When used with the EnSite Array™ Catheter, the EnSite System 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.
OR
When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Device Description

The EnSite Velocity System consists of the following:

Display Workstation
Amplifier

AI/ML Overview

The provided text is a 510(k) Summary for the EnSite Velocity System. It details the device's regulatory information, intended use, and comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of AI/ML performance evaluation.

The "Summary of Non-Clinical Testing" section states, "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." The "Summary of Clinical Testing" section states, "Cross-vendor interoperability testing sessions were conducted between EnSite Courier and 15 different PACS models/versions, seven vendors. This clinical test report can be found in Appendix S."

This submission appears to be for an update to an existing system (EnSite Velocity v.1.3 (K093942)) to include "EnSite Courier™" which is a networking software feature. The testing described is focused on interoperability and verifying that changes did not negatively impact safety or effectiveness compared to the predicate device, rather than establishing performance metrics against a defined acceptance criterion for a novel diagnostic accuracy claim.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can be inferred or confirmed:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic performance study, nor does it report such metrics. The non-clinical testing focused on "meeting design requirements" and not affecting safety/effectiveness. The clinical testing focused on "interoperability."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- For the "Cross-vendor interoperability testing sessions," the "test set" consisted of "15 different PACS models/versions, seven vendors." No patient data sample size, provenance, or retrospectivity/prospectivity is mentioned as the testing was on interoperability, not clinical diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This information is relevant for studies evaluating diagnostic accuracy against expert ground truth. The described testing was for interoperability and non-inferiority via bench testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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. An MRMC study was not described. The device is an electrophysiology mapping system, and the update involves networking software. This type of study is not relevant to the described testing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a "Cardiac Mapping System" and the update is for "EnSite Courier™" networking software. It is not an "algorithm only" device in the AI/ML sense. The testing described (bench testing and interoperability) is a form of standalone testing for the specific aspects evaluated (design requirements and data exchange).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical bench testing, the "ground truth" would be the engineering design requirements.
- For the clinical interoperability testing, the "ground truth" would be successful data exchange with various PACS systems. No medical ground truth (pathology, expert consensus, outcomes) was established as this was not a diagnostic accuracy study.
The sample size for the training set:
- Not applicable. This device and its update (networking software) are not described as using an AI/ML algorithm that would require a "training set" in the context of machine learning model development.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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12 510(k) Summary for Public Disclosure

JUN
11 2010

12.1 Submitter's Name/Contact Person

Donna R. Lunak St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 USA

The Establishment Registration Number is 2184149.

12.2 Common or Usual Name

Electrophysiology Mapping System with console and catheter

12.3 Proprietary Name

EnSite Velocity System Consisting of: EnSite Multi-electrode Diagnostic Catheter (EnSite Array™ - Model EC1000) EnSite Electrophysiology Workstation - Model EE3000 EnSite NavX Surface Electrode Kit - Model EN0010

12.4 Classification Name

DQK, Programmable diagnostic computer (21 CFR 870.1425), Class II, Circulatory Systems Device Panel

12.5 Hardware Description

The EnSite Velocity System consists of the following:

Display Workstation .
Amplifier ●

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12.6 Indications for Use

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

When used with the EnSite Array™ Catheter, the EnSite System 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.
OR
When used with the EnSite NavX Surface Electrode Kit, the EnSite . System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

12.7 Device Comparison to the Predicate Device

The EnSite Velocity System with EnSite Courier™ has the same intended use and fundamental scientific technology as the predicate device, EnSite Velocity System v.1.3 (K093942). All technological characteristics of the EnSite Velocity System with EnSite Courier™ are substantially equivalent to the predicate device, EnSite Velocity System v. 1.3 (K093942).

12.8 DICOM Conformance Statement

The EnSite Velocity System with EnSite Courier ™ conforms to the ACR-NEMA Digital Imaging and Communications in Medicine (DICOM) standard. A DICOM Conformance Statement is presented in Appendix R.

12.9 Summary of Non-Clinical Testing

Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product.

12.10 Summary of Clinical Testing

Cross-vendor interoperability testing sessions were conducted between EnSite Courier and 15 different PACS models/versions, seven vendors. This clinical test report can be found in Appendix S.

12.11 Summary of Design Control Activities

The development of the EnSite Networking Software Feature - EnSite Courier™ was performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design controls

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requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls follows in section 13.4.

12.12 Conclusion

The EnSite Velocity System with EnSite Courier ™ has the same indications for use, intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System with EnSite Courier ™ are substantially equivalent to the predicate device, EnSite Velocity System v.1.3 (K093942).

Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.

Therefore, St. Jude Medical considers the EnSite Velocity System to be substantially equivalent to the predicate device, EnSite Velocity System v.1.3 (K093942).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird-like figure with flowing lines, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 1 2010

St. Jude Medical c/o Ms. Donna Lunak Regulatory Specialist II One St. Jude Medical Drive Saint Paul, MN 55117

K101419 Re:

Trade/Device Name: EnSite Velocity System Regulatory Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: May 19, 2010 Received: May 20, 2010

Dear Ms. Lunak:

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. 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.

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.

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Page 2 – Ms. Donna Lunak

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Directo Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7 Indications for Use

Device Name: EnSite Velocity System

Indications for Use:

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

When used with the EnSite Array™ Catheter, the EnSite System 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.
OR
When used with the EnSite NavX Surface Electrode Kit, the EnSite System is � intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Prescription Use X
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sia Devices

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).