(52 days)
The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware, It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 510K approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis.
The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 31d party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NovaRad PACS (K063153):
This 510(k) summary explicitly states that no clinical tests were performed to compare the device to a predicate. The justification provided is that the device is "merely software products that send and store images and information. Since the images are not changed or analyzed by the product, there is no safety issue, except possible related to the safety of the archived images."
Therefore, the following table and subsequent sections will reflect this lack of clinical study data.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Provide the exact same ability to replace film with digital. | Meets criterion. Stated as "the exact same ability to replace film with digital." |
| Functional Equivalence | Perform the exact same functions as the predicate device. | Meets criterion. Stated as "perform the exact same functions." |
| Safety (Image Integrity) | Not change or analyze images. | Meets criterion. Stated as "images are not changed or analyzed by the product." |
| Safety (Archiving) | Ensure safety of archived images. | Meets criterion. NovaRad offers "more redundancy than the predicate device" with multiple RAID 5 archives on-site and a third redundant copy at corporate headquarters. |
| DICOM Compliance | Use DICOM for presentation of Mammography studies. | Meets criterion. Explicitly stated that it "is for using DICOM for presentation of Mammography studies." |
| Mammography Viewing | Include standard Mammography features (window/level/zoom, volumetric measurements, other Mammo tools). | Meets criterion. Explicitly stated that it "will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools." |
| Mammography Display | Mammography only interpreted on 510(k) approved 5 Mp LCD monitors. | Meets criterion. Explicitly stated that "Mammo will only be interpreted on 510K approved 5 Mp LCD monitors." |
| Mammography Storage | Mammography images stored lossless (non-lossy compressed). | Meets criterion. Explicitly stated that "The Mammo images will be stored lossless (non-lossy compressed)." |
| Mammography Limitations | Digitized conventional screen film mammograms not used in soft copy format for primary diagnosis. | Meets criterion. Explicitly stated that "Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis." |
Study Details (or lack thereof)
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Sample size used for the test set and the data provenance:
- Not applicable. No clinical test set was used, as no clinical study comparing the devices was conducted. The equivalence was based on functional comparison and safety considerations regarding image storage.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth establishment by experts was performed for comparison between the predicate and the NovaRad PACS. The submission primarily relies on the functional equivalency of a PACS system and its ability to store and display images without alteration.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set was used, therefore no adjudication method was employed.
-
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. An MRMC comparative effectiveness study was not performed. The device is a Picture Archiving and Communication System (PACS) and does not involve AI assistance for image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a PACS for image management and viewing, not an AI algorithm. Therefore, a standalone performance study as understood for AI devices was not conducted.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth was established or used for the purpose of demonstrating substantial equivalence. The claim of substantial equivalence is based on the system's ability to perform the same functions as the predicate PACS without altering image data.
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The sample size for the training set:
- Not applicable. As this is a PACS system designed for image storage and viewing, and not an AI or image analysis device, there is no "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there was no ground truth to establish for it.
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510K Summary
NovaRad Corporation
DEC - 7 2006
NovaRad Corporation, located at 758 E. Utah Valley Dr., Ste 200 in American Fork, UT 84003 is submitting its PACS product. The contract person is Paul Shumway. The name of the device is PACS. It is a class 2 device under 892.2050. The trade name is NovaPACS.
This device is being represented as substantially equivalent to the Kodak DirectView (Carestream) PACS product, a class 2 device under 892.2050. The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 31d party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.
The general use of this device is to be used to read images and information from modalities and store this data so that it can be easily retrieved.
As compared to the predicate device, ignoring dissimilarities of hardware brand and specific tools, menus, shortcuts, usability, desktop appearance, price and data base type, the products are exactly similar. The both provide the exact same ability to replace film with digital and they both perform the exact same functions. Both products could be used interchangeable in most aspects. When a customer is looking at our product compared to the predicate device, they are mostly considering differences in service level, price, and ease of use.
There are no clinical tests to compare the two as they are merely software products that . send and store images and information. Since the images are not changed or analyzed by the product there is no safety issue, except possible related to the safety of the archived images. NovaRad has more redundancy than the predicate device in that they store the original images on-site with a redundant RAID 5 configuration and then they have another RAID 5 archive on site as a redundant archive and then NovaRad stores a 3ª multiple redundant copy of each image and accompanying information at its corporate headquarters.
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Although NovaRad is only a PACS with all the customary tools and features of any other major PACS, the reader may wish to glance at the accompanying brochure to gain a sense of what the product looks like.
:
:
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Paul Shumway Vice President NovaRad Corporation 758 East Utah Valley Drive, Suite 200 AMERICAN FORK UT 84003
DEC - 7 2006
Re: K063153
Trade/Device Name: NOVAPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 21, 2006 Received: November 21, 2006
Dear Mr. Shumway:
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 is a black and white logo or emblem. The logo is circular and contains the text "1906-2006" at the top. Below the text is a large, stylized "PA" with the word "Centennial" underneath. There are three small stars at the bottom of the emblem. The image appears to be a commemorative logo for a centennial celebration.
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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/cdrlv/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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Statement of Indications of Use
NovaRad Corporation
October 9, 2006
892.2050, class II
The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware, It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 510K approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis.
Prescription Use
David R. Ingram
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
§ 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).