STAR Apollo™ Mapping System assists users in manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

Device Description

The STAR Apollo 100 Mapping System is a software driven system designed to assist operators in identifying Early Site of Activations (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use in association with a commercially approved electroanatomic mapping system, specifically, Ensite Precision Cardiac Mapping System Model EE 3000 (V2.6) or Ensite X EP System (V 1.1.1) (Abbott Medical), and the commercially approved catheter, Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (Abbott Medical). The system consists of proprietary Star Apollo Mapping System software and a hardware component. Star Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 10 or later operating system. Star Apollo Mapping System software is pre-installed onto the laptop. The STAR Apollo Mapping System uses export data from the Ensite Precision or Ensite X EP system that has been collected with the HD Grid catheter during the mapping procedure. The HD Grid is used to collect anatomy, localization and electrogram data in the atria. Recordings are made for 30 seconds with the HD Grid in a stable position and in contact with the atrial wall. These 30 seconds acquisitions are made in multiple, non-overlapping locations, so as to generate recordings over the entire atrial chamber. Once the data has been acquired, the data is anonymized and exported, via a portable external data storage device, to the laptop computer running the STAR Apollo Mapping System. The export data from the Ensite Precision or Ensite X EP systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data are imported, utilizing the portable external data storage device, into the STAR Apollo Mapping System and then processed by the STAR Apollo engine to generate a STAR Apollo map visualized by the GUI.

AI/ML Overview

The provided FDA 510(k) summary for the STAR Apollo™ Mapping System outlines the device's acceptance criteria and the studies conducted to demonstrate its performance.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from "Software design verification testing" and "Verification of algorithm calculations and graphic output." The performance is reported by stating that the software met these criteria.

Acceptance Criterion	Reported Device Performance
Software design verification testing	(Implied: Passed) No specific metrics are detailed, but the document states testing was conducted to demonstrate substantial equivalence.
Identification of each algorithm and testing to demonstrate mathematical calculations match predetermined output. (Algorithm description and testing)	"testing to demonstrate that the mathematical calculations performed by the software match that of the correct, predetermined output." (Implied: Passed, with output matching predetermined results)
Software requirement specifications met for test cases, numerical and graphical output correct. (Verification of algorithm calculations and graphic output)	"demonstrated that the software performance met the acceptance criteria for each of the test cases and both numerical and graphical output was correct." (Implied: Passed, with correct outputs)
Manual annotation yielded similar results to STAR Apollo Mapping System output. (Blinded Physician Validation)	"Testing demonstrated that manual annotation yielded similar results to the STAR Apollo Mapping System output." (Implied: Passed, with similarity to human experts)
Overall use of STAR Apollo Mapping System software rated as appropriate for use. (STAR Apollo Physician Use)	"Testing demonstrated that the STAR Apollo System Mapping System software was appropriate for use." (Implied: Passed, with positive user feedback)

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not explicitly stated in the provided document. The descriptions refer to "test cases" and "electrophysiologists performing manual annotation of ECGs" and "electrophysiologists and rated the overall use." No specific number of cases or patient data points is given.
Data Provenance: Not explicitly stated. The studies are described as "simulated testing." It is not clear if these simulations used real patient data (retrospective/prospective) or synthetically generated data. There is no mention of country of origin for the data.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated. The document mentions "electrophysiologists" (plural), but not a specific count.
Qualifications of Experts: They are identified as "electrophysiologists," which implies medical doctors specializing in cardiac electrophysiology. No further details regarding their experience level (e.g., years of experience, board certification) are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. For the "Blinded Physician Validation," it says "electrophysiologists performing manual annotation of ECGs and comparing the results with the STAR Apollo Mapping System." This suggests a comparison to individual expert annotation rather than a formal consensus or adjudication process among multiple experts to establish a single ground truth.

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

MRMC Study: No, a formal MRMC comparative effectiveness study demonstrating how human readers improve with AI vs. without AI assistance was not reported. The studies described are:
- Blinded Physician Validation: This compares the device's output to manual human annotation, suggesting a standalone performance aspect relative to human interpretation, but not the human-in-the-loop improvement.
- STAR Apollo Physician Use: This assessed the usability and appropriateness of the device, which is a qualitative assessment of user experience, not an effectiveness study.
Effect Size: Not applicable, as no MRMC study was performed or reported.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, aspects of standalone performance were evaluated.
- "Algorithm description and testing" and "Verification of algorithm calculations and graphic output" describe testing the core algorithms' accuracy against predetermined outputs, which is a standalone assessment.
- The "Blinded Physician Validation (Manual Annotation versus STAR Apollo Mapping System)" also assesses the device's output independently, comparing it to human annotation, rather than measuring human improvement when using the device.

