(284 days)
Not Found
No
The document describes a software system for managing, processing, and displaying ophthalmic data. It focuses on data management, viewing functionalities, and integration with other systems. There is no mention of AI, ML, or any related terms or concepts in the provided text.
No.
The device is a software system for managing, processing, and displaying patient, diagnostic, video, and image data. It does not provide any therapeutic action or treatment.
No
Explanation: The device is a software system intended for managing, processing, and displaying patient, diagnostic, and image data from computerized diagnostic instruments, but it does not perform the diagnosis itself. It is explicitly described as an "ophthalmic data management solution" that works with other diagnostic instruments.
Yes
The device description explicitly states "FORUM and its accessories are a computer software system" and focuses on data management, processing, and display. While it interacts with hardware (diagnostic instruments), the device itself, as described, is the software system. The mention of "non-medical device accessories" further reinforces that the core medical device is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that FORUM is a software system for the management, processing, review, and display of patient, diagnostic, video, and image data from computerized diagnostic instruments. It is intended for use by trained healthcare professionals for reviewing this data.
- Device Description: The description reinforces this, highlighting its function as a data management solution that receives, stores, and allows access to data from ophthalmic diagnostic instruments. It provides viewing and annotation functionalities.
- Lack of In Vitro Testing: The description does not mention any interaction with biological samples or performing tests in vitro (outside of the living body). IVD devices are specifically designed to perform tests on biological specimens to provide information for diagnosis, monitoring, or screening.
- Focus on Data Management and Review: The core function of FORUM is to handle and present data generated by other diagnostic instruments. It is a tool for healthcare professionals to organize and review existing diagnostic information.
While the software processes and displays diagnostic data, it does not generate diagnostic information through testing of biological samples, which is the defining characteristic of an IVD. It acts as a data management and viewing platform for data acquired by other medical devices.
N/A
Intended Use / Indications for Use
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace).
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
FORUM and its accessories are a computer software system designed for management, processing, and display of patient diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.
FORUM receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments.
This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates.
This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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)
FORUM (version 4.3) has successfully undergone extensive software verification and validation testing to ensure that all requirements for proposed changes have been met. Software Verification and Validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
All testing followed internally approved procedures and processes. These procedures and processes are in compliance with referenced standards and FDA guidance documents.
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).
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Carl Zeiss Meditec AG % Maria Golovina Head of Regulatory - USA Carl Zeiss Meditec USA Inc 5300 Central Parkway Dublin, California 94548
Re: K213527
Trade/Device Name: Forum Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: NFJ Dated: June 30, 2022 Received: July 6, 2022
Dear Maria Golovina:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213527
Device Name FORUM
Indications for Use (Describe)
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace).
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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FORUM: 510(k) Summary
In accordance with 21 CFR 807.92, the following summary of information is provided in the 510(k) submission.
1. Identification of the Submitter
| Applicant | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Maria Golovina
Head of Regulatory Affairs - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 216-1078 Phone (925) 557-4259 Fax
E-mail: maria.golovina@zeiss.com (preferred) |
| Secondary Contact | Tanesha Bland
Senior Regulatory Affairs Specialist- USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 216-7963 Phone
E-mail: tanesha.bland@zeiss.com (preferred) |
| Date Prepared | August 11, 2022 |
2. Identification of the Product
| Trade Name | FORUM |
|---|---|
| Software Version | Software Version 4.3 |
| Classification/Common Name | System, Image Management, Ophthalmic |
| Device Class | II |
| Product Code | NFJ |
3. Predicate Device to which Equivalence is Claimed
Primary Predicate:
| Device Name | FORUM Archive and Viewer |
|---|---|
| Manufacturer | Carl Zeiss Meditec AG |
| Goeschwitzer Strasse 51-52 D-07745 Jena, Germany | |
| 510(k) Number | K122938 |
| Product Code | NFJ |
| Classification | System, Image Management, Ophthalmic |
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Image /page/4/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The letters are white and are set against a solid blue background. The logo is simple and modern, with a focus on the company name.
4. Summary of Device Description
FORUM and its accessories are a computer software system designed for management, processing, and display of patient diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.
FORUM receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments.
This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates.
This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow.
5. Intended Use and Indications for Use
The Indications for Use (IFU) statement for the subject device is as follows:
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace).
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
Prescription Use (Rx)
6. Substantial Equivalence Comparison to the Predicate Device
The substantial equivalence was drawn solely on the medical device features as they were related to the predicate.
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| Table 1. Subject Device to Reference Device Comparison (Technical Characteristics) |
|---|
| ------------------------------------------------------------------------------------ |
| Attribute/Function | Subject Device
(K213527) | Primary Predicate Device
(K122938) | Equivalency
Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | FORUM | FORUM Archive and
Viewer | Updated |
| Software version | Software version 4.3 | Software version 3.0 | Updated |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| Device Classification
Name | System, Image
Management, Ophthalmic | System, Image
Management, Ophthalmic | Identical |
| Regulation Description | Medical image
management and
processing system | Picture archiving and
communications system | Equivalent.
