(88 days)
Not Found
Unknown
The summary mentions "image acquisition and processing" and "3D modeling based on 2D images," which could potentially utilize AI/ML techniques, but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The description of performance studies and key metrics also doesn't provide definitive evidence of AI/ML use.
No
The device is described as an "image acquisition and processing modular software package" that "assists in diagnosis, procedure planning, therapeutic staging and post deployment analysis." It does not directly provide therapy.
No
This device is described as an "image acquisition and processing modular software package" that "assists in diagnosis, procedure planning, therapeutic staging and post deployment analysis." While it assists in diagnosis, its primary functions listed in "Intended Use / Indications for Use" are related to image processing for projection selection, dimensional measurements, and device positioning, rather than providing a diagnostic output itself. It provides "quantitative data" and "localizes device," which are tools for diagnosis but not a diagnosis itself.
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 enhances existing hardware, rather than a standalone hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device processes medical images (2D images, DICOM images, live fluoroscopy) of the cardiovascular system.
- The intended use and device description clearly state its function is related to image acquisition, processing, and analysis for diagnosis, procedure planning, and therapeutic staging within the body. It assists in procedures and analyzes images of the patient's anatomy.
Therefore, the C-THV system falls under the category of medical imaging software or a medical device that utilizes imaging, rather than an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IZI, LLZ
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:
- Optimal Projection
- Dimensional Measurements
- Virtual Valve
- Positioning
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray angiography Systems, DICOM images, DICOM XA, Bitmap imaging formats, live fluoroscopy
Anatomical Site
vessel, heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests have yielded accuracy and precision results within the predetermined specifications.
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/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: | +972 3 915 0000 |
| Fax Number: | +972 3 901 2324 |
| 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: Optimal ProjectionDimensional MeasurementsVirtual ValvePositioning |
.
:
1
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.
.
| 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- |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Standards: | procedural analysis.
None |
| Performance Data: | Testing included software validation and performance evaluation.
Performance tests have yielded accuracy and precision results
within the predetermined specifications. |
| Substantial
Equivalence: | All C-THV System modules are substantially equivalent to their
cleared predicate device modules in terms of indication and
intended use, technological characteristics, input and output,
measurements and operating environment.
All C-THV System modules, but the positioning are functioned the
same, have similar specifications and performances as in IC-PRO
System (version 3.5, model B).
The IC-PRO System is also an image acquisition and processing
software that has the ability to work with DICOM XA and Bitmap
imaging formats.
All found differences raise no new safety and effectiveness issues
or concerns. |
| Conclusion: | The testing reported in this 510(K) establishes that the C-THV
(version 4.6) is substantially equivalent to its predicate device and it
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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