CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA

K073328 · Paieon, Inc. · IZI · Sep 9, 2008 · Radiology

Device Facts

• Record ID: K073328
• Device Name: CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
• Applicant: Paieon, Inc.
• Product Code: IZI · Radiology
• Decision Date: Sep 9, 2008
• Decision: SESE
• Submission Type: Traditional
• 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 can also perform quantitative analysis of the left ventricle based on left ventricular angiograms. 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 System is a software add-on for conventional X-ray angiography systems; processes 2D angiography images to generate 3D reconstructions of coronary vessel segments; performs quantitative analysis of arterial dimensions and left ventricular function. Used in catheterization labs or off-line by clinicians, technicians, and researchers. Output provides 3D visualization and quantitative metrics to assist in lesion evaluation and clinical decision-making; benefits include improved assessment of coronary stenosis and ventricular performance.

Clinical Evidence

Bench testing only. Software validation and performance evaluation were conducted to assess modifications. Results confirmed accuracy and precision within predetermined specifications, comparable to predicate devices.

Technological Characteristics

Software-based image processing system; functions as an add-on to conventional X-ray angiography systems. Utilizes 2D angiography inputs to perform 3D reconstruction and quantitative analysis. No specific hardware materials or energy sources listed as it is a software system.

Indications for Use

Indicated for clinicians, technicians, and research personnel to assist in the evaluation of coronary lesions and left ventricular function. Used in catheterization labs for real-time or post-procedural analysis of coronary vessel segments and left ventricular angiograms.

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 (K072591)
• QLV-CMS (K993765)
• CAAS Software package (K052988)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Paieon, Inc. % Ravit Barkama, M.D. Medical Director Paieon Medical Ltd. 747 Third Ave., 4th Floor NEW YORK NY 10017-2803

Re: K073328

Trade/Device Name: CardiOp-B System (version 2.1 with LVA) Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: August 21, 2008 Received: August 27, 2008

Dear Dr. Barkama:

We have reviewed your Section 510(k) premarket notification of intent to market the device for use stated in the 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.

SEP - 9 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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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" (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 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.

forque In Whang

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/2/Picture/1 description: The image shows the word "Paieon" in a stylized font, with a line underneath it. Below the word "Paieon" is the phrase "Realizing Cardiac Imaging". The text is black and the background is white.

## Indications for Use

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 can also perform quantitative analysis of the left ventricle based on left ventricular angiograms. 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)

Heidi Reem

(Posted November 13, 2003)

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

November 2007

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Image /page/3/Picture/0 description: The image shows the logo for Paieon. The logo consists of the word "Paieon" in a stylized font, with the first letter "P" in orange and the rest of the letters in black. Below the word "Paieon" is the phrase "Realizing Cardiac Imaging" in a smaller, sans-serif font.

510(k) SUMMARY

| 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: | Nov 22, 2007 |
| Device Trade Name: | The CardiOp-B System |
| Device Common Name: | Cardiovascular Angiography Analysis System |
| Classification Name: | Angiographic x-ray system |
| Predicate Devices: | CardiOp-B cleared for marketing under K072591, QLV-CMS<br>cleared under K993765 and CAAS Software package cleared<br>under K052988 |
| Device Description: | The CardiOp-B System is an image acquisition and<br>processing software system designed as an add-on to<br>conventional X-ray angiography systems. The CardiOp-B<br>system improves the output of coronary angiography by<br>presenting a three-dimensional reconstruction of the<br>stenosed vessel as well as quantitative cross-section<br>information. The LVA (Left Ventricular Analysis)<br>package is an addition to the CardiOp-B System which is<br>the subject of this Traditional 510(K). |

## 510(k) SUMMARY—CardiOp-B System

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510(k) SUMMARY

Image /page/4/Picture/1 description: The image shows the logo for Paieon. The logo consists of the word "Paieon" in a stylized font, with the first letter "P" in orange and the rest of the letters in black. Below the word "Paieon" is the phrase "Realizing Cardiac Imaging" in a smaller, bold font.

| 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<br>images of coronary vessel segments based on two to three 2D<br>angiography images obtained from single plane angiography.<br>CardiOp-B provides quantitative information regarding the<br>calculated dimensions of arterial segments based on the 3D<br>image. CardiOp-B can also perform quantitative analysis of the<br>left ventricle based on left ventricular angiograms. CardiOp-B is<br>intended for use in real-time in the catheterization lab and off-line<br>for post-procedural analysis. It is intended for use by clinicians,<br>technicians and research personnel. |
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| Performance Standards: | None |
| Performance Data: | Testing included software validation and performance evaluation.<br>Performance testing was performed to evaluate the modifications<br>to the CardiOp-B system and produced accuracy and precision<br>results within the predetermined specifications and comparable to<br>results obtained by the marketed predicate devices. |
| Substantial Equivalence: | The CardiOp-B system with the LVA package is similar in<br>intended use and technology (overall design, principle of action,<br>mode of operation, performance characteristics, etc.) to the<br>cleared predicate devices. |
| Conclusion: | The testing reported in this 510(K) establishes the modified<br>CardiOp-B is substantially equivalent to the predicate devices<br>and is safe and effective for its intended use. |