(14 days)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are flat panel hi-resolution LCD monitor systems for displaying gray scale medical images for diagnostic and referral use. The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower electro-magnetic emissions and heat, and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly to a common graphics display controller via a Digital Visual Interface (DVI) 1.0 interface. The Displays' Thin Film Transistors (TFTs) control transmissive liquid-crystal elements and use intedrated Cold Cathode Fluorescent Tube (CCFT) backlight systems. The DOME C2 displays two megapixels of data in a portrait or landscape orientation of 1200 x 1600 8-bit pixels. The DOME C5i displays five megapixels of data in a portrait or landscape orientation of 2048 x 2560 8-bit pixels. Both display systems include the LCD display panel, integrated drive electronics, integrated backlight, and an external power supply. Optional connections to USB can provide enhanced system functionality, including kevboard, mouse, and calibration technology.
Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:
Device: DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K032202) is a 510(k) summary for a medical device. For image display systems, the acceptance criteria are generally related to demonstrating substantial equivalence to a legally marketed predicate device rather than specific performance metrics like sensitivity or specificity for disease detection. The performance is assessed against the predicate's established technical characteristics and intended use.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Intended Use | Must be for displaying and viewing medical images for review and analysis by trained medical practitioners. | The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. (Matches predicate's implied intended use). |
| Technological Characteristics | Must demonstrate similar basic technological design for displaying grayscale images (e.g., flat panel, active matrix liquid-crystal display, integrated backlight). | The DOME CX™ uses active matrix liquid-crystal display (AMLCD) panels, integrated drive electronics, integrated backlight, and an external power supply. The DOME C2 displays two megapixels (1200 x 1600 pixels) and the DOME C5i displays five megapixels (2048 x 2560 pixels). These specifications align with the 2MP and 5MP predicate devices (CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM and CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM) in terms of pixel count and general technology. The document states: "The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use." |
| Safety and Efficacy | Must not raise new questions of safety or efficacy compared to the predicate device. | The device "does not contact the patient, nor does it control any life sustaining devices." It relies on "competent human intervention to interpret images." A hazard analysis was performed, and potential hazards were classified as "Minor." The conclusion explicitly states: "Any difference between the two devices does not affect safety or efficacy." |
| Regulatory Compliance | Must comply with relevant voluntary and safety standards. | The device "will be manufactured by in accordance with voluntary and safety standards." (Specific standards are not listed in this summary but are implied to be part of the full submission). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set of medical images or data. The evaluation is focused on the device's technical specifications and how they compare to a predicate device, as this is a 510(k) for a display system, not an algorithm that interprets images. The "performance" being evaluated is the display's ability to render images according to its specifications, which are deemed equivalent to the predicate. Therefore, there's no mention of:
- Sample size for a test set
- Data provenance (country of origin, retrospective/prospective)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, there isn't a test set of images requiring expert ground truth for this type of device (a display system). The assessment is on the display's characteristics themselves.
4. Adjudication Method for the Test Set
Not applicable, as there is no test set or clinical endpoint requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
Not applicable. This is a display system, not an AI algorithm designed to assist human readers in image interpretation. Therefore, an MRMC study demonstrating human reader improvement with AI assistance would not be relevant for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a display system, not an algorithm. Its function is to present images for human interpretation, not to provide standalone diagnostic output.
7. The Type of Ground Truth Used
Not applicable. There is no diagnostic "ground truth" established as part of this submission, as the device's function is image display, not image analysis or diagnosis. The "ground truth" in this context would implicitly be the technical specifications (e.g., pixel count, luminance, contrast) of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a display system; it does not employ machine learning or require a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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AUG - 1 2003
K032202
PLANAR
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
June 24, 2003
Submitter's Information: 21 CFR 807.92(a)(1)
Planar Systems, Inc. 400 Fifth Ave. Waltham, MA 02451-8738 USA
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™Models C2™ and C5i™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification: | 892.2050 |
| Name: | System, Image Processing |
Predicate Devices: 21 CFR 807. 92(a)(3)
| DeviceClassificationName | SYSTEM, IMAGEPROCESSING,RADIOLOGICAL | SYSTEM, IMAGEPROCESSING,RADIOLOGICAL |
|---|---|---|
| Regulation Number | 892.2050 | 892.2050 |
| 510(k) Number | K023341 | K023322 |
| Device Name | CORONIS 5MP MEDICALFLAT PANEL DISPLAYSYSTEM | CORONIS 2MP MEDICALFLAT PANEL DISPLAYSYSTEM |
| Applicant | BARCO NVP.O. BOX 12038LA JOLLA, CA 92039 2038 | BARCO NVP.O. BOX 12038LA JOLLA, CA 92039 2038 |
| Product Code | LLZ | LLZ |
Device Description: 21 CFR 807 92(a)(4)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are flat panel hi-resolution LCD monitor systems for displaying gray scale medical images for diagnostic and referral use.
The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower electro-magnetic emissions and heat, and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly to a common graphics display controller via a Digital Visual Interface (DVI) 1.0 interface. The Displays' Thin Film Transistors (TFTs) control transmissive liquid-crystal elements and use intedrated Cold Cathode Fluorescent Tube (CCFT) backlight systems. The DOME C2 displays two megapixels of data in a portrait or landscape orientation of 1200 x 1600 8-bit pixels. The DOME C5i displays five megapixels of data in a portrait or landscape orientation of 2048 x 2560 8-bit pixels. Both display systems include the LCD
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PLAVAR
display panel, integrated drive electronics, integrated backlight, and an external power supply. Optional connections to USB can provide enhanced system functionality, including kevboard, mouse, and calibration technology.
Indications for Use: 21 CFR 807 92(a)(5)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is an image display system consisting of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.
Conclusion: 21 CFR 807 92(b)(1)
- The new Planar, Inc. DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM, Models . C2™ and C5i™ is substantially equivalent to the predicate devices BARCO NV, CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM™ (K023341) and BARCO NV, CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023322)
- The new and predicate devices are both 2/5Million Pixel Medical Flat Panel Display . Systems intended to be used in displaying and viewing digital images for review by trained medical practitioners. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Any difference between the two devices does not affect safety or efficacy.
- The 510(k) Pre-Market Notification for the DOME CX™ DIGITAL FLAT-PANEL DISPLAY . SYSTEM™, Models C2™ and C5i™ contain adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices.
- The Planar Systems, Inc., DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ will be manufactured by in accordance with voluntary and safety standards.
- . The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures. The figures are connected and appear to be moving forward.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Planar Systems, Inc.. c/o Ned E. Devine, Jr. Entela®, Inc 3033 Madison Ave., S.E. GRAND RAPIDS MI 49548
Re: K032202
Trade/Device Name: DOME CX" DIGITAL FLAT-PANEL DISPLAY SYSTEM
Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: 90 LLZ Dated: June 24, 2003 Received: July 18, 2003
Dear Mr. Devine:
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 (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 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.
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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 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 Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer 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 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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103228
Page 1 of -1
(Indications for Use Form)
510(k) Number:
Device Name:
DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ from Planar Systems, Inc.
Indications for Use:
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ 1:
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
- Nancy C Brogdon
and Radiological Dev 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).