(138 days)
No
The summary describes a medical imaging informatics system for storage, management, display, and basic processing of data. It mentions "automatic data processing rules" and "analytics," but these are described in the context of configurable rules and summarizing statistics, not AI/ML algorithms. There is no mention of AI, ML, deep learning, or any related terms, nor is there any description of training or test sets which are typical for AI/ML device submissions.
No
This device is an imaging informatics system for displaying and managing medical images and data, not for providing therapy or treatment.
No
The device is described as an "imaging informatics system" that allows for storage, management, display, and analysis of "imaging and non-imaging data". It displays "medical images" and data but does not perform diagnostic interpretations. The prompt states that "Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications". This indicates that the device itself is not a diagnostic tool, but rather a system for managing and displaying data for trained professionals to interpret.
Yes
The device description explicitly states it is a "medical imaging informatics system" that allows for storage, management, display, and analysis of data. It describes software functionalities like data processing rules, indexing, searching, de-identification, and analytics. While it interacts with external systems and displays images, the core device itself is described as a software system without mention of proprietary hardware components. The performance studies focus on software verification and system validation in simulated use settings, further supporting its classification as a software-only device.
Based on the provided text, the Synaptive ImageDrive Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Synaptive ImageDrive Pro's Function: The description clearly states that the device displays and processes medical images and data from various imaging sources. It's a system for managing, viewing, and analyzing imaging information, not for analyzing biological specimens.
- Intended Use: The intended use is for displaying and processing medical images for interpretation by trained professionals. This is consistent with a medical imaging informatics system, not an IVD.
- Device Description: The description focuses on features like data storage, management, display, and analysis of imaging and non-imaging data. It mentions receiving DICOM objects and HL7 messages, which are standard formats for medical imaging and health information systems.
- Lack of Specimen Analysis: There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
In summary, the Synaptive ImageDrive Pro is a medical imaging informatics system used for managing and displaying medical images and related data. Its function falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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 data repository can be populated either by manually uploading data through the user interface (UI) or in an unattended fashion by automatically receiving DICOM objects or HL7 messages from other information systems such as PACS and EMRs. Automatic data processing rules can be configured to process data when it arrives in the system. An example of this is when pre-operative MR scans are done and sent to ImageDrive to ensure that they were acquired using appropriate scan protocol before they are consumed downstream by other Synaptive applications, such as BrightMatter Plan (cleared as a Class-II device, K140337). Once in the system, the data is indexed so that it can be easily searched in the future. Imaging data can also be de-identified and securely shared with authorized persons. Further, the system provides an extensible architecture to enable local or distributed processing of the data. As data accumulates in the system, analytics can be generated to summarize, for example, intra- and inter-patient statistics and trends in surgical treatment planning based on surgical plan data that is output from external software that can generate data in compatible formats. An example of such external system is the surgical planning software manufactured by this applicant - - BrightMatter Plan. The subject device is composed of the following key features: A hierarchical folder system Three data storage areas Data processing functionality Analytics capability Image viewing capability
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
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)
Non-Clinical Testing: Software verification testing for each requirement specification. System validation testing using intended users. The following quality assurance measures were applied during development of the software system: Software development life cycle, Software risk assessment, Risk assessment of OTS software, Risk assessment from Cyber and Information security perspective, 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.
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 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.
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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) 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)
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510(K) Summary
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
|---|---|
| Submitter: | Synaptive Medical Inc. |
| MaRS Centre, South Tower | |
| 101 College Street, Suite 200 | |
| Toronto, ON M5G 1L7 Canada | |
| Contact Person: | Cameron Piron |
| President | |
| Telephone: 416-673-6679 | |
| Email: cameron.piron@synaptivemedical.com | |
| Synaptive Medical Inc. | |
| MaRS Centre, South Tower | |
| 101 College Street, Suite 200 | |
| Toronto, ON M5G 1L7 Canada | |
| Date Prepared: | November 10, 2015 |
| Trade Name: | Synaptive ImageDrive Pro |
| Common/Usual Name: | PACS |
| Classification: | 21 CFR 892.2050 |
| System, Image Processing, Radiological | |
| Product Code: | LLZ |
| Manufacturer: | Synaptive Medical Inc. |
| MaRS Centre, South Tower | |
| 101 College Street, Suite 200 | |
| Toronto, ON M5G 1L7 Canada | |
| Establishment Registration: | 3010439744 |
| Predicate Device: | Manufacturer: GE Healthcare |
| Trade name: Centricity PACS-IW with Universal Viewer | |
| 510(k) Number: K123174 | |
| Date Cleared: 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 | |
| data through the user interface (UI) or in an unattended fashion | |
| by automatically receiving DICOM objects or HL7 messages from | |
| other information systems such as PACS and EMRs. | |
| Automatic data processing rules can be configured to process | |
| data when it arrives in the system. An example of this is when | |
| pre-operative MR scans are done and sent to ImageDrive to | |
| ensure that they were acquired using appropriate scan protocol | |
| before they are consumed downstream by other Synaptive | |
| applications, such as BrightMatter Plan (cleared as a Class-II | |
| device, K140337). | |
| Once in the system, the data is indexed so that it can be easily | |
| searched in the future. Imaging data can also be de-identified | |
| and securely shared with authorized persons. Further, the | |
| system provides an extensible architecture to enable local or | |
| distributed processing of the data. | |
| As data accumulates in the system, analytics can be generated to | |
| summarize, for example, intra- and inter-patient statistics and | |
| trends in surgical treatment planning based on surgical plan data | |
| that is output from external software that can generate data in | |
| compatible formats. An example of such external system is the | |
| surgical planning software manufactured by this applicant - - | |
| BrightMatter Plan. | |
| The subject device is composed of the following key features: | |
| 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 |
| (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. | |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| 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. | |
| Summary of | |
| Technological | |
| Comparisons | Design comparison: Both the subject device and the predicate are |
| internet based software-only medical devices that allow storage, | |
| management, display and analysis of imaging and non-imaging | |
| data. Both systems support communication of data to and from | |
| the system using DICOM and HL7 data communication standards. | |
| Both systems are capable of communicating with EMR and PACS. |
Technology comparison: Both systems are designed to be
deployed over conventional TCP/IP networking infrastructure
available in most healthcare organizations and utilize commercial
computer hardware platforms and operating systems. Neither of
the systems produce any original medical images and receive
medical images and information various data sources. The
information can be stored, communicated, processed and
displayed across computer networks at distributed locations. |
| Non-Clinical Testing | Following testing was conducted on Synaptive ImageDrive Pro
device:
Software verification testing for each requirement
specification. System validation testing using intended users. The following quality assurance measures were applied during
development of the software system: Software development life cycle Software risk assessment Risk assessment of OTS software Risk assessment from Cyber and Information security
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. |
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