(26 days)
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.
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
The Paieon CardiOp-B System, a 3D Vessel Analysis System, received 510(k) clearance (K072591) based on its substantial equivalence to predicate devices. The system is designed to create 3D images of coronary vessel segments from 2D angiography images and provide quantitative information about arterial dimensions.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or a detailed performance table from a clinical study. Instead, it mentions that "Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system," which 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." Without specific criteria, it's impossible to populate a table with acceptance criteria and their corresponding reported values.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "phantom performance evaluation." This suggests that the test set likely consisted of images from phantoms (simulated anatomical structures), rather than human patient data. No specific sample size is provided for this phantom test set. Data provenance is not explicitly stated beyond "phantom performance evaluation," which implies controlled, synthetic data rather than retrospective or prospective human clinical data. The country of origin for the data is not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their qualifications. Given that the testing involved "phantom performance evaluation," the ground truth likely came from the known, precisely manufactured dimensions of the phantoms, rather than expert consensus on medical images.
4. Adjudication Method for the Test Set:
No adjudication method is described. For phantom studies, adjudication by human experts is typically not necessary as the "ground truth" is inherent in the design specifications of the phantom.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned, nor is there any information about the effect size of human readers improving with or without AI assistance. The study described focuses on the device's inherent performance rather than its impact on human reader performance.
6. Standalone Performance Study (Algorithm Only):
Yes, a standalone performance evaluation was conducted. The document states, "Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system. Testing included software validation and phantom performance evaluation." This indicates that the device's algorithms were tested independently, likely by comparing its measurements against the known dimensions of the phantoms.
7. Type of Ground Truth Used:
The ground truth used was based on the known dimensions of phantoms. The phrase "phantom performance evaluation" strongly suggests that precisely engineered phantoms were used, where the true dimensions of the vessels/stenoses are known by design.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size of a training set. This suggests that the device's underlying algorithms may not have been developed using a supervised learning approach requiring a labeled training set, or that information was not deemed necessary for a Special 510(k) submission focused on modifications.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, information on how its ground truth was established is not provided.
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K07259/
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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 clearedunder K993763 and CAAS QCA 3D cleared under K063344 | ||
| Device Description: | The CardiOp-B System is an image acquisition and processing softwaresystem designed as an add-on to conventional X-ray angiographysystems. The CardiOp-B system improves the output of coronaryangiography by presenting a three-dimensional reconstruction of thestenosed vessel as well as quantitative cross-section information. Themodifications to the CardiOp-B System which are the subject of thisSpecial 510(K) include:Bifurcation and side-branch analysis |
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Realizing Cardiac Imaging
510(k) SUMMARY
| Intended Use: | The CardiOp-B System is a software system that assists in theevaluation of coronary lesions by enabling the creation of 3D images ofcoronary vessel segments based on two to three 2D angiographyimages obtained from single plane angiography. CardiOp-B providesquantitative information regarding the calculated dimensions of arterialsegments based on the 3D image. CardiOp-B is intended for use inreal-time in the catheterization lab and off-line for post-proceduralanalysis. It is intended for use by clinicians, technicians and researchpersonnel |
|---|---|
| Technological CharacteristicsCompared to Predicate Device: | The technological characteristics, e.g., overall design, principle ofaction, mode of operation, performance characteristics, etc., and theintended use of the Cardio-Op B system are substantially equivalent tothe predicate devices cited above. |
| Performance Data: | Applicable performance testing was performed to evaluate themodifications to the CardiOp-B system. Testing included softwarevalidation and phantom performance evaluation. The test results werefound to be acceptable as required by the respective test plans andprotocols, demonstrating that the modified device performs accordingto its specifications. The test results did not raise new safety oreffectiveness issues. |
| Conclusion: | The testing reported in this 510(K) establishes the modified CardiOp-Bis substantially equivalent to the predicate devices and is safe andeffective for its intended use. |
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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.
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Promoting and Promoting Public Health.
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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
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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
§ 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.