(109 days)
Not Found
No
The document describes a standard PACS system for image storage, retrieval, and display. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic image processing and display. The testing described focuses on system functionality, data integrity, and image display quality, not on the performance of any AI/ML algorithms.
No
The device is described as a software application that handles and manipulates digital medical images for diagnostic, clinical, research or education purposes. It is explicitly stated that a physician interprets images and information on DG PACS; the software itself is not making therapeutic decisions or directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "DG PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images."
Yes
The device description explicitly states "DG PACS is a software application" and describes its function as handling and manipulating digital medical images. It does not mention any associated hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for the "primary diagnostic and analysis tool for diagnostic images." This refers to the interpretation of medical images (like X-rays, CT scans, etc.) by a physician. IVDs, on the other hand, are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description emphasizes handling and manipulating "digital medical images." It also explicitly states that the device "does not contact the patient, nor does it control any life sustaining devices." This aligns with a medical imaging system, not an IVD which typically involves analyzing biological samples.
- Nature of the Data: The input is "multiple modalities" of medical images (DICOM format). IVDs work with data derived from biological specimens.
- Lack of IVD-Specific Information: The document does not mention any analysis of biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a Picture Archiving and Communication System (PACS), which is a type of medical device used in radiology and other medical imaging specialties.
N/A
Intended Use / Indications for Use
DG PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
DG Viewer, a component of DG PACS, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
Not intended for diagnostic use on mobile devices.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
DG PACS is considered a 'Continuous Use' device. This device is compliant with HIPAA/HITECH, Safe Harbor, and 21 CFR Part 11 regulations regarding patient privacy (such as restricting access to particular studies, logging access to data), data integrity, patient safety and best software development and validation practices.
DG PACS is a software application that handles and manipulates digital medical images for diagnostic, clinical, research or education purposes. The device does not contact the patient, nor does it control any life sustaining devices. A physician interprets images and information on DG PACS.
In general, a Picture Archiving and Communication System (PACS) is a medical imaging technology that provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS: this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is the Digital Imaging and Communications in Medicine (DICOM 3.x). Non-image data, such as scanned documents or dictated reports, may be incorporated using consumer industry standard formats like Portable Document Format (PDF) once encapsulated in DICOM.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
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Input Imaging Modality
images from multiple modalities
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The complete DG PACS system access specifications, configuration and functional specifications have been assessed, tested and passed all in-house testing criteria. The test plan was designed to evaluate all input functions, output functions, and actions performed by DG PACS software in each operational mode and followed the process documented in the test plan. The System Access Test Plan and Report specifically evaluated data integrity and PHI confidentiality, and similarly passed in-house testing and evaluation. Supporting software and IT infrastructure went through a congruent validation and verification process including risk assessment, requirements specification, testing planning and execution.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing results are provided in the 510(k) and more detailed reports are included in the Annex. Verification and validation testing indicated that as required by the risk analysis, designated trained individuals performed all validation activities and that the results demonstrated that the predetermined acceptance criteria were met. Devices installed or implemented by DICOM Grid, Inc include integration and installation testing against defined user acceptance criteria, the results of which are disclosed to the client prior to release.
Additionally, DG PACS quality testing was conducted based upon industry QC monitor benchmarks developed by Society of Motion Picture & Television Engineers (SMPTE). American Association of Physicists in Medicine (AAPM), and David Clunie's pixel spacing test images for DICOM. All image display quality validation was successful, and can be reviewed in detail in the software testing and validation portion of the 510(k) or live at dicomgrid.com/compliance/qc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are arranged to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2016
DICOM Grid, Inc. % Ms. Calley Herzog Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314
Re: K152977
Trade/Device Name: DG PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 4, 2016 Received: January 6, 2016
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041
1
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.htm.
Sincerely yours,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152977
Device Name DG PACS
Indications for Use (Describe)
DG PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
DG Viewer, a component of DG PACS, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
Not intended for diagnostic use on mobile devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for Dicom Grid. The logo features the letters "DG" in a large, bold, sans-serif font, colored in a teal blue. Below the letters, in a smaller font, is the text "DICOM GRID". To the right of the letters, there is a grid of squares, with some squares filled in with a lighter shade of blue and others in gray, creating a visual element that complements the text.
Application Version: 3.0
Prepared: Oct 10, 2015
Submission Number: K152977
This 510(k) summary of safety and effectiveness information for DG PACS is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
Oct 10, 2015
Submitter Information 21 CFR 807.92(a)(1):
DICOM Grid, Inc. 4530 E Muirwood Drive, Suite 113 Phoenix, AZ 85048 Office: 888-587-2280 Fax: 415-484-7149
Company Contact:
Ms. Lauren Still Compliance Manager, DICOM Grid, Inc. 210 Carnelian Rd South San Francisco, CA 94080 lstill@dicomgrid.com Office: 571-480-6367 Fax: 415-484-7149
510(k) Correspondent Information 21 CFR 807.92(a)(1):
Ms. Calley A. Herzog Senior Consultant, Medical Devices Biologics Consulting Group, Inc. cherzog@bcg-usa.com Phone: 720-883-3633 Fax: 703-548-7457
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2):
Trade Name: DG PACS Common Name: Picture, archive and communications system Classification Name: System, Image Processing, Radiological Product Code: LLZ
Predicate Device 21 CFR 807.92(a)(3):
| Device Classification Name | System, Image Processing, Radiological |
|---|---|
| 510(K) Number | K120995 |
| Device Name | ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE |
| VIEWER SOFTWARE PRODUCT | |
| Original Applicant | ERAD, INC. |
| 23 Griswold Lane | |
| Winsted, CT 06098 | |
| Original Contact | Jillian M Reed |
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Image /page/4/Picture/0 description: The image shows the logo for Dicom Grid. The logo features the letters "DG" in a large, bold, sans-serif font, colored in a teal blue. Below the letters, in a smaller font, is the text "DICOM GRID". To the right of the letters, there is a square grid pattern made up of four smaller squares. The top left square is gray, the top right square is a lighter blue, and the bottom two squares are gray.
