(206 days)
No
The document describes a PACS/RIS software system for viewing, manipulating, storing, and communicating medical images. It mentions standard image processing functions and integration with HIS/RIS. There is no mention of AI, ML, deep learning, or any related technologies in the intended use, device description, or performance studies sections.
No
The device is a software for viewing and manipulating medical images, not for therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states: "InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices." While it's used for viewing and manipulating medical images, it specifically excludes diagnostic use.
Yes
The device description explicitly states "InstaRISPACS / InstaZFP / InstaMobi, is a software application" and details its function as viewing, manipulating, storing, and communicating digital images across computer networks. While it interacts with hardware (imaging devices, servers, mobile devices), the device itself, as described, is the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of InstaRISPACS / InstaZFP / InstaMobi clearly states it is used for viewing and manipulating digital images from various imaging modalities (CT, MR, US, etc.). It does not mention analyzing biological samples like blood, urine, or tissue.
- The intended use is for viewing and manipulating medical images for clinical purposes. While it integrates with HIS/RIS and provides access to reports, its primary function is image management and display, not diagnostic testing performed on biological specimens.
- The device description focuses on software features for image handling. It details how images are displayed, processed, stored, and communicated, which are typical functions of a PACS/RIS system, not an IVD.
Therefore, InstaRISPACS / InstaZFP / InstaMobi falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
InstaRISPACS / InstaZFP / InstaMobi is a software device (Enterprise Server, Diagnostic Workstation, Physician Zerofoot print Viewer and a Mobile Viewer) used for viewing and manipulating digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS modules can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices.
Product codes
LLZ
Device Description
InstaRISPACS / InstaZFP / InstaMobi, is a software application used for viewing and manipulating medical images. Digital images and data from various sources (including CT. MR. US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation and various image manipulations.
InstaRISPACS, is a server-based application for use by Physicians, which comes with the Diagnostic Viewer.
InstaZFP, is a Zero Foot print viewer for use by Physicians to display images after fetching them from the InstaRISPACS server.
InstaMobi, is a Mobile application (for iOS & Android), for use by Physicians to fetch images from InstaRISPACS and display them on the mobile device.
In addition, InstaRISPACS, can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources (including mammography)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Hospital Information System (HIS) or Radiology Information System (RIS)
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
Non-clinical performance testing has been performed on the subject device and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices Application of risk management to medical devices .
- IEC 62304 Medical device software - Software life cycle processes
- NEMA-PS 3.1 - PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
InstaRISPACS/ InstaZFP/InstaMobi, was tested in accordance with Meddiff verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on the subject device and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices Application of risk management to medical devices .
- IEC 62304 Medical device software - Software life cycle processes
- NEMA-PS 3.1 - PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
The test results in this 510(k), demonstrate that InstaRISPACS/ InstaZFP/InstaMobi: - complies with the aforementioned international and FDA-recognized consensus standards and
- FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use.
Therefore, InstaRISPACS/ InstaZFP/InstaMobi is substantially equivalent to the currently marketed predicate device K120718, INSTAPACS/INSTARISPACS V4.0, in terms of safety and effectiveness.
Clinical Testing:
InstaRISPACS/ InstaZFP/InstaMobi does not require clinical studies to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 "meddiff". The logo consists of the letters "MD" inside of a teal circle on the left side of the image. To the right of the circle is the word "meddiff" in black, with the "diff" portion in teal. Below the word "meddiff" is the phrase "We make the Difference" in a smaller font.
This 510(k) Summary information is being submitted in accordance with the requirements of 21 CFR Part 807.92
- l. SUBMITTER
MEDDIFF Technologies Pvt. Ltd. Salarpuria Palladium, 3rd floor, #2021, 100 ft Road, HAL 2ndStage Bangalore - 560 008, Karnataka - India Tel: +91-80-65350192
Contact person: Mr. Sanjeev, Managing Director and CEO Date Prepared: April 8, 2019
II. DEVICE
Name of Device: InstaRISPACS / InstaZFP/ InstaMobi, V5.0 Common or Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ
III. PREDICATE AND REFERENCE DEVICES
Primary Predicate: InstaPACS/InstaRISPACS V4.0, K120718 This predicate has not been subject to a design-related recall.
Reference Device #1: OSIRIX MD, K101342
IV. DEVICE DESCRIPTION
InstaRISPACS / InstaZFP / InstaMobi, is a software application used for viewing and manipulating medical images. Digital images and data from various sources (including CT. MR. US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation and various image manipulations.
- . InstaRISPACS, is a server-based application for use by Physicians, which comes with the Diagnostic Viewer.
- InstaZFP, is a Zero Foot print viewer for use by Physicians to display images after ● fetching them from the InstaRISPACS server.
