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 describes a 510(k) summary for the EnSite Velocity System, a medical device. However, it does not contain information regarding detailed acceptance criteria or a study proving that the device meets such criteria.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices. This pathway typically relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. This often involves demonstrating that any differences do not adversely affect safety or effectiveness, which might be supported by bench testing.

Here's a breakdown of what is present and what is missing from your request based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Available. The document states: "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." However, it does not provide specific acceptance criteria (e.g., "accuracy must be >90%") or a table of reported device performance against such criteria. The "changes" refer to modifications between version 1.3 and 2.0 of the EnSite Velocity System.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. There is no mention of a "test set" in the context of clinical data or patient samples. The testing described is "bench testing," which typically involves simulated conditions or controlled environments, not patient data in the sense of sample size and provenance.

3. 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. Since no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set is described.

5. 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

Not Available. This document describes an electrophysiology mapping system, not an AI-assisted diagnostic tool for image interpretation or a system that modifies human reader performance in the way described. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Available. The device is an "Electrophysiology Mapping System" which is an interactive tool used by clinicians (human-in-the-loop). Standalone algorithm performance is not discussed as it's not relevant to this type of device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The testing mentioned is bench testing. For bench testing, "ground truth" typically refers to engineering specifications, reference standards, or expected outputs based on known inputs, not clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

Not Applicable. This document describes a medical device, not an AI model that undergoes a "training set" in the machine learning sense. The development of the device followed "St. Jude Medical's Quality System requirements" and "design controls requirements," which is a different process than AI model training.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

In summary: The provided 510(k) summary focuses entirely on demonstrating "substantial equivalence" of the EnSite Velocity System v.2.0 to its predicate device (EnSite Velocity System v.1.3) through modifications meeting design requirements and bench testing. It does not provide the kind of detailed information about acceptance criteria, clinical study designs, sample sizes, expert ground truth, or AI performance metrics that your request specifies. Such information is typically found in PMAs (Premarket Approval applications) or specific clinical trial reports, not usually in a 510(k) summary focused on substantial equivalence.

Summary

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12 510(k) Summary for Public Disclosure

JUL 14 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 Predicate Device

EnSite Velocity System v.1.3 (K093942)

12.3 Common or Usual Name

Electrophysiology Mapping System with console and catheter

12.4 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

12.5 Classification Name

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

12.6 Hardware Description

The EnSite Velocity System consists of the following:

Display Workstation .
Amplifier

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12.7 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.

12.8 Device Comparison to the Predicate Device

The EnSite Velocity System v.2.0 has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v.2.0 are substantially equivalent to the predicate device.

Summary of Non-Clinical Testing 12.9

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 Design Control Activities

The development of the EnSite Velocity System v.2.0 was performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design controls requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls follows in section 13.4.

12.11 Conclusion

The EnSite Velocity v.2.0 has the same indications for use, intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity v.2.0 are substantially equivalent to the predicate device.

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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 v.2.0 to be substantially equivalent to the predicate device.

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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 eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle. The text is in all capital letters and is arranged to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 1 4 2010

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

Re: K101328

Trade/Device Name: EnSite Velocity System V.2,0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: June 23, 2010 Received: June 24, 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.

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

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Page 2 - Ms. Donna Lunak

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical or ice 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.

Director 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 t intended to display the position of conventional electrophysiology (EP) catheters in the heart.
AND/OR Over-The-Counter Use
(21 CER 801 Subnart C Prescription Use X (Part 21 CFR 801 Subpart D) (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)

W. Wood.

510(k) Number k01328

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).