(84 days)
The intended use of the Holter Recorder Rz153+/ Cardio ID+ is to perform ambulatory ECG and impedance recording, on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. The data is intended to be downloaded to an analysis software package after the recording is completed.
Detection of Arrhythmia. The Rozinn 153+ is indicated for use in continuous monitoring of Cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ is indicated for use to determine whether current pharmacological treatment (s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. Pacemaker evaluation is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician
The basic operation of the Holter Recorder RZ153+ is to collect and store multiple channels of ECG data along with impedance measurements. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:
Acceptance Criteria and Device Performance Study for Holter Recorder Cardio ID+ RZ153+
The provided document describes a 510(k) summary for a new Holter Recorder, the Cardio ID+ RZ153+, seeking substantial equivalence to a predicate device, the Holter Recorder DR180 II (K001288). The acceptance criteria are implicitly defined by the technical specifications and performance characteristics of the predicate device. The study performed is a comparison of technology characteristics to demonstrate substantial equivalence, rather than a clinical performance study with specified numerical acceptance criteria for a diagnostic outcome.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the specifications of the predicate device, and the reported device performance is the specifications of the new device.
| Specification | Acceptance Criteria (Predicate Device: DR180 II) | Reported Device Performance (RZ153+ New Device) |
|---|---|---|
| Online data monitoring & alarm | No | No |
| Recorded ECG channels | Multiple | Multiple |
| Sample rate & resolution | 180/360/720 S/s & 12 bits | 1024 S/s & 12 bits |
| Bit resolution | 6.25 µV / LSB | 1.465 µV / LSB |
| Max. input voltage range | ± 1.5 mV | ± 6, ± 3 or ± 1.5 mV |
| Amplification factors | 1 | 1/2, 1 or 2 |
| Analogue bandwidth | 0.05 Hz to 20 Hz | 0.05 Hz to 75 Hz |
| Pacemaker detection & reporting | Yes | Yes |
| Open-Lead detection & reporting | Yes | Yes |
| Impedance Measurement | Yes | Yes |
| Preferred recording period | 24 h or continuously | 24h, 48h or user defined |
| Storage capacity | Up to 512MB | Up to 512 MB |
| Recording capacity | Up to 50 hours | Up to 120 hours / 5 days |
| Memory type | CompactFlash™ Memory Card | CompactFlash™ Memory Card Type II or Type I |
| Data transfer method | Via removable Memory Card | Via removable Memory Card |
| Memory Card data format | Standard file system | Standard file system |
| Data overwrite protection | Yes | Yes |
| Internal memory card management | Reformat, erase cards | Reformat, erase cards |
| Liquid crystal display (LCD) | Yes | Yes |
| Keyboard | protected touch keys | protected touch keys |
| Number of keys | 13 | 5 |
| Patient leakage current | 0 mA |
§ 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).