Synaptive ImageDrive Pro

K153284 · Synaptive Medical, Inc. · LLZ · Mar 29, 2016 · Radiology

Device Facts

• Record ID: K153284
• Device Name: Synaptive ImageDrive Pro
• Applicant: Synaptive Medical, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Synaptive ImageDrive Pro is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Device Story

Medical imaging informatics system for storage, management, display, and analysis of imaging/non-imaging data. Inputs: DICOM objects or HL7 messages from PACS/EMR or manual UI uploads. Operation: Data indexed for search; de-identification/secure sharing capabilities; automated processing rules (e.g., scan protocol verification). Output: Displayed images/data for clinical review. Used in clinical settings by trained professionals. Benefits: Facilitates surgical treatment planning and data management; enables inter/intra-patient statistics and trend analysis via integration with external software like BrightMatter Plan. Supports distributed network access.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing, including software verification and system validation in simulated use settings by intended users.

Technological Characteristics

Software-only medical device; operates on commercial computer hardware/OS. Connectivity via standard TCP/IP networking. Supports DICOM and HL7 communication standards. Features hierarchical folder system, data storage, processing, and analytics modules.

Indications for Use

Indicated for trained professionals (radiologists, physicians, nurses, technicians, assistants) to view, communicate, process, and display medical images and data from various sources. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images.

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

• Centricity PACS-IW with Universal Viewer (K123174)

Reference Devices

• BrightMatter Plan (K140337)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus symbol is composed of three human profiles facing to the right.

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

March 29, 2016

Synaptive Medical Inc. % Mr. Cameron Piron President MaRS Centre, South Tower, 101 College Street, Suite 200 TORONTO, ON M5G 1L7 Canada

Re: K153284

Trade/Device Name: Synaptive ImageDrive Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 1, 2016 Received: February 3, 2016

Dear Mr. Piron:

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 [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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K153284

Device Name Synaptive ImageDrive Pro

#### Indications for Use (Describe)

Synaptive ImageDrive Pro is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) Summary

| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Synaptive Medical Inc.<br>MaRS Centre, South Tower<br>101 College Street, Suite 200<br>Toronto, ON M5G 1L7 Canada |
| Contact Person: | Cameron Piron<br>President<br>Telephone: [phone]<br>Email: [e-mail]<br>Synaptive Medical Inc.<br>MaRS Centre, South Tower<br>101 College Street, Suite 200<br>Toronto, ON M5G 1L7 Canada |
| Date Prepared: | November 10, 2015 |
| Trade Name: | Synaptive ImageDrive Pro |
| Common/Usual Name: | PACS |
| Classification: | 21 CFR 892.2050<br>System, Image Processing, Radiological |
| Product Code: | LLZ |
| Manufacturer: | Synaptive Medical Inc.<br>MaRS Centre, South Tower<br>101 College Street, Suite 200<br>Toronto, ON M5G 1L7 Canada |
| Establishment Registration: | 3010439744 |
| Predicate Device: | <b>Manufacturer:</b> GE Healthcare<br><b>Trade name:</b> Centricity PACS-IW with Universal Viewer<br><b>510(k) Number:</b> K123174<br><b>Date Cleared:</b> November 16, 2012 |
| Device Description | Synaptive ImageDrive Pro is a medical imaging informatics system that allows the storage, management, display and analysis of imaging and non-imaging data. The Synaptive ImageDrive Pro |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| data repository can be populated either by manually uploading<br>data through the user interface (UI) or in an unattended fashion<br>by automatically receiving DICOM objects or HL7 messages from<br>other information systems such as PACS and EMRs.<br>Automatic data processing rules can be configured to process<br>data when it arrives in the system. An example of this is when<br>pre-operative MR scans are done and sent to ImageDrive to<br>ensure that they were acquired using appropriate scan protocol<br>before they are consumed downstream by other Synaptive<br>applications, such as BrightMatter Plan (cleared as a Class-II<br>device, K140337).<br>Once in the system, the data is indexed so that it can be easily<br>searched in the future. Imaging data can also be de-identified<br>and securely shared with authorized persons. Further, the<br>system provides an extensible architecture to enable local or<br>distributed processing of the data.<br>As data accumulates in the system, analytics can be generated to<br>summarize, for example, intra- and inter-patient statistics and<br>trends in surgical treatment planning based on surgical plan data<br>that is output from external software that can generate data in<br>compatible formats. An example of such external system is the<br>surgical planning software manufactured by this applicant - -<br>BrightMatter Plan.<br>The subject device is composed of the following key features:<br>A hierarchical folder system Three data storage areas Data processing functionality Analytics capability Image viewing capability | |
| Indications for Use | Synaptive ImageDrive Pro is a device that displays medical images<br>(including mammograms) and data from various imaging sources.<br>Images and data can be viewed, communicated, processed and<br>displayed within the system or across computer networks at<br>distributed locations. |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| | Lossy compressed mammographic images and digitized film<br>screen images must not be reviewed for primary image<br>interpretations. Mammographic images may only be interpreted<br>using an FDA approved monitor that offers at least 5 Megapixel<br>resolution and meet other technical specifications reviewed and<br>accepted by the FDA.<br>Typical users of this system are trained professionals, including<br>but not limited to radiologists, physicians, nurses, medical<br>technicians, and assistants. |
| Summary of<br>Technological<br>Comparisons | Design comparison: Both the subject device and the predicate are<br>internet based software-only medical devices that allow storage,<br>management, display and analysis of imaging and non-imaging<br>data. Both systems support communication of data to and from<br>the system using DICOM and HL7 data communication standards.<br>Both systems are capable of communicating with EMR and PACS.<br><br>Technology comparison: Both systems are designed to be<br>deployed over conventional TCP/IP networking infrastructure<br>available in most healthcare organizations and utilize commercial<br>computer hardware platforms and operating systems. Neither of<br>the systems produce any original medical images and receive<br>medical images and information various data sources. The<br>information can be stored, communicated, processed and<br>displayed across computer networks at distributed locations. |
| Non-Clinical Testing | Following testing was conducted on Synaptive ImageDrive Pro<br>device:<br>Software verification testing for each requirement<br>specification. System validation testing using intended users. The following quality assurance measures were applied during<br>development of the software system: Software development life cycle Software risk assessment Risk assessment of OTS software Risk assessment from Cyber and Information security<br>perspective |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| | Software configuration management and version control Software issue tracking and resolution. |
| Design Validation | Design validation was performed using Synaptive ImageDrive Pro in simulated use settings by intended users. The results support substantial equivalence to the predicate device and demonstrate that Synaptive ImageDrive Pro is safe for its intended use. |
| Clinical Testing | This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, the substantial equivalence of the device is supported by the non-clinical testing. |
| Conclusion: | Synaptive ImageDrive Pro system is a medical system that allows the storage, management, display and analysis of imaging and non-imaging data. It has been shown in this 510(k) submission that the differences between the subject device and the predicate device do not raise any new questions regarding safety and effectiveness. Synaptive ImageDrive Pro as designed and manufactured, is substantially equivalent to, and as safe and effective as, the referenced predicate device. |

{4}------------------------------------------------

{5}------------------------------------------------

{6}------------------------------------------------