VANTAGE VIEW SYSTEM

K110085 · St Jude Medical · DXJ · Jan 26, 2011 · Cardiovascular

Device Facts

• Record ID: K110085
• Device Name: VANTAGE VIEW SYSTEM
• Applicant: St Jude Medical
• Product Code: DXJ · Cardiovascular
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.

Device Story

VantageView System is a 56-inch high-definition LCD monitor designed for electrophysiology (EP) laboratories. It accepts video inputs from up to 16 commercially available EP lab systems (e.g., fluoroscopy, EP-WorkMate, EnSite Velocity, MediGuide) and integrates up to 8 simultaneous video displays onto a single screen. Operated by healthcare professionals via a touchpad, the device provides a centralized observation point for monitoring multiple data sources. By consolidating disparate video feeds, the system facilitates real-time clinical monitoring and decision-making during complex EP procedures, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

Bench testing only. Testing included system verification, standard-based testing, simulated clinical testing, and Instructions for Use (IFU) validation. Electrical safety testing was conducted to meet IEC 60601-1 and IEC 60601-1-1 standards.

Technological Characteristics

56-inch high-definition (HD) LCD display monitor. Integrates up to 8 video displays from up to 16 video sources. Controlled via external touchpad. Complies with IEC 60601-1 and IEC 60601-1-1 electrical safety standards.

Indications for Use

Indicated for use by healthcare professionals during electrophysiology procedures to integrate multiple video outputs into a single display.

Regulatory Classification

Identification

A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Predicate Devices

• Cardio-View Manufactured by: Carrot Medical-CurlView (083321-)

Submission Summary (Full Text)

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AN 2: 6 2011

One St. Jude Medical Drive St. Paul, MN 55117-9913

K110085 /

**Date Prepared:** December 21, 2010

Establishment Address and Registratio St. Jude Medical One St. Jude Medical Drive t. Paul, MN 55117-9913 stablishment Registration Number: 218414

## 12.2 Submitter's Name/Contact Pers

Kris Miller St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117-9913

## Device Classific.

Trade Name: Common Name: Classification Name:

VantageView System Medical cathode-ray tube display 870.2450, display, cathode-ray tube, medical

### 12.4 Predicate Device

Cardio-View Manufactured by: Carrot Medical-CurlView (083321-

## 12.5 Indications for Us

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he VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device

## Traditional 510(k) VantageView System

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One St. Jude Medical Drive St. Paul, MN 55117-9913

# 12.6 Device Description

The VantageView System uses a 56 inch, high definition (HD), LCD display monitor that is able to integrate up to 8 video displays from up to 16 video sources. The video inputs are typically from common electrophysiology (EP) equipment used in an EP Lab (e.g. Fluoroscopy, the EP-WorkMate System, the EnSite Velocity System, MediGuide Technology, etc.) This technology creates one focused observation point for monitoring the selected displays simultaneously. ಿಗೆ ಮಾಡಿ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರ

### 12.7 Summary of Non-Clinical Testing

SJM has conducted extensive testing of the VantageView System during development and installation.

Bench testing was performed to confirm that the product met design requirements and did not affect the safety or effectiveness of the product. The following non-clinical tests were performed: system verification testing, standard based testing, simulated clinical testing, and Instructions for Use (IFU) validation.

In addition, all electrical safety necessary to meet the IEC 60601-1 and collateral standard IEC 60601-1-1 was completed by an experienced medical device electrical testing facility.

### 12.8 Summary of Design Control Activities

The development of the VantageView System was performed in accordance with St. Jude Medical's Quality System requirements and in compliance with Quality System Regulations design controls requirements documented in 21 CFR 820.30.

# Traditional 510(k) VantageView System

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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 Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

JAN 26 Car

.

Re: K110085

Trade/Device Name: Vantage View System Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: January 10, 2011 Received: January 11, 2011

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), if your device is elabilities not about of . 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.

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Page 2 – St. Jude Medical c/o Mr. 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 (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/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/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 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 Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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One St. Jude Medical Drive St. Paul, MN 55117-9913

- ട് Indications for Use
510(k) Number (if known):

Device Name: VantageView System

Indications for Use:

The VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.

Prescription Use______________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K161652

Traditional 510(k) VantageView System