(135 days)
Not Found
No
The document describes a software platform for data management, display, and integration of ophthalmic data and images, but there is no mention of AI or ML capabilities. The focus is on data handling and viewing.
No
The device is a software platform for data management and review, not for direct diagnosis or treatment.
No
Explanation: The OIS Symphony is described as a software platform that integrates, manages, and reviews patient data and clinical information from various medical devices. It does not generate new diagnostic information itself but rather provides a viewing and management solution for information imported from other devices.
Yes
The device description explicitly states "OIS Symphony is a software solution" and details its functions related to data management, display, and integration, without mentioning any accompanying hardware components that are part of the device itself. While it interacts with other medical devices and systems, the device being submitted for 510(k) is described solely as software.
Based on the provided information, OIS Symphony is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that OIS Symphony is a software platform for the import, integration, and review of patient data and clinical information in an eye care environment. It focuses on managing and displaying data from other medical devices.
- Device Description: The description reinforces this by stating it's a software solution for the display, management, archive, interface, and integration of ophthalmic device reports, images, and data.
- No mention of analyzing biological samples: IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. OIS Symphony deals with data and images from medical devices, not biological samples.
- Focus on data management and display: The core function described is the handling and presentation of data and images generated by other ophthalmic devices.
While the software "processes, measures, analyzes" data, this analysis is of data and images from other devices, not direct analysis of biological samples, which is the hallmark of an IVD.
N/A
Intended Use / Indications for Use
OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.
Product codes
NFJ
Device Description
The OIS Symphony System is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. OIS Symphony consists of image display via Symphony Web, Image Import via Symphony Import and integration of imaging performed in OIS WinStation.
OIS Symphony is a software solution consistent with the predicate devices listed herein, using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment.
Symphony provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
Mentions image processing
Not Found
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
Intended User: physicians (ophthalmologists), optometrists, ophthalmology technicians/ photographers.
Care Setting: hospital departments, ophthalmology clinics, and related medical facilities.
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)
The OIS Symphony System has been subjected to extensive performance testing and validation before release. Final testing of OIS Symphony included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications.
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).
0
.
510(K) SUMMARY
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM
510(k) Number K_ / / / 00 / __________________________________________________________________________________________________________________________________________________
| Applicant's Name: | Ophthalmic Imaging Systems
221 Lathrop Way
Suite I
Sacramento, CA 95815
USA
Tel: (916) 646-2020
Fax: (916) 646-0207
e-mail:aambrose@oisi.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrea Ambrose / Gil Allon
221 Lathrop Way
Suite I
Sacramento, CA 95815
USA
Tel: (916) 646-2020
Fax: (916) 646-0207
e-mail:aambrose@oisi.com or gallon@oisi.com |
| Manufacturing Site: | 221 Lathrop Way
Suite I
Sacramento, CA 95815
USA |
| Date Prepared: | December 31, 2010 |
| Trade Name: | OIS Symphony |
| Classification Name: | CFR classification section 892.2050 (product Code NFJ). |
| Classification: | Class II Medical Device |
i
:
1
Predicate Device:
OIS Symphony Image Management System is substantially equivalent to the following predicate devices:
(1) Zeiss Forum (K090439) Manufactured by Carl Zeiss Meditec Inc. is intended as a software system in storing, managing, and displaying patient data, diagnostic data, videos, and images from computerized diagnostic instruments through networks.
(2) Nidek Advanced Vision Information System (NAVIS) (K013694) manufactured by Nidek is a computer technology software that collects, stores, and maintains patient data information; providing real-time diagnostic patient information from a number of diagnostic ophthalmic instruments at any PC workstation. Navis contains core software that can be augmented by additional software modules, supporting the various applications used clinically.
Synergy (K093313) Manufactured by Topcon Medical Systems Inc. is a (3) 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.
Comparison of Technology with Predicates:
The OIS Symphony employs the same, or similar, technological characteristics as the predicate devices.
Device Description:
The OIS Symphony System is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. OIS Symphony consists of image display via Symphony Web, Image Import via Symphony Import and integration of imaging performed in OIS WinStation.
2
OIS Symphony is a software solution consistent with the predicate devices listed herein, using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment.
Symphony provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
Intended Use / Indication for Use: -
OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.
Performance Standards:
None. There are no mandatory performance standards for this type of device.
Test Data:
The OIS Symphony System has been subjected to extensive performance testing and validation before release. Final testing of OIS Symphony included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. See Section 9 for statement and declaration of conformity.
3
Substantial Equivalence:
OIS Symphony is a comprehensive platform that collects, processes, measures, analyzes, and manages patient data and clinical information in an eye care environment. OIS Symphony provides a real time viewing environment for the collection and management of the patient demographics, image data, and clinical reports from a variety of approved medical devices, either directly or via a computer network. Similarly the predicate devices, including Zeiss Forum, NAVIS, and Topcon Synergy, are platforms for the import, acquisition, storage, and review of clinical images and tests of the eye, produced via a network or direct connection to the clinical instrument. The intended operators of OIS Symphony, similar to those of the predicate devices, are physicians (ophthalmologists), optometrists, ophthalmology technicians/ photographers. OIS Symphony and the predicate devices are used in environments that include hospital departments, ophthalmology clinics, and related medical facilities.
Conclusions:
The conclusions drawn from the above comparison to predicate devices is that OIS Symphony is substantially equivalent in safety and effectiveness to the predicate devices listed above.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in bold, black letters. A line is drawn underneath the text. To the left of the text is a graphic of a symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ophthalmic Imaging Systems % Ms. Andrea Ambrose Quality Manager 221 Lanthrop Way, Suite I Sacramento, CA 95864
MAY 18 2011
Re: K110006
Trade/Device Name: OIS Symphony Image Management System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NFJ Dated: May 11, 2011 Received: May 16, 2011
Dear Ms. Ambrose:
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
5
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.fda.gov/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,
Debra Falls
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): ★ // 0 0 0 k
Device Name: OIS Symphony
Indications for Use:
OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.
Prescription Use V (Per 21 C.F.R. 801 Subpart D) OR
Over-The-Counter Use (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110006