(166 days)
The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the Mortara H-12 digital recorder or to other compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.
The H-Scribe Holter system is intended for use in a clinical setting, by qualified medical professionals, for patients requiring ambulatory (Holter) monitoring of 24 - 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:
- Evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting . arrhythmia.
- . Evaluation of adult patients for ST segment changes
- . Evaluation of adult patients with pacemakers
- . Reporting of time domain heart rate variability
- Infant patient evaluation is limited to QRS .
The H-Scribe Holter Analysis system is a PC based diagnostic tool consisting of a Holter analysis software application running on a commercial PC using Windows 98 operating system. Designed in conjunction with the Mortara H-12 Holter recorder, the H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H-12 recorder, or other compatible tape or digital recorders. The system provides three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The software automatically detects arrhythmia and ST events, and creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
System features and options include a DVD RAM drive provided for long term archival of full disclosure recordings on DVD disks, an included modem for remote technical support, a network card for remote printing and data transfer, and networking capability allowing interface to Hospital Information Systems, through standard protocols.
This document is a 510(k) summary for the Mortara H-Scribe Holter Analysis System. It describes the device, its intended use, and indications for use. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory submission details and a general description of the device's functionality, not on its clinical performance evaluation or the studies proving it meets specific acceptance criteria.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).