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 Description

The RhythmView™ Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Keyboard, Mouse, Software. RhythmView™ takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView™ computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Rhythm View™ Workstation 4.1, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) for the Rhythm View™ Workstation 4.1. The performance data section broadly states:

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to requirements for intended use	"Based upon the software testing that has been performed, which provide reasonable assurance that the proposed device has been tested to verify conformance to requirements for its intended use. Therefore, it has been demonstrated that the RhythmView™ Workstation is safe and effective for its intended use."

It appears that the approval was based on the software testing demonstrating conformance to its intended use and a finding of substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics. The focus is on the functional equivalence of the new display option ("Rotational Activity Profile") to existing functionalities.

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It only mentions "software testing" in a general sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The provided text does not mention any experts being used to establish ground truth for a test set, nor does it describe their qualifications.

4. Adjudication Method for the Test Set

The provided text does not describe an adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or discuss any effect size of human readers improving with or without AI assistance. The submission is for a workstation that assists in diagnosis, not explicitly an AI-driven diagnostic tool in the modern sense as described here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The provided text does not specify if a standalone performance study was done. The device is described as assisting in diagnosis and displaying information for physician review, implying a human-in-the-loop system.

7. The Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used for any performance evaluation. Given the nature of the device (analyzing electrical signals to display spatial organization for rhythm disorders), ground truth would likely involve confirmed clinical diagnoses or expert consensus on arrhythmia classification, but this is not detailed.

8. The Sample Size for the Training Set

The provided text does not specify any sample size for a training set. The document primarily focuses on a 510(k) submission for a new version (4.1) of an existing device, which introduces an additional display option. It's less about a new algorithm with a distinct training phase.

9. How the Ground Truth for the Training Set Was Established

The provided text does not provide information on how ground truth was established for any training set.

Summary

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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'sinformation	Topera, Inc.3668 S. Geyer Road, Suite 365St. Louis, MO 63127Contact: Dennis PozzoPhone 314-300-6580Date: Oct. 24, 2013	DEC 16 2013
Device/classificationname	Device Name: RhythmView™ WorkstationClassification/Common name: Programmable diagnostic computerThe marketed device(s) to which substantial equivalence is claimed:• K123295, cleared April 24, 2013• K110878, cleared Sept. 23, 2011
Devicedescription	The RhythmView™ Workstation is comprised of the following components:
	Cart	Keyboard
	Monitor/Display	Mouse
	Computer	Software
	RhythmView™ takes electrical signals collected from multi-polarelectrophysiology catheters and outputs a graphic display that assists in thediagnosis of cardiac arrhythmias.The RhythmView™ computes and displays electrical rotors or focal beatsources responsible for maintaining human heart rhythm disorders includingfocal AT, AFL, other SVT, AF, VT and VF in a given patient. The producttakes 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 foruse	The Rhythm View™ Workstation is a computerized system that assists in thediagnosis of complex cardiac arrhythmias. The RhythmView™ Workstationis used to analyze electrogram and electrocardiogram signals and displaythem in a visual format.
Technologicalcharacteristics	Both the proposed and predicate Rhythm View™ Workstations allows theuser to:Review and select a time sequence of electrical signals from variouselectrodes;Analyze the signals;View a graphic display (Electrical Activity) of the signal potentialsshowing progressive depolarization and repolarization in grayscale forthe particular arrhythmia;Play (or replay) this animated graphic representation of electricalsignals.The new Rhythm View™ provides an additional display option, "RotationalActivity Profile" display as an overlay on the UI.Both are software driven devices that translate electrical signals within theheart into graphic representations in order to assist the physician in diagnosis.
	Device Characteristic	Predicate DeviceRhythm View™ 4.0	Proposed DeviceRhythm View™ 4.1
	Signal processing	Yes	Yes
	Post-processing display	Yes	Yes
	Grid display ofelectrode signals	Yes	Yes
	ProgrammingLanguage	C++	C++
	Export of processed fileinto video format	Yes	Yes
	Manual tagging by userof electrograms	No	No
	OTS Softwarerequirements	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

Technologicalcharacteristicscontinued	Display options forreview of processedsignals	• Electrical Activity• Contours Only• DContours• P+RContours• P+Contours• P+DContours	• Electrical Activity• Contours Only• DContours• Rotational ActivityProfile”
Performancedata	Based upon the software testing that has been performed, which providereasonable assurance that the proposed device has been tested to verifyconformance to requirements for its intended use. Therefore, it has beendemonstrated that the RhythmView™ Workstation is safe and effective for itsintended 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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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

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'

Page _ of _

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).