(444 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 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
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.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria in the typical sense (e.g., "accuracy > X%"). Instead, the performance data describes the results in relation to pre-determined specifications and comparison to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy & Precision (Phantom Data) | Within pre-determined specifications and comparable to currently marketed QCA systems. | Overall accuracy and precision results were within pre-determined specifications and comparable to those achieved with currently marketed QCA systems. |
| Correlation with Predicate QCA System (Clinical Images) | Demonstrated correlation between Minimal Lumen Diameter and Length results with an FDA-approved QCA system. | There is a correlation between the Minimal Lumen Diameter as well as Length results between the systems. |
| 3D Reconstruction Skeleton | Comparable to skeletons of 2D images in terms of spatial distribution. | 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. |
| Ability to Analyze Clinical Images | Able to analyze clinical images and provide diameter and length results. | 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. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either the phantom or clinical image validation.
- Data Provenance:
- Phantoms: The study used "phantoms," which are engineered objects designed to mimic biological structures for testing purposes. Their origin is not specified but is typically controlled laboratory settings.
- Clinical Images: "Clinical images" were used. The country of origin is not specified, and it's not explicitly stated whether the data was retrospective or prospective. Given the context of a 510(k) summary from 2003, it's more common for such data to be retrospective, but this is an inference.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified. The document primarily refers to "comparison to those achieved with currently marketed QCA systems" for phantoms and "correlation... between the systems" for clinical images. This implies a comparative analysis rather than an explicit expert adjudication process against a distinct ground truth for the device's measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not described or indicated. The CardiOp-B system's evaluation was primarily focused on its own performance against phantoms and correlation with a predicate device, not on how it augmented human performance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described performance data appears to be for the standalone (algorithm-only) performance of the CardiOp-B System. The system "provides quantitative information," "analyzes 2-3 angiography images," and "creates a 3D image as well as quantitative data." The evaluation compares the system's output directly to phantom specifications and the predicate device's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Phantom Data: The ground truth was based on the known, engineered dimensions of the phantoms, which serve as a gold standard for accuracy and precision measurements in a controlled environment.
- For Clinical Data: The "ground truth" was effectively established by the measurements from the predicate QCA-CMS system. The study sought to demonstrate correlation with this established device, implying the predicate device's measurements served as a reference for comparison, rather than an independent "expert consensus" or "pathology" ground truth for the clinical cases themselves.
8. The sample size for the training set:
- Training Set Sample Size: Not specified. The document focuses exclusively on performance data and validation, with no mention of training data or how the model was developed (e.g., machine learning approaches).
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not specified, as there is no information provided about a training set or its ground truth.
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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 andprocessing software system designed as an add-on toconventional X-ray angiography systems. The CardiOp-B system presents a three-dimensional reconstruction ofthe stenosed vessel as well as quantitative cross-sectioninformation. The system includes a software packagethat runs on off-the-shelf hardware. CardiOp-B'sfeatures and benefits include 3D reconstruction, real-time and quantitative measurements. |
| Intended Use: | The CardiOp-B System is an add-on system to singleplane angiography that assists in the evaluation ofcoronary lesions by enabling the creation of 3D imagesof coronary vessel segments based on 2D angiographyimages. CardiOp-B provides quantitative informationregarding the calculated dimensions of arterial segmentsbased on the 3D image. CardiOp-B is intended for usein real-time in the catheterization lab and off-line forpost-procedural analysis. |
November 2002
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CardIOp-B Traditional 510(k) Summary
| Device TechnologicalCharacteristics andComparison toPredicate Device(s): | The CardiOp-B system is comprised of software thatruns on the Windows XP operating system.The QCA-CMS system runs on Windows NT.The CardiOp-B system analyzes 2-3 angiographyimages to create a 3D image as well as quantitative dataof vessel segments, while the QCA-CMS systemanalyzes a single angiography images. Quantitativeparameters that are presented by the CardiOp-B systemare based on cross-sectional area measurements whilethe quantitative parameters that are presented by QCA-CMS are based primarily on a diameter analysis. |
|---|---|
| Performance Data: | Validation on phantoms produced overall accuracy andprecision results within the predetermined specificationsand comparable to those achieved with currentlymarketed QCA systems.The CardiOp-B system has been tested on clinicalimages and results compared to those of the predicateQCA device. There is a correlation between the MinimalLumen diameter as well as Length results between thesystems. |
| Conclusion: | The CardiOp-B system provides accurate and preciseresults for area, diameter, and length on phantoms. Theskeleton of the 3D reconstruction that is created by thesystem is comparable to the skeletons of 2D images ofthe vessel in terms of its spatial distribution.Furthermore, the CardiOp-B system is able to analyzeclinical images and provide diameter and length resultsthat correlate to those of an FDA approved QCA system. |
November 2002
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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.
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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
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сагаюр-в Traditional 510(k) indications for Use
510(k) Number (if known):
TBD K
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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.
§ 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.