(22 days)
No
The document describes a medical image viewer and distribution system, focusing on image acquisition, transmission, storage, retrieval, and display. There is no mention of AI, ML, or any related technologies like deep learning or neural networks in the provided text. The performance studies focus on software validation and risk analysis, not AI/ML performance metrics.
No
The device is a medical image viewer and distributor, facilitating image viewing and archiving. It does not exert any direct therapeutic action on a patient.
No
The "Intended Use" explicitly states, "This software is not appropriate for primary diagnosis of Mammograms," and the "Device Description" mentions that it "facilitates image viewing at diagnostic, reporting, consultation, and remote computer workstations," but its primary function is the distribution and viewing of images rather than performing a diagnosis itself.
Yes
The device description explicitly states it is a "ZERO FOOTPRINT VIEWER" which is a common term for software that runs within a web browser without requiring local installation of dedicated hardware or software components beyond the browser itself. It focuses on the distribution, acquisition, transmission, storage, retrieval, and display of digital images and related information, all functions typically performed by software. The performance studies section also focuses on "software validation and risk analysis."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "distribute medical images & associated documents" and facilitate "image viewing at diagnostic, reporting, consultation, and remote computer workstations." This describes a system for managing and displaying medical images, not a test performed on biological samples to diagnose a condition.
- Device Description: The description focuses on the acquisition, transmission, storage, retrieval, and display of digital images and related patient information. This aligns with a Picture Archiving and Communication System (PACS) or image viewer, not an IVD.
- Lack of IVD Characteristics: An IVD typically involves:
- Analysis of biological samples: Blood, urine, tissue, etc.
- Reagents or kits: Used to perform the test.
- Measurement of specific analytes or markers: To detect or quantify substances in the sample.
- Diagnosis or monitoring of a disease or condition based on the test results.
The MEDSYNAPSE ZERO FOOTPRINT VIEWER is a software device for managing and displaying medical images, which falls under the category of medical imaging software or a PACS component. It does not perform any in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes
LLZ
Device Description
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
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
View all image modalities, including Xray, CT, MRI, color ultrasound and XRay angiography.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The users of the systems will be trained healthcare professionals. within or out of hospital.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
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.
1
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
2
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) | |
|---|---|
| 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
-
- 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.
-
- 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.
-
- 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.
-
- 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 ZERO
FOOTPRINT VIEWER | Technological
Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Indications | 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 | The indications
mean the same
thing with
slightly
different
wording. |
| 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 but
not mobile devices. | SAME | SAME |
| | Window/Level, Zoom, Rotation,
Flip, Pan, Measure, and
Annotation. Does not produce or
alter any images and medical
data. | SAME | SAME |
| | | SAME | SAME |
| Modalities | View all image modalities,
including Xray, CT, MRI, color
ultrasound and XRay
angiography. | SAME | SAME |
| HIPAA
Compliance | The Viewer secured connects to
the PACS using HTTPS. Images
stay in the PACS, not on the
device. When the web browser
or mobile application is closed, all
images and information are gone
from the device. It does not store
images on any user's device. | SAME | SAME |
| Architecture | Server-based software solution
that display images and reports
from a PACS using a zero-
footprint application (HTML5), no
installation needed. | SAME | SAME |
| Characteristic | RapidResults, K141881,
RamSoft, Inc. | MEDSYNAPSE ZERO
FOOTPRINT VIEWER | Technological
Comparison |
| Technology | Use of various technology
standards (LDAP, SSO, HTTPS,
HTML, HTML5, CSS, XML, web
services, etc.) | SAME | SAME |
5
-
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.