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K Number
K021347
Device Name
MODIFICATION TO M2376A DEVICELINK SYSTEM
Manufacturer
PHILIPS MEDICAL SYSTEMS
Date Cleared
2002-05-07

(8 days)

Product Code
MWI
Regulation Number
870.2300
Type
Special
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The M2376A Device Link 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 6xemat and transmits that information to any networked Clinical Information System.

AI/ML Overview

This submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the M2376A Device Link System, a device that collects digital data from external medical devices and transmits it to clinical information systems. It primarily describes:

  • Device Identification: The name, common name, and classification of the device and connected external devices.
  • Intended Use: How the device functions (data conversion and transmission) and its purpose (electronic data collection and clinical information management).
  • Limitations: What the device is not intended for (patient connection, remote control, monitoring).
  • Regulatory Communication: An FDA letter of substantial equivalence, confirming the device's classification and allowing it to be marketed.

There is no mention of performance metrics, acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for evaluating the device's efficacy or accuracy. The "study" referenced in the prompt (and relevant for AI/ML devices) is absent in this traditional medical device submission for a data link system.

§ 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).