C-THV SYSTEM

K113594 · Paieon, Inc. · IZI · Mar 2, 2012 · Radiology

Device Facts

• Record ID: K113594
• Device Name: C-THV SYSTEM
• Applicant: Paieon, Inc.
• Product Code: IZI · Radiology
• Decision Date: Mar 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

C-THV, an image acquisition and processing modular software package, is indicated for use as follows: • Assists in projection selection using 3D modeling based on 2D images • Performs dimensional measurements based on DICOM images. • Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. The system is to be used in-procedure and off-line for post-procedural analysis.

Device Story

C-THV (v4.6) is a modular software add-on for conventional X-ray angiography systems. It processes DICOM XA and bitmap images to assist clinicians in diagnosis, procedure planning, therapeutic staging, and post-deployment analysis. Modules include Optimal Projection (3D modeling from 2D images), Dimensional Measurements, Virtual Valve, and Positioning (real-time localization on roadmaps/live fluoroscopy). Used by clinicians in-procedure or off-line to guide device placement and assess anatomy. Output provides quantitative data and visual roadmaps, aiding clinical decision-making during cardiac interventions. Benefits include improved procedural accuracy and planning for complex heart disease and valve deployment.

Clinical Evidence

Bench testing only. Software validation and performance evaluation were conducted. Results demonstrated accuracy and precision within predetermined specifications.

Technological Characteristics

Modular software package; operates as an add-on to conventional X-ray angiography systems. Processes DICOM XA and bitmap imaging formats. Features include 3D modeling from 2D images, dimensional measurement algorithms, and real-time localization on roadmaps/live fluoroscopy. Standalone software architecture.

Indications for Use

Indicated for patients with vascular, congenital, valvular, and myopathic heart disease, and patients undergoing artificial valve deployment. Used in-procedure and 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

• IC-PRO System (version 3.5, model B) (K110256)

Submission Summary (Full Text)

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K113594

Image /page/0/Picture/1 description: The image shows the word "Paieon" in a stylized font, with the first letter "P" having a unique design. Below the word, there is a phrase "Realizing Cardiac Imaging" in a smaller, bold font. The text appears to be a logo or heading, possibly for a medical imaging company or service.

510(k) SUMMARY

## 510(k) SUMMARY- C-THV System

MAR 2 2012

MAR - 2

| Submitter Name: | Paieon Inc. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 |
| Contact Person: | Erez Ben-Zvi |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | November 24, 2011 |
| Device Trade Name: | C-THV System |
| Device Common Name: | Cardiovascular Angiography Analysis System |
| Classification Name: | Angiographic x-ray system |
| Predicate Devices: | The IC-PRO System (version 3.5, model B) cleared under K110256; |
| Device Description: | The C-THV (version 4.6) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system enhances the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic staging and post deployment analysis. The C-THV provides quantitative data of vessel and localizes device on predefined roadmaps. The C-THV is intended to be used in patients with vascular, congenital, valvular, and myopathic heart disease as well as with patients undergoing artificial valve deployment. The C-THV package includes and elaborates on previously developed, 510(k) cleared, and marketed modules of IC-PRO (version 3.5, model B) system. It comprised of the following modules: <ol><li>Optimal Projection</li><li>Dimensional Measurements</li><li>Virtual Valve</li><li>Positioning</li></ol> |

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Image /page/1/Picture/0 description: The image shows the word "Pajeon" in a stylized font, with a line underneath it. Below the line, the words "Realizing Cardiac Imaging" are printed in a smaller, bold font. The text appears to be a logo or heading, possibly for a medical imaging company or project.

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| Intended Use: | C-THV, an image acquisition and processing modular software<br>package, is indicated for use as follows:<br>• Assists in projection selection using 3D modeling based on 2D<br>images<br>• Performs dimensional measurements based on DICOM images.<br>• Assists in device positioning by providing real time localization<br>on predefined roadmaps and live fluoroscopy.<br>The system is to be used in-procedure and off-line for post- |
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| Performance<br>Standards: | procedural analysis.<br>None |
| Performance Data: | Testing included software validation and performance evaluation.<br>Performance tests have yielded accuracy and precision results<br>within the predetermined specifications. |
| Substantial<br>Equivalence: | All C-THV System modules are substantially equivalent to their<br>cleared predicate device modules in terms of indication and<br>intended use, technological characteristics, input and output,<br>measurements and operating environment.<br>All C-THV System modules, but the positioning are functioned the<br>same, have similar specifications and performances as in IC-PRO<br>System (version 3.5, model B).<br>The IC-PRO System is also an image acquisition and processing<br>software that has the ability to work with DICOM XA and Bitmap<br>imaging formats.<br>All found differences raise no new safety and effectiveness issues<br>or concerns. |
| Conclusion: | The testing reported in this 510(K) establishes that the C-THV<br>(version 4.6) is substantially equivalent to its predicate device and it<br>is safe and effective for its intended use. |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's body and wings.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAR - 2 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Paieon Medical Ltd. % Mr. Omer Barlev CEO Paieon, Inc. 747 Third Ave., 4th Floor NEW YORK NY 10017-2803

Re: K113594

Trade/Device Name: The C-THV System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI and LLZ Dated: November 24, 2011 Received: December 5, 2011

#### Dear Mr. Barlev:

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 (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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

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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Image /page/4/Picture/0 description: The image contains the word "Paieon" in a stylized font, with a line drawn underneath it. Below the line, the words "Realizing Cardiac Imaging" are printed in a smaller, sans-serif font. The text is black and the background is white.

INDICATIONS FOR USE

# Indications for Use

Device Name: The C-THV System

Indications for Use:

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

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

- Assists in projection selection using 3D modeling based on 2D images ■
- Performs dimensional measurements based on DICOM images. 트
- Assists in device positioning by providing real time localization on predefined 트 roadmaps and live fluoroscopy.

The system is to be used in-procedure and off-line for post-procedural analysis.

X 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 In Vitro Diagnostic Device Evaluation and Safety (OIVD)

(Posted November 13, 2003)

Mary Pastel
Division Sign-Off;

ין . מקומות Sizeneralical De vices Office of In Vitto Diagnestic Device Evanuation and Safety

510K K.113594