(138 days)
The H12+ Holter recorder is intended to acquire, record and store up to 48 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.
Holter analysis is appropriate for the indications below:
- Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia. .
- Evaluation of adult patients for ST segment changes .
- Evaluation of adult patients with pacemakers .
- Reporting of time domain heart rate variability .
- Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or . cardiac surgery.)
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients .
- Clinical and epidemiological research studies .
- Infant patient evaluation is limited to QRS detection only .
The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H12+ recorder. The H12+ utilizes a 10-lead electrode hookup and placement that will result in three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
The H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keyboard is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keyboard can be used to enter event markers.
H12+ has a large LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various warning messages for the hook-up technician.
H12+ uses one AA battery, and a removable Compact Flash card as a memory support.
This document is a 510(k) premarket notification for the Mortara H12+ Holter Recorder. It describes the device's intended use, indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on establishing that the H12+ Holter Recorder is substantially equivalent to a legally marketed predicate device (Mortara PR4 Holter analysis Recorder (K9110977), later named H-12), based on its design, intended use, and indications for use.
Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for device clearance, not a performance study report.
§ 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).