(63 days)
Not Found
No
The summary describes image processing and quantitative analysis based on 2D and 3D images, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The description focuses on traditional image processing techniques and quantitative measurements.
No
The device is described as an image acquisition and processing software package designed to assist in diagnosis, procedure planning, and post-deployment analysis by providing quantitative data, enhancing visualization, and localizing devices. It does not directly provide therapy.
Yes
The description explicitly states, "This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis." Additionally, its intended use includes "Assists in the evaluation of coronary lesions" and "Performs quantitative analysis of the left ventricle," both of which are diagnostic activities.
Yes
The device is explicitly described as a "software package" and an "add-on to conventional X-ray angiography systems," indicating it is a software component that integrates with existing hardware, rather than a standalone hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device function: The IC-PRO software processes imaging data (X-ray angiography) obtained directly from the patient's body. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes image processing and analysis of anatomical structures (coronary vessels, left ventricle) based on imaging data, not laboratory analysis of biological samples.
Therefore, based on the provided information, the IC-PRO system falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
-
- Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
-
- Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- Assist in device positioning by providing real time 4. localization on predefined roadmaps.
-
- To be used in-procedure in the catheterization lab and off-line for post-procedural analysis
Product codes
IZI
Device Description
The IC-PRO (version 3.2) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. IC-PRO (version 3.2) provides quantitative data of vessel, left ventricular and stent dimensions enhances visualization and localizes device on predefined roadmaps.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray angiography
Anatomical Site
coronary vessel segments, left ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended for use by clinicians, technicians and research personnel.
To be used in-procedure in the catheterization lab and off-line for post-procedural analysis
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing included software validation and performance evaluation. Performance Data: The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082907, K081379, K060483, K062192
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
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.(b)
Classification. Class II.
0
FEB 1.7 2009
510(k) SUMMARY
510(k) SUMMARY- IC-PRO System
Submitter Name:
Paieon Inc.
Submitter Address:
Contact Person: Phone Number:
+972 3 915 0000
+972 3 901 2324
Shahar Mandelboim
Fax Number:
Device Trade Name:
Classification Name:
Predicate Devices:
Device Description:
Device Common Name:
Date Prepared:
December 8, 2008
The IC-PRO System
Cardiovascular Angiography Analysis System
Angiographic x-ray system
The IC-PRO (version 3.1) System cleared under K082907; The inReach system cleared for marketing under K081379; The Angio IVUS Mapping System cleared under K060483. The Ostial PRO Stent Positioning System cleared under K062192;
747 Third Ave., 4th floor New York, NY 10017-2803
The IC-PRO (version 3.2) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. IC-PRO (version 3.2) provides quantitative data of vessel, left ventricular and stent dimensions enhances visualization and localizes device on predefined roadmaps.
1
510(k) SUMMAR Y
lizing Cardiac Imagin
Performance Standards:
Intended 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.
-
- Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
-
- Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- Assist in device positioning by providing real time 4. localization on predefined roadmaps.
-
- 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.
None
Testing included software validation and performance evaluation. Performance Data: The performance tests were made to evaluate the IC-PRO System and vield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices.
Substantial Equivalence: The intended use and technological characteristics of the IC-PRO (version 3.2) are substantially equivalent to a combination of the intended use and technological characteristics of the 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.
2
Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paieon, Inc. % Mr. Shahar Mandelboim Vice President R & D Paieon Medical Ltd. 23 Hamelacha St., P.O.B 11355 Rosh Haavin 48091 ISRAEL
Re: K083745
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: December 11, 2008 Received: December 17, 2008
Dear Mr. 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.
FEB 1 7 2009
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.
3
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 os 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 892.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 Manufactures. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.
Sincerely yours,
Laima B. Murrel
anine M. Morris Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE
,
Indications for Use
Device Name: The IC-PRO System
Indications for Use:
ieon Realizing Cardiac Imaging
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.
- Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
- Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- Assist in device positioning by providing real time localization on predefined roadmaps.
- To be used in-procedure in the catheterization lab and off-line for postprocedural analysis
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)
Hulstine
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
(Posted November 13, 2003)