Medsynapse RIS PACS Software is intended for use as a fully web based application on an off-the shelf PC which is networked with a Medsynapse RIS PACS server. The Medsynapse RIS PACS software can process medical images from DICOM compliant modalities and non DICOM sources. The Medsynapse RIS PACS software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports.

It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians. MIP, MPR, and Fusion are not intended for Mammography use.

Medsynapse VNA is an open standards based archiving methodology used for storing images in non-proprietary format.

The Medsynapse RIS PACS Software may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.

Device Description

Medsynapse RIS (Radiology Information System) PACS is a fully web based, enterprise-wide application intended for communication, storage, display, printing, and processing of medical images. Its software components perform operations related to image manipulation and measurements relevant to radiology and cardiology. As a software-only device, it does not control image acquisition. Typical users of Medsynapse RIS PACS are radiologists, technologists, sonographers, technicians, nurses, and clinicians. The software runs on standard PC equipment using MS Windows operating systems meeting minimum system requirements. Medsynapse VNA (Vendor Neutral Archive) is an open standards-based archiving methodology used for storing images in non-proprietary format.

AI/ML Overview

The provided document describes a 510(k) premarket notification for Medsynapse RIS PACS & Medsynapse VNA, claiming substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, often through a comparison of technological characteristics and performance testing.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for the Medsynapse RIS PACS & Medsynapse VNA itself. Instead, the submission for this PACS system focuses on demonstrating substantial equivalence to a predicate device (K190232, Fujifilm Synapse PACS) by comparing their characteristics.

The "acceptance criteria" in this context are implicitly that the new device performs equivalently to the predicate device and meets relevant regulatory and safety standards. The reported device performance is largely a qualitative comparison against the predicate.

Feature/Characteristic	Acceptance Criteria (Implicit - Equivalent to Predicate)	Reported Device Performance (Medsynapse RIS PACS & VNA)
Indications for Use	Functionally identical to predicate for processing, display, measurement, calculations, reporting, 3D display (MIP/MPR) for CT, MR, PET, SPECT, and lossless/non-compressed mammography.	"The indications mean the same thing with slightly different wording." (Directly stated in comparison table).
DICOM Compatibility	DICOM compatible.	DICOM compatible (SAME as predicate).
Application Type	Multipurpose, enterprise-wide application for communication, storage, display, printing, and medical image processing.	SAME (as predicate).
Typical Users	Radiologists, cardiologists, technologists, sonographers, technicians, nurses, clinicians.	SAME (as predicate).
Supported Modalities	Plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, DICOM compliant modalities, mammography with appropriate display resolution.	SAME (as predicate).
HIPAA Compliance	YES (HIPAA compliant).	SAME (as predicate).
Computer/Operating System	Windows PC.	SAME (as predicate).
Software Validation & Risk Analysis	No new issues of safety or effectiveness; meets guidance documents: Content of Premarket Submissions for Software, Off-The-Shelf Software Use, Cybersecurity, Content of Premarket Submissions for Management of Cybersecurity; Risk management in accordance with IEC 14971.	"The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention any specific test set or clinical data for assessing the performance of Medsynapse RIS PACS & Medsynapse VNA against a ground truth in a clinical setting. The evaluation is based on "Bench/Performance Testing" which refers to software validation and risk analysis, not a clinical study involving a test set of patient data.

3. Number of Experts and Qualifications for Ground Truth Establishment

Since no clinical test set or ground truth establishment is described, there is no information provided regarding the number or qualifications of experts used for establishing ground truth.

4. Adjudication Method for the Test Set

As no clinical test set is mentioned, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was conducted. The submission focuses on demonstrating substantial equivalence by comparing technological characteristics and software validation, not by measuring improvement in human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device itself is a PACS (Picture Archiving and Communications System) and VNA (Vendor Neutral Archive) software, which are tools for managing, displaying, and processing medical images. It does not appear to be an AI algorithm designed for automated interpretation or diagnosis. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study in the context of diagnostic AI is not applicable to this device as described. The software provides "toolsets for performing measurements," "solving clinical calculations," and "creating and distributing structured reports," implying it assists human users rather than performing standalone diagnostic tasks.

