(43 days)
The LIFENET System is an optional data transmission system that provides the capability to transmit real time 12-Lead ECG reports and other physiological data to a receiving destination at a remote location. Data received from the field can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
The system is an optional data transmission system that is used in conjunction with monitoring devices. The system provides real time data transfer from the originating/transmitting device to a user selected remote receiving destination (RD). The users of the LIFENET System are qualified medical professionals and include Advanced Life Support providers (e.g. Paramedics) and Basic Life Support providers (e.g. Emergency Medical Technicians) in a variety of hospital and pre-hospital settings. The system is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical, clinics, physician offices, and cardiac catheterization labs). The system is also used for hospital transport (air and ground ambulance, in-hospital transport, etc). The modified system includes optional data management features that provide the user with expanded data management capabilities and increased efficiencies. Additionally, a new feature, the LIFENET Consult, provides users the capability to forward unattered patient information for review and comment, by initiating a clinician consult. Upon receipt of patient data, health care professionals, using a hand held wireless device are able to view patient information and provide a "consult" reply to the hospital user intended for purposes of diagnosis, disposition, and therapy decisions.
The provided text describes a 510(k) premarket notification for the Physio-Control Inc LIFENET System. This system is an optional data transmission system for physiological monitors, allowing real-time transfer of 12-lead ECG reports and other physiological data. The text explicitly states that the "modified LIFENET System performs and functions in the same manner as the predicate system" and that its "Technological Characteristics" are similar to the previously cleared predicate device.
The FDA 510(k) submission process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device (LIFENET System (K093925)). When substantial equivalence is claimed through this pathway, the focus is often on comparing the new device's technological characteristics and performance to the predicate device, rather than requiring new clinical studies to establish independent acceptance criteria and performance against a gold standard for specific diagnostic or therapeutic outcomes.
Therefore, the provided document DOES NOT contain information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- A standalone algorithm-only performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document's conclusion states: "The information in this 510(k) demonstrates that the modified LIFENET® System is substantially equivalent to the predicate LIFENET System with respect to safety, effectiveness, and performance." This indicates that the demonstration of effectiveness relied on showing similar functionality and performance to the predicate device, not on new studies specifically establishing performance against explicit acceptance criteria.
§ 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).