(95 days)
Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Model Dome S6c is not intended for mammography use.
The Dome model S6c is a widescreen 30-inch 6 megapixel color monitor. Its sleek design, high brightness and bezel free separation between two 3MP displays makes Dome model S6c ideal for read of patient images acquired from multiple medical imaging modalities.
The provided text describes NDS Surgical Imaging's Dome® S6c color monitor, a 6-megapixel display intended for displaying and viewing medical images. The submission focuses on demonstrating substantial equivalence to a predicate device, the Dome model C3 color.
However, the document does not contain the following information regarding acceptance criteria and performance studies:
- A table of acceptance criteria and reported device performance (beyond basic specifications and regulatory compliance). The document primarily compares the technical specifications to a predicate device for the purpose of demonstrating substantial equivalence, not against specific performance acceptance criteria for diagnostic tasks.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance. This device is a display monitor, not an AI-powered diagnostic tool.
- Whether a standalone performance study was done. This device is a display monitor, not an AI-powered diagnostic tool.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The core of the submission is a comparison of technical specifications and regulatory compliance, and not a clinical performance study using patient data and expert ground truth.
Based on the provided text, here is what can be extracted:
The device is a medical display monitor, and the "acceptance criteria" discussed are primarily related to its technical specifications and compliance with safety and EMI standards, rather than diagnostic performance metrics. The study presented is a technical comparison for substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the context of a performance study with diagnostic outcomes. Instead, it compares the technical specifications and regulatory approvals of the Dome® S6c with a predicate device (K032638 Dome model C3 color). The argument for acceptance is based on demonstrating substantial equivalence in these technical and regulatory aspects.
| Characteristic Items | Predicate device K032638 (Dome C3 Color) | Reported Device Performance (Dome® S6c K133609) |
|---|---|---|
| Intended Use | Displaying and viewing medical images for review and analysis by trained medical practitioners. | Displaying and viewing medical images for review and analysis by trained medical practitioners. (Not for mammography use) |
| Screen diagonal | 20.8" Diagonal (528 mm) | 30" Diagonal (762 mm) |
| Resolution | 1536 x 2048 pixels (portrait) / 2048 x 1536 pixels (landscape) | Dual 1536 x 2048 pixels (portrait) (future implementation) / Dual 1640 x 2048 pixels (portrait) / 3280 x 2048 pixels (landscape) (Equivalent resolution of dual 3MP radiology displays, described as 6MP) |
| Pixel pitch | 0.207 mm | 0.197 mm |
| Contrast ratio | 600:1 - typical | 1000:1 - typical |
| Brightness | 235 cd/m² typical | 800 cd/m² typical |
| Pixel rise/fall time | 50 ms | 30 ms typical |
| Viewing angle (CR 10:1) | +/- 85° (170°) horizontal / +/- 85° (170°) vertical | +/- 85° (170°) horizontal / +/- 85° (170°) vertical |
| Stabilization, calibration, automated QA | Built in RightLight rear sensor for backlight stabilization. Factory calibrated. QA through manual external photometer. | Built in RightLight rear sensor for backlight stabilization. Factory calibrated. QA through embedded RightCheck front sensor and manual external photometer. |
| Look up table | 10/12 bit | 10/12 bit |
| Digital Video Input | 1x DVI Revision 1.0 single channel connector | 1x DVI Revision 1.0 digital dual-channel connector |
| Input Formats (Landscape) | 2048x1536 (8 bits per pixel, 24 bit color) | 3280x2048 (8 or 10 bit per pixel, 24 bit or 30 bit color) |
| Input Formats (Portrait) | 1536x2048 (8 bits per pixel, 24 bit color) | 2x 1536x2560 or 2x 1640x2048 (8 or 10 bit per pixel, 24 bit or 30 bit color) |
| Power Supply | 100 | 100 |
| Safety | EN 60601-1 Part 1. General requirements for safety | IEC 60601-1: 2005 |
| EMI | EN 55011 Class B | EN 60601-1-2: 2007 |
| Primary Claim of Equivalence | The Dome model C3 color, a 3MP display. | The Dome model S6c ("6MP display device, equivalent to the resolution of dual 3MP radiology displays"). The difference is that S6c is "one package that replaces two Dome model C3 color side by side displays in use." The device meets IEC/EN60601-1 and 60601-1-2 standards for safe design and operation. |
2. Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for a display device, not a study of diagnostic performance using a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is a display monitor, which does not incorporate AI or directly assist human readers in diagnostic interpretation in the manner of an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is adherence to technical specifications and regulatory standards.
8. The sample size for the training set: Not applicable. This is a display device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
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NDS
SURGICAL · IMAGING
K133609
Page 1 of 3
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
November 15, 2013
Revision: January 29, 2014 Revision: February 20, 2014
408-776-0085 408-776-9878
The Dome® S6c monitor
Picture Archiving Communication System
System, Image Processing, Radiological
Bl, Address:
NDS Surgical Imaging, LLC 5750 Hellyer Avenue San Jose, CA 95138 USA
C. Date of Preparation:
- D. Contact Information:
E. Classification:
F. Common Name:
G. Proprietary Name:
- H. Classification Number: 21 CFR 892.2050
- I Product Code:
LLZ
Tel:
Fax:
Dome model S6c is substantial equivalent to the predicate device K032638 J. Substantial Equivalence: Dome model C3 color. Both devices have the same indication for use with the same characteristics. Dome model S6c series is a 6MP display device, equivalent to the resolution of dual 3MP radiology displays. Both devices have the same viewing angle, number of colors and utilize the same backlight stabilization and calibration technologies. The physical size difference does not impact display information and viewing.
