Who is the manufacturer of THE CARDIOP-B SYSTEM?

Paieon, Inc. filed the 510(k) submission for THE CARDIOP-B SYSTEM (K030139).

What is the FDA product code for THE CARDIOP-B SYSTEM?

IZI. It is classified under 21 CFR 892.1600 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for THE CARDIOP-B SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for THE CARDIOP-B SYSTEM?

QCA-CMS by MEDIS Medical Imaging Systems Inc. (K993763).

Who can help prepare an FDA 510(k) submission like THE CARDIOP-B SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

THE CARDIOP-B SYSTEM

K030139 · Paieon, Inc. · IZI · Apr 2, 2004 · Radiology

Device Facts

Record ID	K030139
Device Name	THE CARDIOP-B SYSTEM
Applicant	Paieon, Inc.
Product Code	IZI · Radiology
Decision Date	Apr 2, 2004
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 an add-on system to single plane angiography that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on 2D angiography images. 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.

Device Story

CardiOp-B is a software-based add-on for conventional X-ray angiography systems; operates on off-the-shelf hardware. Input: 2-3 2D angiography images of coronary vessels. Processing: 3D reconstruction of stenosed vessel segments; quantitative analysis of cross-sectional area, diameter, and length. Output: 3D vessel visualization and quantitative dimensional data. Used in catheterization labs (real-time) or offline for post-procedural analysis by clinicians, technicians, and researchers. Assists healthcare providers in evaluating coronary lesions; provides objective measurements to support clinical decision-making regarding arterial segments.

Clinical Evidence

Bench testing on phantoms demonstrated accuracy and precision within specifications, comparable to marketed QCA systems. Clinical validation involved testing on clinical images; results showed correlation in Minimal Lumen diameter and length measurements compared to the predicate QCA device.

Technological Characteristics

Software-based system running on Windows XP. Performs 3D reconstruction from 2-3 2D angiography images. Quantitative analysis based on cross-sectional area, diameter, and length. Operates as an add-on to existing X-ray angiography systems.

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 measurements of coronary vessel segments using 2-3 2D 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

QCA-CMS by MEDIS Medical Imaging Systems Inc. (K993763)

Related Devices

K072591 — CARDIOP-B SYSTEM, VERSION 2.1 · Paieon, Inc. · Oct 10, 2007
K073328 — CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA · Paieon, Inc. · Sep 9, 2008
K082907 — IC-PRO SYSTEM, VERSION 3.1.0.4 · Paieon, Inc. · Nov 18, 2008
K110256 — THE IC-PRO SYSTEM · Paieon, Inc. · May 27, 2011
K083745 — THE IC-PRO SYSTEM, MODEL VERSION 3.2 · Paieon, Inc. · Feb 17, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "Paieon Inc." in a stylized font. Below the company name, there is a handwritten string of characters that appears to be a signature or code. To the left of the company name, the number "2.2004" is printed, likely indicating a date. CardıUp-B Traditional 510(k) Summary ## APR - 2 2004 RY—CardiOp-B System 510(k | Submitter Name: | Paieon Inc. | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 | | Contact Person: | Hadar Marom, MD | | Phone Number: | +972 3 938 6796 | | Fax Number: | +972 3 903 1830 | | Date Prepared: | 07/01/2003 | | Device Trade Name: | The CardiOp-B System | | Device Common Name: | 3D Vessel Analysis System | | Classification Name: | Accessory to x-ray angiographic system | | Predicate Devices: | QCA-CMS by MEDIS Medical Imaging Systems Inc. (K993763) | | Device Description: | The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp- B system presents a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The system includes a software package that runs on off-the-shelf hardware. CardiOp-B's features and benefits include 3D reconstruction, real- time and quantitative measurements. | | Intended Use: | The CardiOp-B System is an add-on system to single plane angiography that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on 2D angiography images. 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. | November 2002 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "Paieon Inc.". The text is in a stylized font, with the "P" being larger than the other letters. There is a line underneath the text. 36139 CardIOp-B Traditional 510(k) Summary | Device Technological Characteristics and Comparison to Predicate Device(s): | The CardiOp-B system is comprised of software that runs on the Windows XP operating system. The QCA-CMS system runs on Windows NT. The CardiOp-B system analyzes 2-3 angiography images to create a 3D image as well as quantitative data of vessel segments, while the QCA-CMS system analyzes a single angiography images. Quantitative parameters that are presented by the CardiOp-B system are based on cross-sectional area measurements while the quantitative parameters that are presented by QCA- CMS are based primarily on a diameter analysis. | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data: | Validation on phantoms produced overall accuracy and precision results within the predetermined specifications and comparable to those achieved with currently marketed QCA systems. The CardiOp-B system has been tested on clinical images and results compared to those of the predicate QCA device. There is a correlation between the Minimal Lumen diameter as well as Length results between the systems. | | Conclusion: | The CardiOp-B system provides accurate and precise results for area, diameter, and length on phantoms. The skeleton of the 3D reconstruction that is created by the system is comparable to the skeletons of 2D images of the vessel in terms of its spatial distribution. Furthermore, the CardiOp-B system is able to analyze clinical images and provide diameter and length results that correlate to those of an FDA approved QCA system. | November 2002 Page 301 of 305 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 2 2004 Mr. Omer Barlev CEO Paieon Medical, Inc. 747 Third Ave., 4th Floor NEW YORK NY 10017-2803 Re: K030139 Trade/Device Name: The CardiOp-B System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: March 22, 2004 Received: March 22, 2004 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 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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 the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brygdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "Paieon Inc.". The text is in a serif font. There is a horizontal line under the text. сагаюр-в Traditional 510(k) indications for Use 510(k) Number (if known): **TBD** K $$\phi 3 \phi i 39$$ 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 Segments based on 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 offline for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) David R. Severson (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ November 2002 Page 12 of 305 Paieon's Proprietary. It is forbidden to use this document, quote or copy any part of it without explicit permission.