(41 days)
Synergy is a comprehensive software platform intended for use in acquisition or importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.
Synergy is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy is used together with a number of computerized digital imaging devices. In addition, Synergy software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Synergy enables a real-time review of diagnostic patient information at a PC workstation. In addition to the desktop application, Synergy also includes an internet-browser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.
This 510(k) summary provides information for the Topcon Medical Systems, Inc. Synergy, an ophthalmic image management system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance data was required or provided. Software validation and verification demonstrate that the Synergy performs as intended and meets its specifications. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No performance data was required or provided." Therefore, there is no test set sample size and no data provenance mentioned for a clinical performance study. The evaluation focused on software validation and verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no performance data was provided, there was no test set and therefore no experts used to establish ground truth for a clinical performance evaluation.
4. Adjudication method for the test set
Not applicable, as no performance study with a test set was conducted.
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 MRMC comparative effectiveness study was done. The device description indicates it is a software platform for image management and analysis, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone performance study was done in the context of clinical accuracy or diagnostic capability, as explicitly stated: "No performance data was required or provided." The "standalone" aspect described is the software itself performing its intended functions (acquisition, processing, measurement, analysis, storage, management) rather than a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since no performance data or clinical study was conducted, no ground truth was established or used in the context of diagnostic accuracy. The "ground truth" for the device's functionality would have been its own specifications, verified through software validation and verification.
8. The sample size for the training set
Not applicable, as this device is an image management system and not an AI/ML diagnostic algorithm that typically requires a training set for model development.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for an AI/ML model.
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10093313
510(k) SUMMARY
DEC - 2 2009
Topcon Medical Systems, Inc. Synergy
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Topcon Medical Systems, Inc. 37 West Century Road Paramus, NJ 07652 Phone: (201) 599-5153 Facsimile: (201) 599-5240 Contact Person: Randy Samuels
OR
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541
Date Prepared: September 14, 2009
Name of Device and Name/Address of Sponsor
Synergy Topcon Medical Systems, Inc. 37 West Century Road Paramus, NJ 07652
Common or Usual Name
System, image management, ophthalmic
Classification Name
21 C.F.R. 892.2050
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Common or Usual Name
System, image management, ophthalmic
Classification Name
21 C.F.R. 892.2050
Predicate Devices
Topcon Corporation IMAGEnet Professional PC Software System (K082364) Nidek Advanced Vision Information System (NAVIS) (K013694) Digital Healthcare, Ltd. Oculab IP (K071299) Topcon Corporation 3D OCT-1000 (K072971)
Intended Use / Indications for Use
Synergy is a comprehensive software platform intended for use in acquisition or importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.
Technological Characteristics
18
Synergy is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy is used together with a number of computerized digital imaging devices. In addition, Synergy software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Synergy enables a real-time review of diagnostic patient information at a PC workstation. In addition to the desktop application, Synergy also includes an internet-browser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.
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Performance Data
No performance data was required or provided. Software validation and verification demonstrate that the Synergy performs as intended and meets its' specifications.
Substantial Equivalence
Synergy is as safe and effective as the identified predicate devices including Topcon Corporation's IMAGEnet Professional PC Software System (K082364). Nidek's Advanced Vision Information System (NAVIS) (K013694), Digital Healthcare's Oculab IP (K071299) and Topcon Corporation's 3D OCT-1000 (K072971). Synergy has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Both Synergy and the predicate devices have similar technological characteristics. Synergy and all the identified predicate devices with the exception of the Topcon 3D OCT-1000 are software only devices.
Capturing devices for Synergy are OCT, mydriatic and non-mydriatic retinal cameras and slit lamps which are similar to the other predicate devices. Topcon Corporation's IMAGEnet Professional PC Software System, Digital Healthcare's Oculab IP and Nidek's Advanced Vision Information System (NAVIS) all allow capture with mydriatic and non-mydriatic retinal cameras and slit lamps. The 3D OCT-1000 captures images with OCT.
Synergy, Digital Healthcare's Oculab IP, Topcon Corporation's IMAGEnet Professional PC Software System and Nidek's Advanced Vision Information System (NAVIS) all allow importing and management of files and images from a range of ophthalmic diagnostic devices including DICOM files, image files of known format, and video images. Synergy and the Digital Healthcare, Ltd. Oculab IP both also allow import of printer files.
In regards to measurement and analysis functions, Synergy, Digital Healthcare's Oculab IP, Topcon Corporation's IMAGEnet Professional PC Software System and Nidek's Advanced Vision Information System (NAVIS) all perform line/area measurements of retinal images. Additionally, Synergy and Topcon's 3D OCT-1000 both provide OCT retinal and RNFL thickness measurements functions.
In conclusion. Synergy shares similar technological characteristics as the predicate devices, both in terms of the manner in which images are captured, analyzed, and
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stored, as well as the operation of the device by the intended user. Any minor differences in operation do not raise new questions of safety and effectiveness. Synergy raises the same issues of safety and effectiveness as the predicate devices.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings and tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC - 2 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Topcon Medical Systems, Inc. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K093313
Trade/Device Name: Synergy Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NFJ and LLZ Dated: November 19, 2009 Received: November 23, 2009
Dear Mr. Borsai:
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.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):_
Device Name: Synergy
Indications for Use:
Synergy is a comprehensive software platform intended for use in acquisition or importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi Reimer
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 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).