MEDSYNAPSE Zero Footprint Viewer by MEDSYNAPTIC PRIVATE LTD.

With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms.

Device Description

MEDSYNAPSE ZERO FOOTPRINT VIEWER allows distribution of images within and outside the Hospital. It acquires, transmits, stores, retrieves, and displays digital images and related patient information from a variety of imaging sources and communicates the information over a network. It facilitates image viewing at diagnostic, reporting, consultation, and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short- or long-term storage devices. MEDSYNAPSE ZERO FOOTPRINT VIEWER allows communication using local or wide-area networks, public communications services, systems that include modality interfaces, and gateways to healthcare facility and departmental information systems.

AI/ML Overview

The Medsynapse Zero Footprint Viewer is a Picture Archiving and Communications System (PACS) software. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed acceptance criteria and a comprehensive study report for the device's performance.

Based on the information provided, here's what can be extracted and what is not available:

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

The document does not explicitly state acceptance criteria in a quantitative or pass/fail format typical for device performance metrics. Instead, it relies on demonstrating technological similarities and equivalence to a predicate device.

The "Technological Comparison" table (pages 4-5) serves as the primary "performance" demonstration in this context, showing that the Medsynapse Zero Footprint Viewer shares identical characteristics and functionality with the predicate device, RapidResults (K141881, RamSoft, Inc.).

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Medsynapse Zero Footprint Viewer)
Indications for Use	"This software displays medical images and associated documents. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the software is intended for use as a primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for use by trained healthcare professionals. Each healthcare professional must determine if the level of loss is acceptable for their purpose. This software is not suitable for primary diagnosis of mammograms."	"With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms."
Features	Zero-download Image Viewer, Devices: Windows, Android, MAC, iPhone, iPad, Touch or Keyboard and Mouse, Multiple browser support, Diagnostic use on desktops but not mobile devices, Window/Level, Zoom, Rotation, Flip, Pan, Measure, and Annotation. Does not produce or alter any images and medical data.	Identical features as the predicate device.
Modalities Supported	View all image modalities, including Xray, CT, MRI, color ultrasound and XRay angiography.	Identical modalities supported as the predicate device.
HIPAA Compliance	Secured connection to PACS using HTTPS. Images stay in PACS, not on the device. Images and information are gone from the device when the browser/app is closed, no storage on user's device.	Identical HIPAA compliance characteristics as the predicate device.
Architecture	Server-based software solution that displays images and reports from a PACS using a zero-footprint application (HTML5), no installation needed.	Identical architecture as the predicate device.
Technology Standards	Use of various technology standards (LDAP, SSO, HTTPS, HTML, HTML5, CSS, XML, web services, etc.)	Identical technology standards use as the predicate device.

The study proving these "acceptance criteria" (i.e., equivalence to the predicate) is the Bench/Performance Testing described in Section 6 of the 510(k) Summary. It states: "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 sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench testing" and "software validation" but does not detail the specific test cases, datasets, or their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. For a PACS viewer claiming substantial equivalence based on technological characteristics and software validation, detailed expert-established ground truth for a test set (like in an AI algorithm validation) is typically not required or reported in this format. The validation would focus on software functionality and image display accuracy against established standards, not diagnostic accuracy against expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. See point 3.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. This type of study is relevant for AI-powered diagnostic aids, not for a PACS viewer which is a tool for displaying images.

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

No, a standalone algorithm performance study is not applicable/not done in the context of this device. A PACS viewer does not operate as a standalone algorithm in the way an AI diagnostic tool would. Its function is to display images for human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided in the context of a PACS viewer's validation for 510(k) clearance. The ground truth for such a device would relate to the accurate display of medical images according to DICOM standards and its own specifications, rather than diagnostic outcomes.

