(53 days)
The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.
Patient Monitoring Cables are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) for their respective monitors. It is a non-patient-contact, insulated, shielded, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect ECG electrodes, SpO2 sensor, IBP transducer to a patient monitor). It is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality.
This document does not contain an AI/ML device study. Instead, it is a 510(k) premarket notification for Patient Monitoring Cables. The filing asserts substantial equivalence to predicate devices (K082959 and K142489) based on the fact that the subject device's cables are "exactly the same" and "identical" to the predicate devices.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device study is not applicable to this submission.
The document primarily discusses:
- Intended Use: Patient Monitoring Cables are used with ECG, EKG, SpO2, and BP monitoring devices to connect electrodes, catheters, and/or sensors to a monitoring device for general monitoring and/or diagnostic evaluation by healthcare professionals.
- Comparison to Predicate Devices: The submission states that the subject device is "exactly the same" as the predicate devices in terms of intended use, design/appearance, cable length, material, usage (reusable and disposable), sterility, and conformance to standards (IEC 60601-1, EC53, ISO 10993-5, -10).
- Non-clinical Test Data: The device meets recognized standards for safety (IEC 60601-1), performance (ANSI AAMI EC53), and biocompatibility (ISO 10993-1, -5, -10). Biocompatibility tests for cytotoxicity, sensitization, and skin irritation were conducted on the proposed device, showing no adverse effects.
- Clinical Test Data: No clinical testing was deemed necessary because the subject and predicate devices are stated to be "exactly the same."
§ 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).