- . InstaMobi, is a Mobile application (for iOS & Android), for use by Physicians to fetch images from InstaRISPACS and display them on the mobile device.
In addition, InstaRISPACS, can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
V. INDICATIONS FOR USE
InstaRISPACS/ InstaZFP/InstaMobi is a software device (Enterprise Server, Diagnostic Workstation. Physician Zero-foot print Viewer and a Mobile Viewer) used for viewing and manipulating digital medical images (including mammography and data
1
Image /page/1/Picture/0 description: The image shows the logo for "meddiff". The logo consists of a teal circle with the letters "MD" inside, followed by the word "meddiff" in black. Below the word "meddiff" is the phrase "We make the Difference".
from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRISPACS/InstaZFP modules can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA. InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices.
The subject device and predicate device IFU are not identical, however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate.
The subject device includes InstaZFP (Zero Foot print viewer) and InstaMobi (a Mobile application for iOS & Android).
- InstaZFP, allows launching studies directly in a browser, regardless of the type . of browser, or operating system. Unlike standard PACS viewing, which requires installations onto a PC/workstation, zero-footprint viewer does not involve any additional browser installations. InstaZFP, has been considered in the device risk analysis, tested and has passed the validation criteria. InstaZFP has no impact on safety or efficacy and new potential safety risks have not been mitigated.
- InstaMobi, is used to view images on a mobile device (iOS or Android). A . statement is put onto the viewing screen that InstaMobi, is not intended for diagnostic image review or diagnostic use on mobile devices. The mobile viewer has been considered in the device risk analysis has been tested, and passed the validation criterion. InstaMobi has no impact on safety or efficacy and new potential safety risks have been mitigated.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device is a software product that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Both systems have been developed to replace traditional film handling in radiology. The devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use.
Meddiff believes that the subject device is substantially equivalent to the legally marketed predicate, with additional/enhanced functionality deriving from reference device #1: K101342, OSIRIX-MD
Below is the comparison table to summarize the similarities and differences of the subject, predicate, and reference device. The differences in technology do not raise new or different questions of safety and effectiveness.
See Conclusion statement at the end of this section for substantial equivalency assessment of the differences indicated in the table.
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Image /page/2/Picture/0 description: The image contains a logo for a company called "mediff". The logo consists of the letters "MD" inside of a teal circle on the left side of the image. To the right of the circle is the company name in bold, black font, with the last two letters in teal. Below the company name is the text "We make the Difference".
| Feature/Functions | InstaRISPACS/ InstaZFP/ InstaMobi,
Subject Device | InstaPACS/InstaRISPACS K120718
Predicate | |
|-------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| System | Indications for Use | The subject device and predicate device
IFU are not identical, however, the
differences do not alter the intended use of
the device nor do they affect the safety
and effectiveness of the device relative to
the predicate. | Picture archive and communications
system |
| Hardware server
(recommended) | Computer processor | Dual Hexa Core Intel Xeon Processor | Quad Core Intel Xeon |
| | Operating System | Windows Server 2016 | Windows Server 2008 |
| | Hard disk array | Capacity depends on the usage volume.
Recommended 5TB | Capacity depends on the usage volume.
Recommended 250GB |
| | Ram | 16 GB | 8 GB |
| Workstation
Client Hardware
(recommended) | Processor | Core i7 / Quad Core Xeon | Pentium 2.0+Ghz. Dual core |
| | Operating System | Windows 10 (64 bit) | Windows XP/Vista/7 |
| | Display | Medical Grade Monitor is recommended.
Resolution depends on the modality type. | Medical Grade Monitor is recommended.
Resolution depends on the modality
type. |
| | RAM | Minimum 8GB RAM | Minimum 2GB RAM |
| | Hard Disk | 750GB minimum | 400 GB minimum |
| | System Architecture | Web based | Web based |
| | Hardware | Vendor Agnostic | Vendor Agnostic |
| | Security | Log-on user ID & password | Log-on user ID & password |
| Server features | Remote monitoring | Yes | Yes |
| | Database | MySQLv5.7 | MySQLv5.1 |
| | Storage | RAID | RAID |
| Viewer Features | Image Viewing Layout | Std. formats (up to 44) | Std. formats (up to 44) |
| | WW/WL | Yes | Yes |
| | PET-CT fusion viewing | Subject device was tested and compared
to Reference device #1, (K101342) Data
indicated that the subject device was
found to be similar to the reference device. | Not supported. |
| | Embedded & basic
Volume Rendering | Subject device supports basic 'VR'
functionality that includes image rotate,
zoom, and crop. Comparison was done
against Reference device #1, (K101342)
for image rotate, zoom, and crop.
