(117 days)
The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for the generation of a patient record.
The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips Cableless Measurements and Philips Patient Monitors that are connected through networks.
The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue Patient Monitors. The IntelliVue GuardianSoftware provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.
The IntelliVue GuardianSoftware can currently acquire physiological data from the following compatible measuring devices:
- Philips IntelliVue Measurements CL SpO2 Pod, CL NBP Pod, CL Resp Pod and l
- Philips IntelliVue Patient Monitors MP5 and MP5SC. -
The subject modification adds the Philips IntelliVue MX400/450 patient monitors and the Philips Suresigns VS3/VS4 patient monitors as additional optional Philips patient monitors to the list of measuring devices compatible with the IntelliVue GuardianSoftware and updates the versions of the supported SQL database versions.
To support the before described purposes the IntelliVue GuardianSoftware was modified to maintain a consistent numbering scheme. The modified common software revision is Rev.C.0
The provided document pertains to an FDA 510(k) premarket notification for the Philips IntelliVue Guardian Software Revision C.0, which is a Clinical Information Management System. However, the document does not contain specific details regarding acceptance criteria, reported device performance metrics, or the study used to prove the device meets such criteria.
The document focuses on:
- Administrative changes: Updating a previous SE determination letter to remove a secondary product code.
- Description of the device: Stating that the IntelliVue GuardianSoftware collects and manages vital signs data from Philips Cableless Measurements and IntelliVue Patient Monitors. It provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories (including EWS deterioration status), remote viewing and operating, interfacing, storage, and printing.
- Modifications: The subject modification adds Philips IntelliVue MX400/450 and Philips Suresigns VS3/VS4 patient monitors as compatible devices and updates supported SQL database versions.
- Technological characteristics: Stating that the modified device has the same technological characteristics as the predicate device (software-only, client-server architecture, runs on standard PC/Server with specified Microsoft OS and databases).
- Verification, Validation, and Testing: A general statement about software functional testing, regression testing, and hazard analysis testing, confirming that pass/fail criteria were met. It also mentions compliance with IEC 62304:2006 for software life cycle processes.
Therefore, I cannot provide the requested information. The document explicitly states: "The 510(k) submission was not re-reviewed" (page 0), and "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject modified devices with respect to the predicate. Testing involved software functional testing and regression testing on an integration and system level as well as testing from the hazard analysis." (page 6). It also states: "Pass/Fail criteria were based on the specifications cleared for the predicate devices and all test results showed substantial equivalence." (page 6).
This indicates that clinical performance data, specific acceptance criteria, or detailed study results are not included in this summary. The focus is on demonstrating substantial equivalence to a predicate device through software verification and validation, rather than proving performance against new, explicit acceptance criteria with detailed study data.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).