(164 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard patient monitoring functionalities and embedded analysis from an earlier submission, without mentioning any AI/ML capabilities.
No.
This device is described as monitoring software that displays and reviews physiological data and provides alarm annunciation, but it does not directly apply treatment or therapy to the patient. Its physiological purpose is "To gain information for treatment, to monitor adequacy of treatment, or to rule out causes of symptoms."
Yes
The device monitors cardiac arrhythmia and ST segments, and its physiological purpose is "To gain information for treatment, to monitor adequacy of treatment, or to rule out causes of symptoms." This directly aligns with the definition of a diagnostic device, which is used to identify or determine the nature of a condition.
Yes
The device description explicitly states "CentralVue Software is a centralized patient monitoring application that executes on an NT Workstation and operates on data received from other networked medical devices." It also clarifies that "all patient connections are made by other remote devices," indicating the software itself does not have direct patient contact or integrated hardware for data acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The CentralVue Software operates on data received from other networked medical devices. It displays and analyzes physiological waves and parameters (like cardiac arrhythmia and ST segment). It does not interact with or analyze specimens from the human body.
- Intended Use: The intended use is for central monitoring of patients based on data from remote devices, not for analyzing biological samples.
- Part of Body/Tissue Interacted With: Explicitly states "None, all patient connections are made by other remote devices." This further confirms it doesn't interact with bodily specimens.
The device is a patient monitoring system that processes and displays physiological data collected by other devices connected to the patient. This falls under the category of patient monitoring equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The indications for use of the Hewlett-Packard CentralVue Software are:
-
· Condition: the clinician decides to centrally monitor up to 8 adult, pediatric, and/or neonatal patients:
and for the embedded STAR: -
· Condition: the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and/or
neonatal patients and/or ST segment of adult patients.
Product codes
Not Found
Device Description
CentralVue Software is a centralized patient monitoring application that executes on an NT Workstation and operates on data received from other networked medical devices. CentralVue Software displays physiologic waves and parameters, provides retrospective review of physiologic waves and parameters and provides the secondary annunciation of alarms for up to eight patients at a centralized location. CentralVue Software embeds STAR ST Segment and Arrhythmia analysis for up to eight patients. CentralVue Software can format data for compliant strip chart recorders such as the CentralVue Recorder.
Mentions image processing
None
Mentions AI, DNN, or ML
None
Input Imaging Modality
None
Anatomical Site
None, all patient connections are made by other remote devices.
Indicated Patient Age Range
neonatal, pediatric, or adult patients.
Intended User / Care Setting
CentralVue Software is intended to be used by trained clinicians to monitor cardiac function in neonatal, pediatric, or adult patients.
CentralVue Software is intended to be used in a professional health care facility.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The development team tested the device during development by performing unit and integration testing. STAR ST Segment and Arrhythmia monitoring software embedded in CentralVue Software was tested to assure that it performed as disclosed in an earlier submission. When the black box, gray box, white box, and STAR regression tests were completed a separate test group validated that CentralVue Software meets its performance claims and is safe and effective in its intended use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The development team tested the device during development by performing unit and integration testing. STAR ST Segment and Arrhythmia monitoring software embedded in CentralVue Software was tested to assure that it performed as disclosed in an earlier submission. When the black box, gray box, white box, and STAR regression tests were completed a separate test group validated that CentralVue Software meets its performance claims and is safe and effective in its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K9CC4832
MAY 15 1997
1.0 Use
1.1 What it is
CentralVue Software is a centralized patient monitoring application that executes on an NT Workstation and operates on data received from other networked medical devices.
1.2 What it does
CentralVue Software displays physiologic waves and parameters, provides retrospective review of physiologic waves and parameters and provides the secondary annunciation of alarms for up to eight patients at a centralized location. CentralVue Software embeds STAR ST Segment and Arrhythmia analysis for up to eight patients. CentralVue Software can format data for compliant strip chart recorders such as the CentralVue Recorder.
1.3 Who Uses it on Whom
CentralVue Software is intended to be used by trained clinicians to monitor cardiac function in neonatal, pediatric, or adult patients.
1.4 Who Prescribes it
In the USA. Federal law restricts CentralVue Software to sale by or on the order of a physician.
1.5 Where is it Used
CentralVue Software is intended to be used in a professional health care facility.
CentralVue Software is not intended for home use.
2.0 Indications for Use
The indications for use of the Hewlett-Packard CentralVue Software are:
-
· Condition: the clinician decides to centrally monitor up to 8 adult, pediatric, and/or neonatal patients:
and for the embedded STAR: -
· Condition: the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and/or
neonatal patients and/or ST segment of adult patients.
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- · Part of body or type of tissue interacted with: None, all patient connections are made by other remote devices.
- · Frequency of use: As prescribed by clinician.
- · Physiological purpose: To gain information for treatment, to monitor adequacy of treatment, or to rule out causes of symptoms.
- · Prescription versus over-the-counter: Central-Vue Software is a prescription device.
3.0 How it Works
System Requirements 3.1
Central Vue Software can only be used on NT Workstations that are specified in the labeling or that are subsequently qualified by Hewlett-Packard.
3.2 How CentralVue Software Functions
CentralVue Software is a software device that consists of monitoring applications, STAR ST Segment and Arrhythmia monitoring software that run in the monitoring mode. In addition, system management software runs when in the non-monitoring mode.
Monitoring mode applications provide patient monitoring functionality. STAR ST Segment and Arrhythmia monitoring is a subset of the patient monitoring software that runs in monitoring mode.
Non-monitoring mode software provides the startup, shut-down, installation, and other system management functions.
4.0 Summary of Major Features
Key features of CentralVue Software are shown in the patient monitoring Main Screen and All Controls menu:
Main Screen - up to 8 patients, up to 2 waves per patient, maximum of 16 waves per screen.
Patient Management - easy patient admit, discharge, bed transfer, change of monitoring equip
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ment from bedside to telemetry, and customization of the Main Screen patient sector.
Alarm Management and Setup - separate adjustment of arrhythmia and ST segment monitoring alarms for each patient.
Patient Data Review - access to stored patient data for alarms, trends, events, full disclosure waveform, and ST segment review.
Configuration and Support - direct access to sound volume control, device status and error information, and service support information; clinical password access to monitor default configurations; support password access to a wide range of service support functions.
5.0 How it Compares to other Devices
CentralVue Software is similar to the predicates in that it has the same use, features, and specifications.
6.0 How was it Verified and Validated
The development team tested the device during development by performing unit and integration testing. STAR ST Segment and Arrhythmia monitoring software embedded in CentralVue Software was tested to assure that it performed as disclosed in an earlier submission. When the black box, gray box, white box, and STAR regression tests were completed a separate test group validated that CentralVue Software meets its performance claims and is safe and effective in its intended use.
7.0 How we Know it is Safe and Effective When Used as Labeled
The defined and controlled development processes followed, and the documented test results obtained from extensive testing produces a very high confidence level that the device is safe and effective when used as intended.
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