(51 days)
Multi-Link Cable and Lead Wire Systems are electrocardiograph cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Multilink Cables and Lead Wire Systems are intended to be used by trained operators in a medical professional's environment.
The Multilink Cables and Leadwires are part of the GE Medical Systems Information Technologies line of supplies and accessories used to transmit patient ECG and RESP signals to diagnostic and monitoring equipment. The system is designed to provide a family of leadwires that will link the patient and patient cable system. Leadwires are available in multiple lengths and in multiple lead sets. Patient end terminations are available in Snap, Banana, Mactrode, or Grabber configurations. The multi-lead individual set design allows single leadwires to be individually removed and replaced as necessary. Mulilink leadwires are also available in a radiotranslucent version.
The provided document is a 510(k) Premarket Notification Submission for the GE Multilink Cable and Leadwire Systems. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, the document states: "The subject of this premarket submission, Multilink Cable and Leadwire Systems, did not require clinical studies to support substantial equivalence."
Therefore, based on the provided text, there is no study provided that proves the device meets specific acceptance criteria based on performance. The submission relies on non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) and the claim that the device employs the same functional scientific technology as its predicate device. This implies that the acceptance criteria are met by virtue of being substantially equivalent to a previously approved device through engineering and quality assurance measures, rather than a clinical performance study.
Given this, I cannot provide the detailed information requested in points 1-9 as there is no performance study or specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for a new clinical performance being evaluated. The submission focuses on safety, effectiveness, and substantial equivalence to the predicate device through non-clinical testing and shared technology.
§ 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).