(49 days)
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:
- 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. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
- Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
- Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- To be used in-procedure in the catheterization lab and off-line for postprocedural analysis
The IC-PRO System is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning and post deployment analysis. IC-PRO enhances visualization and provides quantitative data of vessel, left ventricular and stent dimensions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IC-PRO System, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "accuracy greater than X%", "precision within Y mm"). Instead, it describes performance in general terms relative to validation and predicate devices.
| Acceptance Criteria (Stated Implicitly/Generally) | Reported Device Performance |
|---|---|
| Accuracy within predetermined specifications | Produced accuracy within predetermined specifications |
| Precision within predetermined specifications | Produced precision within predetermined specifications |
| Performance comparable to marketed predicate devices | Comparable to results obtained by the marketed predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified (e.g., 2+1, 3+1, none). The document only mentions "performance evaluation."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: Not explicitly mentioned as a comparative effectiveness study with human readers. The wording "comparable to results obtained by the marketed predicate devices" suggests a comparison, but it doesn't specify if human readers were part of an MRMC study comparing AI-assisted vs. non-AI-assisted performance.
- Effect Size: Not provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The document implies that "performance testing was performed to evaluate the IC-PRO System" and produced "accuracy and precision results." This suggests a standalone evaluation of the algorithm's output (e.g., derived measurements) against a ground truth, rather than being solely a human-in-the-loop study. However, it doesn't definitively exclude human interaction during the acquisition or initial parameter setting that might influence the reported performance.
7. The Type of Ground Truth Used
- The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, phantom measurements, or another form of reference standard). It mentions comparison to "predetermined specifications" and "marketed predicate devices," which implies that the ground truth would have been established measurements for the same anatomical structures.
8. The Sample Size for the Training Set
- The document does not mention a training set or its sample size. This is common for older 510(k)s, especially for systems that might not rely on machine learning in the modern sense (e.g., rule-based algorithms, advanced image processing) for their primary function, or if the training data details were not deemed essential for the summary.
9. How the Ground Truth for the Training Set Was Established
- Since a training set is not mentioned, the method for establishing its ground truth is also not provided.
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NOV 1 8 2008
Realizing Cardiac Imaging
510(k) SUMMARY
| Submitter Name: | Paieon Inc. |
|---|---|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 |
| Contact Person: | Shahar Mandelboim |
| Phone Number: | +972 3 915 0000 |
| Fax Number: | +972 3 901 2324 |
| Date Prepared: | June 4, 2008 |
| Device Trade Name: | The IC-PRO System |
| Device Common Name: | Cardiovascular Angiography Analysis System |
| Classification Name: | Angiographic x-ray system |
| Predicate Devices: | CardiOp-B cleared for marketing under K073328, StentBoostcleared for marketing as a feature of Allura Xper FD10 underK041949 and CAAS Software Package cleared for marketingunder K052988. |
| Device Description: | The IC-PRO System is an image acquisition and processingmodular software package designed as an add-on to conventionalX-ray angiography systems. This system improves the output ofcardiovascular angiography by providing software modules thatassist in diagnosis, procedure planning and post deploymentanalysis. IC-PRO enhances visualization and providesquantitative data of vessel, left ventricular and stent dimensions. |
510(k) SUMMARY- IC-PRO System
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510(k) SUMMARY
IC-PRO, an image acquisition and processing modular software Intended Use: package, is indicated for use as follows: a. To assist 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. b. To provide quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. c. To perform quantitative analysis of the left ventricle based on left ventricular angiograms. d. To enhance visualization of the stent deployment region and provide quantitative data based on manual stent tracing. To be used in-procedure in the catheterization lab and offe. line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel. Performance Standards: None Performance Data: Testing included software validation and performance evaluation. Performance testing was performed to evaluate the IC-PRO System and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices. The IC-PRO System is similar in intended use and technology Substantial Equivalence: (overall design, principle of action, mode of operation, performance characteristics, etc.) to the cleared predicate devices. The testing reported in this 510(K) establishes that IC-PRO is Conclusion: substantially equivalent to the predicate devices and is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paieon, Inc. % Ms. Shahar Mandelboim VP R&D Paicon Medical LTD. 23 Hamelacha St, P.O.B. 11355 Rosh Haayin, 48091 ISRAEL
Re: K082907
Trade/Device Name: The IC-PRO System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: September 11, 2008 Received: October 15, 2008
Dear Ms. Mandelboim:
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.
NOV 1 8 2008
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.
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Page 2
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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
Jorge M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Image /page/4/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.
L082907
Indications for Use
Device Name: The IC-PRO System
Indications for Use:
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:
- 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. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
- 트 Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
- 트 Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- 트 To be used in-procedure in the catheterization lab and off-line for postprocedural analysis
Prescription Use X (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)
(Posted November 13, 2003) (Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.