(168 days)
Not Found
No
The document explicitly states that the recorder "does not perform any analysis on the ECG data" and the analysis is performed by separate software. There are no mentions of AI, ML, or related terms in the description of the software's analysis capabilities.
No
The device is a recorder for ECG data and does not perform any therapeutic intervention; its purpose is diagnostic data collection.
Yes.
The device is intended to record ECG data, which is then analyzed by associated software to review and report these data, indicating a clear role in diagnosing conditions based on ECG analysis.
No
The device description clearly outlines a hardware component, the "VISTA PLUS holter recorder," which is a physical device that records ECG data. While the system includes software for analysis, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vista Plus recorder and HolterSoft Ultima software system are designed to record and analyze electrical activity of the heart (ECG) from a patient's body surface. This is a non-invasive procedure that does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states the recording and analysis of surface ECG data for ambulatory patients. This aligns with the function of a Holter monitoring system, which is used to assess heart rhythm over an extended period.
Therefore, because the device works by recording electrical signals directly from the patient's body rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Recorder :
Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channel, 6 days on two channels, 4 days on three channels. Recorded data are intended to be analysed by holterSoft Ultima analysis on the ECG data.
Software :
HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.
Product codes (comma separated list FDA assigned to the subject device)
MLO
Device Description
The VISTA PLUS holter recorder is a miniature ambulatory ECG recorder (ECG holter) which can continuously record one, two or three channels for a period up to several days ( 11 days on 1 channel, 6 days on 2 channels, 4 days on 3 channels).
The entire ECG is stored on a removable memory (compact falsh card) and can be read directly by HolterSoft Ultima software installed in a computer.
The VISTA PLUS has a microphone allowing the recording of voice messages from the physician or the patient (patient diary) during monitoring.
This ECG holter recorder does not perform any analysis on the ECG data.
The VISTA PLUS recorder weighs about 100gr. including flash card and batteries and is connected to the patient with a single multilead cable connected to the ECG electrodes.
The VISTA PLUS is supplied in a case containing a 128 MB compact flash memory card, one standard ECG cable 180cm, two neck protective pouches, one protective pouch for belt, one shoulder strap, two 1,5V AAA batterics, and a CD-Rom which contains multilingual user's manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The QT option is intended to be used for adult patients only
Intended User / Care Setting
The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.
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.
K032466, K022540, K993617, K002817, K010949, K991786, K020825
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
Image /page/0/Picture/0 description: The image shows the word "NOVACOR" in a bold, sans-serif font. Above the word is a barcode. The barcode is made up of a series of vertical black lines of varying widths. The word "NOVACOR" is in all caps.
JAN | 9 2005
Image /page/0/Picture/2 description: The image shows a document with the address "4, passage Saint Antoine, 92508 Rueil Malmaison Cedex 08 France". It also includes the telephone number "Tel: +33 1 41 39 01 61" and fax number "Fax: +33 1 41 39 01 99". There is also some handwritten text at the top of the image that says "K042/08/ P1/5".
510(k) SUMMARY of SAFETY & EFFECTIVENESS
Submitter : NOVACOR France 4, Passage Saint Antoinc 92508 Rueil Malmaison cedex - France
Phone : 00 33 1 41 39 05 78 Fax : 00 33 1 41 39 01 99 E-mail : dgrenier(@novacor.fr
Contact person : Mrs. Dominique GRENIER - Regulatory Affairs Director
Device trade name : VISTA PLUS HOLTER RECORDER
Common/Usual name: Ambulatory ECG Holter Recorder
Classification name : Electrocardiograph, Ambulatory with analysis algorithm.
Predicate devices :
Spiderview - ELA MEDICAL Inc. - K032466 Cardio ID+(RZ153+) - ROZINN ELECTRONICS Inc. - K022540 Digitrak Plus -- BRAEMER CORP -- K993617
Device description :
The VISTA PLUS holter recorder is a miniature ambulatory ECG recorder (ECG holter) which can continuously record one, two or three channels for a period up to several days ( 1 1 days on 1 channel, 6 days on 2 channels, 4 days on 3 channels).
The entire ECG is stored on a removable memory (compact falsh card) and can be read directly by HolterSoft Ultima software installed in a computer.
The VISTA PLUS has a microphone allowing the recording of voice messages from the physician or the patient (patient diary) during monitoring.
This ECG holter recorder does not perform any analysis on the ECG data.
The VISTA PLUS recorder weighs about 100gr. including flash card and batteries and is connected to the patient with a single multilead cable connected to the ECG electrodes.
The VISTA PLUS is supplied in a case containing a 128 MB compact flash memory card, one standard ECG cable 180cm, two neck protective pouches, one protective pouch for belt, one shoulder strap, two 1,5V AAA batterics, and a CD-Rom which contains multilingual user's manual.
1
Image /page/1/Picture/0 description: The image shows the word "NOVACOR" in a bold, serif font. Above the word is a barcode-like graphic consisting of vertical black lines of varying widths. The word is in all caps and is centered below the graphic.
