(84 days)
Not Found
No
The document explicitly states that the device is not capable of diagnosis or interpretation and only displays and stores data. There is no mention of AI or ML in the description or the "Mentions AI, DNN, or ML" section.
No
The device is described as a recorder for collecting and storing ECG data and impedance measurements, which is then downloaded to analysis software. It does not perform diagnosis or interpretation, nor does it deliver any therapy.
No
The "Device Description" explicitly states, "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." While it collects data for later analysis, the device itself does not perform the diagnostic function.
No
The device description explicitly states it is a "Holter Recorder RZ153+" which collects and stores ECG data and impedance measurements. This indicates a physical hardware component (the recorder) is part of the device.
Based on the provided information, the Holter Recorder Rz153+/ Cardio ID+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Holter Recorder Rz153+/ Cardio ID+ records electrical signals from the body (ECG) and impedance measurements. It does not analyze or test biological specimens.
- Intended Use: The intended use is to record physiological data (ECG and impedance) for later analysis by software and a physician. It is used for monitoring cardiac function and detecting arrhythmias based on these electrical signals.
- Device Description: The description explicitly states that the recorder is "not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data." This further reinforces that it's a data acquisition device, not a diagnostic test performed on a specimen.
Therefore, the Holter Recorder Rz153+/ Cardio ID+ falls under the category of a medical device used for physiological monitoring, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Indications for use: 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
Product codes (comma separated list FDA assigned to the subject device)
DSH
Device Description
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
OCT 2 4 2002
510(K) Summary
510 (k) Summary
Submitter:
Mark Rosoff, President Rozinn Electronics, Inc. 71-22 Myrtle Avenue Telephone: 718-386-5526 718-366-4574
718-366-4574
mark @roziml.com
Mark @roziml.com
7 318-30030ff
7 31 10030ff
7 31 10030ff
7 31 10030ff Fax: E-mail: Contact: Date of Summary:
Name of Device: Holter Recorder Cardio ID+ RZ153+ Common Name: RZ153+ Classification Name: Recorder, Magnetic Tape, Medical
Substantial Equivalence claimed to legally marketed device: Holter Recorder DR180 II (K001288)
Description of Device:
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.
Intended Use of Device
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.
1
The data is intended to be downloaded to an analysis software package after the recording is completed.
| Specification | RZ153+ New Device | DR180 II Predicate
Device |
|-----------------------------------------------------|------------------------------------------------|------------------------------------------|
| Online data monitoring &
alarm | No | No |
| Recorded ECG channels | Multiple | Multiple |
| Sample rate & resolution | 1024 S/s & 12 bits | 180/360/720 S/s & 12
bits |
| Bit resolution | $1,465 \mu V / LSB$ | $6.25 \mu V / LSB$ |
| Max. input voltage range | $\pm 6, \pm 3 or \pm 1.5 mV$ | $\pm 1.5 mV$ |
| Amplification factors | 1/2, 1 or 2 | 1 |
| Analogue bandwidth | 0.05 Hz to 75 Hz | 0.05 Hz to 20 Hz |
| Pacemaker detection &
reporting | Yes | Yes |
| Open-Lead detection &
reporting | Yes | Yes |
| Impedance Measurement | Yes | Yes |
| Preferred recording period | 24h, 48h or user defined | 24 h or continuously |
| Storage capacity | Up to 512 MB | Up to 512MB |
| Recording capacity | Up to 120 hours / 5 days | Up to 50 hours |
| Memory type | CompactFlash™ Memory Card
Type II or Type I | CompactFlash™
Memory Card |
| 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 | 5 | 13 |
| Patient leakage current |