(K101342) has additional VR functionality
such as vessel rendering, not included in
the subject device. | Not Supported |
| | Zoom in/Zoom out | Yes | Yes |
| | Hounsfield Measurement | Yes | Yes |
| | Linear and angle
measurements | Yes | Yes |
| | Series Comparison | Yes | Yes |
| | Scout line display | Yes | Yes |
| | MPR/MIP capabilities | Yes | Yes |
| | Stack mode | Yes | Yes |
| | Gray scale invert | Yes | Yes |
| Feature/Functions | | InstaRISPACS/ InstaZFP/ InstaMobi,
Subject Device | InstaPACS/InstaRISPACS K120718
Predicate |
| | Filters | Yes | Yes |
| | Rotate | Yes | Yes |
| | Key Image selection | Yes | Yes |
| | DICOM Print | Yes | Yes |
| | Windows print | Yes | Yes |
| | Query/Retrieve | Yes | Yes |
| | Image compression | Lossless Viewing | Lossless Viewing |
| | Selection tools | Thumbnails | Thumbnails |
| Reporting
module | Report text can be
entered from a keyboard | Yes | Yes |
| | Report text can be
entered from a 3rd party
conversion "voice to text"
software | Yes | Not supported. |
| | Reporting Interface | Can be opened from the from study list | Can be opened from the viewer or from
study list |
| | Report Template Support | User Defined templates | User Defined templates |
| | Digital Signature | Yes | Yes |
| | Report Formats | MS word | MS word |
| Other features | Link to Hospital
Information System (HIS) | Yes | Yes |
| | Link to Radiology
Information System RIIS) | Yes | Yes |
| | Electronic patient record | Through Broker Software | Through Broker Software |
| Configurations | PACS Server
(InstaRISPACS server) | Yes | Yes |
| | Radiology Workstation
(InstaRISPACS radiology
workstation) | Yes | Yes |
| | Basic web image Viewer
(InstaZFP Viewer) | Yes | Not supported |
| | Mobile app viewer
(InstaMobi Viewer) | Yes | Not supported |
3
Image /page/3/Picture/0 description: The image shows the logo for Medclif. The logo consists of a teal circle with the letters "MD" in white inside of it. To the right of the circle is the word "medclif" in black, with the tagline "We make the Difference" in a smaller font below it.
VII. PERFORMANCE DATA
Non-clinical performance testing has been performed on the subject device and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971Medical devices Application of risk management to medical devices .
- . IEC 62304 Medical device software - Software life cycle processes
- . NEMA-PS 3.1 - PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
- . Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
4
Image /page/4/Picture/0 description: The image shows the logo for "medclif". The logo consists of the letters "MD" in a teal circle on the left, followed by the word "medclif" in black. Below the word "medclif" is the phrase "We make the Difference" in a smaller font.
-
. InstaRISPACS/ InstaZFP/InstaMobi, was tested in accordance with Meddiff verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results.
The test results in this 510(k), demonstrate that InstaRISPACS/ InstaZFP/InstaMobi: -
complies with the aforementioned international and FDA-recognized consensus . standards and
-
. FDA guidance document, and
-
. Meets the acceptance criteria and is adequate for its intended use.
Therefore, InstaRISPACS/ InstaZFP/InstaMobi is substantially equivalent to the currently marketed predicate device K120718, INSTAPACS/INSTARISPACS V4.0, in terms of safety and effectiveness.
Clinical Testing:
InstaRISPACS/ InstaZFP/InstaMobi does not require clinical studies to demonstrate substantial equivalence to the predicate device.
VIII CONCLUSIONS
Verification and Validation activities required to establish the safety and effectiveness of InstaRISPACS/ InstaZFP/InstaMobi were performed. Testing involved system level tests, performance tests, and safety testing from risk analysis. Testing performed demonstrated the InstaRISPACS/ InstaZFP/InstaMobi meets pre-defined functionality requirements.
The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, and intended use. Nonclinical tests demonstrate that the subject device is as safe and effective and therefore substantially equivalent to the predicate device.
5
Image /page/5/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
MEDDIFF Technologies Pvt. Ltd. % Mr. Carl Alletto Consultant OTech, Inc. 8317 Belew Drive MCKINNEY TX 75071
April 12, 2019
Re: K182572
Trade/Device Name: InstaRISPACS / InstaZFP / InstaMobi V5.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 20, 2019 Received: March 25, 2019
Dear Mr. Alletto:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
6
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known) K182572
Device Name InstaRISPACS / InstaZFP / InstaMobi V5.0
Indications for Use (Describe)
InstaRISPACS / InstaZFP / InstaMobi is a software device (Enterprise Server, Diagnostic Workstation, Physician Zerofoot print Viewer and a Mobile Viewer) used for viewing and manipulating digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS modules can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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