(116 days)
The H3+ 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 H3+ recorder and are undergoing Holter monitoring. The H3+ performs no cardiac analysis by itself and is intended to be used with the Mortara H-Scribe Holter analysis system (K004017) or other compatible Holter Analyzer. ECG data prerecorded by the H3+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Hotter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The H3+ 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. The Mortara Holter Recorder H3+ is not a life-supporting device. It is diagnostic tool intended to acquire, record and store ECG data of patients requiring ambulatory (Holter) monitoring of 24 or 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
- 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 H3+ Holler Recorder is intended for use as part of a Holter Analysis system and is designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H3+ Holter Recorder provides two or three channels of continuous ECG data recorded over a 24-hour or 48-hour period.
The H3+ is a Holter Recorder offering micro-sized, extremely lightweight patient utility. Using existing Mortara approved technology, the H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H3+ recorder. 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 H3+ provides the ability to choose between a 3-Channel patient cable to record modified leads II, III and V; and a 2-Channel patient cable to record bipolar leads positioned according to clinician preference. The 3-Channel 5-lead patient cable allows for recording modified leads II, III and V. The 2-Channel 5-lead patient cable allows for recording two bipolar leads. Either patient cable can be used with the H3+ according to user preference. A LCD screen and Enter button allow for checking the lead quality during palient hook-up and starting the recording.
The H3+ uses a single AAA alkaline battery and stores acquired ECG data in internal, non-volatile memory. Stored ECG data will be downloaded for analysis to the H-Scribe, a PC based Holter Analysis system, via a standard USB interface. The recorded data will remain in memory until it has been cleared by the clinician.
The provided text describes a 510(k) notification for the Mortara H3+ Holter Recorder. However, it explicitly states that the H3+ Holter Recorder performs no cardiac analysis by itself. Its primary function is to acquire, record, and store ECG data. The analysis of this data is performed by the separate Mortara H-Scribe Holter Analysis system.
Therefore, the document does not contain information related to acceptance criteria for algorithmic performance, any accompanying study showing the device meets such criteria, or details regarding ground truth, expert adjudication, or reader studies as the H3+ device itself is merely a data acquisition and storage unit.
The provided text focuses on:
- Description of the Device: H3+ Holter Recorder, its features (2 or 3 channels, 24-hour or 48-hour recording, single AAA battery, internal non-volatile memory, USB interface).
- Intended Use: To acquire, record, and store ECG data for Holter monitoring, to be analyzed by the Mortara H-Scribe Holter Analysis system.
- Indications for Use: Evaluation of adults with suspected arrhythmia, pacemakers, heart rate variability, post-MI/cardiac surgery, therapeutic interventions, research studies. Infant evaluation is limited to QRS detection.
- Substantial Equivalence: Claimed against Mortara H12+ Holter Recorder (K021373), Ela Medical Spiderview (K032466), and Braemer / Phillips Digitrack Plus (K993617).
To address the request fully, it's important to reiterate that the H3+ is a data capture device, not an analytical one. The criteria and studies requested would be relevant for the H-Scribe Holter Analysis system (K004017), which performs the cardiac analysis, but not for the H3+ 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).