The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View 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, Keyboard, Monitor/Display, Mouse, Computer Software, Radio-Frequency Identification (RFID) Reader/Writer (new component), Two Port USB Switch (new component), Solid State Hard Drive (new optional component). 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 RhythmView™ 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 to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table detailing device performance against such criteria. The closest information is a general statement about testing:

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to requirements for intended use, safety, and effectiveness.	"The Software, Hardware (RFID, Two Port USB Switch and SSD Performance data Qualification Testing and EMC Testing) and User testing that have been performed 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 Rhythm View™ Workstation is safe and effective for its intended use."

Acceptance Criteria (Implied)

Reported Device Performance

Conformance to requirements for intended use, safety, and effectiveness.

"The Software, Hardware (RFID, Two Port USB Switch and SSD Performance data Qualification Testing and EMC Testing) and User testing that have been performed 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 Rhythm View™ Workstation is safe and effective for its intended use."

2. Sample Size for Test Set and Data Provenance

The document does not specify a sample size for any test set or the provenance (country of origin, retrospective/prospective) of the data used in testing. It only mentions "User testing" in a general sense.

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

The document does not mention the use of experts to establish ground truth for a test set, nor does it provide qualifications for any such experts. The device is described as assisting physicians in diagnosis, implying that the physician ultimately establishes the diagnosis.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. It focuses on the device assisting physicians rather than comparing physician performance with and without the device.

6. Standalone (Algorithm Only) Performance Study

The document implies a standalone function as the device "computes and displays electrical rotors or focal beat sources" using algorithms, but there is no explicit separate study reporting standalone algorithm-only performance. The "User testing" mentioned likely involves human interaction with the device.

7. Type of Ground Truth Used

The document does not explicitly define the type of ground truth used for any testing. Given the device's function to "assist in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals," it is implied that the ultimate ground truth would be a clinical diagnosis established by a physician based on all available clinical information, potentially including the device's output.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information regarding how ground truth for a training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them. The profiles are black, and the text is also in black.

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

December 19, 2014

Topera, Inc. Dennis Pozzo Senior Regulatory Affairs Master Specialist 3668 S. Gever Road. Suite 365 St. Louis, Missouri 63127

K142901 Trade/Device Name: Rhythmview Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 24, 2014 Received: November 25, 2014

Dear Dennis Pozzo,

Re:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Melissa A. Torres -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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Indications for Use

510(k) Number (if known)

K142901

Device Name

RhythmView Workstation

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

Submitter's information	Topera, Inc.3668 S. Geyer Road, Suite 365St. Louis, MO 63127Contact: Dennis PozzoPhone 314-300-6580Date: May XX, 2014
Device/classification name	Device Name: RhythmView™ Workstation Classification/Common name: Programmable diagnostic computer The marketed device(s) to which substantial equivalence is claimed: K130827, cleared Dec. 16, 2013 K123295, cleared April 24, 2013 K110878, cleared Sept. 23, 2011
Device description	The RhythmView™ Workstation is comprised of the following components:
	Cart Keyboard Monitor/Display Mouse Computer Software Radio-Frequency Identification (RFID) Reader/Writer (new component) Two Port USB Switch (new component) Solid State Hard Drive (new optional component)
	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 RhythmView™ 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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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

Indications for use	The RhythmView™ 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 RhythmView™ Workstations are softwaredriven devices that translate electrical signals within the heart into graphicrepresentations in order to assist the physician in diagnosis. They also allowthe user 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/Replay the animated graphic representation of electrical signals. Furthermore, The ventricular maps appear in the panoramic animation display in thesame manner as atrial maps. All of the same display options available in atrial maps may be usedfor ventricular maps.

Indications for use

The RhythmView™ 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 RhythmView™ Workstations are softwaredriven devices that translate electrical signals within the heart into graphicrepresentations in order to assist the physician in diagnosis. They also allowthe user 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/Replay the animated graphic representation of electrical signals. Furthermore, The ventricular maps appear in the panoramic animation display in thesame manner as atrial maps. All of the same display options available in atrial maps may be usedfor ventricular maps.

Continued on next page

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

Device Characteristic	Predicate DeviceRhythmView™ 4.1	Proposed DeviceRhythmView™ 4.2
Signal processing	Yes	Yes
Post-processing display	Yes	Yes
Grid display of electrode signals	Yes	Yes
Programming Language	C++	C++
Export of processed file into videoformat	Yes	Yes
Manual tagging by user ofelectrograms	No	No
OTS Software requirements	Same	Same
Display options for review ofprocessed signals	• Electrical Activity• Contours Only• DContours• Rotational ActivityProfile	• Electrical Activity• Contours Only• DContours• Rotational ActivityProfile"
RFID Reader/Writer Function	No	Yes
Data transfer via Two Port Switch	No	Yes
Direct data transfer via USB cableto RV Workstation from EP system	No	Option available
Atrial Function	Yes	Yes
Ventricular Function	No	Option available

The Software, Hardware (RFID, Two Port USB Switch and SSD Performance data Qualification Testing and EMC Testing) and User testing that have been performed 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 Rhythm View™ Workstation is safe and effective for its intended use.

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).