(28 days)
The Component Monitoring System and V24/V26 family of patient monitors is intended for the monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by healthcare professionals whenever there is a need for monitoring the physiologic parameters of adult, neonatal, and pediatric patients.
The modification in this submission is the addition of an alternate blood analysis module to the current plug-in i-STAT module as a component to the CMS and V24/V26 family of patient monitors. The proposed M3560A Blood Analysis Portal System is substantially equivalent to the Diametrics IRMA Blood Analysis System but provides a plug-in interface instead of an RS232 interface connection. Only Diametrics analysis cartridges (IRMA cartridges) are used with this module. The new M3560A Blood Analysis Portal System is also smaller than the current Diametrics IRMA Blood Analysis System and does not operate via battery power.
This 510(k) submission describes the M3560A Blood Analysis Portal System Plug-In Module for the Philips Component Monitoring System and V24/V26 family of patient monitors. It does not contain information about the acceptance criteria or a specific study proving the device meets acceptance criteria.
The document focuses on:
- Device Description: The M3560A is an alternate blood analysis module that provides a plug-in interface, is smaller, and does not operate via battery power compared to its predicate device (Diametrics IRMA Blood Analysis System). It uses only Diametrics analysis cartridges (IRMA cartridges).
- Intended Use: Monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal, and pediatric patients in healthcare facilities by healthcare professionals.
- Substantial Equivalence: It claims substantial equivalence to several predicate devices, including the Agilent Component Monitoring System, HP Viridia Component Monitoring System, M1032A VueLink Plug-In Module, Diametrics Medical, Inc. IRMA Blood Analysis System, HP Component Monitoring System, and i-STAT 200 Portable Clinical Analyzer.
- Performance Standards: It states that components with arrhythmia and alarm capability remain compliant with 21 CFR Part 898, as they are unchanged from previous cleared submissions.
- Fundamental Technology: The fundamental scientific technology is described as unchanged from the predicate devices.
- Design Controls: Mentions that "Verification, validation, and testing activities will be successfully conducted and completed prior to commercialization to establish the safety, performance, and reliability characteristics of the M3560A Blood Analysis Portal System," including system level tests, integration tests, safety tests, and predicate device comparison. However, the details of these tests, including specific acceptance criteria or study results, are not provided in this summary.
Therefore, based on the provided text, the requested information regarding acceptance criteria and the study proving the device meets them cannot be extracted. The document states that testing will be conducted, implying this 510(k) summary is submitted before the detailed results of those tests are available or summarized for the FDA in this specific document.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.