(49 days)
Not Found
No
The document describes image processing and quantitative analysis based on 2D angiography images, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The description focuses on traditional image processing techniques and quantitative measurements.
No
The device is described as an image acquisition and processing software package that assists in diagnosis, procedure planning, and post-deployment analysis. It processes existing angiography images to provide quantitative information and enhance visualization, but it does not directly treat or restore the structure or function of a body part.
Yes
The "Device Description" explicitly states that the system "assists in diagnosis." Additionally, the "Intended Use" section describes how it "assists in the evaluation of coronary lesions" and provides "quantitative information," which are common functions of diagnostic devices.
Yes
The device is explicitly described as a "software package" and an "add-on to conventional X-ray angiography systems," focusing solely on image acquisition and processing without mentioning any proprietary hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- IC-PRO's Function: IC-PRO processes images obtained from a medical imaging modality (X-ray angiography). It does not analyze biological specimens taken from the body. Its purpose is to assist in the evaluation of anatomical structures (coronary vessels, left ventricle) and implanted devices (stents) based on these images.
Therefore, while IC-PRO is a medical device used in a clinical setting to aid in diagnosis and treatment planning, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: a. To assist 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. b. To provide quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. c. To perform quantitative analysis of the left ventricle based on left ventricular angiograms. d. To enhance visualization of the stent deployment region and provide quantitative data based on manual stent tracing. To be used in-procedure in the catheterization lab and offe. line for post-procedural analysis.
Also:
- 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
- To be used in-procedure in the catheterization lab and off-line for postprocedural analysis
Product codes (comma separated list FDA assigned to the subject device)
IZI
Device Description
The IC-PRO 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 and post deployment analysis. IC-PRO enhances visualization and provides quantitative data of vessel, left ventricular and stent dimensions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray angiography images, 2D angiography images, left ventricular angiograms
Anatomical Site
coronary vessel segments, arterial segments, left ventricle/ventricular, stent deployment region
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
Testing included software validation and performance evaluation. Performance testing was performed to evaluate the IC-PRO System and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed to evaluate the IC-PRO System and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
NOV 1 8 2008
Realizing Cardiac Imaging
510(k) SUMMARY
| Submitter Name: | Paieon Inc. |
|---|---|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 |
| Contact Person: | Shahar Mandelboim |
| Phone Number: | +972 3 915 0000 |
| Fax Number: | +972 3 901 2324 |
| Date Prepared: | June 4, 2008 |
| Device Trade Name: | The IC-PRO System |
| Device Common Name: | Cardiovascular Angiography Analysis System |
| Classification Name: | Angiographic x-ray system |
| Predicate Devices: | CardiOp-B cleared for marketing under K073328, StentBoost |
| cleared for marketing as a feature of Allura Xper FD10 under | |
| K041949 and CAAS Software Package cleared for marketing | |
| under K052988. | |
| Device Description: | The IC-PRO 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 and post deployment | |
| analysis. IC-PRO enhances visualization and provides | |
| quantitative data of vessel, left ventricular and stent dimensions. |
510(k) SUMMARY- IC-PRO System
・
1
510(k) SUMMARY
IC-PRO, an image acquisition and processing modular software Intended Use: package, is indicated for use as follows: a. To assist 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. b. To provide quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. c. To perform quantitative analysis of the left ventricle based on left ventricular angiograms. d. To enhance visualization of the stent deployment region and provide quantitative data based on manual stent tracing. To be used in-procedure in the catheterization lab and offe. line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel. Performance Standards: None Performance Data: Testing included software validation and performance evaluation. Performance testing was performed to evaluate the IC-PRO System and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices. The IC-PRO System is similar in intended use and technology Substantial Equivalence: (overall design, principle of action, mode of operation, performance characteristics, etc.) to the cleared 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paieon, Inc. % Ms. Shahar Mandelboim VP R&D Paicon Medical LTD. 23 Hamelacha St, P.O.B. 11355 Rosh Haayin, 48091 ISRAEL
Re: K082907
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: September 11, 2008 Received: October 15, 2008
Dear Ms. 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.
NOV 1 8 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.
3
Page 2
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). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jorge M. Zhang
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
4
INDICATIONS FOR USE
Image /page/4/Picture/1 description: The image shows the word "Paieon" in a stylized font. Below the word "Paieon" is the phrase "Realizing Cardiac Imaging". The text is black and the background is white.
L082907
Indications for Use
Device Name: The IC-PRO System
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.
- 트 Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
- 트 Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- 트 To be used in-procedure in the catheterization lab and off-line for postprocedural analysis
Prescription Use X (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)
(Posted November 13, 2003) (Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number