7. Type of Ground Truth Used

Ground Truth Type:
- For algorithm and software verification, the ground truth was "correct, predetermined output" and "acceptance criteria for each of the test cases" set during development. This implies a ground truth defined by the developers based on internal specifications.
- For the "Blinded Physician Validation," the ground truth was "manual annotation" performed by electrophysiologists, essentially using expert interpretation as a reference. There is no mention of pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. The document describes the device as using "fixed algorithms and equations" rather than deep learning or machine learning that would typically require a training set. The comparison to the predicate (VX1) explicitly states: "VX1 is a software that utilizes deep learning based algorithms to analyze data sets, whereas the STAR Apollo Mapping System software uses fixed algorithms and equations to analyze the data sets." Therefore, a traditional "training set" as understood in machine learning may not apply in the same way, or its size is not relevant for a fixed-algorithm system.

9. How Ground Truth for Training Set was Established

Training Set Ground Truth Establishment: Not applicable given that the device uses "fixed algorithms and equations" and not deep learning, negating the need for a labeled training dataset in the conventional sense. The "ground truth" for its development would be the fundamental principles of electrophysiology and the expected mapping outcomes that the algorithms are designed to mimic.

Summary

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December 1, 2022

Rhythm AI Ltd. % Linda D'Abate VP, Regulatory, Clinical & Quality 124 Gilbert Stuart Drive East Greenwich, Rhode Island 02818

Re: K220786

Trade/Device Name: STAR Apollo™ Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: October 27, 2022 Received: October 28, 2022

Dear Linda D'Abate:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220786

Device Name STAR Apollo™ Mapping System

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)

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1) SUBMITTER

Rhythm AI Ltd. Witney Business & Innovation Center Windrush Industrial Park Witney, Oxfordshire OX29 7DX United Kingdom Phone: (714) 235-6608 website: n/a

Contact Person: Linda D'Abate Date Prepared: October 27, 2022

2) DEVICE

510(k) Number: K220786 Name of Device: STAR Apollo™ Mapping System Common or Usual Name: Electroanatomic mapping system Classification Name: Programmable, Diagnostic, Computer Regulation Number: 21 CFR 870.1425 Regulatory Class: II Product Code: DQK

3) PREDICATE DEVICE

510(k) Number: K201298 Primary Predicate: VX1 manufactured by Volta Medical

4) DEVICE DESCRIPTION

The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.

The system consists of proprietary Star Apollo Mapping System software and a hardware component. Star Apollo Mapping System software consists of 3 main components:

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Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 10 or later operating system. Star Apollo Mapping System software is pre-installed onto the laptop.

The STAR Apollo Mapping System uses export data from the Ensite Precision or Ensite X EP system that has been collected with the HD Grid catheter during the mapping procedure. The HD Grid is used to collect anatomy, localization and electrogram data in the atria. Recordings are made for 30 seconds with the HD Grid in a stable position and in contact with the atrial wall. These 30 seconds acquisitions are made in multiple, non-overlapping locations, so as to generate recordings over the entire atrial chamber. Once the data has been acquired, the data is anonymized and exported, via a portable external data storage device, to the laptop computer running the STAR Apollo Mapping System. The export data from the Ensite Precision or Ensite X EP systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data are imported, utilizing the portable external data storage device, into the STAR Apollo Mapping System and then processed by the STAR Apollo engine to generate a STAR Apollo map visualized by the GUI.

The STAR Apollo Mapping System operates outside the sterile field and is not connected directly to the Ensite Precision or Ensite X EP mapping system, or any other devices used in the procedure. The system uses the data transferred, via a portable external data storage device, from the Ensite Precision or Ensite X EP mapping system, which is then disconnected from that Ensite Precision or Ensite X EP mapping system and then loaded onto the laptop computer running STAR Apollo Mapping System software. No data is transferred from the STAR Apollo Mapping System back to the Ensite Precision or Ensite X EP mapping system i.e. data transfer is only in one direction. No modifications to the Ensite Precision or Ensite X EP mapping systems are made to accommodate the STAR Apollo Mapping System. The Star Apollo maps may be used to give physicians information about the AF activations. The physicians may use them as an additional aid to identify areas within the atria that may warrant further and close examination using the Ensite Precision or Ensite X EP mapping system, and the HD Grid catheter. The system is never directly connected to a patient, nor does it deliver therapy. It is used as a software tool that provides supplementary information to the physician. The STAR Apollo Mapping System is intended to be used in an electrophysiology procedure and/or outside of the electrophysiology lab.

