(60 days)
Not Found
No
The description focuses on standard monitoring, data storage, and basic analysis (arrhythmia, ST segment) without mentioning AI/ML techniques. The "analysis" described appears to be rule-based or algorithmic rather than learned.
No
The device is described as a "Central Monitoring System" intended for monitoring patient data, waveforms, and alarms, but it does not provide treatment or therapy.
Yes
The Acuity® Central Monitoring System, with its optional modules like Arrhythmia Analysis and ST Analysis, provides real-time monitoring and alarms for specific physiological parameters (cardiac rhythms, ST segment deviations) to aid clinicians in determining the clinical significance of these events, which is a characteristic of a diagnostic device.
No
The device description explicitly mentions "hardwired and wireless Acuity LT and Mobile Acuity LT System configurations," indicating the presence of hardware components beyond just software. While it includes software modules, it is part of a larger system that includes hardware for central monitoring and connectivity.
Based on the provided information, the Acuity® Central Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Acuity System Function: The Acuity System is described as a central monitoring system that receives and displays patient data, waveforms, alarms, and alerts. It also offers optional modules for extended recording and analysis of this data (like arrhythmia and ST analysis).
- Lack of Specimen Handling: The description explicitly states that the "Devices running Clinician Notifier software are not directly connected to patients." While the system receives data from patient monitors, it does not involve the collection, preparation, or examination of specimens from the human body.
- Focus on Physiological Monitoring: The system's function is centered around monitoring physiological parameters and providing information based on those real-time measurements, not on analyzing biological samples.
Therefore, the Acuity® Central Monitoring System falls under the category of a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities.
In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules:
- . The Full Disclosure module stores patient data for up to 96 hours with Acuity LT and Mobile Acuity LT).
- . The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
- . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
- . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuity System patient printout files available on Web browsers) and HL7 options.
Product codes
MSX
Device Description
The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities.
In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules:
- The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
- . The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
- . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
- . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.
The Link To Acuity option is Welch Allyn's mobile alarm management solution. It consists of Clinician Notifier software for non-proprietary mobile devices and administrative software for the Welch Allyn Connectivity Server (WACS).
Mobile devices running the Clinician Notifier software deliver patient alarm information and real-time waveforms gathered from patient monitors connected to the Acuity Central Monitoring System. The devices are not intended for use as primary alarm notification devices. Devices running Clinician Notifier software are not directly connected to patients.
The Link To Acuity option is designed to extend the patient monitoring functions of the Acuity Central Monitoring System. The software enables administrators to track the status of clinician-patient assignments, and it enables clinicians to track, respond to and view Acuity System patient alarms, view historical alarm details and waveforms, and view real-time patient waveforms. The mobile devices can be used for barcode scanning to enter patient ID and room number.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric and adult
Intended User / Care Setting
The Link To Acuity option is to be used by authorized health care professionals using standard institutional procedures and good clinical practice guidelines for patient monitoring. Staff training in the operation of the Link To Acuity option is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' vital signs data.
Individuals using the Link To Acuity option should be familiar with its operation as described in the directions for use manual, and they should understand all warnings and cautions in the directions for use manual.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been tested in accordance with the following Welch Allyn documents using production equivalent units prior to market release.
| 830-1423-00 | Test Plan, Acuity V7.00 |
| 831-1285-00 | Pre-Validation Clinical Entry Test Report Clinician Notifier 2.35/WACS 2.10.00 |
| 830-1472-00 | Welch Allyn Link to Acuity® - Simulated Clinical Engineering Test Protocol |
| 831-1248-00 | Link To Acuity® Simulated Clinical Testing Report |
A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Welch Allyn Protocol's product development procedure. Welch Allyn Protocol's Quality System conforms to 21 CFR 820 and is certified to ISO 13485:2003.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is black and the background is white.
Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)
Premarket Notification [510(k)} Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness, is outlined below.
| Date Prepared: | March 5, 2007 |
|---|---|
| Name of Submitter: | Welch Allyn Protocol, Inc. |
| 8500 S.W. Creekside Place | |
| Beaverton, OR 97008-7107 USA |
Contact:
Jeffrey W. Wagner, Director, Regulatory Affairs
Phone: (503) 530-7909
Fax: (503) 526-4901 |
| Device Proprietary Name: | Link To Acuity® Clinician Notifier
(Modification to the Acuity® Central Monitoring System) |
| Classification Name: | System, network and communication, physiological monitors (MSX)
Detector and Alarm, Arrhythmia (DSI) |
| Common/Usual Names: | Central monitoring system |
Predicate Devices:
| K052160 | Acuity® Central Monitoring Station | Welch Allyn Protocol, Inc. |
|---|---|---|
| K052975 | S/5 Pocket Viewer | Datex-Ohmeda |
Device Description:
The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities.
In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules:
- The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
MAR 2 3 2007
K070204/51
1
WelchAllyn
Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)
C7C20451 72/3
- . The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
- . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
- . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.
The Link To Acuity option is Welch Allyn's mobile alarm management solution. It consists of Clinician Notifier software for non-proprietary mobile devices and administrative software for the Welch Allyn Connectivity Server (WACS).
Mobile devices running the Clinician Notifier software deliver patient alarm information and real-time waveforms gathered from patient monitors connected to the Acuity Central Monitoring System. The devices are not intended for use as primary alarm notification devices. Devices running Clinician Notifier software are not directly connected to patients.
The Link To Acuity option is designed to extend the patient monitoring functions of the Acuity Central Monitoring System. The software enables administrators to track the status of clinician-patient assignments, and it enables clinicians to track, respond to and view Acuity System patient alarms, view historical alarm details and waveforms, and view real-time patient waveforms. The mobile devices can be used for barcode scanning to enter patient ID and room number.
The Link To Acuity option is to be used by authorized health care professionals using standard institutional procedures and good clinical practice guidelines for patient monitoring. Staff training in the operation of the Link To Acuity option is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' vital signs data.
Individuals using the Link To Acuity option should be familiar with its operation as described in the directions for use manual, and they should understand all warnings and cautions in the directions for use manual.
Technological Characteristics:
The Welch Allyn Link To Acuity Clinician Notifier option allows for alarm management remote from the central monitoring station. Through a network of wireless and/or hardwired devices connected to the Welch Allyn Acuity Central Monitoring System, alarms, real time data, and other information can be viewed from a generic mobile computer configured with Welch Allyn Link To Acuity Clinician Notifier option software. The Welch Allyn Link To Acuity Clinician Notifier is to be used as a supplement to other patient monitoring and not as a primary alarm notification device.
2
WelchAllyn
Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)