(46 days)
Picture Archiving and Communications for presenting images and information from the modalities to radiologists or others for reading. Includes standard viewing tools made to help the radiologist or cardiologist or others organize the images and read them in an efficient and easy manner.
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 3 party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.
The provided text is a 510(k) summary for the NovaRad Corporation's PACS product (NovaPACS). It explicitly states that "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."
Therefore, based on the provided document, the following answers apply:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria or reported device performance from a study are provided in the document. The device is a Picture Archiving and Communication System (PACS) and is not intended to change or analyze medical images, but rather to present and store them. Substantial equivalence was claimed based on functional similarity to a predicate device, not clinical performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical or performance studies using a test set were conducted or mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical or performance studies using a test set were conducted or mentioned, hence no ground truth was established by experts for such a purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance studies using a test set were conducted or mentioned.
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
Not applicable. No MRMC study was conducted. The device is a PACS for image viewing and storage, not an AI-powered diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a PACS for image viewing and storage and does not involve a standalone algorithm for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical or performance studies requiring ground truth were conducted or mentioned.
8. The sample size for the training set
Not applicable. No machine learning or AI components requiring a training set are described for this PACS device.
9. How the ground truth for the training set was established
Not applicable. No machine learning or AI components requiring a training set are described for this PACS device, therefore no ground truth for a training set was established.
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510K Summary
AUG 2 1 2006
NovaRad Corporation
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 3 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 3th 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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:
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 1 2006
Mr. Paul Shumway VP Operations NovaRad Corporation 758 E. Utah Valley Dr., Ste 200 AMERICAN FORK UT 84003
Re: K061920
Trade/Device Name: NovaPACS, NovaView, NovaCardio, and NovaER Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2006 Received: July 7, 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/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. Below that is the text "PA Centennial" in a stylized font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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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 (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.
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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Indications for Use
510(k) Number (if known):
ﭘﺎ ﮨﮯ ﮨﯿﮟ
Device Name: NovaPACS, NovaView, NovaER, NovaCardio
Indications For Use: Picture Archiving and Communications for presenting images and information from the modalities to radiologists or others for reading. Includes standard viewing tools made to help the radiologist or cardiologist or others organize the images and read them in an efficient and easy manner.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of
David H. Ingram
§ 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).