MEDSYNAPSE Zero Footprint Viewer

K163158 · Medsynaptic Private, Ltd. · LLZ · Dec 2, 2016 · Radiology

Device Facts

• Record ID: K163158
• Device Name: MEDSYNAPSE Zero Footprint Viewer
• Applicant: Medsynaptic Private, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Medsynapse Zero Footprint Viewer is a server-based PACS software solution; enables distribution, retrieval, and display of digital medical images and patient information. Inputs include images from various modalities (X-ray, CT, MRI, ultrasound, angiography) transmitted over local or wide-area networks. Operates via zero-download HTML5 web browser interface; no installation required on client devices. Used by trained healthcare professionals in clinical or remote settings. Provides viewing tools including window/level, zoom, rotation, flip, pan, measurement, and annotation. Does not store images locally; data remains on PACS server; connection secured via HTTPS. Facilitates clinical consultation and reporting workflows; supports diagnostic decision-making by providing remote access to imaging data.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, software validation, and risk analysis for a moderate level of concern device.

Technological Characteristics

Server-based software; zero-footprint HTML5 architecture. Supports Windows, Linux, Android, iOS, Blackberry. Connectivity via HTTPS, LDAP, SSO, XML, web services. No local image storage. Moderate level of concern software.

Indications for Use

Indicated for trained healthcare professionals to view and distribute medical images and associated documents on desktop and mobile platforms. Not indicated for primary diagnosis of mammograms.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• RapidResults (K141881)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> 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 : [phone] Telefax [phone] 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.
- 2. 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.
- 3. 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.
- 4. 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,<br>RamSoft, Inc. | MEDSYNAPSE ZERO<br>FOOTPRINT VIEWER | Technological<br>Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Indications | This software displays medical<br>images and associated<br>documents. With appropriate<br>display monitors, lighting, image<br>quality, and level of lossy image<br>compression, the software is<br>intended for use as a primary<br>diagnostic (on desktop platform)<br>and non-diagnostic review tool<br>(on mobile platform) for use by<br>trained healthcare professionals.<br>Each healthcare professional must<br>determine if the level of loss is<br>acceptable for their purpose. This<br>software is not suitable for<br>primary diagnosis of<br>mammograms. | With appropriate display<br>monitors, lighting, image quality,<br>and level of lossy image<br>compression the use of<br>MEDSYNAPSE ZERO FOOTPRINT<br>VIEWER is to distribute medical<br>images & associated documents<br>on desktop (Windows & Linux) &<br>mobile platform (Android, iOS,<br>Blackberry, Windows) using<br>browsers like Internet Explorer,<br>Mozilla Firefox, Safari, UC<br>Browser or Google Chrome<br>within or out of hospital. The<br>users of the systems will be<br>trained healthcare professionals.<br>This software is not appropriate<br>for primary diagnosis of<br>Mammograms | The indications<br>mean the same<br>thing with<br>slightly<br>different<br>wording. |
| Features | Zero-download Image Viewer | SAME | SAME |
| | Devices: Windows, Android,<br>MAC, iPhone, iPad | SAME | SAME |
| | Touch or Keyboard and Mouse | SAME | SAME |
| | Multiple browser support | SAME | SAME |
| | Diagnostic use on desktops but<br>not mobile devices. | SAME | SAME |
| | Window/Level, Zoom, Rotation,<br>Flip, Pan, Measure, and<br>Annotation. Does not produce or<br>alter any images and medical<br>data. | SAME | SAME |
| | | SAME | SAME |
| Modalities | View all image modalities,<br>including Xray, CT, MRI, color<br>ultrasound and XRay<br>angiography. | SAME | SAME |
| HIPAA<br>Compliance | The Viewer secured connects to<br>the PACS using HTTPS. Images<br>stay in the PACS, not on the<br>device. When the web browser<br>or mobile application is closed, all<br>images and information are gone<br>from the device. It does not store<br>images on any user's device. | SAME | SAME |
| Architecture | Server-based software solution<br>that display images and reports<br>from a PACS using a zero-<br>footprint application (HTML5), no<br>installation needed. | SAME | SAME |
| Characteristic | RapidResults, K141881,<br>RamSoft, Inc. | MEDSYNAPSE ZERO<br>FOOTPRINT VIEWER | Technological<br>Comparison |
| Technology | Use of various technology<br>standards (LDAP, SSO, HTTPS,<br>HTML, HTML5, CSS, XML, web<br>services, etc.) | SAME | SAME |

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6. 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.

7. Clinical Testing: Not required for a showing of substantial equivalence.

8. 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.