(197 days)
The PageWriter 200 series cardiographs with option #A05 transmit ECGs for management or physician review or copying. ECGs can be transmitted to another PageWriter cardiograph or to a general purpose fax device. Option #A05 also provides ECG storage capability in the cardiograph.
The intended use of the PageWriter 200i and 200 with option #A05 is substantially equivalent to the intended use of the PageWriter XLi with Direct Digital FAX (Model M1706B) currently marketed which received FDA's substantial equivalence determination under K#941282. i.e., it is intended to transmit ECGs for management or physician review or copying and transmit to another device.
The PageWriter 200i and 200 with option #A05 is intended to be used in a hospital environment or in a physician's office. The cardiograph is used to acquire, digitize, record, and transmit conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data. The cardiograph also records patient data entered through the alphanumeric keyboard. Additionally, the PageWriter 200i cardiograph measures and provides ECG interpretation. The interpreted ECG with measurements and diagnostic statements is offered to the physician on an advisory basis only, and the physician is asked to overread and validate (or change) the ECG interpretation.
PageWriter 200 series cardiographs with option A05 will:
- Transmit via direct connect or fax modem using a Hewlett Packard digital communications protocol to PageWriter XLi cardiographs (Model M1700A. K#895520) and PageWriter 200 series cardiographs with A05
- Transmit to and receive from an automated HP ECG management system.
- Transmit to CCITT group III fax machines.
- Store up to 30 AUTO ECGs in solid state memory for later retrieval or transmission.
PageWriter 200 series cardiographs with option AC5 will NOT:
- Receive fax from CCITT group III fax machines.
Option A05 adds a new printed circuit board to the predicate device hardware. The new printed circuit board interfaces to the predicate hardware via an existing connector located on the main control board. The existing connector is used during production to interface with our manufacturing test system.
Option A05 does not include the fax modem device. The fax modem device may be ordered using Model number M1706B or the customer may purchase an equivalent fax modem device. A modem is connected to the cardiograph via the RS 232 connector on the rear of the cardiograph. The modem derives power from AC line power. The modem is connected to the phone line via a cable. The modem is a standard general purpose modem. Software is added to the cardiograph to enable the cardiograph to recognize the modem.
The predicate device is the PageWriter XLi cardiograph with the M1706B Direct Digital ECG Fax modem. The predicate device was cleared for market by the FDA in 1995.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria in the format requested. The document describes the device, its indications for use, and a general assessment of safety. There is no mention of a formal study with acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics in relation to those criteria.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as this information is not present in the provided text.
N/A