7. Type of Ground Truth Used

Given that no clinical performance study involving a test set is described, no specific type of ground truth (expert consensus, pathology, outcomes data, etc.) was used for this submission. The validation relies on software engineering principles and comparison to the predicate.

8. Sample Size for the Training Set

Similar to the test set, the document does not mention a training set sample size. This device is a PACS/VNA system, not a machine learning model that would typically require a training set for its development.

9. How the Ground Truth for the Training Set was Established

As there is no mention of a training set, the question of how its ground truth was established is not applicable.

Summary

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November 22, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medsynaptic Private Ltd. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K192508

Trade/Device Name: MEDSYNAPSE RIS PACS & MEDSYNAPSE VNA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 19, 2019 Received: November 20, 2019

Dear Mr. Kamm:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192508

Device Name MEDSYNAPSE RIS PACS & MEDSYNAPSE VNA

Indications for Use (Describe)

Medsynapse VNA is an open standards based archiving methodology used for storing images in non-proprietary format.

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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Image /page/3/Picture/0 description: The image shows the words "510(K) Summary K192508" at the top. Below that is the logo for MED Synaptic. The logo is green and yellow.

Medsynaptic Private Ltd 5th Floor, Mantri Galleria, Off S.B. Road, Model Colony, Shivaji Nagar, Pune - 411016, India. Phone : +91-20-25650411 Telefax +91-20-25650412

URL: http://www.medsynaptic.com Contact: Dr Ashish Dhawad, Chief Executive Officer Date prepared: November 18, 2019

1. Trade Name: MEDSYNAPSE RIS PACS & MEDSYNAPSE VNA Common Name: PACS Software Classification Name: System, image processing, radiological Regulation Description: Picture archiving and communications system Product code LLZ, Regulation: 892.2050 Class of device: Class II.
1. The legally marketed device to which we are claiming equivalence: K190232, Synapse PACS, FUJIFILM Corporation Common Name: PACS Software Classification Name: System, image processing, radiological Regulation Description: Picture archiving and communications system Product code LLZ, Regulation: 892.2050 Class of device: Class II.
1. Reference device: K093247, Medsynaptic Private Ltd Trade Name: Medsynapse PACS Software Common Name: PACS Software Classification Name: System, image processing, radiological Regulation Description: Picture archiving and communications system Product code LLZ, Regulation: 892.2050 Class of device: Class II.
1. Description of device: Medsynapse RIS (Radiology Information System) PACS is a fully web based, enterprise-wide application intended for communication, storage, display, printing, and processing of medical images. Its software components perform operations related to image manipulation and measurements relevant to radiology and cardiology. As a software-only device, it does not control image acquisition. Typical users of Medsynapse RIS PACS are radiologists, technologists, sonographers, technicians, nurses, and clinicians. The software runs on standard PC equipment using MS Windows operating systems meeting minimum system requirements. Medsynapse VNA (Vendor Neutral Archive) is an open standards-based archiving methodology

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used for storing images in non-proprietary format.

1. Indications for use: Medsynapse RIS PACS Software is intended for use as a fully web based application on an off-the shelf PC which is networked with a Medsynapse RIS PACS server. The Medsynapse RIS PACS software can process medical images from DICOM compliant modalities and non DICOM sources. The Medsynapse RIS PACS software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports.
  It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians. MIP, MPR, and Fusion are not intended for Mammography use.

Medsynapse VNA is an open standards based archiving methodology used for storing images in non-proprietary format.

