(57 days)
The H12+ Holter recorder is intended to acquire, record and store up to 24 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 24 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 patients 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 H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H12+ utilizes a 10-lead electrode hookup and placement to provide the H-Scribe system with three channels of full disclosure for Holter 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 keypad 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 keypad can be used to enter event markers.
H12+ has a LCD screen to allow ECG display during the hook-up. lead quality check. system configuration and various messages for the hook-up technician.
H12+ uses one AA battery, and a removable memory card for data storage.
This document does not contain the information required to populate the requested tables and descriptions regarding acceptance criteria and study results. The provided text is a 510(k) summary for a Holter Recorder (H12+), which focuses on device description, intended use, indications for use, and regulatory substantial equivalence to a predicate device. It does not include:
- Specific acceptance criteria for device performance (e.g., accuracy metrics for ECG acquisition).
- Details of a study proving the device meets acceptance criteria.
- Information on sample size, data provenance, ground truth establishment, or expert involvement for any performance study.
- Mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
The document states that the H12+ "performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017)." This indicates that the H12+ is a data acquisition device, and therefore, performance metrics related to cardiac analysis would likely be evaluated for the H-Scribe system, not the H12+ recorder itself.
§ 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).