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The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.

The Multi-Link™ X2 ECG Cable, Adapter and Direct Connect Leadwires is an FDA cleared accessory portfolio. The cleared device portfolio consists of adapters & leadwires (reusable adapters and direct connect disposable single patient use leadwires, K163316), and (leadwires reusable, and disposable single patient use, K162432). The cleared portfolio is compatible multiple FDA cleared ECG monitoring platforms, such as Philips, Mindray, Nihon Kohden, GE and Spacelabs. This pre-market notification is to expand the portfolio to be used with additional FDA cleared ECG monitoring platforms.

The Subject device, Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES consists of reusable adapters and direct connect single patient use leadwires that connect to FDA cleared Dräger Infinity (R) monitoring platforms. Design modifications are made to allow for connections with specific additional platforms to allow patients to move throughout the facility without the hassle of disconnecting and reconnecting leadwires.

The system is used to transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitorina.

This device is common to both industry and medical establishments. The Multi-Link™ X2 ECG ADAPTER AND LEADWIRES is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals.

The provided document is a 510(k) summary for Vyaire Medical's Multi-Link X2 ECG Adapter and Leadwires. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets a set of acceptance criteria through a clinical study.

Therefore, this document does not contain the information requested about acceptance criteria and a study proving the device meets them. It details non-clinical performance testing against established standards for medical electrical equipment and ECG cables, but it does not describe a study to establish performance metrics against acceptance criteria as typically defined for an AI/ML-driven device or a diagnostic accuracy study.

Specifically, the document states:

• "No clinical studies were deemed needed to support this submission." This explicitly indicates that a study demonstrating device performance against clinical acceptance criteria was not conducted or required for this 510(k) clearance.
• The performance data section (Section 7.0, 7.1, 7.3) lists compliance with various safety and electrical standards (e.g., AAMI ANSI ES 60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53). These are general safety and performance requirements for the device type, not specific diagnostic performance metrics (like accuracy, sensitivity, specificity) for a particular medical condition.
• The device's function is to transmit ECG signals, not to interpret them or provide a diagnosis. This means the performance metrics would revolve around signal integrity and electrical safety, which are covered by the listed standards, rather than diagnostic accuracy.

Given this, I cannot extract the requested information as it is not present in the provided text.

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