(15 days)
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is a display for viewing digital images, used for diagnosis and analysis, not for treatment or therapy.
Yes
The "Device Description" explicitly states, "The PrimeVue 21 inch 3MP Color Display is a diagnostic display."
No
The device description explicitly states it is a "high-resolution Liquid Crystal Display (LCD) with electronic capabilities," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PrimeVue 21 inch 3MP Radiological Medical Display is a display device used to view and analyze digital images. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display radiological images for review and analysis by medical practitioners. This is a function related to medical imaging, not in vitro testing.
The information provided clearly describes a medical imaging display, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The PrimeVue 21 inch 3MP Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners. However, This device must not be used in primary image diagnosis in mammography.
Product codes
90LLZ
Device Description
The PrimeVue 21 inch 3MP Color Display is a diagnostic display.
The PrimeVue 21 inch 3MP Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Coronis, Mdnc 3120 (Barco) K061927, RadiForce R31-C (Eizo Nanao) K052344
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of squares on the left, followed by the letters "NDS" in large, bold font. Below the letters is the text "SURGICAL · IMAGING" in a smaller font. The logo is black and white.
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Image /page/0/Picture/1 description: The image shows the text "K080320" in a bold, sans-serif font. Below this, the text "FEB 21 2000" is visible, indicating a date. The text appears to be part of a document or label, with the upper text likely serving as an identification code or serial number.
510(k) SUMMARY
| A. Manufacturer: | NDS Surgical Imaging, LLC
5750 Hellyer Avenue
San Jose, CA 95138
USA |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Jim Leng
Regulatory Engineer
NDS Surgical Imaging, LLC |
| C. Date of Preparation: | Oct. 15, 2007 |
| D. Contact Information: | Tel: 408-776-0085
Fax: 408-776-9878 |
| E. Classification: | System, image processing, radiological |
| F. Common Name: | Monitor, display, and others |
| G. Proprietary Name: | PrimeVue 21" 3MP Color Display |
| H. Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| I. Substantial Equivalence: | Coronis, Mdnc 3120 (Barco) K061927
RadiForce R31-C (Eizo Nanao) K052344 |
| J. Device Description: | The PrimeVue 21 inch 3MP Color Display is
a diagnostic display. |
| K. Intended Use: | The PrimeVue 21 inch 3MP Radiological
Medical Display is intended to be used to
display and view digital images for review and
analysis by trained medical practitioners.
However, This device must not be used in
primary image diagnosis in mammography. |
| L. Technological Characteristics: | The PrimeVue 21 inch 3MP Display is a high-
resolution Liquid Crystal Display (LCD) with
electronic capabilities used for the review and
analysis of high-resolution medical images by
trained medical practitioners. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
'APR - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NDS Surgical Imaging, LLC c/o Mr. Tamas Borsai Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K080320
Trade/Device Name: PrimeVue 21" 3MP Radiology Medical Display Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 28, 2008 Received: February 6, 2008
Dear Mr. Borsai:
This letter corrects our substantially equivalent letter of February 21, 2008.
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 (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 (PMA), it may be subject to 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.
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
2
Page 2 - Mr. Tamas Borsai
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 continue marketing your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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/dsma/dsmamain.html
Sincerely vours.
Nancy C. Brogdon
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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Image /page/3/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of black squares on the left, followed by the letters "NDS" in large, bold, black font. Below the letters, the words "SURGICAL - IMAGING" are printed in a smaller font. The logo is simple and professional, and it is likely used to represent a company that provides surgical imaging products or services.
Indications for Use
510(k) Number (if known): N/A
Device Name: PrimeVue 21" 3MP Radiology Medical Display
Indications for Use:
The PrimeVue 21 inch Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners.
Prescription Use X
AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIE LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harvey C. Hodgon
Division of Reproductive. Abdon Radiological Devices 510(k) Number
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