ENSITE VELOCITY SYSTEM V.3.0

K112688 · St Jude Medical · DQK · Nov 9, 2011 · Cardiovascular

Device Facts

• Record ID: K112688
• Device Name: ENSITE VELOCITY SYSTEM V.3.0
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended 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.

Device Story

The EnSite Velocity System is an electrophysiology mapping system used in clinical settings by physicians to diagnose cardiac arrhythmias. It functions as a programmable diagnostic computer. The system processes signals from specialized catheters (EnSite Array) or tracks conventional EP catheters using surface electrodes (EnSite NavX). It transforms these inputs into a visual display of catheter positions and cardiac electrical activity. This visualization assists clinicians in identifying complex arrhythmias within the right atrium. The system provides real-time mapping data, enabling physicians to make informed clinical decisions regarding arrhythmia management. The primary benefit is improved diagnostic capability for complex arrhythmias that are challenging to map with standard systems.

Clinical Evidence

Bench testing and animal study testing were performed to confirm that design changes met requirements and did not impact safety or effectiveness.

Technological Characteristics

The system comprises a display workstation and an amplifier. It functions as a programmable diagnostic computer (21 CFR 870.1425). It utilizes surface electrode kits and specialized mapping catheters for signal acquisition and catheter positioning. The system is designed for use in electrophysiology studies.

Indications for Use

Indicated for patients requiring electrophysiology studies. Specifically, the EnSite Array™ Catheter is indicated for use in the right atrium of patients with complex arrhythmias difficult to identify via conventional mapping. The EnSite NavX Surface Electrode Kit is indicated for displaying the position of conventional EP catheters in the heart.

Regulatory Classification

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.

Predicate Devices

• EnSite Velocity System with PRT (K101667)

Submission Summary (Full Text)

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K11 2688 1/3

NOV - 9 2011

# 12 510(k) Summary for Public Disclosure

## 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 with PRT (K101667)

## 12.3 Common or Usual Name

Electrophysiology Mapping System with console and catheter

### 12.4 Proprietary Name

EnSite Velocity System

Consisting of:

.

EnSite Electrophysiology Workstation – Model EE3000 EnSite ElectrophySiblogy Workstation - Model Size Array™ – Model EC1000) 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.3.0 has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v.3.0 are substantially equivalent to the predicate device.

#### Summary of Non-Clinical Testing 12.9

Bench testing and animal study testing (Appendix S) were 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.3.0 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.3.0 has the same indications for use, intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity v.3.0 are substantially equivalent to the predicate device.

510(k): EnSite Velocity System v.3.0

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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.3.0 to be substantially equivalent to the predicate device.

510(k): EnSite Velocity System v.3.0

. '

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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

NOV - 9 2011

Re: K112688

Trade/Device Name: EnSite Velocity System V.3.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 18, 2011 Received: October 19, 2011

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 intestate 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, Or to 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 1 ct 1 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 (OS) 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/CDRH0ffices/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 [phone] or [phone] 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 Cardiology Devices

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 The EnSile Velooky - toolsy studies are indicated.

- When used with the EnSite Array™ Catheter, the EnSite System is intended to . When used with the Enone Anaj - Guinbicomplex arrhythmias that may be de used in the fight atham or preptional mapping systems alone.
OR

- When used with the EnSite NavX Surface Electrode Kith, the EnSite System is t When used with the EnSite Navx Sundos Liostract Chical Castleters in the heart.
Prescription Use
(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 |
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| Division of Cardiovascular Devices |

510(k): EnSite Velocity System v.3.0

510(k) Number

13