The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

Device Description

EnSite 3000® System Components

EnSite® Multi-electrode Diagnostic Catheter

The EnSite® Multi-electrode Diagnostic Catheter (EnSite® catheter) is a single use, 9 French, percutaneous catheter. The EnSite® catheter is designed for use only with the EnSite 3000® System in an electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces.

EnSite 3000® Electrophysiology Workstation

The EnSite 3000® Electrophysiology Workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multi-electrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac clectrograms. The EnSite 3000® may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs.

The EnSite 3000® System is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.

AI/ML Overview

Acceptance Criteria and Study Details for EnSite 3000® System

Based on the provided 510(k) summary, the EnSite 3000® System did not include specific quantitative acceptance criteria or a detailed clinical study demonstrating its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
No specific quantitative acceptance criteria were explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device and safety through non-clinical testing.	The EnSite 3000® System, including the EnSite® Multi-electrode Diagnostic Catheter and EnSite 3000® Electrophysiology Workstation, was found to be substantially equivalent to the currently marketed EnSite 3000® System (itself, indicating a modification or updated version) for the stated intended use. Non-clinical performance data included "a battery of bench and user tests" conducted in accordance with in-house procedures.

Acceptance Criteria

Reported Device Performance

No specific quantitative acceptance criteria were explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device and safety through non-clinical testing.

The EnSite 3000® System, including the EnSite® Multi-electrode Diagnostic Catheter and EnSite 3000® Electrophysiology Workstation, was found to be substantially equivalent to the currently marketed EnSite 3000® System (itself, indicating a modification or updated version) for the stated intended use. Non-clinical performance data included "a battery of bench and user tests" conducted in accordance with in-house procedures.

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not specified. The document mentions "a battery of bench and user tests," but does not provide details on the number of cases or subjects involved in these tests.
Data Provenance: Not specified. The tests were "conducted in accordance with in-house procedures," suggesting an internal testing environment rather than a specific country or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Given the nature of the device (electrophysiology cardiac mapping), "user tests" would likely involve electrophysiologists or cardiac technicians, but their number and specific qualifications are not detailed.

4. Adjudication Method:

Adjudication Method: Not applicable or not specified. The document does not describe a process for establishing ground truth through expert adjudication. The focus was on demonstrating functionality and safety during bench and user testing.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this submission. The device is a diagnostic tool for mapping cardiac arrhythmias, and the study as described focused on demonstrating its functionality and substantial equivalence, not comparing its effectiveness with and without AI assistance for human readers.
Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study with AI assistance was performed.

6. Standalone Performance Study (Algorithm Only):

Standalone Performance Study: Yes, to some extent. The "Non-clinical performance data" section refers to "proprietary software algorithms to reconstruct and display right atrial endocardiograms." While not a formal "standalone performance study" as understood in modern AI/ML device evaluations, the bench and user tests inherently assessed the performance of the system's algorithms in reconstructing and displaying data, albeit within a simulated or controlled environment. However, specific metrics for the algorithm's standalone accuracy are not provided.

7. Type of Ground Truth Used:

Type of Ground Truth: Not explicitly stated or defined beyond the context of "bench and user tests." For a device that maps intracardiac electrograms, ground truth would typically involve comparing the device's output to known electrical activity (e.g., from a simulator or a highly accurate reference mapping system) or clinical outcomes. The document does not specify how "ground truth" was established for validating the accuracy of the reconstructed endocardiograms during these tests.

8. Sample Size for Training Set:

Sample Size for Training Set: Not applicable. The document describes the EnSite 3000® System as utilizing "proprietary software algorithms." There is no indication that these algorithms were developed using machine learning or required a "training set" in the contemporary sense. The focus is on the functionality and accuracy of the pre-programmed algorithms rather than a learned model.

9. How Ground Truth for Training Set was Established:

How Ground Truth for Training Set was Established: Not applicable, as there is no indication of a training set being used for machine learning.

Summary

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Endocardial Solutions, Inc.

DEC - 2 1999	510(k) Summary
Submitter:	James W. BullockPresident and CEOEndocardial Solutions1350 Energy Lane, Suite 110St. Paul, MN 55108
Contact:	James W. BullockPresident and CEO
Date Prepared:	July 22, 1999
Trade Name:	EnSite 3000® System
	a) Model EC 1000 EnSite® Multi-electrode Diagnostic Catheterb) EnSite 3000® Electrophysiology Workstation
Common name:	Electrophysiology cardiac mapping system
	a) Electrode recording catheter or electrode recording probe(21CFR 870.1220)
	b) Programmable diagnostic computer (21 CFR 870.1425)
Equivalence to:	a) Endocardial Solutions EnSite 3000® System
Description:	EnSite 3000® System ComponentsEnSite® Multi-electrode Diagnostic CatheterThe EnSite® Multi-electrode Diagnostic Catheter (EnSite® catheter) is a single use, 9 French, percutaneous catheter. The EnSite® catheter is designed for use only with the EnSite 3000® System in an electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at

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specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces.

EnSite 3000® Electrophysiology Workstation

Intended use:

The EnSite® Multi-electrode Diagnostic Catheter used with the EnSite 3000® Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

Technological Characteristics:

Unlike currently available electrode recording catheters, the EnSite® catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000 Flectrophysiology Workstation connected to the EnSite® catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms detected by the EnSite® catheter's MFA.

Non-clinical performance data:

July 22, 1999 Endocardial Solutions. Inc. EnSite 30000 System

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The changes made to the 3000° System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures.

Conclusion:

An evaluation of the device changes indicates that this EnSite 3000® System is substantially equivalent to the currently marketed system.

July 22, 1999 Endocardial Solutions, Inc. EnSite 3000® System

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

2 1688 DEC

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James W. Bullock President and Chief Executive Officer Endocardial Solutions, Inc. 1350 Energy Lane, Suite 110 Saint Paul, MN 55108-5254

K992479 Re: R92479
Trade Name: EnSite ™ Multi-Electrode Diagnostic Catheter and EnSite 3000 ™ Electrophysiology Workstation Regulatory Class: II (two) Product Code: MTD, DQK Dated: October 15, 1999 Received: October 15, 1999

Dear Mr. Bullock:

We have reviewed your Section 510(k) notification of intent to market nt have reviews for above and we have determined the device is che device is equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate encrosure, eo rogarij mainent date of the enactment date of the Medical Device Commerce prior co hay boy bean reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls may sions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual eenstration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause Therefore, in accordance with Section 513(i)(1)(E) of the Act, harm. the following limitation must appear in the Warnings section of the device's labeling:

The use of this device in conjunction with radiofrequency WARNING: ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.

The warning should appear in a black box, and the font size of the text should be at least 2 points larger than any surrounding text. The Warning must be present on the first page of your Catheter Instructions for Use and on the packaging for each individual catheter. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device

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Page 2 - Mr. James W. Bullock

can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(l)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

David W. Feigal, Jr., M.D., M.P.H.

fice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of 1 . T

510(k) Number (if known) K992479.

Device Name: EnSite ™ Multi-Electrode Diagnostic Catheter and EnSite 3000 ™ Electrophysiology Workstation

FDA's Statement of the Indications For Use for device:

Nancy C brogdon

rdiovascular, Respiratory, and Neurological I

510(k) Number N77277

Prescription Use xx (Per 21 CFR 801.109)

Over-The-Counter 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).