(274 days)
EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
EZPACS® is a PACS system that runs on off-the-shelf monitors and PCs running the Microsoft Windows® operating system. It consists of software that displays images and provides functions for image manipulation, enhancement, compression and quantification.
The provided document (K062878) does not describe a study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI-powered CADe or CADx device would. This 510(k) pertains to a Picture Archiving Communications System (PACS) software called EZPACS®, which is a medical image management system, not an AI diagnostic or assistive tool.
Therefore, many of the requested elements (like sample size for test set, number of experts for ground truth, MRMC study effect size, standalone performance, training set details) are not applicable to this type of device and submission.
The submission focuses on establishing substantial equivalence to predicate devices. This means demonstrating that the new device has the same intended use, features, safety, and effectiveness as already legally marketed devices.
Here's how to address the questions based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
For a PACS system like EZPACS®, the "acceptance criteria" are primarily related to its functional equivalence and conformity to standards, rather than diagnostic performance metrics. The "performance" is its ability to perform the stated functions.
| Acceptance Criteria (Implied from Substantial Equivalence Claim) | Reported Device Performance (as stated in submission) |
|---|---|
| Functional Equivalence to Predicate PACS Systems: | |
| - Runs on Commercial PCs (Windows® O/S) | Yes |
| - Supports Commercial Monitors | Yes |
| - Multi-monitor support | Yes |
| - JPEG/wavelet compression | Yes |
| - DICOM conformance | Yes |
| - Measurement tools (ROI, distance, angle) | Yes |
| - Viewing tools (window/level, magnify, pan, annotation) | Yes |
| - Comparison cases functionality | Yes |
| - Cine/stack view functionality | Yes |
| - Supports teleradiology | Yes |
| - 3D viewing functionality | Yes |
| Intended Use: | Same as predicate devices |
| Safety and Effectiveness: | Same as predicate devices |
Note: The "study" that proves the device meets "acceptance criteria" in this context is the substantiation of substantial equivalence through comparison of features and intended use with the identified predicate devices (IMPAX by Agfa and DirectView by Kodak). No quantitative performance metrics are provided because it's not an AI diagnostic device.
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a PACS software system, not a diagnostic AI algorithm that requires a test set of medical images for performance evaluation. The "test" is a feature-by-feature comparison against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "test set" of medical images for diagnostic performance evaluation for this type of device.
4. Adjudication method for the test set
- Not Applicable. No test set requiring expert adjudication.
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
- No. This is not an AI diagnostic or assistive device. An MRMC study is not relevant to demonstrating substantial equivalence for a PACS system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a PACS system, primarily for image management and display, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this submission, the "ground truth" is effectively the functionality and regulatory status of the predicate devices. The claim is that EZPACS® performs the same functions as those already approved devices.
8. The sample size for the training set
- Not Applicable. As this is a PACS software system, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved for this type of device.
Summary of the "Study" and "Proof":
The "study" in this context is a feature-by-feature comparison and analysis for substantial equivalence against legally marketed predicate devices. The "proof" is the detailed comparison table provided in the submission (see "Substantial Equivalence" section in the document) which demonstrates that EZPACS® shares the same core functionalities, hardware requirements, and intended use as the predicate devices. The conclusion reached by the FDA (as stated in the letter) is that based on this comparison, the device is substantially equivalent, and therefore, its safety and effectiveness are established.
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KAa2878
Advanced Imaging Solutions, LLC
43731 N. 15th St. West, Lancaster CA
(661) 949-2131 FAX: (661) 940-0994
Summary
JUN 2 7 2007
Summary Preparation Date 3 Dec 2004
Company Identification
Advanced Imaging Solutions, LLC 43731 N. 15th St West Lancaster CA 93534
Contact Person
Ray H. Hashemi, M.D., Ph.D. 43731 N. 15th St. West Lancaster, CA 93534 (661) 949-8111 fax: (661) 940-0994 aic@qnet.com
Device Identification
| Trade Name: | EZPACS® |
|---|---|
| Common Name: | Picture Archiving Communications System (PACS) |
| Classification: | Class II (Product Code: LLZ) |
Predicate Devices
DirectView by Kodak (K030781 approved 5/29/03) IMPAX by Agfa (K022292 approved 9/12/02)
Description of Device
EZPACS® is a PACS system that runs on off-the-shelf monitors and PCs running the Microsoft Windows® operating system. It consists of software that displays images and provides functions for image manipulation, enhancement, compression and quantification.
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Intended Use
EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Substantial Equivalence
| EZPACS | IMPAX | DirectView | |
|---|---|---|---|
| Commercial PCs runningWindows® O/S | yes | yes | yes |
| Commercial monitors | yes | yes | yes |
| Multi-monitor support | yes | yes | yes |
| JPEG/wavelet compression | yes | yes | yes |
| DICOM conformance | yes | yes | yes |
| Measurement tools (ROI, distance, angle) | yes | yes | yes |
| Viewing tools (window/level, magnify, pan, annotation | yes | yes | yes |
| Comparison cases | yes | yes | yes |
| Cine/stack view | yes | yes | yes |
| Supports teleradiology | yes | yes | yes |
| 3D viewing | yes | yes | yes |
The EZPACS® software is substantially equivalent to IMPAX and DirectView in functions, features, intended use, hardware, safety and effectiveness. Any differences have no significant effect on safety and effectiveness.
Conclusion
The EZPACS® software has the same intended use, features, safety and effectiveness as IMPAX and DirectView, therefore it is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 2 7 2007
Ray Hashemi, M.D., Ph.D. CEO Advance Imaging Solutions, LLC 43731 N. 15th St. West LANCASTER CA 93534
Re: K062878
Trade/Device Name: EZPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 14, 2007 Received: May 16, 2007
Dear Dr. Hashemi:
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/9 description: The image shows a logo and some text. The logo is for the FDA Centennial, with the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The text is in a decorative font.
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Page 2 -
Enclosure
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 Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indication for Use
Re: EZPACS
510(k)# K062878
EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
[x] Prescription Use
[ ] Non Prescription Use
Herbert Reinerth
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K062878
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).