The Medsynapse RIS PACS Software may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or noncompressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.. (Rx Only)

Characteristic	K190232, Fujifilm Synapse PACS.	MEDSYNAPSE RIS PACS &	Technological
		MEDSYNAPSE VNA	Comparison
Indications	FUJIFILM Synapse PACS Software isintended for use as a web basedapplication on an off-the shelf PC whichmeets or exceeds minimum specificationsand is networked with a FUJIFILM SynapsePACS server. The FUJIFILM Synapse PACSSoftware can process medical images fromDICOM compliant modalities and non-DICOM sources. The FUJIFILM SynapsePACS Software provides toolsets forperforming measurements on DICOMimages, importing and presenting datafrom modalities (DICOM and non-DICOM),solving clinical calculations, and creatingand distributing structured reports. TheFUJIFILM Synapse PACS Software isintended to serve as the primary userinterface for the processing of medicalimages for presentation on displaysappropriate to the medical task beingperformed. It enables the display,comparison and fusion of 3D (MIP/MPR) ofCT, MR, PET and SPECT studies. Typicalusers are radiologists, cardiologists,technologists, sonographers, technicians,nurses and clinicians. MIP, MPR, andFusion are not intended formammography use. The FUJIFILM SynapsePACS Software may be used to processFUJIFILM's DICOM MG "For Processing"	Medsynapse RIS PACS Software isintended for use as a fully web basedapplication on an off-the shelf PC whichis networked with a Medsynapse RISPACS server. The Medsynapse RIS PACSsoftware can process medical imagesfrom DICOM compliant modalities andnon DICOM sources. The MedsynapseRIS PACS software provides toolsets forperforming measurements on DICOMimages, importing and presenting datafrom modalities (DICOM and non-DICOM), solving clinical calculations,and creating and distributing structuredreports. It enables the display,comparison and fusion of 3D(MIP/MPR) of CT, MR, PET and SPECTstudies. Typical users are radiologists,cardiologists, technologists,sonographers, technicians, nurses andclinicians. MIP, MPR, and Fusion are notintended for Mammography use.Medsynapse VNA is an open standardsbased archiving methodology used forstoring images in non-proprietaryformat. The Medsynapse RIS PACSSoftware may be used to processDICOM MG "For Processing" imagesand also for the display, manipulation,and interpretation of lossless	Theindicationsmean thesame thingwith slightlydifferentwording.

6. Technological characteristics: Comparison Table

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Characteristic	K190232, Fujifilm Synapse PACS.	MEDSYNAPSE RIS PACS &MEDSYNAPSE VNA	TechnologicalComparison
	images and also for the display,manipulation, and interpretation oflossless compressed or non-compressedmammography images that have beenreceived in the DICOM For Presentationformat and displayed on FDA cleared,DICOM compatible displays formammography.	compressed or non-compressedmammography images that have beenreceived in the DICOM For Presentationformat and displayed on FDA cleared,DICOM compatible displays formammography
Features	DICOM compatible	DICOM compatible	SAME
	Multipurpose, enterprise-wideapplication intended forcommunication, storage, display,printing, and processing of medicalimages	SAME	SAME
	Typical users of Synapse PACs areradiologists, cardiologists,technologists, sonographers,technicians, nurses, and clinicians	SAME	SAME
Modalities	Plane X-ray radiography, X-raycomputed tomography, magneticresonance imaging, ultrasound,nuclear medicine, and images fromDICOM compliant modalities.Mammography with appropriatedisplay resolution	SAME	SAME
HIPAACompliance	YES	SAME	SAME
Computer/OperatingSystem	Windows PC	SAME	SAME

1. Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device. Software and labeling was developed in accordance with the following FDA guidance documents: Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices; Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Risk management was conducted in accordance with IEC 14971, Application of Risk Management to Medical Devices.
1. Clinical Testing: Not required for a showing of substantial equivalence.

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1. Conclusion: Based on comparison to the 510(k) summary of the predicate device, its technical characteristics, the indications for use, and the near identical characteristics of the two products, we conclude that the MEDSYNAPSE RIS PACS & MEDSYNAPSE VNA is substantially equivalent to the named predicate device.

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).