RHYTHMVIEW (TM)

K110878 · Topera, Inc. · DQK · Sep 23, 2011 · Cardiovascular

Device Facts

• Record ID: K110878
• Device Name: RHYTHMVIEW (TM)
• Applicant: Topera, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™ Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

Device Story

RhythmView Workstation is a programmable diagnostic computer used to assist in the diagnosis of complex cardiac arrhythmias. The system takes electrical signals collected from multi-polar electrophysiology catheters as input. It processes these electrogram and electrocardiogram signals to produce a visual output, including a propagation map and a grid display of electrode signals. The device is intended for use by clinicians in a clinical setting. By providing a visual representation of cardiac electrical activity, the system aids healthcare providers in identifying and diagnosing arrhythmias, potentially improving clinical decision-making and patient outcomes.

Clinical Evidence

Bench testing only. The system underwent extensive verification and validation testing using a wide variety of cardiac electrogram data to confirm performance against predetermined specifications. No clinical study data was provided.

Technological Characteristics

Programmable diagnostic computer consisting of a computer, monitor, keyboard, and mouse. Features include signal processing, post-processing propagation map display, and grid display of electrode signals. Does not perform signal capture or location tracking. Software-based analysis of electrogram and electrocardiogram signals.

Indications for Use

Indicated for use as a computerized system to assist in the diagnosis of complex cardiac arrhythmias by analyzing and displaying electrogram and electrocardiogram signals.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Astronomer + (K003362)
• CARTO XP Mapping System (K013083)

Submission Summary (Full Text)

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# Appendix 4 — 510(k) Summary

# 510(k) Summary of Safety and Effectiveness

SEP 2 3 2011

| Submitter's<br>information | Topera, Inc.<br>Contact: Ruchir Sehra, MD<br>Phone: [phone]<br>03/22/2011 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/<br>classification<br>name | Device Name:<br>• RhythmView Workstation<br><br>Classification/Common name:<br>• Programmable diagnostic computer<br><br>The marketed device(s) to which substantial equivalence is claimed:<br>• Astronomer + (K003362)<br>• CARTO XP Mapping System (K013083) |
| Device<br>description | The RhythmView is comprised of these major components,<br><br>1. RhythmView hardware – Computer, monitor, keyboard, and mouse<br>2. RhythmView Software – Software pre-installed<br><br>The RhythmView Workstation takes electrical signals collected from multi-<br>polar electrophysiology catheters and outputs a graphic display that assists in<br>the diagnosis of cardiac arrhythmias. |
| Indications for<br>use | The RhythmView™ Workstation is a computerized system that assists in the<br>diagnosis of complex cardiac arrhythmias. The RhythmView™ Workstation<br>is used to analyze electrogram and electrocardiogram signals and display<br>them in a visual format. |
| | Continued on next page |

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## 510(k) Summary of Safety and Effectiveness, Continued

Technological The table below lists the technological characteristics for both the new and characteristics predicate devices

| Device Characteristic | New Device<br>Rhythm ViewTM | Predicate Device<br>Astronomer + | Predicate Device<br>CARTO XP |
|----------------------------------------------|-----------------------------|----------------------------------|------------------------------|
| Signal capture | No | Yes | Yes |
| Signal processing | Yes | Yes | Yes |
| Location capability | No | Yes | Yes |
| Post processing display -<br>propagation map | Yes | No | Yes |
| Grid display of electrode<br>signals | Yes | Yes | No |

### Performance The RhythmView System underwent extensive bench testing, including a data wide variety of cardiac electrogram data, to demonstrate that it was as safe and as effective as the predicate devices.

The Rhythm View System passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria. There were no new questions of safety and effectiveness raised.

### Conclusion Verification and validation testing were conducted to establish the performance characteristics of the RhythmView System. The results demonstrate that the Rhythm View is safe and effective when used in accordance with its intended use and labeling.

K110878

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WC066-G609 Silver Spring, MD 20993-0002

Topera, Inc. c/o Dr. Ruchir Schra 11445 E. Via Linda Suite 2 P.O. Box 224 Scousdale. AZ 85259

SEP 2 3 201

Re: K110878

Trade/Device Name: RhythmView Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 12, 2011

Dear Dr. Sehra:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonants, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, youg, 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 The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbaranding and adulteration. Please note: CDRH does not evaluate information related to contractly antity warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Dr. Ruchir Schra

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,

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Pari 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

uckerman, M.D. Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix 3 - Indications for Use

### Indications for Use Statement

Statement The Indications for Use Statement:

510(k) Number: K110878

Device Name: RhythmView Workstation

The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

Prescription Use X -AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of Cardiovascular Devices | |
| 510(k) Number | K110878 |

Topera, Inc.