InstaRISPACS / InstaZFP / InstaMobi v5.0 by Meddiff Technologies Pvt. Ltd.

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.

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.

AI/ML Overview

The provided text describes the Meddiff InstaRISPACS / InstaZFP / InstaMobi V5.0 system, a software application for viewing and manipulating medical images. However, it does not contain information about a study that specifically proves the device meets quantifiable acceptance criteria related to its performance metrics (e.g., sensitivity, specificity, accuracy) for image interpretation or against a clinical gold standard.

The document does describe non-clinical performance testing for compliance with standards and the device's functional requirements.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document clearly states the following under "VII. PERFORMANCE DATA":
"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."

However, the specific "acceptance criteria" for quantifiable device performance (e.g., image quality metrics, processing speed thresholds, diagnostic accuracy) are not explicitly detailed or quantified in the provided text. The "reported device performance" is described as compliance with standards and meeting functional requirements, rather than clinical performance metrics.

Based on the provided text, a table of quantifiable acceptance criteria and device performance cannot be generated. The document focuses on showing substantial equivalence based on technical characteristics and compliance with regulatory standards, rather than a clinical performance study.

Study Details (Based on available information)

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly quantifiable clinical or diagnostic performance metrics described. The acceptance criteria mentioned relate to compliance with regulatory standards and functional requirements.
Reported Device Performance: "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." No specific performance numbers (e.g., accuracy, sensitivity, specificity) are reported.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified. This was a non-clinical study focused on technical compliance and functional verification, not clinical data evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This was a non-clinical study; no ground truth was established by experts for a test set of clinical images.

4. Adjudication method for the test set:

Not applicable. This was a non-clinical study; no image interpretation or adjudication occurred.

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:

No. The document explicitly states: "InstaRISPACS/ InstaZFP/InstaMobi does not require clinical studies to demonstrate substantial equivalence to the predicate device." Later, it also states: "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." This indicates the device is an image viewing and manipulation system, not an AI-powered diagnostic aid meant to directly improve human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. The device is an image viewing and manipulation system, not an algorithm performing standalone diagnostic tasks. Its performance is assessed in terms of its functionality and compliance with standards.

7. The type of ground truth used:

Not applicable. As a non-clinical study focusing on functional compliance and technical characteristics, there was no clinical "ground truth" (like pathology or outcomes data) involved in a diagnostic performance evaluation.

8. The sample size for the training set:

Not applicable. This device is a PACS/RIS software for image management and viewing, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as it's not a machine learning model requiring a training set.

Summary of the "Study" (Non-Clinical Performance Testing):

The "study" described in the document is limited to non-clinical performance testing to demonstrate compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, NEMA-PS 3.1 - PS 3.20 DICOM) and FDA guidance documents. It also involved Meddiff's internal verification and validation processes to address intended use, technological characteristics claims, requirement specifications, and risk management results.

The comparison table provided (pages 2-3) primarily highlights technological characteristics and feature parity/differences with predicate and reference devices, rather than a clinical performance study involving patient data. For instance, for "PET-CT fusion viewing" and "Embedded & basic Volume Rendering," it states the subject device was "tested and compared to Reference device #1, (K101342)" and "Data indicated that the subject device was found to be similar to the reference device." This indicates functional equivalence rather than a clinical performance claim.

Conclusion stated by the submitter: Based on these non-clinical tests, the subject device is considered "substantially equivalent" to the predicate device in terms of safety and effectiveness, and no clinical studies were deemed necessary.

Summary

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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, 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.

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

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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 K120718Predicate
System	Indications for Use	The subject device and predicate deviceIFU are not identical, however, thedifferences do not alter the intended use ofthe device nor do they affect the safetyand effectiveness of the device relative tothe predicate.	Picture archive and communicationssystem
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
WorkstationClient 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 modalitytype.
	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 4*4)	Std. formats (up to 4*4)
	WW/WL	Yes	Yes
	PET-CT fusion viewing	Subject device was tested and comparedto Reference device #1, (K101342) Dataindicated that the subject device wasfound to be similar to the reference device.	Not supported.
	Embedded & basicVolume Rendering	Subject device supports basic 'VR'functionality that includes image rotate,zoom, and crop. Comparison was doneagainst Reference device #1, (K101342)for image rotate, zoom, and crop.(K101342) has additional VR functionalitysuch as vessel rendering, not included inthe subject device.	Not Supported
	Zoom in/Zoom out	Yes	Yes
	Hounsfield Measurement	Yes	Yes
	Linear and anglemeasurements	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 K120718Predicate
	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
Reportingmodule	Report text can beentered from a keyboard	Yes	Yes
	Report text can beentered from a 3rd partyconversion "voice to text"software	Yes	Not supported.
	Reporting Interface	Can be opened from the from study list	Can be opened from the viewer or fromstudy list
	Report Template Support	User Defined templates	User Defined templates
	Digital Signature	Yes	Yes
	Report Formats	MS word	MS word
Other features	Link to HospitalInformation System (HIS)	Yes	Yes
	Link to RadiologyInformation System RIIS)	Yes	Yes
	Electronic patient record	Through Broker Software	Through Broker Software
Configurations	PACS Server(InstaRISPACS server)	Yes	Yes
	Radiology Workstation(InstaRISPACS radiologyworkstation)	Yes	Yes
	Basic web image Viewer(InstaZFP Viewer)	Yes	Not supported
	Mobile app viewer(InstaMobi Viewer)	Yes	Not supported

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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.

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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.

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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

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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

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Indications for Use

510(k) Number (if known) K182572

Device Name InstaRISPACS / InstaZFP / InstaMobi V5.0

Indications for Use (Describe)

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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Regulation Number and Section

§ 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).