CARDIOP-B SYSTEM, VERSION 2.1

K072591 · Paieon, Inc. · IZI · Oct 10, 2007 · Radiology

Device Facts

• Record ID: K072591
• Device Name: CARDIOP-B SYSTEM, VERSION 2.1
• Applicant: Paieon, Inc.
• Product Code: IZI · Radiology
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CardiOp-B System is a software system that 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. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

Device Story

CardiOp-B is an add-on software system for conventional X-ray angiography systems; used in catheterization labs or off-line for post-procedural analysis. Input: two to three 2D angiography images from single-plane angiography. Processing: 3D reconstruction of coronary vessel segments; quantitative analysis of stenosed vessels, including bifurcation and side-branch analysis. Output: 3D images and quantitative cross-section measurements of arterial segments. Clinicians use output to evaluate coronary lesions and inform clinical decision-making regarding vessel stenosis. Benefits include improved visualization and objective dimensional data for cardiac assessment.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software validation and phantom performance evaluation to verify the accuracy of 3D reconstruction and quantitative measurements for the modified features.

Technological Characteristics

Software-based 3D vessel analysis system; add-on to conventional X-ray angiography systems. Utilizes 3D reconstruction algorithms to process 2D angiography inputs. Operates in real-time or off-line environments.

Indications for Use

Indicated for clinicians, technicians, and research personnel to assist in the evaluation of coronary lesions by creating 3D images and providing quantitative dimensional analysis of coronary vessel segments using 2-3 2D single-plane angiography images.

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 (K030139)
• QCA-CMS (K993763)
• CAAS QCA 3D (K063344)

Submission Summary (Full Text)

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K07259/

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510(k) SUMMARY

### 510(k) SUMMARY—CardiOp-B System

OCT 』0 2007

| Submitter Name: | Paieon Inc. | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 | | |
| Contact Person: | Ravit Barkama, MD | | |
| Phone Number: | [phone] | | |
| Fax Number: | [phone] | | |
| Date Prepared: | Sept 12, 2007 | | |
| Device Trade Name: | The CardiOp-B System | | |
| Device Common Name: | 3D Vessel Analysis System | | |
| Classification Name: | 3D Vessel Analysis System | | |
| Predicate Devices: | CardiOp-B cleared for marketing under K030139, QCA-CMS cleared<br>under K993763 and CAAS QCA 3D cleared under K063344 | | |
| Device Description: | The CardiOp-B System is an image acquisition and processing software<br>system designed as an add-on to conventional X-ray angiography<br>systems. The CardiOp-B system improves the output of coronary<br>angiography by presenting a three-dimensional reconstruction of the<br>stenosed vessel as well as quantitative cross-section information. The<br>modifications to the CardiOp-B System which are the subject of this<br>Special 510(K) include:<br>Bifurcation and side-branch analysis | | |

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Realizing Cardiac Imaging

### 510(k) SUMMARY

| Intended Use: | The CardiOp-B System is a software system that assists in the<br>evaluation of coronary lesions by enabling the creation of 3D images of<br>coronary vessel segments based on two to three 2D angiography<br>images obtained from single plane angiography. CardiOp-B provides<br>quantitative information regarding the calculated dimensions of arterial<br>segments based on the 3D image. CardiOp-B is intended for use in<br>real-time in the catheterization lab and off-line for post-procedural<br>analysis. It is intended for use by clinicians, technicians and research<br>personnel |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics<br>Compared to Predicate Device: | The technological characteristics, e.g., overall design, principle of<br>action, mode of operation, performance characteristics, etc., and the<br>intended use of the Cardio-Op B system are substantially equivalent to<br>the predicate devices cited above. |
| Performance Data: | Applicable performance testing was performed to evaluate the<br>modifications to the CardiOp-B system. Testing included software<br>validation and phantom performance evaluation. The test results were<br>found to be acceptable as required by the respective test plans and<br>protocols, demonstrating that the modified device performs according<br>to its specifications. The test results did not raise new safety or<br>effectiveness issues. |
| Conclusion: | The testing reported in this 510(K) establishes the modified CardiOp-B<br>is substantially equivalent to the predicate devices and is safe and<br>effective for its intended use. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT 1 0 2007

Paieon, Inc. % Ravit Barkama, M.D. Medical Director Paieon Medical Ltd. 23 Hamelacha St., P.O.B 11355 Rosh Haavin 48091 ISRAEL

Re: K072591

Trade/Device Name: The CardiOp-B System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI

Dated: September 12, 2007 Received: September 14, 2007

#### Dear Dr. Barkama:

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 either class II (Special Controls) or class III (Premarket Approval), 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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Promoting and Promoting Public Health.

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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). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Paieon
Realizing Cardiac Imaging

INDICATIONS FOR USE

# Indications for Use

510(k) Number (if known): K072591

Device Name: The CardiOp-B System

Indications for Use:

The CardiOp-B System is a software system that 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. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

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)

Ami M. M.

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

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(Posted November 13, 2003)

Sept 2007