(11 days)
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.
The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.
The provided text is a 510(k) summary for the Philips M2376A DeviceLink System. It primarily focuses on the device's function, classification, and substantial equivalence to predicate devices. Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary describes the device as one that "receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System." Its intended use is "for electronic data collection and clinical information management." It explicitly states that "DeviceLink is neither patient connected, nor does it remotely control the attached source device."
Because the device's function is data conversion and transmission within a medical information system, and not diagnostics or treatment, the regulatory approval process for such a device typically focuses on aspects like:
- Software Validation: Ensuring the software correctly performs its data conversion and transmission functions.
- Interoperability: Verifying it can correctly interface with various medical devices and clinical information systems.
- Data Integrity and Security: Ensuring data is accurately and securely transferred, without loss or corruption.
- Risk Management: Assessing and mitigating any potential risks associated with data handling.
However, the provided document does not detail any specific performance acceptance criteria or a study that evaluates these criteria. Therefore, I cannot extract the requested information.
If this were a diagnostic or AI-driven device, the information you requested would be critical. However, for a data integration device like this, the nature of "performance" and its "study" would be different and is not described in this 510(k) summary.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).