CARDIO-VIEW

K083321 · Curlview Igt, LLC · DXJ · Nov 26, 2008 · Cardiovascular

Device Facts

• Record ID: K083321
• Device Name: CARDIO-VIEW
• Applicant: Curlview Igt, LLC
• Product Code: DXJ · Cardiovascular
• Decision Date: Nov 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments 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

Cardio-View is a large-screen medical display system designed for procedure rooms (e.g., electrophysiology, heart surgery). It functions as a video integrator and repeater, consolidating disparate video signals from multiple sources—such as anesthesiology monitors, EKG systems, CAT/MRI simulators, and fluoroscopes—onto a single display. Physicians and medical technologists operate the system via a touchpad, which allows for customized layouts, overlapping images, and selection of areas of interest. The device enables simultaneous monitoring of multiple procedure room activities, facilitating clinical decision-making by providing a centralized view of patient data. It also supports data recording and archiving from connected sources. The system benefits patients by improving the efficiency and situational awareness of the clinical team during complex procedures.

Clinical Evidence

Bench testing only. Electrical safety testing was conducted to meet IEC 60601-1 and IEC 60601-1-1 standards.

Technological Characteristics

Large-screen medical display; integrates off-the-shelf video sources; touchpad control interface; supports data recording and archiving; electrical safety compliant with IEC 60601-1 and IEC 60601-1-1.

Indications for Use

Indicated for use by healthcare professionals in medical procedure laboratories to integrate and display video outputs from multiple commercially-available 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

• Electrophysiology Systems Integrator (EPSI) SystemsOne, LLC (K073372)

Submission Summary (Full Text)

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## TRADITIONAL 510(K) SUMMARY 5.0

| Submitted by: | CurlView IGT, LLC<br>1242 Chestnut Street<br>Newton, MA 02464<br>Phone: [phone] |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ward Sparacio, CEO |
| Summary Date: | November 3, 2008 |
| Proprietary Name: | Cardio-View |
| Common Name: | Display, Cathode-Ray, Medical |
| CFR Reference: | 21CFR§870.2450 |
| Class: | II |
| Product Code: | DXJ |
| Equivalent Marketed<br>Device(s): | Electrophysiology Systems Integrator (EPSI)<br>SystemsOne, LLC (K073372) |
| Device Description: | Cardio-View is a very large screen monitor for integrating the<br>outputs from multiple video sources onto a single display.<br>This unit is ideally suited for training labs where physicians<br>and medical technologists can simultaneously view the<br>disparate systems in use in the procedure rooms for complex<br>procedures such as electrophysiology and heart surgery.<br><br>The single display can be set up with customized views of<br>many different procedure room activities to emphasize a<br>particular area of interest while still providing the ability to<br>monitor many others.<br><br>For example, the display might simultaneously show the<br>information being provided by an anesthesiology monitoring<br>system, an EKG monitoring system, a CAT/MRI simulator,<br>and fluoroscope; with each optimally-positioned for the type<br>of procedure underway.<br><br>While the display is primarily designed as an integrator and<br>repeater of the many individual monitors typically in use in<br>the procedure room; there is really no limit as to where it can<br>actually be used. |
| intended Use: | The Cardio-View system is intended to be used by health<br>care professionals to integrate the video outputs from several<br>commercially-available instruments commonly used in a<br>medical procedure laboratory into a single video display.<br>Control of the video sources is accomplished using a<br>touchpad device. |
| Technological<br>Characteristics: | The Cardio-View system integrates multiple technologies<br>available "off-the-shelf" from different manufacturers so they<br>can be easily managed with less equipment. The system<br>allows for numerous overlapping images from existing<br>medical instrumentation to be viewed on the same large<br>screen; records and archives data from multiple sources that<br>are accessible on a single station and provides easy retrieval<br>and control of all onscreen data via touchpad controls. |
| Substantial Equivalence<br>Rationale: | Based on an analysis of the technology and intended use of<br>the predicate device cited, CurlView IGT, LLC, believes that<br>the Cardio-View system is substantially equivalent to the<br>device currently approved and on the market. |
| Test Conclusions: | CuriView IGT, LLC, has conducted extensive testing of the<br>Cardio-View system during development and installation. In<br>addition, all electrical safety testing necessary to meet the<br>IEC 60601-1 and its collateral standard IEC 60601-1-1 was<br>completed by an experienced medical device electrical<br>testing facility. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Curlview IGT, LLC c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

NOV 2 6 2008

Re: K083321

Trade/Device Name: Cardio-View Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: November 11, 2008 Received: November 12, 2008

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 cquivalent (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. 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

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## Page 2 - Mr. Mark Job

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

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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K083321 pg 1 of 1

Page 4-1 of 1

## 4.0 INDICATIONS FOR USE STATEMENT

510(k) Number: N/A

Device Name: Cardio-View

Indications For Use:

The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments 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: YES

AND/OR

Over-the-Counter Use: NO

(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) | for B Zuckerman |
|------------------------------------|-----------------|
| | 11/26/08 |
| Division of Cardiovascular Devices | |
| 510(k) Number | K083321 |