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 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.

AI/ML Overview

The provided text for the Sync-Rx System 510(k) Summary and FDA clearance letter does not contain a detailed description of acceptance criteria or a specific study proving the device meets those criteria.

However, based on the information provided, we can infer some general aspects of the performance and the type of testing conducted.

Here's an attempt to structure the information based on your request, highlighting what is implicitly or explicitly mentioned and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Explicit)	Reported Device Performance (Inferred/Explicit)
Functional Specifications	Meets all functional specifications	Device meets all its functional specifications.
Intended Use	Fit for its intended use	Device is fit for its intended use.
Industry Standards	Complies with industry standards	Device complies with industry standards.
Safety Standards	Complies with safety standards	Device complies with safety standards.
Quantitative Information	Provides quantitative information regarding calculated dimensions of arterial segments.	The system effectively performs quantitative coronary measurements (lesion diameter, vessel diameter, lesion length, percent stenosis).
Enhance Visualization	Enhances visualization of the stent deployment region.	Provides an on-line enhanced image stream displayed side-by-side to the existing fluoroscopic image stream.
Software Validation	Software functions correctly and reliably.	Subjected to "Software Verification and Validation Tests" and "Sync-Rx System Usability Validation".
QCA Validation	Quantitative Coronary Angiography (QCA) measurements are accurate and reliable.	"Sync-Rx System QCA Validation" was performed. Specific metrics like accuracy, precision, or correlation were not provided.
Electrical Safety	Meets electrical safety requirements.	"Electrical Safety" testing was performed.
EMC	Meets electromagnetic compatibility requirements.	"Electromagnetic Compatibility" testing was performed.
Mechanical Compliance	Input devices are mechanically compliant.	"Input Device Mechanical Compliance" testing was performed.
Design Verification	Design meets specified requirements.	"Sync-Rx System Design Verification" was performed.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: This information is not provided in the document. The text mentions "various performance tests" and "Final testing," but no specific sample sizes for cases or measurements are given.
Data Provenance: This information is not provided. It is not specified if the data used for the tests was from a specific country, or if it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention an MRMC comparative effectiveness study or any studies comparing human reader performance with and without AI assistance. The device description focuses on the system assisting the interventional cardiologist, but no performance improvement metrics for human readers are provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document mentions "Sync-Rx System QCA Validation" and "Software Verification and Validation Tests," which typically involve evaluating the algorithm's performance. The "Lesion Evaluation" function specifies that "The system performs angiogram selection and quantitative coronary measurements." This suggests that the algorithm performs these tasks in a standalone manner, providing output to the user. However, specific standalone performance metrics (like sensitivity, specificity, accuracy for QCA) are not reported.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document mentions "Sync-Rx System QCA Validation." For QCA, ground truth is typically established by:
- Expert measurements/consensus: Manual measurements by experienced cardiologists or technicians, often considered the gold standard for comparison.
- Phantom studies: Using precisely manufactured phantoms with known dimensions.
- In-vitro measurements: Direct measurements of vessels or lesions in a controlled setting.
The specific type of ground truth used for the QCA validation and other performance tests is not explicitly stated.

8. The Sample Size for the Training Set

The document provides information on testing/validation but does not mention a training set or its sample size. This is common for 510(k) summaries where the focus is on validation rather than AI model development details. Given the date of the submission (2010), the term "AI" might not have been prevalent in regulatory submissions, and the system might rely on more conventional image processing algorithms rather than deep learning requiring extensive training data.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned (see point 8), this information is not applicable/provided.

Summary

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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. +972-9-8362020 E-mail: info@sync-rx.com

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Page 1 of 1
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K	K100849

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
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.(b)
Classification. Class II.