RHYTHM VIEW WORKSTATION

K133305 · Topera, Inc. · DQK · Dec 16, 2013 · Cardiovascular

Device Facts

• Record ID: K133305
• Device Name: RHYTHM VIEW WORKSTATION
• Applicant: Topera, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 16, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Rhythm View™ 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 diagnostic computer system used by physicians during electrophysiology studies. It accepts electrical signals from multi-polar electrophysiology catheters placed within the heart. Proprietary algorithms compute spatial organization of electrical activity during arrhythmias, identifying rotors or focal beat sources. The system outputs animated graphic displays of electrical potentials, showing progressive depolarization and repolarization. Physicians review these interactive displays to aid in the diagnosis of complex arrhythmias like AF, VT, and VF. The workstation includes a cart, monitor, computer, keyboard, and mouse. It provides visual aids to help clinicians localize arrhythmia sources, potentially improving diagnostic accuracy during cardiac procedures.

Clinical Evidence

Bench testing only. Software verification and validation testing were performed to confirm the device meets requirements for its intended use. No clinical trial data was required or provided for this 510(k) submission.

Technological Characteristics

Programmable diagnostic computer (Class II, Product Code DQK). Software-driven system; C++ programming language. Features signal processing, post-processing display, and grid display of electrode signals. Includes 'Rotational Activity Profile' display. Connectivity via standard workstation peripherals. No specific material standards or sterilization methods listed as the device is a non-patient-contact workstation.

Indications for Use

Indicated for patients with complex cardiac arrhythmias, including focal AT, AFL, other SVT, AF, VT, and VF, to assist physicians in diagnosing heart rhythm disorders during electrophysiological studies.

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

• Rhythm View Workstation (K123295)
• Rhythm View Workstation (K110878)

Submission Summary (Full Text)

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Special Premarket Notification Topera, Inc., Rhythm ViewTM Workstation 4.1 October 24, 2013

### Appendix 1: 510(k) Summary per 21CFR §807.92

| Submitter's<br>information | Topera, Inc.<br>3668 S. Geyer Road, Suite 365<br>St. Louis, MO 63127<br>Contact: Dennis Pozzo<br>Phone [phone]<br>Date: Oct. 24, 2013 | DEC 16 2013 | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|
| Device/<br>classification<br>name | Device Name: RhythmView™ Workstation<br>Classification/Common name: Programmable diagnostic computer<br>The marketed device(s) to which substantial equivalence is claimed:<br>• K123295, cleared April 24, 2013<br>• K110878, cleared Sept. 23, 2011 | | | | |
| Device<br>description | The RhythmView™ Workstation is comprised of the following components: | | | | |
| | Cart | Keyboard | | | |
| | Monitor/Display | Mouse | | | |
| | Computer | Software | | | |
| | RhythmView™ takes electrical signals collected from multi-polar<br>electrophysiology catheters and outputs a graphic display that assists in the<br>diagnosis of cardiac arrhythmias.<br><br>The RhythmView™ computes and displays electrical rotors or focal beat<br>sources responsible for maintaining human heart rhythm disorders including<br>focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product<br>takes as input electrical signals recorded during the heart rhythm disorder | | | | |

under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The Rhythm View™ then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.

Continued on next page

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Special Premarket Notification Topera, Inc., RhythmView™ Workstation 4.1

## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

| Indications for<br>use | The Rhythm View™ 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. | | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------|--|--|--|
| Technological<br>characteristics | Both the proposed and predicate Rhythm View™ Workstations allows the<br>user to:<br>Review and select a time sequence of electrical signals from various<br>electrodes;<br>Analyze the signals;<br>View a graphic display (Electrical Activity) of the signal potentials<br>showing progressive depolarization and repolarization in grayscale for<br>the particular arrhythmia;<br>Play (or replay) this animated graphic representation of electrical<br>signals.<br>The new Rhythm View™ provides an additional display option, "Rotational<br>Activity Profile" display as an overlay on the UI.<br>Both are software driven devices that translate electrical signals within the<br>heart into graphic representations in order to assist the physician in diagnosis. | | | | | |
| | Device Characteristic | Predicate Device<br>Rhythm View™ 4.0 | Proposed Device<br>Rhythm View™ 4.1 | | | |
| | Signal processing | Yes | Yes | | | |
| | Post-processing display | Yes | Yes | | | |
| | Grid display of<br>electrode signals | Yes | Yes | | | |
| | Programming<br>Language | C++ | C++ | | | |
| | Export of processed file<br>into video format | Yes | Yes | | | |
| | Manual tagging by user<br>of electrograms | No | No | | | |
| | OTS Software<br>requirements | Same | Same | | | |

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Special Premarket Notification Topera, Inc., RhythmView™ Workstation 4.1

## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

| Technological<br>characteristics<br>continued | Display options for<br>review of processed<br>signals | • Electrical Activity<br>• Contours Only<br>• DContours<br>• P+RContours<br>• P+Contours<br>• P+DContours | • Electrical Activity<br>• Contours Only<br>• DContours<br>• Rotational Activity<br>Profile” |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Performance<br>data | Based upon the software testing that has been performed, which provide<br>reasonable assurance that the proposed device has been tested to verify<br>conformance to requirements for its intended use. Therefore, it has been<br>demonstrated that the RhythmView™ Workstation is safe and effective for its<br>intended use. | | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2013

Topera, Inc. Mr. Dennis Pozzo 3668 S. Geyer Road Suite 365 St. Louis, MO 63127 US

Re: K133305

> Trade/Device Name: Rhythm View Workstation V4.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 15, 2013 Received: November 18, 2013

Dear Mr. Dennis Pozzo:

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 interstate commerce prior 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability 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 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.

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Page 2 - Mr. Dennis Pozzo

ーンでおーしい

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 of medical devicerelated 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 Part 801 , please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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,

# Owen P. Faris -S

for

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

Enclosure

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### Appendix 2: Indications for Use Statement

Statement The Indications for Use Statement:

510(k) Number: K_133305

Device Name: Rhythm View™ Workstation

The Rhythm View™ 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.

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)

Digitally signed by Owen
P. Faris -S
Date: 2013.12.16 16:30:51
-05'00'

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