5) STATEMENT OF INDICATION for USE

STAR Apollo™ Mapping System assists users in manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

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6) SUMMARY OF NON-CLINICAL TESTING

The following testing was conducted to demonstrate substantial equivalence to the primary predicate.

Software design verification testing
●
Algorithm description and testing- Identification of each of the algorithms within the software code and ● testing to demonstrate that the mathematical calculations performed by the software match that of the correct, predetermined output.
o Verification of algorithm calculations and graphic output – Test cases were performed for each of the software requirement specifications and demonstrated that the software performance met the acceptance criteria for each of the test cases and both numerical and graphical output was correct.
Software design validation testing ●
- Blinded Physician Validation (Manual Annotation versus STAR Apollo Mapping System) Simulated ● testing was completed with electrophysiologists performing manual annotation of ECGs and comparing the results with the STAR Apollo Mapping System. Testing demonstrated that manual annotation yielded similar results to the STAR Apollo Mapping System output.
- STAR Apollo Physician Use- Simulated testing was completed with electrophysiologists and rated the overall use of the STAR Apollo Mapping System software. Testing demonstrated that the STAR Apollo System Mapping System software was appropriate for use.

7) TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE

The STAR Apollo Mapping System and its predicate Volta VX1(K201298) both work with standard electrophysiology catheters to aid in mapping the atria. The predicate device outputs multiple real-time sequential annotation in order to complete a global assessment of the atria (the map updates each time an acquisition is processed but the aim is to map the entire atria to produce a global assessment after multiple analysis). The STAR Apollo device outputs information as a single global output of sequentially acquired input data (the map produced is global and is a single analysis of multiple sequential acquisitions). Both are separate stand alone software systems. Whether these functions are presented sequentially, or as one global map of sequentially acquired data in real-time, or performed separately during the same procedure, does not affect the subject device's performance nor raise different questions of safety or effectiveness. The information provided is used independently from the clinical procedure, and requires further clinical validation by the physician before any mapping or treatment decisions are made.

In particular, the STAR Apollo Mapping System performs an equivalent function to the Volta VX1 device. Both devices aid operators by assisting in annotating complex electrical maps of the atria, and both devices process and output information, via a computer and displays that are operated by use of a keyboard/mouse. Additionally, the input data used by STAR Apollo Mapping System software are of the same nature (multipolar atrial electrograms) as those used by the Volta VX1 device. Both devices also have similar outputs, the results of these signals and representation of this analysis on a computer display.

The STAR Apollo Mapping System software performs analysis of individual per procedural data sets, with the algorithms based on fundamental principles of electrophysiology, in order to replicate what a physician would do manually, given sufficient time. VX1 also automates the process that can be performed manually, but the analytical parameters pertain to recordings of previous procedures. VX1 is a software that utilizes deep learning based algorithms to analyze data sets, whereas the STAR Apollo Mapping System software uses fixed algorithms and equations to analyze the data sets. Both STAR Apollo Mapping system software and VX1 are not connected to

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a server network.

Like the predicate device, the STAR Apollo Mapping System assists in the annotation of complex 3D anatomical and electrical maps of the human atria, including the presence of multipolar electrograms. Thus, both the subject and predicate device have similar intended use.

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Neither device is intended for directing treatment or affecting the outcome of any particular heart arrhythmia.

