RhythmView Workstation

K171583 · Abbott Electrophysiology · DQK · Sep 1, 2017 · Cardiovascular

Device Facts

• Record ID: K171583
• Device Name: RhythmView Workstation
• Applicant: Abbott Electrophysiology
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 1, 2017
• Decision: SESE
• Submission Type: Traditional
• 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 Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

Device Story

RhythmView Workstation 6.1 is a computerized diagnostic system used in clinical electrophysiology (EP) studies. It ingests electrical signals from multi-polar EP catheters placed within the heart. Proprietary algorithms compute spatial organization of electrical activity during arrhythmias, identifying rotors or focal beat sources. The system transforms these signals into dynamic, visual representations, including electrical activity maps, stability maps, and rotational activity profiles. Physicians use these interactive displays to identify arrhythmia patterns and guide clinical decision-making during procedures. The workstation includes tools for signal quality indication, epoch timeline management, and procedure documentation. It provides a simplified, dynamic view of wave propagation to aid in the diagnosis of complex arrhythmias like AF, VT, and VF.

Clinical Evidence

Bench testing only. Validation included software and user verification/validation protocols. Testing confirmed the accuracy of Stability Maps and Summation Maps, validated that Rotational Activity Profile (RAP) detection of rotational targets is at least as effective as prior versions, and utilized simulated user testing to evaluate UI updates. Clinical data sets were used to validate the Stability Map and default filter settings.

Technological Characteristics

Programmable diagnostic computer. Operates on 120V, 60Hz power with a 40 Ah, 12V DC Lithium Iron Phosphate battery. Connectivity includes USB data transfer from EP systems and two-port switch data transfer. Software is C++ based. Complies with ISO 14971:2012, IEC 60601-1 (3rd Ed), and IEC 60601-1-2:2007. Features include signal quality indicator (SQI), RAP intensity scale, spotlight feature, stability map, and epoch timeline.

Indications for Use

Indicated for patients with complex cardiac arrhythmias, including focal AT, AFL, other SVT, AF, VT, and VF, to assist in diagnosis 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

• RhythmView Workstation (K161240)
• RhythmView Workstation (K151245)

Submission Summary (Full Text)

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

September 1, 2017

Abbott Electrophysiology Dennis Pozzo Senior Regulatory Affairs Specialist 3668 S. Gever Road. Suite 365 St. Louis, Missouri 63127

Re: K171583

Trade/Device Name: RhythmView Workstation 6.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: August 4, 2017 Received: August 8, 2017

Dear 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.

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 device

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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 Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Wilhelm

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K171583

Device Name

RhythmView Workstation 6.1

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (7/17)

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# Section 5: 510(k) Summary per 21CFR §807.92

| Submitter's<br>information | Abbott Electrophysiology<br>3668 S. Geyer Road, Suite 365<br>St. Louis, MO 63127<br>Contact: Dennis Pozzo<br>Phone [phone] | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device/<br>classification<br>name | Device Name: RhythmView Workstation 6.1<br>●<br>Classification/Common name: Programmable diagnostic computer<br>●<br>Product Code/Classification No .: DQK/21 CFR 870.1425<br>●<br>The marketed device to which substantial equivalence is claimed:<br>●<br>RhythmView Workstation, K161240, cleared August 10, 2016<br>RhythmView Workstation, K151245, cleared September 15, 2015<br>(ventricular function) | |
| Device<br>description | RhythmView uses electrical signals collected from the electrodes of one or<br>more multi-polar electrophysiology (EP) catheters. It provides a dynamic,<br>simplified representation of wave propagation.<br>The RhythmView computes and displays electrical rotors or focal beat<br>sources that may sustain human heart rhythm disorders including focal AT,<br>AFL, other SVT, AF, VT and VF in a given patient. The product takes as<br>input electrical signals recorded during the heart rhythm disorder under<br>consideration, typically from multiple specified locations within the heart<br>during an electrophysiological study. The RhythmView then uses proprietary<br>patented algorithms and methods to compute spatial organization during the<br>heart rhythm disorder. These computed elements are displayed graphically in<br>interactive form for review to aid diagnosis by the physician during an<br>electrophysiology study. | |
| Indications for<br>use | The RhythmView Workstation is a computerized system that assists in the<br>diagnosis of complex cardiac arrhythmias. The RhythmView Workstation is<br>used to analyze electrogram and electrocardiogram signals and display them<br>in a visual format. | |
| Technological<br>characteristics | The RhythmView Workstation currently allows the user to:<br>Review and select a time sequence of electrical signals from various electrodes; Analyze the signals; View a graphic display (Electrical Activity) of the signal potentials showing progressive depolarization and repolarization in greyscale for the particular arrhythmia; Play/Replay the animated graphic representation of electrical signals. Review various display options to assist the provider with the identification of arrhythmia patterns. Evaluate the quality of the electrograms exported from the EP system to RhythmView Workstation ("Signal quality indicator" (SQI)) Enable an option to improvements usability of RAP ("RAP intensity scale" and "Spotlight" feature) Review the composite RAP profile (Stability Map) over the entire epoch under analysis (vs. just a single 4-second time segment) A method of thresholding the Stability Map image analysis tool for delineating the persistence of RAP over the course of the entire epoch A mechanism for displaying and selecting all time segments within an epoch ("epoch timeline") Create a procedure history within RhythmView ("Procedure Notebook") and allow the user to add freeform text notes. The RhythmView software is being modified to improve the feedback and usability during a RhythmView procedure by updating the following functions: Caliper tool; ECG lead; SQI; RAP calculation; and Stability map | |

