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 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 Multielectrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac electrograms. 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 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

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary for the EnSite 3000 System, does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics. Instead, it describes a foundational approach to demonstrating substantial equivalence through various tests and comparisons.

The "reported device performance" is described qualitatively as:

Non-clinical performance data:
- The EnSite catheter underwent "a battery of in vitro tests including tensile, torsion, inflation, deflation testing."
- Biocompatibility was confirmed "in accordance with ISO 10993."
- The EnSite 3000 was tested and conforms to "IEC 601-1 and IEC 601-2-27 international standards."
- "Device validation testing was conducted in accordance with in house procedures."
- "Animal studies were utilized to show initial catheter and system safety of the catheter."
Clinical Data:
- "Clinical studies were conducted which demonstrate that the EnSite 3000 System is as safe and effective as EP mapping catheter systems presently marketed."
- "The results indicate that it can map complex atrial arrhythmias."

Therefore, while no specific numerical acceptance criteria are given, the overarching acceptance criterion appears to be "as safe and effective as EP mapping catheter systems presently marketed" and the ability to "map complex atrial arrhythmias."

Study Details

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

A table of acceptance criteria and the reported device performance:
As noted above, no quantitative table is provided. The acceptance criterion is broadly defined as "as safe and effective as EP mapping catheter systems presently marketed" and the ability to "map complex atrial arrhythmias."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states "Clinical studies were conducted," but neither the specific sample size nor the data provenance (country, retrospective/prospective) is mentioned for these clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The text only vaguely refers to "EP mapping catheter systems" for comparison.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study is mentioned. The device is an electrophysiology cardiac mapping system, not specifically described as an AI-assisted diagnostic tool that human readers would interact with in a 'before-and-after' scenario to measure improvement. The comparison is between the EnSite 3000 System and "EP mapping catherer systems presently marketed" in terms of safety and effectiveness, implying a direct comparison of device performance rather than human reader performance with and without AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The clinical studies assess the "EnSite 3000 System," which includes the hardware and proprietary software algorithms. The statement "The EnSite 3000 connected to the EnSite catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms" indicates the algorithm's direct role in the device's function. The clinical studies would inherently be evaluating this standalone performance as part of the system's overall function in diagnosing arrhythmias.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While the clinical studies demonstrate the system "can map complex atrial arrhythmias," the specific method for establishing the "ground truth" (i.e., definitive diagnosis of these arrhythmias against which the device's mapping was compared) is not detailed. It's implied that conventional EP mapping techniques or expert clinical judgment would have served as the benchmark, but this is not explicitly stated.
The sample size for the training set:
The document describes "proprietary software algorithms" but does not mention a "training set" in the context of machine learning or AI that would typically be associated with such a term. This submission predates the widespread regulatory focus on AI/ML training data.
How the ground truth for the training set was established:
As no training set is explicitly mentioned, this information is not provided.

Summary

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18. CERTIFICATIONS AND SUMMARIES

18.1 Summary for Public Disclosure

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510(k) Summary

Submitter:	Andrew BaloVice President Regulatory Affairs, Quality Assurance, Clinical Affairs1350 Energy Lane Suite 110St. Paul, MN 55401
Contact:	Andrew BaloVice President Regulatory Affairs, Quality Assurance, Clinical Affairs
Date Prepared:	September 25, 1998
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) EP Technologies, Inc. Asymmetric Curve Steerocathand other similar recording catheters.
	b) Biosense CARTO System and other similar programmablediagnostic computer
Description:	EnSite 3000 System Components
	EnSite Multi-electrode Diagnostic Catheter
	The EnSite Multi-electrode Diagnostic Catheter (EnSite catheter) is asingle use, 9 French, percutaneous catheter. The EnSite catheter isdesigned for use only with the EnSite 3000 electrophysiology laboratoryand for deployment in the right atrium. The proximal end contains thepatient 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 theMEA. The shaft is a coaxial design with a polyurethane outer sheath. At

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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 Multielectrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac electrograms. The EnSite 3000 may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs.

Intended use:

For use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. contact 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 connected to the EnSite catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms detected by the EnSite catheters MEA.

Non-clinical performance data:

The EnSite catheter underwent a battery of in vitro tests including tensile, torsion, inflation, deflation testing. Biocompatibility was confirmed in accordance with ISO 10993.

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The EnSite 3000 was tested and conforms to IEC 601-1 and IEC 601-2-27 international standards. Device validation testing was conducted in accordance with in house procedures.

Animal studies were utilized to show initial catheter and system safety of the catheter.

Clinical Data:

Clinical studies were conducted which demonstrate that the EnSite 3000 System is as safe and effective as EP mapping catherer systems presently marketed. The results indicate that it can map complex atrial arrhythmias.

Conclusion:

An evaluation of the predicate devices, in vitro testing, animal testing and human clinical testing shows that the EnSite 3000 and the EnSite Multielectrode Diagnostic Catheter are substantially equivalent to currently marketed programmable diagnostic computers and electrode recording catheters.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 21 1999

Mr. Andrew Balo Vice President, Regulatory, Clinical Affairs and Quality Assurance Endocardial Solutions, Inc. 1350 Energy Lane, Suite 110 Saint Paul, MN 55108-5254

Re : K983456 EnSite™ Multi-Electrode Diagnostic Catheter and EnSite 3000™ Electrophysiology Workstation Regulatory Class: II (two) Product Code: MTD, DQK Dated: January 29, 1999 Received: January 29, 1999

Dear Mr. Balo:

We have reviewed your Section 510(k) notification of intent to market we have referenced above and we have determined the device is che device researcedent (for the indications for use stated in the substanctarly equivalent (195 predicate devices marketed in interstate enclosure) to regarly manisose, the enactment date of the Medical Device Commerce provices that have been reclassified in accordance with Amendmenton) of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls may, bronsions, m act and the limitations described below. The general provisions of the Act include requirements for annual controls provibient of exices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a file of better of between this device will be used for an intended use readonable in the proposed labeling and that such use could cause Therefore, in accordance with Section 513(1) (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.

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Page 2 - Mr. Andrew Balo

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 should be at read be present on the first page of your Catheter Instructions warning mire be the packaging for each individual catheter.

If your device is classified (see above) into either class II (Special It your dovied be suit (Premarket Approval), it may be subject to such editional controls. Existing major regulations affecting your device auditional controle Code of Federal Regulations, Title 21, Parts 800 to - cound in one in one mination assumes compliance with 895. 693. "A Subscancially Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General che Quartly Sybecal Regulation (1), and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. ens we to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. accon. your device in the found in the comment offect any obligation you premaired nocerritues of through 542 of the Act for devices under Might have and and Doubt 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)(1)(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.

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Page 3 - Mr. Andrew Balo

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

Susan Alpert, Ph.D., M.D.

Susan Alpert, Ph.D Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 5 - Mr. Andrew Balo

Page_ 1

510 (k) Number (if known) : __________________________________________________________________________________________________________________________________________________

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

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

Prescription Use
(Per 21 CFR 801.109)

X. Balle T.ll

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).