(26 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 data, test data, or specific performance metrics typically associated with AI/ML models. The performance studies focus on software validation and phantom evaluation, not AI/ML model performance.
No
The device is a software system that assists in the evaluation of coronary lesions by creating 3D images and providing quantitative information based on 2D angiography images. It is used for diagnosis and analysis, not for treating a condition.
Yes
The device assists in the evaluation of coronary lesions and provides quantitative information about arterial segments, which are used for diagnostic purposes in the assessment of coronary artery disease.
Yes
The device is explicitly described as a "software system" and an "image acquisition and processing software system." While it functions as an "add-on to conventional X-ray angiography systems," the description focuses solely on the software's capabilities and modifications, without mentioning any accompanying hardware components included as part of the CardiOp-B System itself.
Based on the provided information, the CardiOp-B System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- CardiOp-B analyzes medical images: The CardiOp-B System processes and analyzes 2D angiography images to create 3D reconstructions and provide quantitative information about coronary vessels. It does not interact with or analyze biological samples.
- The intended use is image-based evaluation: The intended use clearly states that the system assists in the "evaluation of coronary lesions by enabling the creation of 3D images... based on two to three 2D angiography images." This is an image-based diagnostic process, not an in vitro one.
Therefore, the CardiOp-B System falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 plane angiography. 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. It is intended for use by clinicians, technicians and research personnel.
Product codes
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 improves the output of coronary angiography by presenting a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The modifications to the CardiOp-B System which are the subject of this Special 510(K) include: Bifurcation and side-branch analysis
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray angiography
Anatomical Site
coronary vessel segments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, technicians and research personnel, in real-time 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
Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system. Testing included software validation and phantom performance evaluation. The test results were found to be acceptable as required by the respective test plans and protocols, demonstrating that the modified device performs according to its specifications. The test results did not raise new safety or effectiveness issues.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation and phantom performance evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K07259/
Image /page/0/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.
510(k) SUMMARY
510(k) SUMMARY—CardiOp-B System
OCT 』0 2007
| Submitter Name: | Paieon Inc. | ||
|---|---|---|---|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 | ||
| Contact Person: | Ravit Barkama, MD | ||
| Phone Number: | +972 3 915 0000 | ||
| Fax Number: | +972 3 901 2324 | ||
| Date Prepared: | Sept 12, 2007 | ||
| Device Trade Name: | The CardiOp-B System | ||
| Device Common Name: | 3D Vessel Analysis System | ||
| Classification Name: | 3D Vessel Analysis System | ||
| Predicate Devices: | CardiOp-B cleared for marketing under K030139, QCA-CMS cleared | ||
| under K993763 and CAAS QCA 3D cleared under K063344 | |||
| 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 improves the output of coronary | |||
| angiography by presenting a three-dimensional reconstruction of the | |||
| stenosed vessel as well as quantitative cross-section information. The | |||
| modifications to the CardiOp-B System which are the subject of this | |||
| Special 510(K) include: | |||
| Bifurcation and side-branch analysis |
1
Realizing Cardiac Imaging
510(k) SUMMARY
| Intended 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 plane angiography. 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. It is intended for use by clinicians, technicians and research
personnel |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics
Compared to Predicate Device: | The technological characteristics, e.g., overall design, principle of
action, mode of operation, performance characteristics, etc., and the
intended use of the Cardio-Op B system are substantially equivalent to
the predicate devices cited above. |
| Performance Data: | Applicable performance testing was performed to evaluate the
modifications to the CardiOp-B system. Testing included software
validation and phantom performance evaluation. The test results were
found to be acceptable as required by the respective test plans and
protocols, demonstrating that the modified device performs according
to its specifications. The test results did not raise new safety or
effectiveness issues. |
| Conclusion: | The testing reported in this 510(K) establishes the modified CardiOp-B
is substantially equivalent to the predicate devices and is safe and
effective for its intended use. |
.
:
: : : : :
2
Image /page/2/Picture/0 description: The image shows a circular logo with the words "Department of Health & Human Services USA" written around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a bird in flight or a stylized human figure. The logo is black and white and appears to be of low resolution.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 0 2007
Paieon, Inc. % Ravit Barkama, M.D. Medical Director Paieon Medical Ltd. 23 Hamelacha St., P.O.B 11355 Rosh Haavin 48091 ISRAEL
Re: K072591
Trade/Device Name: The CardiOp-B System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI
Dated: September 12, 2007 Received: September 14, 2007
Dear Dr. Barkama:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular emblem with the text "1906-2006" at the top. Below the text is a large, stylized "PA" and the word "Centennial" underneath. There are three stars at the bottom of the emblem. The emblem is surrounded by a dotted border.
Promoting and Promoting Public Health.
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 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). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Paieon
Realizing Cardiac Imaging
INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): K072591
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 plane angiography. 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. It is intended for use by clinicians, technicians and research personnel.
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)
Ami M. M.
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page _________________________________________________________________________________________________________________________________________________________________________ of
(Posted November 13, 2003)
Sept 2007