(43 days)
Not Found
No
The document describes image processing and analysis but does not mention AI, ML, or any related terms like deep learning or neural networks. The focus is on data management and standard image processing techniques.
No
The device is a software platform for managing clinical images and data, not for direct treatment or diagnosis of a disease.
Yes
The device is described as "importing, processing, measurement, analysis and storage of clinical images and videos of the eye" and "enables a real-time review of diagnostic patient information," directly indicating its role in diagnosis.
Yes
The device description explicitly states that Synergy ODM is a "software platform" and describes its functions as collecting, processing, measuring, analyzing, storing, and managing data. While it interacts with other computerized digital imaging devices, the device itself is presented as the software component that performs these data management and analysis tasks.
Based on the provided information, Synergy ODM is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Synergy ODM's Function: Synergy ODM deals with the processing, analysis, and management of clinical images and videos of the eye. This involves analyzing visual data obtained directly from the patient's body using imaging devices, not analyzing samples taken from the body.
- Lack of Biological Sample Analysis: The description focuses entirely on image and data management, with no mention of analyzing biological samples.
Therefore, Synergy ODM falls under the category of medical imaging software or a picture archiving and communication system (PACS) for ophthalmology, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synergy ODM is a comprehensive software platform intended for use in 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.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition, Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
510(k) SUMMARY
Topcon Medical Systems, Inc. Synergy ODM
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436 Phone: (201) 599-5553 Facsimile: (201) 599-5240 Contact Person: Michael Gusel
OR
OCT 0 9 `2013
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: August 26, 2013
Name of Device and Name/Address of Sponsor
Synergy ODM Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436
Common or Usual Name
System, image management, ophthalmic
Classification Name
21 C.F.R. 892.2050
1
Predicate Devices
Topcon Corporation Synergy (K093313) Carl Zeiss Meditec AG Forum (K122938)
Intended Use / Indications for Use
Synergy ODM is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eve 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
Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition, Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-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.
Performance Data
No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications.
Substantial Equivalence
Synergy ODM is as safe and effective as the identified predicate devices including Topcon Corporation's Synergy (K093313) and Zeiss Forum (K122938). Synergy ODM has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Both Synergy ODM and the predicate devices have similar technological characteristics. Synergy ODM and the identified predicate devices are software only devices.
2
Image /page/2/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 symbol that resembles a stylized human figure with three flowing lines extending from its head.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W()66-G609 Silver Spring, MD 20993-0002
October 9, 2013
Topcon Medical Systems c/o Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K132667
Trade/Device Name: Synergy ODM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: Class II Product Code: NFJ Dated: August 26, 2013 Received: August 27, 2013
Dear Ms. O'Connell:
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 10 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: CDRI-1 docs 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 cither 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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Page 2 - Ms. Maureen O'Connell
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 form in the quant) by over 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K132667 510(k) Number (if known):_
Device Name: Synergy ODM
Indications for Use:
Synergy ODM is a comprehensive software platform intended for use in 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 _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter
Subpart C)
(21 C.F.R. 807
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Rahul K. Ram
-S (Affiliate)
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