- K. Device Description: The Dome model S6c is a widescreen 30-inch 6 megapixel color monitor. Its sleek design, high brightness and bezel free separation between two 3MP displays makes Dome model S6c ideal for read of patient images acquired from multiple medical imaging modalities.
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Image /page/1/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 bold, sans-serif font. Below the letters, the words "SURGICAL IMAGING" are printed in a smaller font size.
| L. Intended Use: | The Dome Sx line, model S6c is intended to be used in displaying andviewing medical images for review and analysis by trained medicalpractitioners. |
|---|---|
| Model Dome S6c is not intended for mammography use. | |
| M. Technological Characteristics: | Bezel-free framing of 6 megapixels of data is presented in a 30 inchdiagonal display landscape format with resolution of 3280 x 2048 and apixel pitch of 0.197mm. The integrated Dome RightLight Controllermonitors and stabilizes backlight luminance. The display unit includes aPCI Express graphics board to support the required dual-link connectivityfor the display. |
| Characteristic Items | Predicate device K032638 | Specification K 133609 |
|---|---|---|
| Intended Use | The DOME CX ™DIGITAL FLAT-PANEL DISPLAY SYSTEM™,Model C3 Color™ and C3 Gray areintended to be used in displaying andviewing medical images for reviewand analysis by trained medicalpractitioners. | Dome Sx line, model Dome S6c isintended to be used in displaying andviewing medical images for reviewand analysis by trained medicalpractitioners. |
| Screen | ||
| Screen diagonal | 20.8" Diagonal (528 mm) | 30" Diagonal (762 mm) |
| Resolution | 1536 x 2048 pixels (portrait)2048 x 1536 pixels (landscape) | Dual 1536 x 2048 pixels (portrait)(Note: future implementation)Dual 1640 x 2048 pixels (portrait)3280 x 2048 pixels (landscape) |
| Pixel pitch | 0.207 mm | 0.197 mm |
| Contrast ratio | 600:1 - typical | 1000:1 - typical |
| Brightness | 235 cd/m² typical | 800 cd/m² typical |
| Pixel rise/fall time | 50 ms | 30 ms typical |
| Viewing angle (CR10:1) | +/- 85° (170°) horizontal+/- 85° (170°) vertical | +/- 85° (170°) horizontal+/- 85° (170°) vertical |
| ViewingCharacteristics | ||
| Stabilization,calibration, andautomated QA | Built in RightLight rear sensor forbacklight stabilization.Factory calibrated.QA through manual externalphotometer | Built in RightLight rear sensor forbacklight stabilization.Factory calibrated.QA through embedded RightCheckfront sensor and manual externalphotometer |
| Characteristics | ||
| Look up table | 10/12 bit | 10/12 bit |
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Image /page/2/Picture/6 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of circles and squares on the left, followed by the letters "NDS" in bold, sans-serif font. Below the letters, the words "SURGICAL - IMAGING" are written in a smaller, sans-serif font.
Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text "K133609" is at the top, followed by "Page 3 of 3" below it. The handwriting is cursive and slightly stylized, with the numbers and letters clearly legible.
| Interface | ||
|---|---|---|
| Digital Video Input | 1x DVI Revision 1.0 single channelconnector | 1x DVI Revision 1.0 digital dual-channel connector |
| Input Formats | ||
| Landscape Orientation | 2048x1536 (8 bits per pixel, 24 bitcolor) | 3280x2048 (8 or 10 bit per pixel, 24bit or 30 bit color) |
| Portrait Orientation | 1536x2048 (8 bits per pixel, 24 bitcolor) | 2x 1536x2560 or 2x 1640x2048 (8 or10 bit per pixel, 24 bit or 30 bit color) |
| Power Requirements | ||
| Power Supply | 100 | 100 |
| Regulatory Approvals | ||
| Safety | EN 60601-1 Part 1. General requirementsfor safety | IEC 60601-1: 2005 |
| EMI | EN 55011 Class B | EN 60601-1-2: 2007 |
N. Conclusion:
Based upon our test results, the Dome model S6c radiology display meets IEC/EN60601-1 and 60601-1-2 standards which establish its safe design and operation. The Dome model S6c and the predicate device model C3 color are identical in terms of indication for use, characteristics, specifications and performance. The difference is Dome model S6c is one package that replaces two Dome model C3 color side by side displays in use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines representing its wings and body. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
NDS Surgical Imaging, LLC % Mr. Jim Leng Regulatory Engineer 5750 Hellyer Avenue SAN JOSE CA 95138
Re: K133609
Trade/Device Name: The Dome® S6c Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2014 Received: February 6, 2014
Dear Mr. Leng:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Leng
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.bum.
Sincerely yours,
ொ
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133609
Device Name
The Dome S6c Color Monitor
Indications for Use (Describe)
Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Model Dome Soc is not intended for mammography use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
لـ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
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§ 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).