(30 days)
The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers.
This submission is a 510(k) summary for the DataCaptor™ Data Acquisition and Distribution Software. The purpose of this 510(k) is to demonstrate substantial equivalence to a previously cleared device (K013019) with the primary change being added compatibility with additional medical devices.
Therefore, the submission does not include any studies related to acceptance criteria or device performance because it relies on the predicate device's established safety and effectiveness. The FDA's letter (Exhibit 3) also confirms that the device is substantially equivalent to legally marketed predicate devices without requiring a PMA.
As a result, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC studies, as these were not part of this 510(k) submission.
§ 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).