ENSITE VELOCITY SYSTEM

K141050 · St Jude Medical · DQK · Jun 6, 2014 · Cardiovascular

Device Facts

• Record ID: K141050
• Device Name: ENSITE VELOCITY SYSTEM
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Traditional
• 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. When used with the EnSite NavX™ Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart. When used with the SJM Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.

Device Story

EnSite Velocity System is an electrophysiology mapping system consisting of a display workstation and amplifier. It processes signals from cardiac catheters (EnSite Array or conventional EP catheters) and surface electrodes (EnSite NavX) to map cardiac electrical activity and visualize catheter position. The EnSite Contact Force Module adds the capability to visualize contact force information from compatible catheters. Used in clinical settings by physicians during electrophysiology procedures to identify complex arrhythmias and guide catheter placement. Output is displayed on the workstation to assist in real-time navigation and diagnostic decision-making, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes display workstation and amplifier. Integrates with EnSite Array catheter, EnSite NavX surface electrode kit, and SJM contact force hardware. Operates as an electrophysiology mapping system. Design controls implemented per 21 CFR 820.30.

Indications for Use

Indicated for patients undergoing electrophysiology studies. EnSite Array catheter use is indicated for patients with complex arrhythmias in the right atrium. EnSite NavX use is indicated for displaying conventional EP catheter positions. Contact Force Module is indicated for visualizing force data from compatible catheters.

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 v.4.0 (K130594)

Submission Summary (Full Text)

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# JUN 0 6 2014

# 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.

#### Common or Usual Name 12.2

Electrophysiology Mapping System with console and catheter

## 12.3 Proprietary Name

EnSite Velocity System EnSite Contact Force Module

## 12.4 Classification Name

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

### 12.5 Hardware Description

The EnSite Velocity System consists of the following:

- . Display Workstation
- Amplifier .

#### 12.6 Predicate Device

The EnSite Velocity System EnSite Velocity System v.4.0 (K130594)

### 12.7 Indications for Use

Device Name: EnSite Velocity System

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

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When used with the EnSite Array™ Catheter, the EnSite Velocity 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 catheters in the heart.

When used with the SJM Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.

#### 12.8 Device Comparison to the Predicate Device

EnSite Velocity System with EnSite Contact Force Module has the same fundamental scientific technology as the predicate device, EnSite Velocity System v.4.0 (K130594). All technological characteristics of the EnSite Velocity System with EnSite Contact Force Module are substantially equivalent to the predicate device, EnSite Velocity System v.4.0 (K130594).

#### 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 Design Control Activities

The development of the EnSite Velocity System EnSite Contact Force Module 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 13.3. The reviewer should note that during development, the EnSite Velocity System EnSite Contact Force Module was referred to as Project Gamma.

#### 12.11 Conclusion

As in the use of the predicate device EnSite Velocity System v.4.0 (K130594). EnSite Contact Force Module has the same fundamental scientific technology as the predicate device, EnSite Velocity System v.4.0 (K130594). All technological characteristics of the EnSite Velocity System with EnSite Contact Force Module

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are substantially equivalent to the predicate device, EnSite Velocity System v.4.0 (K130594).

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 EnSite Contact Force Module to be substantially equivalent to the predicate device, EnSite Velocity System v.4.0 (K130594).

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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

#### Public Health Service

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

#### June 6, 2014

Donna Lunak Sr.Regulatory Specialist St. Jude Medical One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K141050

> Trade/Device Name: Ensite velocity system Regulation Number: 21 CFR 870.1425 Regulation Name: Electrophysiology Mapping System Regulatory Class: Class II Product Code: DQK Dated: April 22, 2014 Received: April 23, 2014

Dear Donna 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 CFR

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Page 2 - Donna Lunak

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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 Industry and Consumer Education 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,

forbram 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.
ଠାର

- 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 Name: EnSite Contact Force Module

Indications for Use:

When used with the St. Jude Medical Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.

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)

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St. Jude Medical

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