ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)

K073372 · Systemsone · DXJ · Dec 7, 2007 · Cardiovascular

Device Facts

• Record ID: K073372
• Device Name: ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
• Applicant: Systemsone
• Product Code: DXJ · Cardiovascular
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.

Device Story

EPSI is a video integration system for clinical environments (electrophysiology, cardiac catheterization, fluoroscopy labs). It accepts video inputs from multiple commercially-available medical instruments via a video splitter. The system uses a KVM switch and a flat-panel LCD monitor to display overlapping images from these sources on a single screen. A touchpad panel allows healthcare professionals to control and manage the video sources. The device facilitates data viewing, recording, and archiving from multiple sources at a single station, aiding clinical decision-making by consolidating information for the provider.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety testing to IEC 60601-1 and IEC 60601-1-1 standards.

Technological Characteristics

Video integration system using off-the-shelf components. Includes video splitter, KVM switch, and flat-panel LCD monitor. Controlled via touchpad. Electrical safety compliant with IEC 60601-1 and IEC 60601-1-1. Provides multi-source image overlay, recording, and archiving.

Indications for Use

Indicated for use by healthcare professionals in electrophysiology, cardiac catheterization, or fluoroscopy labs to integrate and display video outputs from multiple medical instruments on a single screen.

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

• CIC Pro Clinical Information Center Central Station, GE Medical (K053356)
• HP CareVue 9000, Hewlett-Packard (K992636)
• Medical Multi-Disclosure Workstation, SpaceLabs (K962811)

Submission Summary (Full Text)

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## 510(k) Summary or Statement

K073372

## DEC 0 7 2007

| Submitted by: | SystemsOne, LLC<br>6130 Blackberry Street, Suite B<br>Anchorage, AK 99502<br>Phone: [phone] |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | M. W. (Andy) Anderson, Ph.D., RAC<br>Principal Advisor<br>Regulatory and Clinical Research Institute, Inc.<br>5353 Wayzata Boulevard, Suite 505<br>Minneapolis, MN 55416 |
| Summary Date: | November 8, 2007 |
| Proprietary Name: | Electrophysiology Systems Integrator (EPSI) |
| Common Name: | Display, Cathode-Ray, Medical |
| CFR Reference: | 21CFR§870.2450 |
| Class: | II |
| Product Code: | DXJ |
| Equivalent Marketed Device(s): | CIC Pro Clinical Information Center Central<br>Station, GE Medical, K053356<br>HP CareVue 9000, Hewlett-Packard, K992636<br>Medical Multi-Disclosure Workstation,<br>SpaceLabs, K962811 |
| Device Description: | The EPSI is a video integration system that uses<br>a video splitter to take the original source image<br>from a device and send it out to a variety of<br>locations, such as the original intended monitor,<br>a hemodynamics recording system in the control<br>room, etc. The split image is then sent into the<br>EPSI system (Flat Panel LCD monitor) and a<br>Keyboard-Video-Mouse (KVM) switch. The<br>display on the LCD at any time is controlled by a<br>touchpad panel. |

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K073372 p. 2/2

Intended Use: The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device. Technological Characteristics: The EPSI system integrates multiple technologies available "off-the-shelf" from

different manufacturers so they can be easily managed with less equipment. The system allows for numerous overlapping images from existing medical instrumentation to be viewed on the same large screen; records and archives data from multiple sources that are accessible on a single station and provides easy retrieval and control of all onscreen data via touchpad controls.

Substantial Equivalence Rationale: Based on an analysis of the technology and intended use of the predicate devices cited, SystemsOne, LLC, believes that the EPSI system is substantially equivalent to several devices currently on the market.

> Test Conclusions: SystemsOne, LLC, has conducted extensive testing of the EPSI system during development and installation. In addition, all electrical safety testing necessary to meet the IEC 60601-1 and its collateral standard IEC 60601-1-1 was completed by an experienced medical device electrical testing facility.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

DEC 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073372

Electrophysiology Systems Integrator (EPSI) Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: November 30, 2007 Received: December 3, 2007

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 such 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.

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Page 2 - 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Bfimmerman for

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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## Indications for Use Statement

Indications for Use

073372

510(k) Number (if known):
n/a

Device Name: Electrophysiology Systems Integrator (EPSI)

Indications for Use:

The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimmerma

(Division Sign-Off)
Division of Cardiovascular Devices