Application Version: 3.0
Prepared: Oct 10, 2015
Submission Number: K152977
| Regulation Number | 892.2050 |
|---|---|
| Classification Product Code | LLZ |
| Date Received | 04/02/2012 |
| Decision Date | 12/03/2012 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| Summary | Summary |
| Type | Traditional |
| Reviewed By Third Party | No |
| Combination Product | No |
Device Description 21 CFR 807 92(a)(4):
DG PACS is considered a 'Continuous Use' device. This device is compliant with HIPAA/HITECH, Safe Harbor, and 21 CFR Part 11 regulations regarding patient privacy (such as restricting access to particular studies, logging access to data), data integrity, patient safety and best software development and validation practices.
Indications for Use 21 CFR 807 92(a)(5):
DG PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
DG Viewer, a component of DG PACS, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
Not intended for diagnostic use on mobile devices.
Technological Characteristics 21 CFR 807 92(a)(6):
DG PACS is a software application that handles and manipulates digital medical images for diagnostic, clinical, research or education purposes. The device does not contact the patient, nor does it control any life sustaining devices. A physician interprets images and information on DG PACS.
In general, a Picture Archiving and Communication System (PACS) is a medical imaging technology that provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS: this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is the Digital Imaging and Communications in Medicine (DICOM 3.x). Non-image data, such as scanned documents or dictated reports, may be incorporated using consumer industry standard formats like Portable Document Format (PDF) once
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Image /page/5/Picture/0 description: The image contains the logo for DICOM Grid. The logo features the letters "DG" in a large, bold, sans-serif font, colored in a teal or cyan shade. Below the letters, the words "DICOM GRID" are written in a smaller, sans-serif font, also in the same teal/cyan color. To the upper right of the letters, there is a grid-like graphic composed of four squares, with two squares in a light gray color and two squares in a gradient of blue shades.
Application Version: 3.0
Prepared: Oct 10, 2015
Submission Number: K152977
encapsulated in DICOM.
Utilization of Standards:
Digital Imaging and Communications in Medicine (DICOM) Joint Photographic Experts Group (JPEG) Society of Motion Picture and Television Engineers (SMPTE)
Substantial Equivalence 21 CFR 807.87(f)
The new device (DG PACS) and predicate device (eRADS RIS / PACS) are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing leqally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The two devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use. A full comparison of features, equivalency and risk analysis may be found in the Substantial Equivalency Section of the full 510(k) submission.
Nonclinical Testing 21 CFR 807.87(f)
The complete DG PACS system access specifications, configuration and functional specifications have been assessed, tested and passed all in-house testing criteria. The test plan was designed to evaluate all input functions, output functions, and actions performed by DG PACS software in each operational mode and followed the process documented in the test plan. The System Access Test Plan and Report specifically evaluated data integrity and PHI confidentiality, and similarly passed in-house testing and evaluation. Supporting software and IT infrastructure went through a congruent validation and verification process including risk assessment, requirements specification, testing planning and execution.
Nonclinical testing results are provided in the 510(k) and more detailed reports are included in the Annex. Verification and validation testing indicated that as required by the risk analysis, designated trained individuals performed all validation activities and that the results demonstrated that the predetermined acceptance criteria were met. Devices installed or implemented by DICOM Grid, Inc include integration and installation testing against defined user acceptance criteria, the results of which are disclosed to the client prior to release.
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". DG PACS complies with voluntary standards as detailed in this premarket notification submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Requirements Reviews ●
- Design Reviews
- Usability Analysis ●
- Testing on unit level (Verification) ●
- Integration testing (Verification) ●
- Performance testing (Verification)
- Regression testing (Verification)
- System testing (Verification) ●
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Image /page/6/Picture/0 description: The image shows the logo for DICOM Grid. The logo features the letters 'DG' in a large, bold, sans-serif font, colored in teal. Below the letters, the words 'DICOM GRID' are written in a smaller, sans-serif font, also in teal. To the right of the letters, there is a square grid pattern composed of four smaller squares, with varying shades of gray and blue.
Application Version: 3.0
Prepared: Oct 10, 2015
- Simulated use testing (Validation) ●
Additionally, DG PACS quality testing was conducted based upon industry QC monitor benchmarks developed by Society of Motion Picture & Television Engineers (SMPTE). American Association of Physicists in Medicine (AAPM), and David Clunie's pixel spacing test images for DICOM. All image display quality validation was successful, and can be reviewed in detail in the software testing and validation portion of the 510(k) or live at dicomgrid.com/compliance/qc.
Conclusion 21 CFR 807 92(b)(1):
The 510(k) Pre-Market Notification for DG PACS contains adequate information, data, and nonclinical test results to enable FDA-CDRH to determine substantial equivalence to the predicate device, in this case eRADS RIS / PACS. The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device. Therefore, DG PACS is substantially equivalent to the predicate devices.