ENSITE VELOCITY SYSTEM V1.3

K093942 · St Jude Medical · DQK · Feb 25, 2010 · Cardiovascular

Device Facts

• Record ID: K093942
• Device Name: ENSITE VELOCITY SYSTEM V1.3
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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

EnSite Velocity System is an electrophysiology mapping system consisting of a workstation, amplifier, EnSite Array multi-electrode diagnostic catheter, and EnSite NavX surface electrode kit. Used in clinical settings by physicians to perform electrophysiology studies. System inputs include electrical signals from the EnSite Array catheter or conventional EP catheters tracked via surface electrodes. The system processes these inputs to generate cardiac maps or display catheter positions within the heart. Output is visualized on the workstation display, assisting physicians in identifying complex arrhythmias and navigating catheters during procedures. Benefits include improved visualization and diagnostic capability for complex cardiac arrhythmias.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes display workstation, amplifier, EnSite Array multi-electrode diagnostic catheter (Model EC1000), and EnSite NavX surface electrode kit (Model EN0010). Operates as a programmable diagnostic computer (21 CFR 870.1425).

Indications for Use

Indicated for patients requiring electrophysiology studies. Used with EnSite Array Catheter for complex arrhythmias in the right atrium; used with EnSite NavX Surface Electrode Kit for displaying 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.

Submission Summary (Full Text)

{0}------------------------------------------------

## 12 510(k) Summary for Public Disclosure

FEB 2 5 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

{1}------------------------------------------------

#### 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 v. 1.3 (EnSite Derexi Module) has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v. 1.3 are substantially equivalent to the predicate device.

#### Summary of Non-Clinical Testing 12.8

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

#### Summary of Design Control Activities 12.9

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

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.

{2}------------------------------------------------

K093942 \$\frac{3}{3}\$

Therefore, St. Jude Medical considers the EnSite Velocity System to be substantially equivalent to the predicate device.

(

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, abstract design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Regulatory Technology Services LLC. c/o Mr. Mark Job Third Party Official 1394 25th Street NW Buffalo, MN 55313

FEB 2 5 2010

Re: K093942

Trade/Device Name: EnSite Velocity System v1.3 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: January 27, 2010 Received: February 1, 2010

Dear Mr. Job:

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.

{4}------------------------------------------------

Page 2 - Ms. Mark Job

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 (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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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

{5}------------------------------------------------

# ו/ח בו

## 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.
Over-The-Counter Use Prescription Use AND/OR (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.W.W.C.

510(k) Number K0823942