SYNC-RX SYSTEM, MODEL AS00010

K100849 · Sync-Rx, Ltd. · IZI · May 21, 2010 · Radiology

Device Facts

• Record ID: K100849
• Device Name: SYNC-RX SYSTEM, MODEL AS00010
• Applicant: Sync-Rx, Ltd.
• Product Code: IZI · Radiology
• Decision Date: May 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows: - To provide quantitative information regarding the calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.

Device Story

Sync-Rx System is an image acquisition and processing workstation for coronary catheterization labs. It captures fluoroscopic image streams to assist interventional cardiologists. The system performs quantitative coronary analysis (QCA), calculating lesion diameter, vessel diameter, lesion length, and percent stenosis. It also provides an on-line enhanced image stream for stent deployment, displayed side-by-side with native fluoroscopic images in both procedure and control rooms. The device aids clinical decision-making by providing objective measurements and improved visualization of the stent deployment region, potentially benefiting patients through more accurate device positioning and assessment.

Clinical Evidence

Bench testing only. Evidence includes software verification and validation tests, QCA validation, usability validation, input device mechanical compliance, design verification, electrical safety, and electromagnetic compatibility testing.

Technological Characteristics

Image acquisition and processing workstation. Complies with DICOM PS 3.3-2004, IEC 60601-1-4, IEC 62304, IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-6. Operates as a software package for angiographic X-ray systems. Connectivity via DICOM standards.

Indications for Use

Indicated for use in coronary catheterization procedures to provide quantitative arterial dimension measurements (diameter, length, stenosis) and enhance visualization of stent deployment regions. Intended for use by interventional cardiologists in catheterization labs or off-line for post-procedural analysis.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Paieon IC Pro System v 3.2 system (K082907)
• QCA Plus (K915542)

Submission Summary (Full Text)

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## 510(k) Summary: Sync-Rx System

This summary of substantial equivalence information is being submitted in accordance with the requirements set forth in 21 CFR 807.92.

Submitter: Sync-Rx Ltd.

Establishment Registration Number: Not Yet Assigned

#### Contact Information:

Sync-Rx. Ltd. 8 Hamelacha St. P.O.B. 8072 Netanya ISRAEL 42505 Tel. + 972-9-8362001 Fax. [phone] E-mail: [e-mail]

Date Prepared: January, 2010

Name of Device: Sync-Rx System

Classification Name: Angiographic X-ray System

#### Device Classification:

Classification: II Classification Panel: Regulation Number: 892.1600 Product Code: IZI

#### Predicate Device:

- Paieon IC Pro System v 3.2 system (K082907) manufactured by Paieon, Inc. (USA). .
- QCA Plus (K915542) manufactured by Sanders Data Systems, (USA). .

## Device Description:

The Sync-Rx System is an image acquisition and processing workstation situated in the coronary catheterization lab and intended to be used during coronary catheterizations.

The Sync-Rx System captures the fluoroscopic image stream and performs the following for assisting the interventional cardiologist:

- Lesion Evaluation: The system performs angiogram selection and quantitative coronary . measurements (lesion diameter, vessel diameter, lesion length, percent stenosis).
- . Device positioning, deployment and post-deployment: An on-line enhanced image stream is displayed side-by-side to the existing fluoroscopic image stream.

All functions performed by the Sync-Rx System are presented, both in the procedure room and in the control room, on a display that is situated side by side to the already-existing display of the native fluoroscopic image stream.

MAY 2 1 2010

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## Sync-Rx Ltd. - 510(k) Sync-Rx System Section 5: 510(k) Summary

#### Indication for Use:

The Sync-Rx System, an image acquisition and processing modular software package, is indicated for use as follows:

- To provide quantitative information regarding the calculated dimensions of arterial segments. .
- . To enhance visualization of the stent deployment region.
- To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. .

#### Performance Standards:

This 510(k) submission was written in accordance with the FDA Guidance document "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices- July 27, 2000", "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005", and "General Principles for Software Validation; January 2002". The design of the Sync-Rx System conforms to the following voluntary standards:

- Digital Imaging and Communications in Medicine (DICOM): PS 3.3-2004, National Electrical . Manufacturers Association.
- IEC/EN 60601-1-4:1997, General Requirements for Programmable Electrical Medical System. .
- . IEC 62304:2006, Medical Device Software - Software Lifecycle Processes.
- IEC/EN-60601-1: 1988 (201 ed.), Medical Electrical Equipment; Part 1: General Requirements for t Safety. Second edition, including amendments #1(1993), #2(1995) and #3(1996).
- IEC/EN 60601-1-2:2007, Medical Electrical Equipment; Part 1-2: Collateral Standard: ● Electromagnetic Compatibility- Requirements and Tests
- IEC 60601-1-6:2007, Medical electrical equipment Part 1-6:General requirements for basic safety . and essential performance - Collateral Standard: Usability
- . EN 980:2008, Graphical Symbols For Use In The Labeling Of Medical Devices

#### Test Data:

The Sync-Rx System has been subjected to extensive safety, performance testing, and verification / validation. Final testing of the Sync-Rx System included various performance tests and software validation tests designed to ensure that the device meet all of its functional specifications and is fit for its intended use. Tests have also been performed to ensure the device complies with industry and safety standards. The following list summarizes the testing performed on the device;

- Software Verification and Validation Tests �
- Sync-Rx System QCA Validation .
- . Sync-Rx System Usability Validation
- Input Device Mechanical Compliance .
- Sync-Rx System Design Verification ◆
- . Electrical Safety
- Electromagnetic Compatibility .

#### Substantial Equivalence:

The Sync-Rx System is substantially equivalent with respect to the indications for use, technological characteristics and performance characteristics to the identified legally marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, with three curved lines above the person. The symbol is black, and the text is also black.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Sync-Rx Ltd. % Mr. Clay Anselmo President and CEO Reglera LLC 555 Zang St., Suite 100 LAKEWOOD CO 80228

MAY 2 1 2010

Re: K100849

Trade/Device Name: Sync-Rx System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: March 25, 2010 Received: March 26, 2010

Dear Mr. Anselmo:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Sync-Rx System

Indications for Use:

The Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows:

- To provide quantitative information regarding the calculated dimensions of arterial a) segments.
- b) To enhance visualization of the stent deployment region.
- c) To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.

Prescription Use X (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 IF NEEDED)

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| 510K | K100849 |