The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

Device Description

The Ablacon Ablamap® Software is a stand-alone software device that uses a proprietary patented algorithm to process electrogram (EGM) signals from data files. The EGM data files are electrophysiology (EP) recordings that contain intra-cardiac electrogram signals recorded by EP recording systems using Abbott Electrophysiology FIRMap™ Catheters, 50mm and 60mm sizes; cleared under 510(k) K163709; a 64-electrode "basket" mapping catheter. The EP recording systems used are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto a computer with the Ablamap® Software installed.

The user selects an EGM data file through the software user interface and the file is processed by the software where the EGM signals are converted into electrographic flow (EGFTM) maps indicating relative velocity and direction of the action potential wave propagation during predefined time intervals. The resulting EGF™ film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.

A prevalence map is displayed that is the graphical representation of the activity of EGF™ sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF™ with respect to the catheter electrodes.

These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.

The Ablamap® Software may be installed on any commercially available workstation personal computer (PC) with a Linux Ubuntu 18 LTS operating system and that meets minimum requirements for CPU and GPU processing, random access memory (RAM), and hard drive size.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a structured study proving the device meets these criteria in the format requested.

The document is a 510(k) premarket notification summary for the Ablamap® Software, which primarily focuses on demonstrating substantial equivalence to a predicate device (Abbott Electrophysiology RhythmView™ Workstation). While it mentions "Performance testing was completed on the Ablamap® Software which verified that the software device meets the specification requirements and performs as designed," and "Testing demonstrated that the software met design requirements and functioned as intended," it does not provide:

A table of specific numerical acceptance criteria and reported performance values.
Details on the sample size used for the test set or its provenance.
The number or qualifications of experts used for ground truth establishment.
Adjudication methods.
Whether an MRMC comparative effectiveness study was done or its effect size.
Standalone algorithm performance data.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size or ground truth establishment methods for a training set.

The document refers to software design verification and validation testing, which indicates that internal testing was performed to ensure the software met its design specifications and complied with relevant standards (IEC 62304, ANSI/AAMI/IEC 62366-1, ISO 14971). However, these are general statements about internal quality assurance and regulatory compliance, not a detailed clinical performance study with defined acceptance criteria and results as typically released for AI/ML medical devices where clinical efficacy is a primary concern.

Therefore, based on the provided text, it's not possible to answer the requested questions about acceptance criteria and the study that proves the device meets them with specific details. The filing demonstrates equivalence based on intended use, indications for use, and technological characteristics, rather than a quantifiable clinical performance study against specific metrics.

Summary

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August 31, 2021

Ablacon, Inc. Frank Rodrigues V.P. of Quality Assurance/Regulatory Affairs 4800 Wadsworth Blvd. Suite 310 Wheat Ridge, Colorado 80033

Re: K203084

Trade/Device Name: Ablamap® Software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: July 20, 2021 Received: July 30, 2021

Dear Frank Rodrigues:

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 Deoras Assistant Director (Acting) 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) K203084

Device Name Ablamap® Software

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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Image /page/3/Picture/0 description: The image shows the Ablacon logo. The logo consists of an orange heart-shaped icon on the left and the word "ablacon" in black letters on the right. The heart-shaped icon is a stylized heart with a gradient from light to dark orange. The word "ablacon" is written in a sans-serif font.

510(k) Summary per 21 CFR 807.92

Date summary prepared:	April 29, 2021
510(k) Submitter/Holder:	Ablacon, Inc.4800 Wadsworth Blvd. Ste 310Wheat Ridge, CO 80033
Contact:	Frank RodriguesVP Quality Assurance & Regulatory AffairsTelephone: 303-955-5763Fax: 720-390-7541Email: fr@ablacon.com
Trade Name:	Ablamap® Software
Common Name:	Diagnostic Software
Classification Name:	Programmable Diagnostic Computer
Classification:	Class II
Product Code:	DQK
Review Panel:	Cardiovascular
Regulation:	21 CFR 870.1425

Predicate Device(s):

Trade/Proprietary Name:	RhythmView™ Workstation
Common/Usual Name:	Diagnostic Computer
Classification Name:	Programmable Diagnostic Computer
Class:	Class II
Product Code:	DQK
Regulation:	21 CFR 870.1425
Review Panel:	Cardiovascular
510(k) Submitter/Holder:	Abbott Electrophysiology3668 S. Geyser Road Ste 365St. Louis, MO 63127
510(k) #s:	K171583

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Device Description

These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.

