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The M2376A Device Link System is indicated for use in data collection and clinical information management either connected directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purpose, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The Hewlett Packard M2376A Device Link 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 describes a 510(k) summary for the Hewlett Packard M2376A Device Link System. However, it does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The document is a regulatory submission for a device that facilitates electronic data collection and clinical information management by converting data from external devices into the HL7 format. The FDA's response letter confirms substantial equivalence to legally marketed predicate devices.

Therefore, I cannot fulfill your request for the specified information based on the provided input. The input focuses on the device's intended use and regulatory approval, not on performance studies or acceptance criteria.

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The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below;

• 1. IMED 1310 (PC-1) channel IV Pump
• 2. In-line Diagnostic HR Crit-Line Monitor
• 3. Newport Wave Ventilator

The Hewlett Packard M2376A DeviceLink System receives digital data frontuced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical Information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.

The provided document is a 510(k) summary for the Hewlett Packard M2376A DeviceLink System. It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining marketing clearance from the FDA. It does not describe or contain a study proving the device meets acceptance criteria in the way typically expected for a medical device performance study (e.g., clinical trial data, analytical performance data with specific metrics like sensitivity, specificity, accuracy).

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth, expert involvement, MRMC studies, or standalone performance studies cannot be extracted.

The document states:

• Device Function: The Hewlett Packard M2376A DeviceLink System receives digital data from external devices, converts that data into the HL7 format, and transmits that information to any networked Clinical Information System.
• Intended Use: When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.
• Predicate Device: The HP M1032A VueLink Interface Plug-in Module (K923682).
• Technological Characteristics: "The technological characteristics are the same or similar to those found with the predicate device, with the exception that neither waveforms, alarms, nor image data are transmitted in the DeviceLink System."

Conclusion based on the provided text:

This submission is a regulatory clearance document rather than a scientific study report. It focuses on the device's intended use, its functional similarity to a previously cleared device, and its regulatory classification. It does not provide the kind of detailed performance data and study design (acceptance criteria, sample size, ground truth, expert review, standalone performance, etc.) that would typically be associated with proving a device meets specific performance criteria through a dedicated study.

Therefore, the requested information cannot be filled out from the provided text.

If this were a different type of medical device (e.g., an AI-powered diagnostic tool), the 510(k) summary would typically include a section detailing analytical and/or clinical performance studies with the requested metrics. However, for a data communication system like the DeviceLink, the primary focus for regulatory clearance is often on functional equivalence and safety (e.g., no adverse control of connected devices, proper data transmission format).

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