	SUBJECT DEVICE	PRIMARY PREDICATE	COMPARISON
	STAR Apollo Mapping System	Volta VX1	Subject Device to Predicates
Regulatory
510(k) Number	K220786	K201298
Regulation No. (s)	21 CFR 870.1425	21 CFR 870.1425	Identical
Product Code (s)	DQK	DQK	Identical
Indications for Use	STAR Apollo™ Mapping Systemassists users in manualannotation of 3D anatomical andelectrical maps of human atriausing data from multipolar,intracardiac, atrial, electrogramsduring atrial fibrillation.The clinical significance ofutilizing the STAR Apollomapping system, to help identifyareas with intracardiac atrialelectrograms, of atrialarrhythmias, such as atrialfibrillation, has not beenestablished by clinicalinvestigations.	The VX1 assists operators in real-time manual annotation of 3Danatomical and electrical maps ofhuman atria for the presence ofmultipolar intracardiac, atrial,electrograms exhibitingspatiotemporal dispersion duringatrial fibrillation or atrialtachycardia.The clinical significance of utilizingthe VX1 software to help identifyareas with intracardiac atrialelectrograms exhibitingspatiotemporal dispersion forcatheter ablation of atrialarrhythmias, such as atrialfibrillation, has not beenestablished by clinicalinvestigations.	Similar.Like the predicate, both STARApollo Mapping System andVX1 assist operators in manualannotation of anatomical andelectrical maps of human atria,using data from multipolar,intracardiac electrogramsduring atrial fibrillation.STAR Apollo Mapping identifiesareas with intracardiacelectrograms showing repetitivepatterns of activation (RPA)including earliest site ofactivation (ESA); while VX1identifies areas with intra-cardiac atrial electrogramsexhibiting spatiotemporaldispersion. The STAR mappingsystem uses algorithms toanalyze and summarize AFrepetitive activation patterns,allowing physicians tounderstand how the AF may beactivating the atrium. The VX1
	SUBJECT DEVICE	PRIMARY PREDICATE	COMPARISON
	STAR Apollo Mapping System	Volta VX1	Subject Device to Predicates
			uses an algorithm to analyze electrograms and identify dispersed regions. Both the STAR Apollo Mapping system and the VX1 simply provides complimentary additional information regarding atrial fibrillation to the user in addition to the information provided by mapping systems.
			The clinical significance of both the STAR Apollo Mapping system and VX1 have not been established by clinical investigation.
			Neither device is intended for directing treatment or affecting the outcome of any particular atrial arrhythmia.
			The slight difference between the subject device and the predicate device does not alter the intended diagnostic effect and does not introduce any new issues of safety or efficacy
Intended UsePopulation	Individuals undergoing EP procedures	Individuals undergoing EP procedures	Identical
Intended UseEnvironment	Clinical and hospital environment	Clinical and hospital environment	Identical
	SUBJECT DEVICE	PRIMARY PREDICATE	COMPARISON
	STAR Apollo Mapping System	Volta VX1	Subject Device to Predicates
Prescription (RxOnly)/ Over-the-Counter	Prescription Only	Prescription Only	Identical
Device Design	Electrophysiological mapping ofthe atria with visual cues foranalysis of atrial fibrillation usingsoftware	Electrophysiological mapping ofthe atria with visual cues foranalysis of atrial fibrillation usingsoftware	Identical
Mapping DisplayPrincipal MappingApproach	The physician transfers theexport data into the STAR ApolloMapping System software. TheSTAR Apollo Mapping Systemperforms calculations andcomputations using the inputdata. The STAR Apollo MappingSystem displays a graphicalrepresentation of the anatomyof the heart atrial chamberoverlaid with the EarlyActivation Sites (ESAs) andRepetitive Patterns ofActivation(RPAs) for atrialfibrillation.	Displays adjudications as visualcues after analyzing intracardiacatrial electrograms in real-timeusing signal processing and deepand machine learning techniques	Similar, both subject device andpredicate device providegraphics based upon input data.STAR Mapping system displaysESAs and RPAs overlaid agraphical representation of theanatomy; VX1 displays theelectrode locations on acatheter model without theanatomy of the heart atrialchamber.
Cardiac ModelUsed	Using the individualized, patient-specific anatomical modelcreated with the 3D mappingsystems. The locations aredisplayed relative to themapping catheter electrodesoverlaid with the anatomicalmodel.	The locations are displayedrelative to the mapping catheterelectrodes.	Similar, the locations of interestof both the subject device andthe predicate device and bothare displayed as the outputgraphical data.The anatomical representationsmay assist the physicians ininterpreting the electro-physiological data asdemonstrated by the verificationand validation studies.
