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

The EnSite 3000 System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter. 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 Electrophysiology Workstation connected to the EnSite Catheter utilizes proprietary software algorithms to reconstruct and display right atrial electrograms detected by the EnSite Catheter. This information can be presented as color-coded three-dimensional maps to provide global electrical activation patterns of the heart chamber. The EnSite 3000 System may also be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads, and other analog or digital inputs.

The EnSite 3000 System also incorporates a navigational tool to provide real-time feedback regarding the position of an auxiliary catheter for creation of a geometrical model of the heart chamber or for guiding therapy to a designated location.

AI/ML Overview

This 510(k) notification describes a device modification, making it a "Special 510(k)". The core assertion is that the modified device is as safe and effective as its predicate. Therefore, the study presented focuses on demonstrating equivalence rather than establishing new performance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device is as safe and effective as the previously marketed device.	"An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness."
No new issues of safety and effectiveness are raised by the modifications.	"An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness."

Study Details Proving Device Meets Acceptance Criteria

The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a standalone AI or a human-in-the-loop scenario. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device performs comparably to the predicate device without introducing new risks.

The study described is focused on validating the changes made to the EnSite 3000 System.

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

Sample Size for Test Set: The document states "a battery of bench and user tests." It does not specify the sample size for these tests.
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions "in-house procedures" for testing.

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

The document does not provide information about "experts" or the establishment of "ground truth" in the context of clinical performance evaluation. The testing appears to be focused on engineering validation (bench and user tests) to confirm the modified device's functionality and safety equivalent to the predicate.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This type of methodology is usually relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study described is not a clinical effectiveness study involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes "bench and user tests" for the system, not specifically a standalone algorithm performance test. The EnSite 3000 System itself is a computerized system with proprietary software algorithms, but the testing reported is for the system's operational equivalence to the predicate, not a standalone AI performance.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, expert consensus, outcomes data) is not explicitly stated or described. The validation appears to be against established functional specifications of the predicate device and safety standards.

8. The Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This type of information is typically relevant for machine learning model development, and while the EnSite 3000 System uses "proprietary software algorithms," the submission focuses on device modification validation rather than algorithm development or training.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary

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K012926 p.1/2

1350 Energy Lane Suite 110 Saint Paul, MN 55108-5254 Telephone: 651-523-6900 Facsimile: 651-644-7897 info@endocardial.com Email:

Image /page/0/Picture/3 description: The image shows a logo for a company called "ENDOCARE SOLUTIONS". The logo features a stylized letter "E" on the left side, with two diagonal lines intersecting it. To the right of the "E", the company name is written in a simple, sans-serif font, with "ENDOCARE" on the top line and "SOLUTIONS" on the bottom line.

SEP 2 8 2001

510(k) Summary

Submitter: Endocardial Solutions 1350 Energy Lane, Suite 110 St. Paul, MN 55108 USA Phone: 651-523-6900 Fax: 651-523-6990 Eric W. Koehler Contact: Director of Clinical and Regulatory Affairs August 30, 2001 Date Prepared: EnSite 3000® System Trade Name: a) Model EC 1000 EnSite® Multi-electrode Diagnostic Catheter b) EnSite 3000® Electrophysiology Workstation Common name: Electrophysiology cardiac mapping system Classification Name: a) Electrode recording catheter or electrode recording probe (21CFR 870.1220) b) Programmable diagnostic computer (21 CFR 870.1425) Endocardial Solutions EnSite 3000 System Predicate Device: 510(k) No. K001437 Device Description: The EnSite 3000 System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter. 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 Electrophysiology Workstation connected to the EnSite Catheter utilizes proprietary software algorithms to reconstruct and display right atrial electrograms detected by the EnSite Catheter. This information can be presented as color-coded three-dimensional maps to provide global electrical activation patterns of the heart

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Special 510(k) Notification: Device Modification

chamber. The EnSite 3000 System may also be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads, and other analog or digital inputs.

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:

The new device has the same technological characteristics as the legally marketed predicate device.

Non-clinical performance data:

The changes made to the EnSite 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 the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

Mr. Eric W. Koehler Endocardial Solutions, Inc. 1350 Energy Lane, Suite 110 St. Paul, MN 55108-5254

Re: K012926

Trade Name: Endocardial Solutions EnSite 3000 System Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: MTD Dated: August 30, 2001 Received: August 31, 2001

Dear Mr. Koehler:

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). You may, therefore, market the device, subject to the general controls and Countere Free (110) - he limitations described below. 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.

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 harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

WARNING: The use of this device in conjunction with radiofrequency ablation, as part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse the diagnols and live 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 should be present on the first page of your Catheter Instructions for Use and on the packaging for each individual catheter.

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Page 2 - Mr. Eric W. Koehler

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (see above) into in a major regulations affecting your device can be may be subject to additional controls. "Little 21, Parts 800 to 898. In addition, FDA may round in the Ood of I saccar resgueerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backware requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must or any Federal statutes and regulations annualing, but not limited to: registration and listing (21 comply with all the Act s requirements, mercuring practice requirements as set CFK Fart 807), adomig (21 OFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device . This The FDA Inding of substantan equivalence or your device to proceed to the market. This Itsults in a classification for your device as described in your Section 510(k) letter will anow you to begin marketing your avversion in added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above mooting minutions 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 II you desire specific miormation accede are appear........................................................................................................................... device (21 CFR Fart of Compliance at (301) 594-4646. Additionally, for questions on the comact the Office of Compilance at evice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (201) 394-4039. Also, prease note are rogan. Other general information on your responsibilities prematics notification (21 or re rarve Division of Small Manufacturers, International and ulluer the Act nay be obtained from are (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely Burs

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ensite® 3000 System

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

The Ensite® Multi-electrode Diagnostic Catheter used with the Ensite 3000 Electrophysiology I he Ensite "Multi-electrode Diagnostic Catheter asses with complex arthythmias that
Workstation is intended to be used in the right atrium of patients alone (i.o. Jinesr man Workstation is intended to be used in the right atrail. or pareen.
may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

Division of Cardiovascular & Respiratory Devices
510(k) Number 12012926

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_V OR (Per 21 CFR 801.109)

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).