary). |
| Performance Testing | Functional performance testing conducted to demonstrate that the device meets "standard specifications" according to: - IEC 60601-1:2005 (Third Edition) + CORR, 1:2006 + CORR. 2:2007 + A1:2012 = "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance".
- IEC 60601-2-27:2011 "Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
- ANSI/AAMI EC53:2013 - "ECG trunk cables and patient lead wires" | Tests performed and concluded favorably (implied by 510(k) clearance, specific results not provided in summary). |
2. Sample size used for the test set and the data provenance:
This type of information is not provided because the submission describes the testing of physical medical devices (cables and lead wires) against safety and performance standards for their construction and electrical properties, not clinical or algorithmic performance on patient data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable, as this is not an AI/ML device submission evaluating diagnostic or interpretative performance.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
For the performance testing, the "ground truth" would be the established requirements and thresholds within the cited international and national standards (IEC 60601-1, IEC 60601-2-27, ANSI/AAMI EC53) for electrical safety, signal integrity, mechanical durability, and biocompatibility.
8. The sample size for the training set:
Not applicable; this is not an AI/ML or software algorithm device that undergoes a "training set."
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a 510(k) submission for patient cables and lead wires, a type of electro-mechanical medical device. The "study" proving device performance involved non-clinical laboratory testing to ensure the device met established industry-standard specifications for safety and performance, as required for its classification and comparability to a predicate device. It does not involve a clinical study, AI/ML algorithm evaluation, or human-in-the-loop performance assessment.
§ 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).