SYNERGY ODM

K132667 · Topcon Medical Systems, Inc. · NFJ · Oct 9, 2013 · Radiology

Device Facts

• Record ID: K132667
• Device Name: SYNERGY ODM
• Applicant: Topcon Medical Systems, Inc.
• Product Code: NFJ · Radiology
• Decision Date: Oct 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Synergy ODM is a software platform for ophthalmic image and data management. It imports clinical images, videos, and diagnostic reports from ophthalmic instruments via direct connection or network. The system processes, measures, analyzes, and stores this data in a centralized database. Used in clinical settings, it allows healthcare providers to review diagnostic information in real-time at a PC workstation or via an internet-browser-based interface. The software facilitates report creation and data analysis, supporting clinical decision-making by providing centralized access to patient examination history. It benefits patients by enabling efficient data management and review by clinicians.

Clinical Evidence

No clinical data provided. Bench testing only; software verification and validation demonstrated that the device performs as intended and meets specifications.

Technological Characteristics

Software-only platform for data management. Features include PC workstation integration, internet-browser-based user interface, centralized database, dual-level authentication, and 128-bit encryption for secure networking.

Indications for Use

Indicated for the management, processing, analysis, and storage of ophthalmic clinical images, videos, and diagnostic data for patients undergoing eye examinations.

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

• Topcon Corporation Synergy (K093313)
• Carl Zeiss Meditec AG Forum (K122938)

Submission Summary (Full Text)

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K132667

#### 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: [phone] Facsimile: [phone] 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: [phone] Facsimile: [phone]

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

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## 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Rahul K. Ram
-S (Affiliate)

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