92508 Rueil Malmaison ! Fax . +33 | 41 39 01 99
042108/52
43/5
Intended use :
VISTA PLUS and HOLTERSOFT ULTIMA INTENDED USE
Recorder :
Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channels, 4 days on two channels. Recorded data are intended to be analysed by holterSoft Ultima analysis on the ECG data.
Software :
HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Carc practitioner in a hospital or a clinic environment.
The Heart Rate Variability (HRV) Option of HolterSoft Ultima is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of Heart Rate data. HRV option is intended to provide only HRV measurements and is not intended to produce any interpretation of these measurements or any kind of diagnosis
The HRV measurements produces by HRV option are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement.
The HRV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.
The Obstructive Sleep Apnoea Syndrome option is intended to be used for a specific analysis of the Variability of the Increment of the RR Intervals and to report the resulting measurements.
OSAS option is intended to provide only measurements and is not intended to produce any interpretation of these measurements or any kind of diagnosis
The OSAS measurements produces by HRV option are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement.
The QT option of HolterSoft Ultima is intended to be used for analysis each ECG channel separately for obtaining the measurements of the QT Interval and the T wave.
QT option is intended to provide only QT Interval and T wave measurements and is not intended to produce any interpretation of these measurements or any kind of diagnosis
The measurements produces by QT option are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement.
The QT option is intended to be used for adult patients only
Comparison of technology characteristics to predicate devices :
RECORDERS :
Predicate devices :
- Spiderview ELA Medical K032466 -
- Cardio Id+ (RZ153+) ROZINN ELECTRONICS K022540 -
- Digitrak Plus BRAEMAR (commercialisé par ZYMED/PHILIPS) K993617 -
| Specification | Vista Plus | Spiderview | Cardio Id+
(RZ153+) | Digitrak Plus |
|-----------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------|--------------------------------|---------------------------------------------|
| | Novacor | ELA Medical | Rozinn | Braemar |
| Type | Digital | Digital | Digital | Digital |
| Number of channels | 1, 2, 3 | 2, 3, 5, 9 | 2, 3, 12 (option) | 2, 3 |
| Recording duration | Up to :264 h | Up to 96 h | Up to 48 h | Up to 120 h |
| Sampling rate | 200 Hz | 200 Hz | 1024 Hz | 175 Hz |
| Resolution | 10 bits | 15 bits | 12 bits | 10 bits |
| Dynamic range | +/- 6 mV | +/- 16 mV | +/- 6, +/-3 or | +/- 6 mV |
| | | | | +/- 1,5 mV |
| Bit resolution | 12 μV | 10 μV | 1,465 μV | |
| Compression | No | Yes | No | No |
| Analogue
Bandwidth | | 0,05-25 Hz in standard
mode; 0,05-80 Hz in
no compression mode | 0,05-75 Hz | 0,05-60Hz |
| Pacemaker spike
detection and
reporting | Yes | Yes | Yes | Yes |
| Open lead detection | Yes | Yes | Yes | Yes |
| Impedance test | Yes | Yes | Yes | Yes |
| Storage capacity | Up to 512 MB | Up to 64 MB | Up to 512 MB | |
| Memory type | CF card | MMC or SD flash card | CF card | Internal Flash
memory (non
removable) |
| LCD | Yes | Yes | Yes | Yes |
| Keyboard | Yes | Yes | Yes | Yes |
| Size | 86x54x19 | 97x54x23 mm | 108x79x22 mm | 85x65x20 mm |
| Weight | 100g | 110g | 145 g | 100 g |
| Cables | 5 wires | 3, 5, 7 wires | 5, 7 wires | 5 wires |
| Accessories | Belt, shoulder
strap, pouch, neck
pouch | Belt + pouch | Belt + pouch | Belt + pouch |
| Batteries | 2 AAA (1,5 V) | 1 AA (1,5 V) | 1 or 2 AA (1,5 V) | 1 AA (1,5 V)º |
| Rechargcable
batteries | Accepted | Accepted | Accepted | Accepted |
| Patient ID record | Vocal message | With the display +
keyboard | With the display +
keyboard | With the display
- keyboard |
| ECG display | At any time
(programmable) | Preview only | Preview only | Preview only |
| Real-type built in
analysis | Yes, for real-time
HR calculation | No | No | No |
| Event marker | Yes (event key +
vocal message) | Yes | Yes | Yes |
| Display during
recording | | | | |
| | Time programmable | Yes (during hook up
inly) | Yes | Yes |
| | HR programmable | No | No | No |
| | HR curve programmable | No | No | No |
| ECG analysis | Analysis software
on PC | Analysis software on
PC | Analysis software
on PC | Analysis
software on PC |
| Replay and analysis
system | HolterSoft Ultima | Syneview/Synescope | Holter for Windows | Philips 1810
series or 2010
software |
2
NOVACOR
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of