Cardiac MapsProvided	The STAR Apollo MappingSystem displays graphicalrepresentation of the anatomyof a heart chamber overlaid withEarly Activation Sites (ESAs) andRepetitive Activation Patterns(RPAs) using stable contactmultipolar catheter recordingduring atrial fibrillation to	The map type generated by VX1,is a real-timed DispersedElectrograms (DE) subtype ofmultipolar electrogram map. Theoperator is provided with a displayof the electrode locations wheredispersed or non-dispersedelectrograms have been recordedduring atrial fibrillation or atrial	Similar. Both the STAR ApolloMapping system and the VX1simply provides complimentaryadditional information regardingatrial fibrillation to the user, inaddition to the informationprovided by mapping systems.
	SUBJECT DEVICE	PRIMARY PREDICATE	COMPARISON
	STAR Apollo Mapping System	Volta VX1	Subject Device to Predicates
	provide insights of atrialfibrillation.	tachycardia.
System Type	Signal processing-based atrialmapping system	Signal processing-based atrialmapping system	Identical
Display(s)	Color Monitor	Color Monitor	Identical
Control	Laptopkeyboard/mouse/trackpad/touchscreen.	Standard keyboard/mouse	Laptop keyboard versusstandard keyboard.STAR Apollo additionally hastrackpad and touchscreen foradditional usability byphysicians, as demonstrated byverification and validationstudies.
Principles of Operation
Software DrivenAnalysis	Yes	Yes	Identical
Reports ofDiagnostic Results	No	No	Identical
Electrophysiological Cardiac Input	Yes, Patient-specificintracardiac electrograminformation (acquired bycompatible catheter)	Yes, Patient-specificintracardiac electrograminformation (acquired bycompatible catheter)	Identical
Principal MappingOutput	Displays visual cues afteranalyzing intracardiac atrialelectrograms using signalprocessing techniques (not inreal-time)	Displays adjunctive as visualcues after analyzing intra-cardiac atrial electrograms inreal-time using signalprocessing techniques	Identical with the exception ofreal time for Volta VX1. Thelack of not being performed inreal time does not affect theperformance of STAR Apollo'sfunctionality.
CompatibleCatheters	Advisor HD Grid MappingCatheter, Sensor Enabled	Any compatible cathetermeeting the requirements	Although Volta specifies abroader range of specified
SUBJECT DEVICE	PRIMARY PREDICATE	COMPARISON
STAR Apollo Mapping System(K172393)	listed below:Compatibility Requirements:Mapping catheter:-Electrodes size: 1mm-Inter-electrode spacing: 2-3mm-Number of dipoles: 10Coronary sinus catheter-Electrode size: 1mm-Inter electrode Spacing: 2-3mm-Number of selected dipoles: 5Note: The Advisor HD GridMapping Catheter, SensorEnabled, recommended byRhythm AI, is within the rangeof the above statedcompatibility parameters forthe catheters	catheters when compared tothe Rhythm AI recommendedsingle catheter, it does notchange the performancerelative to atrial mapping anddoes not raise differentquestions of safety oreffectiveness.
CompatibleSystem	Ensite Precision CardiacMapping System Model EE3000 (V2.6) (K201148)Ensite X EP System (V 1.1.1)(K213364)	2D Acquisition Data System:LabSystem Pro, AcquisitionSystem (Boston Scientific)(K141185) and MacLabCardioLab Acquisition System(General Electric) (K130626).	SimilarSTAR Apollo Mapping systemuses a 3D electro-anatomicalmapping system versus a 2Dmapping system which does notchange the safety and efficacyof the subject device and thepredicate.
Hardware Designand MaterialsUsed	Off-the Shelf informationtechnology (IT) hardware:Laptop computer and screen,connection cable, acquisitionUSB, proprietary softwarealgorithm	Off-the-shelf informationtechnology (IT) hardware:computer and monitor,connection cable, acquisitionsystem, proprietary softwarealgorithm	SimilarSTAR Apollo Mapping Systemuses a laptop computer andutilizes a USB to transfer theacquisition data to the STARApollo Mapping System.Both the subject device and thepredicate device use proprietarysoftware algorithms.

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8) CONCLUSION

The STAR Apollo Mapping System software and it predicate both work with standard electrophysiology catheters to aid in mapping the human atria. Both STAR Apollo Mapping System and VX1 assist operators in manual annotation of anatomical and electrical maps of human atria, using data from multipolar, intracardiac electrograms during atrial fibrillation.

Specifically, the STAR Apollo Mapping System software is substantially equivalent to the VX1 device. In particular, the STAR Apollo Mapping System performs an equivalent function to the VX1 device and works with mapping systems and compatible catheters to form a system which is equivalent to the predicate system. The STAR Apollo Mapping System and VX1 have similar technological characteristics and principles of operation. The signals identified by the STAR Apollo Mapping System software are of the same nature (multipolar electrograms) and have the same input (intra-cardiac atrial signals) and have similar output. The STAR Apollo Mapping System software has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device as an electrophysiological evaluation tool. In addition, the minor technological differences of the STAR Apollo Mapping System software does not affect substantial equivalence to the predicate. Performance data, as described above, demonstrate that the STAR Apollo Mapping System software is as safe and effective as the predicate. Thus, the STAR Apollo Mapping System software is substantially equivalent.

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).