(129 days)
The Nova Radiology Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The Nova 5MP display is currently not cleared in the U.S. for use with Ful Field Digital Mammography (FFDM). The Nova 1MP, 2MP and 3MP displays are not intended for use with FFDM
The Nova - Radiology Monochrome Display is a diagnostic display.
The provided text is a 510(k) summary for a medical device called "Nova - Radiology Monochrome Display." It describes the device, its intended use, and states that it is substantially equivalent to other marketed predicate devices. However, the document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices in the US. This process typically involves showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and does not raise different questions of safety and effectiveness. It often relies on a comparison table of features and specifications rather than a new clinical study with specific acceptance criteria that the device's performance needs to meet.
Therefore, for aspects of your request that relate to acceptance criteria and performance studies, the information is not available in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document describes the device's technological characteristics (high resolution, LCD, monochrome, image restoration) and intended use, and lists predicate devices for comparison. It does not provide specific performance metrics or acceptance thresholds that the device was tested against in a formal study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. A formal test set and associated data provenance are typically part of a performance study, which is not described here.
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 available in the provided text. Ground truth and expert adjudication are relevant for studies assessing diagnostic accuracy, which is not the focus of this 510(k) submission for a display device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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 and not available in the provided text. This is a passive display device, not an AI-powered diagnostic tool. MRMC studies are not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not available in the provided text. This is a display device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable and not available in the provided text.
8. The sample size for the training set
- Not applicable and not available in the provided text. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not available in the provided text.
Summary of available information from the provided text:
- Device Name: Nova - Radiology 18.1" Monochrome Display (1MP), Nova - Radiology 20.1" Monochrome Display (2MP), Nova - Radiology 20.8" Monochrome Display (3MP), Nova - Radiology 21.3" Monochrome Display (5MP)
- Intended Use: To display and view digital images for review and analysis by trained medical practitioners. (Note: Specific limitations for FFDM use are mentioned for different models).
- Technological Characteristics: High-resolution, Liquid Crystal Display (LCD) with image restoration for viewing and analysis of high-resolution medical images.
- Regulatory Pathway: 510(k) Premarket Notification based on substantial equivalence.
- Predicate Devices:
- Conclusion: The FDA determined substantial equivalence, allowing the device to be marketed. This determination is based on the comparison of the new device's characteristics against the legally marketed predicate devices, not on the results of a new performance study with explicit acceptance criteria.
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KO40310
JUN 1 7 2004
510(k) Summary
| A. Manufacturer: | National Display Systems, Inc16245 Vineyard BoulevardMorgan Hill, CA 95037USA |
|---|---|
| B. Submitted By: | Ron HansenProduct ManagerNational Display System, Inc. |
| C. Date of Preparation: | June 15, 2004 |
| D. Contact Information: | Tel: 408.776.0085 Ext. 128Fax: 408.776.9878 |
| E. Classification Name: | System, image processing |
| F. Common Name: | Monitor, display, and others |
| G. Proprietary Name: | Nova - Radiology 18.1" Monochrome Display (1MP)Nova - Radiology 20.1" Monochrome Display (2MP)Nova - Radiology 20.8" Monochrome Display (3MP) andNova - Radiology 21.3" Monochrome Display (5MP) |
| H. Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| I. Substantial Equivalence: | Nova 1MP = Coronis 1MP (Barco) K023340Nova 2MP = Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K032202Nova 3MP = Coronis 3MP (Barco) K013922 and Dome C3 (Planar Systems) K032638Nova 5MP = Coronis 5MP (Barco) K023341 and Dome C5i (Planar Systems) K032202 |
| J. Device Description: | The Nova - Radiology Monochrome Display is adiagnostic display. |
| K. Intended Use: | The Nova Radiology Medical Displays are intended to beused to display and view digital images for review andanalysis by trained medical practitioners. The Nova 5MPdisplay is currently not cleared in the U.S. for use with FulField Digital Mammography (FFDM). The Nova 1MP,2MP and 3MP displays are not intended for use withFFDM |
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- The Nova Radiology Monochrome Display is a L. Technological Characteristics: high resolution, Liquid Crystal Display (LCD) with mgn resoration, Exquery Exquery and analysis of high-resolution medical images.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping lines that resemble an abstract representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mr. Ron Hansen Product Manager National Display Systems, Inc. 16245 Vinevard Blvd. MORGAN HILL CA 95037
Re: K040310 Trade/Device Name: NOVA Family of Medical Radiology Displays Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 28, 2004 Received: June 2, 2004
Dear Mr. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your becalled is substantially equivalent (for the indications felerenced above and navo user. International marketed predicate devices marketed in interstate for use stated in the encrosary to togethy to together the Medical Device Amendments, or to Conniered phor to May 20, 1978, 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 I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of motice, 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 If your device is classinod (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the 0000 cerments 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 that I DA has made a determinations administered by other Federal agencies. You must comply of ally I each a statures and regulations as but not limited to: registration and listing (21 CFR Part with an the Free Prequirements) ; good manufacturing practice requirements as set forth in the 807), laocimig (21 CFR Part 820), good and if applicable, the electronic product quality Systems (QD) regans (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) I his letter will anow you to begin hanteling your antial equivalence of your device to a legally premarket notification. The PDA miding of bactification 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 If you desire specific advice for your deville 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 Additionally, for questions of the promote the regulation entitled, "Misbranding Office of Compliance at (301) 37 1-1007.97) you may obtain. Other general by reletence to premarket notification (er the Act may be obtained from the Division of Small Information on your responsional 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. Bryden
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): K040310
Device Name: NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
Indications for Use:
The Nova Radiology Medical Displays are intended to display and view digital images for review and analysis by trained model Pied Digital Mammography (FFDM). The currently not cleared in the U.S. for use with First and with FFDM.
Prescription Use __
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Seymon
510k) Nu
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).