(444 days)
Not Found
No
The summary describes image processing and 3D reconstruction based on 2D images, but there is no mention of AI, ML, or related concepts like training sets, test sets, or specific algorithms typically associated with AI/ML in medical imaging. The comparison is made to a predicate QCA device, which is a traditional quantitative coronary angiography system.
No
The device is a software system intended for evaluating coronary lesions and creating 3D images from 2D angiography, which provides diagnostic information rather than directly treating or preventing disease.
Yes
The device "assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments" and "provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image," which are activities related to diagnosis.
Yes
The device is described as a "software system" and "software package" that runs on "off-the-shelf hardware," indicating it is the software component that constitutes the medical device, not the underlying hardware.
Based on the provided information, the CardiOp-B System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- CardiOp-B's Function: The CardiOp-B System processes imaging data (2D angiography images) to create 3D reconstructions and provide quantitative measurements of coronary vessel segments. It does not analyze biological specimens.
- Intended Use: The intended use is to assist in the evaluation of coronary lesions based on imaging data, not to analyze biological samples.
Therefore, the CardiOp-B System falls under the category of medical imaging software or image processing software, not an IVD.
N/A
Intended Use / Indications for 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.
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
Product codes (comma separated list FDA assigned to the subject device)
90 IZI
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.
The CardiOp-B system is comprised of software that runs on the Windows XP operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray angiography images
Anatomical Site
coronary vessel segments, arterial segments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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)
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.
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
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
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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.