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, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Software, Keyboard, Mouse, Two Port USB Switch, Solid State Hard Drive (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 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 an analysis of the provided text to extract information about the device's acceptance criteria and the study proving it meets those criteria.

Note: The provided document is a 510(k) summary for a software update to an existing device, the RhythmView Workstation. As such, the "study" described focuses on verification and validation of the new software features, rather than a full clinical trial to establish initial safety and effectiveness, which would have been done for the original device. This means some of the requested information (like MRMC studies for AI performance) might not be directly applicable or explicitly detailed in this type of submission.

Acceptance Criteria and Device Performance Study for RhythmView Workstation SW V6.0.3

The RhythmView Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals and displaying them in a visual format. The current 510(k) (K161240) pertains to software version 6.0.3, which introduces new features like "Stability Map" and "Epoch Timeline."

The performance testing primarily focuses on validating these new software features and confirming that the device continues to meet its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" for the new software features (e.g., a specific sensitivity or specificity threshold). Instead, it describes types of validation performed to ensure the new features function as intended and do not negatively impact the existing functionality.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
New Features Validation:
Stability Map Accuracy: Verification that the Stability Maps generated are correct compilations of RAP profiles from individual segments.	`Verification that the Stability Maps generated by RhythmView are correct compilations of the RAP profiles from individual segments` has been conducted. Specific numerical results are not provided, but the conclusion states "The testing has demonstrated that the SW updates for RhythmView V6.0 provide reasonable assurance that the proposed device conforms to the appropriate requirements for its intended use."
Stability Map & Default Filter Effectiveness: Validation of the Stability Map and its default filter setting using clinical data sets.	`Validation of the Stability Map and the default Stability Filter setting using clinical data sets` has been conducted.
Consistent Diagnosis (with/without RAP): Confirmation that activation maps, with and without Rotational Activity Profile (RAP) data, lead to a consistent diagnosis by physicians.	`Physician validation to confirm that the activation maps with and without RAP lead to a consistent diagnosis` has been performed.
User Interface (UI) Usability: Evaluation of the new UI features through simulated user testing.	`Simulated User testing to evaluate new features of UI` has been performed.

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

Test Set Sample Size: The document mentions "clinical data sets" for validation of the Stability Map, but does not specify the sample size (i.e., number of patients or cases) used for these tests.
Data Provenance: The document states "clinical data sets" were used. No specific country of origin is mentioned. The testing methods described imply a retrospective analysis of existing clinical data, particularly for validating the Stability Map's compilation and consistency of diagnosis.

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

Number of Experts: The document refers to "Physician validation," implying that multiple physicians were involved in confirming the consistency of diagnoses. However, the exact number of experts is not specified.
Qualifications of Experts: The experts are identified as "Physician(s)." No specific qualifications (e.g., years of experience, sub-specialty) are provided in this summary.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth or resolving discrepancies among readers. The "Physician validation" suggests that physicians reviewed the outputs, but the process for achieving a single "ground truth" or resolving disagreements is not detailed.

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

No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. This submission is for a software update that provides new display and analysis tools, rather than an AI-driven diagnostic aid that would directly assist human interpretation in a comparative manner. The "Physician validation" described is more akin to a usability/consistency check of the new features.

6. Standalone Performance (Algorithm Only)

The device is a "computerized system that assists in the diagnosis" and displays information for physician interpretation. It's not a standalone AI algorithm designed to provide a diagnosis without human interaction. The validation focuses on the accuracy of the output of the system (e.g., Stability Maps as correct compilations) and its utility for physicians, rather than an independent diagnostic performance of the algorithm itself. Therefore, a standalone (algorithm only without human-in-the-loop performance) study, in the sense of an AI model making diagnostic predictions, was not performed or detailed for this type of device and software update.

7. Type of Ground Truth Used

The ground truth for the "Physician validation" appears to be expert consensus on diagnosis. The validation checks if "activation maps with and without RAP lead to a consistent diagnosis," implying that the physicians' established diagnosis (which forms the clinical ground truth for the case) should remain consistent regardless of the presence of the new RAP display features. For the "Stability Map Accuracy," the ground truth seems to be computational correctness (i.e., checking if the map is a "correct compilation" of other data).

8. Sample Size for the Training Set

Not applicable/Not provided. This document describes the validation of a software update for an existing medical device, not the development of a new machine learning model requiring a training set. The algorithms are proprietary, patented, and seem to be based on established computational methods for signal processing and display, rather than data-driven learning from a large training dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable. As no training set is mentioned (see point 8), there is no information on how a ground truth for a training set would have been established.

Summary

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

Auqust 10, 2016

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

Re: K161240

Trade/Device Name: RhythmView Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 13, 2016 Received: July 14, 2016

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 (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.

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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 vours

Mark Jellerson
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) K161240

Device Name RhythmView Workstation SW V6.0.3

Indications for Use (Describe)

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 SW V6.0.3Classification/Common name: Programmable diagnostic computerRegulation No./ Product Code: 870.1425/DQKThe marketed device(s) to which substantial equivalence is claimed:K151245, cleared Sept. 15, 2015K142901, cleared Dec. 19, 2014K130827, cleared Dec. 16, 2013K123295, cleared April 24, 2013K110878, cleared Sept. 23, 2011
Devicedescription	The RhythmView Workstation is comprised of the following components:
	Cart	Keyboard
	Monitor/Display	Mouse
	Computer	Two Port USB Switch
	Radio-Frequency Identification(RFID) Reader/Writer	Solid State Hard Drive (optional component)
	Software
Indications for use	The RhythmView 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.
Technological characteristics	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. Stream near real time electrograms from an EP recording system to RhythmView Workstation (“Streaming electrograms") Evaluate the quality of the electrograms exported from the EP system to RhythmView Workstation ("Signal quality indicator" (SQI)) Use RAP improvements ("RAP intensity scale" and "Spotlight" feature) Create a procedure history within RhythmView ("Procedure Notebook") The RhythmView software is being modified to improve the feedback available to the treating physician during a RhythmView procedure by incorporation of the following new features: A mechanism to display 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")

RhythmView takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.

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

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text notes.

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

Device Characteristic	PredicateRhythmViewWorkstation	ProposedRhythmViewWorkstation
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 signals	• Electrical Activity• Depol Contours• Repol Contours• Rotational ActivityProfile	• Electrical Activity• Depol Contours• Repol Contours• Rotational ActivityProfile
RAP display (optional)	Multi-color withmonochromatic optionavailable	Multi-color withmonochromaticoption available
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 available	No
Signal Quality Indicator	Yes	Yes
Spotlight Feature	Yes	Yes
Streaming real time electrograms	Option available	No
Notebook Procedure	Yes	Yes
Stability Map	No	Option available
Epoch Timeline	No	Option available
Device Characteristic(Technological Comparison)	Predicate RhythmViewWorkstation	Proposed RhythmViewWorkstation
Electrical Rating
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

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 provided in K151245 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

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

The testing encompassed:

Validation of the Stability Map and the default Stability Filter setting using clinical data sets
Verification that the Stability Maps generated by RhythmView are . correct compilations of the RAP profiles from individual segments
Physician validation to confirm that the activation maps with and ● without RAP lead to a consistent diagnosis
. Simulated User testing to evaluate new features of UI

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

Performance data, continued

Conclusion

The testing has demonstrated that the SW updates for RhythmView V6.0 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.

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).