(224 days)
This device is indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use.
StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve 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.
StatView™ has been validated for use with the following networks: Héwlett-Packard CareNet, GE Marquette Medical Unity, and Siemens Medical Systems Infinity.
StatView™ System is a paging system that interfaces with primary patient monitoring systems (PPMS) in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.
StatView interfaces with the PPMS and reads the same alarm information that the PPMS uses, then formats that information into a message that can be transmitted to the receivers carried by mobile health caregivers. Although StatView reads the same alarm information that the PPMS LAN sends, it does not change it or modify it in any way. StatView does not diagnose alarms but transmits what the PPMS determines to be an alarm.
StatView consists of the StatView Server (WT Server), StatView Transmitter, and StatView Receiver.
In addition to the capabilities of the previous version of StatView (predicate device), users of the StatView system can send pre-programmed text messages that can be easily selected when initiating a text page as well as scheduling text messages. Semi-automatic mode is used for facilities that with their monitoring technicians to continue to filter the alarm traffic sent to the mobile caregivers.
The provided text is a 510(k) summary for the StatView™ System, a physiological monitor system, network, and communication device (alarm paging system). This type of document is focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing specific performance studies against defined acceptance criteria in the manner of a clinical trial for a new drug or a novel medical device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states: "StatView has the same safety and efficacy characteristics as the predicate devices." This highlights that the approval is based on equivalence, not a standalone performance study with novel criteria.
Specifically, the following information is NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the StatView™ System. It focuses on functional descriptions and equivalence to predicate devices.
- Sample size used for the test set and the data provenance: No details on a test set, its size, or origin are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about ground truth establishment or experts is present.
- Adjudication method for the test set: Not applicable as no test set or ground truth process is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a paging system for alarm annunciation to human healthcare providers, implying human-in-the-loop by design. No "algorithm only" performance is discussed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth process is described.
- The sample size for the training set: Not applicable; the document refers to the system's function rather than a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Intended Use: "This device is intended for use in real-time monitoring of routine patient status and alarm events... StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve 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."
- Technological Characteristics: States that "StatView is the same in technological characteristics as the cited predicate devices. All the predicate devices consist of a paging system connected to primary patient monitoring equipment that is used to transmit patient data to an appropriate health care provider."
- Equivalence Claim: The core of the submission is the claim that "StatView™ System is substantially equivalent to the following predicate devices: StatView™ System (previously cleared) by Data Critical Corporation, Pager-LAN by GE Marquette Medical Systems, and Palm Vue (M1490A) by Hewlett Packard, and "Paging" by Vitalcom."
In essence, for this type of medical device submission in 1999, the "study" demonstrating that the device met "acceptance criteria" was the argument for substantial equivalence to legally marketed predicate devices, based on similar intended use and technological characteristics, rather than a novel performance study against predefined quantitative metrics.
§ 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).