VISTA PLUS

{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+<br>(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<br>Bandwidth | | 0,05-25 Hz in standard<br>mode; 0,05-80 Hz in<br>no compression mode | 0,05-75 Hz | 0,05-60Hz | | Pacemaker spike<br>detection and<br>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<br>memory (non<br>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<br>strap, pouch, neck<br>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<br>batteries | Accepted | Accepted | Accepted | Accepted | | Patient ID record | Vocal message | With the display +<br>keyboard | With the display +<br>keyboard | With the display<br>+ keyboard | | ECG display | At any time<br>(programmable) | Preview only | Preview only | Preview only | | Real-type built in<br>analysis | Yes, for real-time<br>HR calculation | No | No | No | | Event marker | Yes (event key +<br>vocal message) | Yes | Yes | Yes | | Display during<br>recording | | | | | | | Time programmable | Yes (during hook up<br>inly) | Yes | Yes | | | HR programmable | No | No | No | | | HR curve programmable | No | No | No | | ECG analysis | Analysis software<br>on PC | Analysis software on<br>PC | Analysis software<br>on PC | Analysis<br>software on PC | | Replay and analysis<br>system | HolterSoft Ultima | Syneview/Synescope | Holter for Windows | Philips 1810<br>series or 2010<br>software | {2}------------------------------------------------ # NOVACOR - <042108; toine 92508 Rueil Malmaison Codex 08 Codex 08 92508 Rueil Malmaison Codex 08 Codex 08 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "NOVACOR" in a bold, serif font. Above the word is a graphic that resembles a barcode. The barcode is made up of a series of vertical lines of varying widths. The word "NOVACOR" is in all caps. 142168152 4, passage Saint Antoine 92508 Rueil Malmaison Cedcx 08 France Tel : +33 1 41 39 (1 61 Fax : +33 1 41 39 (1 99 #### SOFTWARE : # Predicate devices for HolterSoft Ultima: - Synetec, ELA Medical K002817 - - Bylietoo, ELF Modical Tredical Tredition K010949 - - MARS Unity, MARQUETTE/GE K991786 - | Specifications | HolterSoft Ultima | Synetec | 2010 plus Holter | Mars Unity | |------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------| | | Novacor | ELA Medical | Agilent | Marquette | | Type | Software | Software | Software | Workstation | | PC based | Yes | Yes | Yes | Yes | | OS compatibility | Windows<br>98,NT,2000, XP | Windows<br>98/NT/2000/XP | Windows 98,<br>NT,2000,XP | NA | | Input data | Digital (CF card<br>from Vista series<br>recorders) | Digital (PCMCIA<br>flashcards from<br>Syneflad/MMC or<br>SM cards from<br>Spiderview) and<br>tape | Digital (USB<br>transfer from<br>Zymed Digitrak<br>Plus recorder) | Digital (USB<br>transfer from the<br>"Seer Light"<br>interface) and<br>tape | | Graphic User Interface | Yes | Yes | Yes | Yes | | Templates (shapes)<br>edition | Yes | Yes | Yes | Yes | | Events list display | Yes | Yes | Yes | No | | Arrhythmia detection | Yes | Yes | Yes | Yes | | Conduction<br>abnormalities<br>detection | Yes | Yes | Yes | Yes | | ST segment | multichannel | multichannel | multichannel | multichannel | | Superimposition | Yes | Yes | Yes | Yes | | PM patient analysis | Yes | Yes | Yes | Yes | | Report customisation | Yes | Yes | Yes | Yes | | Report edition | Yes | Yes | Yes | Yes | | ECG strip edition and<br>printing | Yes | Yes | Yes | Yes | | Archiving | Yes | Yes | Yes | Yes | | Report Export | Yes | No | No | No | | AFib | Yes | No | No | No | | Events | Yes | Yes | ? | Yes | | Histograms/trends | | | | | | RR histrogram | Yes | Yes | Yes | Yes | | Editing/Printing full<br>disclosure | Yes | Yes | Yes | Yes | | Editing tools for QRS<br>insertion/suppression | Yes | Yes | ? | Yes | | Time domain HRV | Yes | Yes | Yes | Yes | | Frequency Domain<br>HRV | Yes | Yes | Yes | Yes | | QT | Yes | Yes (but not<br>commercially<br>available in the<br>US) | Yes | Yes | | | | | | | | OSAS | Yes | No | No | No | | Networking | Yes | Yes | Yes | Yes | | Patient Diary | Voice Messages | No | No | Text Input | {4}------------------------------------------------ 4, passage Saint An oine 92508 Rueil Malmaison Cedex 08 France Tel : +33 1 41 39 (11 61 Fax : +33 1 41 39 (11 99 # Predicate devices for HolterSoft Ultima Atrial Fibrillation Module : | | King of Heart Express + AF K, CARD GUARD/INSTROMEDIX, K020825 | | |------------------------------------------|---------------------------------------------------------------|----------------------------| | Device | HolterSoft Ultima AF module | King of Heart Express + AF | | Type of data recorded | Continuous ECG | ECG strips | | Sampling rate | 200 Hz | 218 Hz | | Bit resolution | 10 μV | 15,6 μV | | Monitoring duration | 264 hours | 7 days | | Recording duration | 264 hours | 10 minutes | | Maximum number of events | No limit | 60 | | Maximum event length | 264 hours | 10 minutes | | Number of channels used for the analysis | 1 to 3 | 1 | #### Conclusion : The information presented in this submission provides reasonable assurance that the VISTA PLUS Holter ECG recorder will perform in a safe and effective manner. {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES DEPARTMENT OF HEALTH & HUMAN SERVICES • USA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 9 2005 Novacor c/o Mr. Dominique Grenier Regulatory Affairs Officer 4 Passage Saint Antoine 92508 Rueil Malmaison Cedex FRANCE Re: K042108 Trade Name: Vista Plus Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: MLO Dated: December 23, 2004 Received: December 29, 2004 Dear Mr. Grenier: We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve rowled your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may) mereleve, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device is elaborition (600 as coprols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {6}------------------------------------------------ Page 2 - Mr. Dominique Grenier Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a backers. In other requirements of the Act that FDA has made a determination that your device complies with other requirements of th that FDA has made a decormination and Jointinered by other Federal agencies. You must of any recetal statutes and regulations and using, but not limited to: registration and listing (21 comply with an the Act 3 requirements, metally, good manufacturing practice requirements as set CrK Fatt 807), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (beeting your device as described in your Section 510(k) This letter will anow you to ocgin maxicoing of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice ior Joan as 1040) 276-0120. Also, please note the regulation entitled, Colliact the Office of Complaner as (21) = 17 = 1 = 1 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Blymmuma for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ K042108/52 # Indications for Use 510(k) Number (if known): k041008 Device Name: VISTA PLUS 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. Blumuma ovision Sign-Off vision of Cardiovascular Devices 42/00 5 | O(k) Number Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of