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

RhythmView uses electrical signals collected from the electrodes of one or more multi-polar electrophysiology (EP) catheters. It provides a dynamic, simplified representation of wave propagation. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain 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 a breakdown of the acceptance criteria and study information for the RhythmView Workstation 6.1, derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on verifying the software updates for the RhythmView Workstation 6.1 and demonstrating that it performs at least as well as the prior versions, particularly concerning Rotational Activity Profile (RAP) detection. While specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) are not explicitly stated in the provided text, the performance is described in terms of validation and verification against its intended functionality.

Acceptance Criteria (Inferred from testing objectives)	Reported Device Performance
Stability Map and default Stability Filter setting validation (using clinical data sets)	The Stability Map and default Stability Filter setting were validated using clinical data sets.
Summation Maps correct compilation of RAP profiles from individual segments	Verification confirmed that the Summation Maps generated are correct compilations of the RAP profiles from individual segments.
RAP detection of known rotational targets (at least as well as prior versions)	Validation confirmed that RAP detects known rotational targets at least as well as prior versions of RAP.
RAP functionality validation (through Physician reads)	The RAP functionality in RhythmView was validated through Physician reads.
New UI features evaluation (through Simulated User testing)	Simulated User testing was conducted to evaluate new features of the UI.

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

Test Set Sample Size: The document mentions "clinical data sets" for validating the Stability Map and default Stability Filter setting, but does not specify the exact number of cases or patients in these data sets.
Data Provenance: The data used for validation are described as "clinical data sets." The document does not specify the country of origin of this data or if it was retrospective or prospective. It uses "clinical data sets," implying real patient data.

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

Number of Experts: The document states that "Physician reads" were used to validate RAP functionality. It does not specify the number of physicians involved.
Qualifications of Experts: The qualifications of the "Physicians" are not explicitly stated (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It only mentions "Physician reads" for validation.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI vs. without AI assistance. The testing described focuses on validating the device's functionality and its comparison to prior versions.

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

The document describes testing that evaluates the algorithm's performance (e.g., RAP detection, Stability Map validation) using "clinical data sets." While these tests indirectly assess the algorithm's capabilities, the validation of RAP functionality involved "Physician reads," suggesting a human-in-the-loop component for some aspects. Therefore, it's not strictly a standalone performance study without any human involvement for interpretation.

7. The Type of Ground Truth Used

The ground truth for the test sets (or validation sets) appears to be based on:

Known rotational targets: For validating RAP detection, the system was validated against "known rotational targets," implying a pre-established understanding of these targets. This could be based on prior clinical assessment, expert consensus, or established electrophysiology principles.
Physician reads: For RAP functionality validation, physician interpretations served as part of the ground truth or a reference point.
Clinical data sets: The term "clinical data sets" implies data derived from patient studies, where the outcomes or characteristics might be considered true based on clinical assessment, although explicit details are lacking.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how the ground truth for the training set was established. In fact, training data details are entirely absent from the provided text, which focuses on validation and verification of software updates.

Summary

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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 (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 (DICE) 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.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (101) 443-6740 EF

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

Submitter'sinformation	Abbott Electrophysiology3668 S. Geyer Road, Suite 365St. Louis, MO 63127Contact: Dennis PozzoPhone 314-300-6580
Device/classificationname	Device Name: RhythmView Workstation 6.1●Classification/Common name: Programmable diagnostic computer●Product Code/Classification No .: DQK/21 CFR 870.1425●The marketed device to which substantial equivalence is claimed:●RhythmView Workstation, K161240, cleared August 10, 2016RhythmView Workstation, K151245, cleared September 15, 2015(ventricular function)
Devicedescription	RhythmView uses electrical signals collected from the electrodes of one ormore multi-polar electrophysiology (EP) catheters. It provides a dynamic,simplified representation of wave propagation.The RhythmView computes and displays electrical rotors or focal beatsources that may sustain human heart rhythm disorders including focal AT,AFL, other SVT, AF, VT and VF in a given patient. The product takes asinput electrical signals recorded during the heart rhythm disorder underconsideration, typically from multiple specified locations within the heartduring an electrophysiological study. The RhythmView then uses proprietarypatented algorithms and methods to compute spatial organization during theheart rhythm disorder. These computed elements are displayed graphically ininteractive form for review to aid diagnosis by the physician during anelectrophysiology study.
Indications foruse	The RhythmView Workstation is a computerized system that assists in thediagnosis of complex cardiac arrhythmias. The RhythmView Workstation isused to analyze electrogram and electrocardiogram signals and display themin a visual format.
Technologicalcharacteristics	The RhythmView Workstation currently allows the user to: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	PredicateRhythmViewWorkstation	ProposedRhvthmViewWorkstation
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
OTS Software requirements	Same	Same
Display options for review ofprocessed signalsRAP display (optional)	· Electrical Activity· Contours Only· DContours• Rotational ActivityProfile• Composite RAPimage ("StabilityMap")• Epoch timeline· SpotlightMulti-color withmonochromaticoption available	· Electrical Activity• Contours Only· DContours· Rotational ActivityProfile· Composite RAPimage ("StabilityMap")• Epoch timeline· SpotlightMulti-color withmonochromatic optionavailable
RFID Reader/Writer Function	Yes	Yes
Data transfer via Two Port Switch	Yes	Yes
Direct data transfer via USB cable toRV 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 RhythmViewWorkstation	Proposed RhythmViewWorkstation
**Spotlight Feature	Option available	Option available
**Stability Map	Option available	Option available
**Epoch Timeline	Option available	Option available
Electrical Rating (Technological Comparison)
Electrical rating – Typical	120V, 60Hz	120V, 60Hz
Battery	40 Ah, 12 V DC,Lithium Iron Phosphate	40 Ah, 12 V DC, LithiumIron 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

Performancedata	Bench testing has been conducted through software and user verification/validation protocols to ensure the RhythmView Workstation meets itsintended use and user needs.
	The testing encompassed:Validation of the Stability Map and the default Stability Filter settingusing clinical data sets Verification that the Summation Maps generated are correctcompilations of the RAP profiles from individual segments Validate that RAP detects known rotational targets at least as well asprior versions of RAP. Validate the RAP functionality in RhythmView through Physicianreads Simulated User testing to evaluate new features of UI
Conclusion	The testing has demonstrated that the SW updates for RhythmView V6.1provide reasonable assurance that the proposed device conforms to the

Performancedata

Bench testing has been conducted through software and user verification/validation protocols to ensure the RhythmView Workstation meets itsintended use and user needs.

The testing encompassed:Validation of the Stability Map and the default Stability Filter settingusing clinical data sets Verification that the Summation Maps generated are correctcompilations of the RAP profiles from individual segments Validate that RAP detects known rotational targets at least as well asprior versions of RAP. Validate the RAP functionality in RhythmView through Physicianreads Simulated User testing to evaluate new features of UI

Conclusion

The testing has demonstrated that the SW updates for RhythmView V6.1provide 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.

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).