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

This 510(k) summary (K101667) describes a resubmission for the EnSite Velocity System with PRT, which is a modification to the previously cleared EnSite Velocity System (K093942). As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a novel device. The document states that the new device has the same indications for use, intended use, and fundamental scientific technology as the predicate and that all technological characteristics are substantially equivalent.

Therefore, the provided document does not contain a detailed study proving the device meets specific performance acceptance criteria in the way one might expect for a new device submission. Instead, it relies on demonstrating that the changes made did not adversely affect the device's safety and effectiveness compared to the already cleared predicate.

Here's a breakdown of the information as requested, extrapolated from the provided text where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific quantitative acceptance criteria or a dedicated performance study for this modified device (EnSite Velocity System with PRT) are not included in this 510(k) summary. The summary focuses on equivalence to a predicate device. The "performance" assessment is based on ensuring the changes did not degrade performance.

Acceptance Criterion	Reported Device Performance
Safety and Effectiveness Equivalence to Predicate Device	Bench testing confirmed that changes met design requirements and did not affect safety or effectiveness. Differences between proposed and predicate device do not adversely affect safety and effectiveness.
Meeting Design Requirements	Changes introduced met design requirements.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "bench testing," which implies some form of in-vitro or simulated testing, but details on sample size (e.g., number of test cases, number of runs) are not provided.
Data Provenance: The testing was "bench testing," indicating it was likely conducted in a laboratory setting by St. Jude Medical. No information on country of origin for data or whether it was retrospective or prospective clinical data is mentioned, as this was not a clinical study.

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

This type of detail is not applicable to the "bench testing" described. Bench testing typically involves engineering verification against specifications or design requirements, not expert-adjudicated ground truth as would be used in a clinical study of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This information is relevant for clinical studies involving human observers or diagnoses, where consensus among experts is often established. Bench testing does not involve adjudication in this sense.

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

No. An MRMC comparative effectiveness study was not conducted for this 510(k) submission. This type of study would typically be performed for new diagnostic algorithms where human reader performance is a key metric, often with and without AI assistance to measure improvement (effect size). This submission focuses on engineering changes and equivalence.

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

The EnSite Velocity System is a tool used by interventional electrophysiologists. Its function is to map cardiac activity and display catheter positions. It is inherently a "human-in-the-loop" device. Therefore, a standalone (algorithm only) performance assessment as might be done for an AI diagnostic algorithm is not applicable in the context described. The "bench testing" was likely verification of the system's ability to accurately perform its technical functions.

7. The Type of Ground Truth Used

For the "bench testing" mentioned, the ground truth would typically be engineering specifications, known physical properties, or pre-defined validation targets established during the device's design and development. For instance, if a change affected how catheter position is displayed, ground truth could be the known, reference position of the catheter in a phantom or simulated environment. It would not be expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The EnSite Velocity System, as described in this summary, is an electrophysiology mapping system, not an AI/machine learning device that relies on a "training set" in the conventional sense. The "PRT" refers to "Positional Reference Tool," which is an engineering-level feature, not an AI algorithm.

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

Not applicable. As explained above, there is no "training set" for this type of device.

In summary, this 510(k) summary pertains to a modification of an existing device and leverages the concept of "substantial equivalence" to a predicate device. The "study" described is limited to "bench testing" to ensure the modifications do not negatively impact safety or effectiveness, rather than a comprehensive de novo clinical performance study with specific acceptance criteria, expert adjudication, or AI performance metrics.

Summary

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K101667 1/3

12 510(k) Summary for Public Disclosure

JUL -- 2 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 PRT has the same intended use and fundamental scientific technology as the predicate device - EnSite Velocity System (K093942). All technological characteristics of the EnSite Velocity System with PRT are substantially equivalent to the predicate device - EnSite Velocity System (K093942).

12.8 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.

12.9 Summary of Design Control Activities

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

12.10 Conclusion

The EnSite Velocity System with PRT 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 PRT 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 System with PRT to be substantially equivalent to the predicate device - EnSite Velocity System (K093942).

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

JUL - 2 2010

Re: K101667

Trade/Device Name: EnSite Velocity System with PRT Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: May 28, 2010 Received: June 14, 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 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-forthe 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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Indications for Use 7

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.

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

Signature

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K101667

Special 510(k): EnSite Velocity™ System with Positional Reference Tool (PRT)

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).