(87 days)
This device is intended for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
AlarmView is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type environments and is not for home use.
AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures.
AlamView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.
AlarmView™ is a paging system that interfaces with a primary patient clinical device in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.
AlarmView reads the patient information from the output data port and does not change the primary monitor in any way. It formats the patient information into a message that can be transmitted to a pager carried by mobile health careqivers. AlarmView does not diagnose alarms.
AlarmView consists of the AV Transmitter, AV Pager, and the AC PDA (Personal Digital Assistant) used for administration.
The provided document, K992848 Summary of Safety and Effectiveness for the AlarmView™ - Physiological Monitor System, Network and Communication, does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on:
- Intended Use: AlarmView™ is a paging system for real-time monitoring of patient status and alarm events, serving as a secondary means to inform mobile healthcare providers. It is intended to supplement existing monitoring, not replace it, and is for use by trained professionals in hospital environments.
- Technological Characteristics: The document states that AlarmView™ has the same technological characteristics as its predicate devices, primarily consisting of a paging system connected to a medical device to transmit patient data.
- Safety and Efficacy: It claims AlarmView™ has the same safety and efficacy characteristics as the predicate devices.
Key points from the document regarding the "study" aspect are:
- The submission is a 510(k) for substantial equivalence to legally marketed predicate devices.
- There is no mention of a clinical study, performance study, or any specific testing with acceptance criteria for the AlarmView™ system itself described in this summary.
- The FDA approval letter from November 19, 1999, confirms the finding of substantial equivalence based on the provided information.
- The device is "validated for use with the N-x9y and N-3x00 data protocols," which implies some level of technical testing, but specifics of this validation (e.g., methodology, results, acceptance criteria) are not detailed in this summary.
Therefore, based solely on the provided text, the requested information cannot be fully extracted for the AlarmView™ device as a new study with explicit acceptance criteria and performance data is not presented.
However, to address the prompt's request for format, if such a study existed and was described in this document, the information would be presented as follows (with "N/A" for details not found in the provided text):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Latency, Message Delivery Rate, Error Rate) | Reported Device Performance |
|---|---|
| No specific acceptance criteria defined in the document. | No specific performance data reported in the document. |
| (Hypothetical: Message delivery time |
§ 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).