ENSITE VELOCITY SYSTEM

K130594 · St Jude Medical · DQK · May 3, 2013 · Cardiovascular

Device Facts

• Record ID: K130594
• Device Name: ENSITE VELOCITY SYSTEM
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: May 3, 2013
• 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. 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 a programmable diagnostic computer for cardiac electrophysiology. System components include a display workstation, amplifier, and interconnects. Operates by processing electrical signals from cardiac catheters or surface electrodes to map cardiac activity or visualize catheter positioning. Used in clinical settings by physicians to identify complex arrhythmias or guide catheter placement. Output is displayed on the workstation to assist in clinical decision-making during EP procedures, potentially improving diagnostic accuracy for complex arrhythmias.

Clinical Evidence

Bench and animal testing performed to confirm design requirements and safety/effectiveness. No clinical trial data provided.

Technological Characteristics

Programmable diagnostic computer (21 CFR 870.1425). System comprises display workstation, amplifier, and interconnects. Functions as an electrophysiology mapping system using catheter-based or surface electrode inputs. Software-based processing for cardiac mapping and catheter visualization.

Indications for Use

Indicated for patients undergoing electrophysiology studies. Used with EnSite Array Catheter for complex arrhythmias in the right atrium; used with EnSite NavX Surface Electrode Kit for displaying EP catheter positions 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 v.3.0 (K112688)

Submission Summary (Full Text)

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K130594

3 2013 MAY

### 12 510(k) Summary for Public Disclosure

#### Submitter's Name/Contact Person 12.1

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 Proprietary Name

EnSite Velocity System, Model EE3000

Consisting of:

Electrophysiology Workstation, Amplifier and Interconnects.

# 12.3 Classification Name

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

## 12.4 Hardware Description

The EnSite Velocity System consists of the following:

- Display Workstation .
- Amplifier ●

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- Interconnects . ●
# 12.5 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.
### 12.6 Device Comparison to the Predicate Device

The EnSite Velocity System v.4.0 has the same intended use and fundamental scientific technology as the predicate device, EnSite Velocity System v.3.0 (K112688). All technological characteristics of the EnSite Velocity System v.4.0 are substantially equivalent to the predicate device, EnSite Velocity System v.3.0 (K112688).

## 12.7 Summary of Non-Clinical Testing

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

#### 12.8 Summary of Design Control Activities

The development of the EnSite Velocity System v.4.0 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.

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# 12.9 Conclusion

The EnSite Velocity System v.4.0 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.4.0 are substantially equivalent to the predicate device, EnSite Velocity System v.3.0 (K112688).

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

May 3, 2013

St. Jude Medical C/O Donna Lunak One St. Jude Medical Drive St. Paul. MN 55117 US

Re: K130594

> Trade/Device Name: EnSite Velocity System v.4.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: March 4, 2013 Received: March 7, 2013

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. 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

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Page 2 - Ms. Donna Lunak

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/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 vours,

Owen P. Faris -S

for Bram D. Zuckerman, Ph.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 intended to display the position of conventional electrophysiology (EP) catheters 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)

Owen P. Faris -S
2013.05.03 10:07:21
-04'00'