Intended Use

The Ablamap® Software is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

Indications for Use

Comparative Technological Characteristics

The Ablacon Ablamap® Software is an electrophysiological mapping application that uses a proprietary algorithm to process EGM signals and display electrical wave propagation information in a visual format during pre-defined time intervals. The intended use, indications for use, and fundamental performance are the same as the predicate device.

A comparison summary of the technological characteristics of the subject device and the predicate device are as follows:

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Device Characteristic	Subject DeviceAblamap® Software	Predicate DeviceAbbottElectrophysiologyRhythmView™Workstation (K171583)
Device classification, Class, andProduct code	Same	Same
Indications For Use	Used to analyze electrogram(EGM) signals and displayresults in a visual format forevaluation by a physician inorder to assist in the diagnosisof complex cardiacarrhythmias	Same
Intended Use	Intended to be used duringelectrophysiology procedureson patients for whom anelectrophysiology procedurehas been prescribed and onlyby qualified medicalprofessionals who are trainedin electrophysiology.	Same
System	Stand-alone software that maybe installed on anycommercially availablecomputer meeting minimumperformance specifications.	Fundamentally the same.Workstation cart withsoftware installed on adesktop computer withmonitor, keyboard andmouse.
Compatible Diagnostic Catheters	Abbott ElectrophysiologyFIRMap™ Catheter; 50mmand 60mm sizes	Same
Compatible EP Recording Systems	Boston Scientific(formerly C.R. Bard)LabSystem Pro™	Same
	GE Healthcare(formerly Prucka)CardioLab™	Same
	St. Jude Medical(formerly EP MedSystems)WorkMate™ Claris System	Same
Signal processing	Yes	Yes
Post-processing display	Yes	Yes
Grid display of electrode signals	Yes	Yes
Graphic display view of signalpotentials (wave propagation)	Yes	Yes
Method to select and display all time	Yes	Yes
segments of the entire electrogramrecording
Play/replay animated (film) graphicrepresentation of signals	Yes	Yes
Various display options to assist theuser with identification ofarrhythmia patterns	Electrical activityRotational activityRecording timelineVariability (Stability)	Same
Evaluate the quality of theelectrogram recording exported fromthe EP recording system	Yes	Yes
Display the electrogram signals(EGM chart)	Yes	Yes
Select and review a time sequence ofthe electrogram signals from variouselectrodes	Yes	Yes
Programming language	Object-oriented (Python)	Fundamentally the same.Object-oriented (C++)
Processing computation method forelectrical wave propagation	Optical Flow	Phase Angle
Generate a procedure history file	Yes	Yes
Allow user to add textnotes/comments	Yes	Yes
Anatomical location capability	No	No

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Performance

Performance testing was completed on the Ablamap® Software which verified that the software device meets the specification requirements and performs as designed. The Ablamap Software is suitable for its intended use.

Performance testing for the subject device included the following:

Software design verification and validation testing was performed and complies with:

IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes .
ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
ISO 14971:2007 Medical devices Application of risk management to medical devices .

The software is considered minor level of concern in accordance with FDA guidelines as a malfunction or failure would not likely contribute to a hazard leading to an injury.

Software usability testing was performed as part of verification and validation testing for functionality and performance.

Testing demonstrated that the software met design requirements and functioned as intended.

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Conclusion

The data presented in this submission demonstrates that the proposed Ablacon Ablamap® Software operated as intended and is substantially equivalent to the cleared predicate device, the Abbott Electrophysiology RhythmView™ Workstation.

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).