8. The sample size for the training set

This information is not applicable/not provided. The Medsynapse Zero Footprint Viewer is a PACS software, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not provided. See point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2016

Medsynaptic Private Ltd. % Daniel Kamm. P.E. Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K163158

Trade/Device Name: Medsynapse Zero Footprint Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 7, 2016 Received: November 10, 2016

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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'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

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Indications for Use

510(k) Number (if known) K163158

Device Name MEDSYNAPSE ZERO FOOTPRINT VIEWER

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows the text "510(K) Summary K16" at the top. Below this text is a logo for Med Synaptic. The logo is green and yellow and has an arrow going through the middle of the text.

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 URL: http://www.medsynaptic.com Contact: Dr Ashish Dhawad, Chief Executive Officer Date prepared: November 7, 2016

1. Trade Name: MEDSYNAPSE ZERO FOOTPRINT VIEWER 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: RapidResults, K141881, RamSoft, Inc. 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 ZERO FOOTPRINT VIEWER allows distribution of images within and outside the Hospital. It acquires, transmits, stores, retrieves, and displays digital images and related patient information from a variety of imaging sources and communicates the information over a network. It facilitates image viewing at diagnostic, reporting, consultation, and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short- or long-term storage devices. MEDSYNAPSE ZERO FOOTPRINT VIEWER allows communication using local or wide-area networks, public communications services, systems that include modality interfaces, and gateways to healthcare facility and departmental information systems.
1. Indications for use: With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms. (Rx Only)
റ്. Technological characteristics: Comparison Table

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Characteristic	RapidResults, K141881,RamSoft, Inc.	MEDSYNAPSE ZEROFOOTPRINT VIEWER	TechnologicalComparison
Indications	This software displays medicalimages and associateddocuments. With appropriatedisplay monitors, lighting, imagequality, and level of lossy imagecompression, the software isintended for use as a primarydiagnostic (on desktop platform)and non-diagnostic review tool(on mobile platform) for use bytrained healthcare professionals.Each healthcare professional mustdetermine if the level of loss isacceptable for their purpose. Thissoftware is not suitable forprimary diagnosis ofmammograms.	With appropriate displaymonitors, lighting, image quality,and level of lossy imagecompression the use ofMEDSYNAPSE ZERO FOOTPRINTVIEWER is to distribute medicalimages & associated documentson desktop (Windows & Linux) &mobile platform (Android, iOS,Blackberry, Windows) usingbrowsers like Internet Explorer,Mozilla Firefox, Safari, UCBrowser or Google Chromewithin or out of hospital. Theusers of the systems will betrained healthcare professionals.This software is not appropriatefor primary diagnosis ofMammograms	The indicationsmean the samething withslightlydifferentwording.
Features	Zero-download Image Viewer	SAME	SAME
	Devices: Windows, Android,MAC, iPhone, iPad	SAME	SAME
	Touch or Keyboard and Mouse	SAME	SAME
	Multiple browser support	SAME	SAME
	Diagnostic use on desktops butnot mobile devices.	SAME	SAME
	Window/Level, Zoom, Rotation,Flip, Pan, Measure, andAnnotation. Does not produce oralter any images and medicaldata.	SAME	SAME
		SAME	SAME
Modalities	View all image modalities,including Xray, CT, MRI, colorultrasound and XRayangiography.	SAME	SAME
HIPAACompliance	The Viewer secured connects tothe PACS using HTTPS. Imagesstay in the PACS, not on thedevice. When the web browseror mobile application is closed, allimages and information are gonefrom the device. It does not storeimages on any user's device.	SAME	SAME
Architecture	Server-based software solutionthat display images and reportsfrom a PACS using a zero-footprint application (HTML5), noinstallation needed.	SAME	SAME
Characteristic	RapidResults, K141881,RamSoft, Inc.	MEDSYNAPSE ZEROFOOTPRINT VIEWER	TechnologicalComparison
Technology	Use of various technologystandards (LDAP, SSO, HTTPS,HTML, HTML5, CSS, XML, webservices, etc.)	SAME	SAME

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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.
Clinical Testing: Not required for a showing of substantial equivalence.
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 Zero Footprint Viewer 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).