IC-PRO SYSTEM, VERSION 3.1.0.4

K082907 · Paieon, Inc. · IZI · Nov 18, 2008 · Radiology

Device Facts

• Record ID: K082907
• Device Name: IC-PRO SYSTEM, VERSION 3.1.0.4
• Applicant: Paieon, Inc.
• Product Code: IZI · Radiology
• Decision Date: Nov 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: a. To assist 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. b. To provide quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. c. To perform quantitative analysis of the left ventricle based on left ventricular angiograms. d. To enhance visualization of the stent deployment region and provide quantitative data based on manual stent tracing. 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.

Device Story

IC-PRO is a modular software add-on for conventional X-ray angiography systems; designed for use in catheterization labs or off-line settings. Input consists of 2D angiography images (single plane). Software processes these inputs to reconstruct 3D images of coronary vessel segments; performs quantitative analysis of left ventricle; enhances visualization of stent deployment regions; provides quantitative dimensional data based on manual stent tracing. Clinicians and technicians use output to assist in diagnosis, procedure planning, and post-deployment analysis. Benefits include improved visualization and objective quantitative assessment of cardiac structures and stent placement.

Clinical Evidence

Bench testing only. Performance evaluation included software validation and accuracy/precision testing against predetermined specifications. Results were comparable to marketed predicate devices.

Technological Characteristics

Modular software package for X-ray angiography systems. Functions as an add-on to existing imaging hardware. Provides 3D reconstruction from 2D images, quantitative vessel/ventricular analysis, and stent visualization. Operates via software-based image processing algorithms.

Indications for Use

Indicated for clinicians, technicians, and research personnel to assist in coronary lesion evaluation, left ventricular analysis, and stent deployment visualization. Uses 2D angiography images to create 3D vessel models and provide quantitative dimensional measurements. Used in-procedure 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

• CardiOp-B (K073328)
• StentBoost (K041949)
• CAAS Software Package (K052988)

Submission Summary (Full Text)

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K082907

# NOV 1 8 2008

# Realizing Cardiac Imaging

## 510(k) SUMMARY

| Submitter Name: | Paieon Inc. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 |
| Contact Person: | Shahar Mandelboim |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | June 4, 2008 |
| Device Trade Name: | The IC-PRO System |
| Device Common Name: | Cardiovascular Angiography Analysis System |
| Classification Name: | Angiographic x-ray system |
| Predicate Devices: | CardiOp-B cleared for marketing under K073328, StentBoost<br>cleared for marketing as a feature of Allura Xper FD10 under<br>K041949 and CAAS Software Package cleared for marketing<br>under K052988. |
| Device Description: | The IC-PRO System is an image acquisition and processing<br>modular software package designed as an add-on to conventional<br>X-ray angiography systems. This system improves the output of<br>cardiovascular angiography by providing software modules that<br>assist in diagnosis, procedure planning and post deployment<br>analysis. IC-PRO enhances visualization and provides<br>quantitative data of vessel, left ventricular and stent dimensions. |

# 510(k) SUMMARY- IC-PRO System

・

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#### 510(k) SUMMARY

IC-PRO, an image acquisition and processing modular software Intended Use: package, is indicated for use as follows: a. To assist 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. b. To provide quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. c. To perform quantitative analysis of the left ventricle based on left ventricular angiograms. d. To enhance visualization of the stent deployment region and provide quantitative data based on manual stent tracing. To be used in-procedure in the catheterization lab and offe. line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel. Performance Standards: None Performance Data: Testing included software validation and performance evaluation. Performance testing was performed to evaluate the IC-PRO System and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices. The IC-PRO System is similar in intended use and technology Substantial Equivalence: (overall design, principle of action, mode of operation, performance characteristics, etc.) to the cleared 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paieon, Inc. % Ms. Shahar Mandelboim VP R&D Paicon Medical LTD. 23 Hamelacha St, P.O.B. 11355 Rosh Haayin, 48091 ISRAEL

Re: K082907

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: September 11, 2008 Received: October 15, 2008

#### Dear Ms. 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.

NOV 1 8 2008

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

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 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 894.xxx. | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 vours.

Jorge M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Image /page/4/Picture/1 description: The image shows the word "Paieon" in a stylized font. Below the word "Paieon" is the phrase "Realizing Cardiac Imaging". The text is black and the background is white.

L082907

# Indications for Use

Device Name: The IC-PRO System

Indications for Use:

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.
- 트 Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
- 트 Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- 트 To be used in-procedure in the catheterization lab and off-line for postprocedural analysis

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003) (Division Sign-Off)

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