Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
Assist in device positioning by providing real time localization on predefined roadmaps.
To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

Device Description

The IC-PRO (version 3.2) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. IC-PRO (version 3.2) provides quantitative data of vessel, left ventricular and stent dimensions enhances visualization and localizes device on predefined roadmaps.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the IC-PRO System based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary states that "Performance Data: The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices."

However, the specific "predetermined specifications" (i.e., the acceptance criteria with numerical targets) and the corresponding "accuracy and precision results" for the IC-PRO System are not explicitly detailed or quantified in the provided text. The document only generically states that the system's performance was acceptable when compared to predicate devices.

Therefore, the table below reflects what can be inferred rather than explicitly stated.

Acceptance Criteria (Inferred from comparison to predicates)	Reported Device Performance (Inferred as meeting criteria)
Device accuracy within predetermined specifications.	IC-PRO System achieved accuracy "within the predetermined specifications" when compared to predicate devices.
Device precision within predetermined specifications.	IC-PRO System achieved precision "within the predetermined specifications" when compared to predicate devices.

Study Information

Based on the provided text, the available study information is as follows:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but given the submitter's address (Israel), it's possible that data originated from Israel or other international sites. It is also not specified whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The document only mentions "Performance Data: The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices." There is no mention of an adjudication process for a test set.
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:
- No, an MRMC comparative effectiveness study was not mentioned. The study described focuses on comparing the device's performance to predicate devices, not on how human readers perform with or without the device's assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The statement "The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices" suggests a standalone evaluation of the software's output against a reference (likely the predicate devices' output or a clinical standard). There is no mention of a human-in-the-loop component in this performance testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation appears to be the results obtained by the marketed predicate devices. The exact nature of how this "ground truth" was established for the predicate devices, or if there was an independent clinical standard used as the ultimate ground truth, is not detailed.
The sample size for the training set:
- Not specified. (The document focuses on performance evaluation rather than development details like training sets).
How the ground truth for the training set was established:
- Not specified, as the training set details are not provided.

Summary

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FEB 1.7 2009

510(k) SUMMARY

510(k) SUMMARY- IC-PRO System

Submitter Name:

Paieon Inc.

Submitter Address:

Contact Person: Phone Number:

+972 3 915 0000

+972 3 901 2324

Shahar Mandelboim

Fax Number:

Device Trade Name:

Classification Name:

Predicate Devices:

Device Description:

Device Common Name:

Date Prepared:

December 8, 2008

The IC-PRO System

Cardiovascular Angiography Analysis System

Angiographic x-ray system

The IC-PRO (version 3.1) System cleared under K082907; The inReach system cleared for marketing under K081379; The Angio IVUS Mapping System cleared under K060483. The Ostial PRO Stent Positioning System cleared under K062192;

747 Third Ave., 4th floor New York, NY 10017-2803

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510(k) SUMMAR Y

lizing Cardiac Imagin

Performance Standards:

Intended Use:

IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:

1. Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
1. Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
1. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
Assist in device positioning by providing real time 4. localization on predefined roadmaps.
1. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

It is intended for use by clinicians, technicians and research personnel.

None

Testing included software validation and performance evaluation. Performance Data: The performance tests were made to evaluate the IC-PRO System and vield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices.

Substantial Equivalence: The intended use and technological characteristics of the IC-PRO (version 3.2) are substantially equivalent to a combination of the intended use and technological characteristics of the predicate devices.

The testing reported in this 510(K) establishes that IC-PRO is Conclusion: substantially equivalent to the predicate devices and is safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paieon, Inc. % Mr. Shahar Mandelboim Vice President R & D Paieon Medical Ltd. 23 Hamelacha St., P.O.B 11355 Rosh Haavin 48091 ISRAEL

Re: K083745

Trade/Device Name: The IC-PRO System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: December 11, 2008 Received: December 17, 2008

Dear Mr. Mandelboim:

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.

FEB 1 7 2009

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.

{3}------------------------------------------------

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 os 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 one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Manufactures. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.

Sincerely yours,
Laima B. Murrel

anine M. Morris Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

Indications for Use

Device Name: The IC-PRO System

Indications for Use:

ieon Realizing Cardiac Imaging

IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:

. Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
Assist in device positioning by providing real time localization on predefined roadmaps.
To be used in-procedure in the catheterization lab and off-line for postprocedural analysis

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulstine

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

(Posted November 13, 2003)

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.