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# Section 5: 510(k) Summary per 21CFR §807.92, Continued

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# Section 5: 510(k) Summary per 21CFR §807.92, Continued

| Device Characteristic | Predicate<br>RhythmView<br>Workstation | Proposed<br>RhvthmView<br>Workstation |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 video<br>format | Yes | Yes |
| OTS Software requirements | Same | Same |
| Display options for review of<br>processed signals<br>RAP display (optional) | · Electrical Activity<br>· Contours Only<br>· DContours<br>• Rotational Activity<br>Profile<br>• Composite RAP<br>image ("Stability<br>Map")<br>• Epoch timeline<br>· Spotlight<br>Multi-color with<br>monochromatic<br>option available | · Electrical Activity<br>• Contours Only<br>· DContours<br>· Rotational Activity<br>Profile<br>· Composite RAP<br>image ("Stability<br>Map")<br>• Epoch timeline<br>· Spotlight<br>Multi-color with<br>monochromatic option<br>available |
| RFID Reader/Writer Function | Yes | Yes |
| Data transfer via Two Port Switch | Yes | Yes |
| Direct data transfer via USB cable to<br>RV Workstation from EP system | Option available | Option available |
| Atrial Function | Yes | Yes |
| *Ventricular Function | Option not available | Option available |
| Signal Quality Indicator | Option available | Option available |
| Procedure Notebook | Option available | Option available |
| Device Characteristic | Predicate RhythmView<br>Workstation | Proposed RhythmView<br>Workstation |
| <b>**Spotlight Feature</b> | Option available | Option available |
| <b>**Stability Map</b> | Option available | Option available |
| <b>**Epoch Timeline</b> | Option available | Option available |
| Electrical Rating (Technological Comparison) | | |
| Electrical rating – Typical | 120V, 60Hz | 120V, 60Hz |
| Battery | 40 Ah, 12 V DC,<br>Lithium Iron Phosphate | 40 Ah, 12 V DC, Lithium<br>Iron Phosphate |
| RF Class per CISPR11 | Group1 | Group 1 |

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#### Section 5: Summary per 21CFR §807.92, Continued

*Ventricular Function: predicate 510(k) K151245 **Atrial function only

Applicable standards

- ISO 14971: 2012, Medical Devices Application of risk management ● to medical devices
Since there are no hardware updates, the EMC and Electrical Safety reports referenced K161240 still apply.

- . IEC 60601-1, 3rd Edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007, Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests

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# Section 5: 510(k) Summary per 21CFR §807.92, Continued

| Performance<br>data | Bench testing has been conducted through software and user verification/<br>validation protocols to ensure the RhythmView Workstation meets its<br>intended use and user needs. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The testing encompassed:<br>Validation of the Stability Map and the default Stability Filter setting<br>using clinical data sets Verification that the Summation Maps generated are correct<br>compilations of the RAP profiles from individual segments Validate that RAP detects known rotational targets at least as well as<br>prior versions of RAP. Validate the RAP functionality in RhythmView through Physician<br>reads Simulated User testing to evaluate new features of UI |
| Conclusion | The testing has demonstrated that the SW updates for RhythmView V6.1<br>provide reasonable assurance that the proposed device conforms to the |

appropriate requirements for its intended use. Therefore, it is substantially equivalent to the predicate device, safe and effective for its intended use.