M2376A DEVICELINK SYSTEM, MODEL M2376A

• K Number: K014181
• Device Name: M2376A DEVICELINK SYSTEM, MODEL M2376A
• Manufacturer: PHILIPS MEDICAL SYSTEMS, INC.
• Date Cleared: 2002-01-15 ( 26 days)
• Product Code: MWI
• Regulation Number: 870.2300
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

Device Description

The 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.

AI/ML Overview

The provided text is a 510(k) summary for the M2376A Device Link System, a device intended for electronic data collection and clinical information management by converting data from external medical devices into HL7 format and transmitting it to clinical information systems.

Based on the provided document, a study proving the device meets acceptance criteria is not included. The 510(k) summary describes the device, its intended use, and its classification, but it does not contain information about:

• Acceptance criteria for device performance.
• Results of a study demonstrating performance against any criteria.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement for such a study.
• Any mention of standalone algorithm performance or multi-reader multi-case studies.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing new clinical performance data in the same way a PMA would require. The document outlines regulatory classification and intent for marketing, but no performance study is detailed within.

Regulation Number and Section

§ 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).