Regulation change. |
| Regulation medical
specialty | Ophthalmic | Ophthalmic | Identical |
| Review panel | Ophthalmic | Ophthalmic | Identical |
| Product code,
subsequent product
codes | NFJ – Class II | NFJ — Class II | Identical |
| Regulation number | 21CFR892.2050 | 21CFR892.2050 | Identical |
| Device class | II | II | Identical |
| Indications for use | FORUM is a software
system intended for use in
management, processing
of patient, diagnostic,
video and image data and
measurement from
computerized diagnostic
instruments or
documentation systems
through networks. It is
intended to work with
other FORUM
applications (including but
not limited to Retina
Workplace, Glaucoma
Workplace). | FORUM is a software
system intended for use in
management, processing of
patient, diagnostic, video
and image data and
measurement from
computerized diagnostic
instruments or
documentation systems
through networks. It is
intended to work with other
FORUM applications. | Equivalent. A
removal of the word
'storage' and display
from the indications
for use due to an
updated definition of
MIMS does not
constitute a
substantial change,
thus is deemed
equivalent. |
| Attribute/Function | Subject Device
(K213527) | Primary Predicate Device
(K122938) | Equivalency
Analysis |
| FORUM is intended for
use in review of patient,
diagnostic and image data
and measurement by
trained healthcare
professionals. | FORUM is intended for use
in review of patient,
diagnostic and image data
and measurement by trained
healthcare professionals. | | |
| Application | Ophthalmology | Ophthalmology | Identical |
| Platform/Operating
System | Server:
• Windows Server 2012 R2,
• Windows Server 2016,
• Windows Server 2019,
• Windows 8.1,
• Windows 10 | Server:
• Windows XP (32 bit) with Service Pack 3
• Windows Server 2003 (32 bit) with Service Pack 2
• Windows 7 (64 bit) with Service Pack 1
Windows Server 2008 R2 (64 bit) with Service Pack 1 | Equivalent; backend
improvements do not
impact the
indications for use,
device risk profile,
and technical
specifications of the
subject device as
demonstrated in risk
documentation and
testing results. |
| | Client:
• Windows Server 2012 R2,
• Windows Server 2016,
• Windows Server 2019,
• Windows 8.1,
• Windows 10
• Apple OS X 11.x (BigSur) | Client:
• Windows XP (32 bit) with Service Pack 3
• Windows 7 (64 bit) with Service Pack 1
Windows Server 2008 R2 (64 bit, English Edition)
• Apple OS 10.7 “Lion” | Equivalent; backend
improvements do not
impact the
indications for use,
device risk profile,
and technical
specifications of the
subject device as
demonstrated in risk
documentation and
testing results. |
| Database Features* | Central database: Yes | Central database: Yes | Identical |
| | Administer patient data:
Yes | Administer patient data: Yes | Identical |
| | Patient chart/ patient
management: Yes | Patient chart/ patient
management: Yes | Identical |
| | Search & sort
patients/documents: Yes | Search & sort
patients/documents: Yes | Identical |
| Attribute/Function | Subject Device
(K213527) | Primary Predicate Device
(K122938) | Equivalency
Analysis |
| | Administer exam data:
Yes | Store & administer exam
data: Yes | Identical |
| | Search Exams: Yes | Search Exams: Yes | Identical |
| | Scheduling exams:
Yes - Modality Worklist
Scheduler (Patient to
Device) | Scheduling exams:
Yes - Modality Worklist
Scheduler (Patient to
Device) | Identical |
| Image Processing | Image Processing
Function (Review of
medical documents) -
Fundus:
Yes - Stereo view for
fundus images, red green
blue (RGB) split for
fundus images, display of
fundus angiography
movies, rotation of fundus
images, measurements on
wide-field fundus images | Image Processing Function
(Review of medical
documents) - Fundus:
- Yes, to general
functionality - No, to specific
functions as
compared to the
subject device | Different; however,
the addition of this
functionality does
not impact the
indications for use,
device risk profile,
and technical
specifications of the
subject device as
demonstrated in risk
documentation and
testing results. |
| | Image Processing
Function (Review of
medical documents)
Image Annotations:
Yes, Addition of free hand
and circle measurement
ability, text annotations on
images, rotation | Image Processing Function
(Review of medical
documents) Image
Annotations: - Yes, to general
functionality - No, to specific
functions as
compared to the
subject device | Different; however,
the addition of this
functionality does
not impact the
indications for use,
device risk profile,
and technical
specifications of the
subject device as
demonstrated in risk
documentation and
testing results. |
| Access/Connectivity* | Connection to LAN: Yes | Connection to LAN: Yes | Identical |
| | DICOM Interface: Yes | DICOM Interface: Yes | Identical |
| | Remote data access via
Internet: No, only via
Virtual Private Network | Remote data access via
Internet: No, only via
Virtual Private Network | Identical |
| | Import exam data from
various ophthalmic
diagnostic devices: Yes | Import exam data from
various ophthalmic
diagnostic devices: Yes | Identical |
| Attribute/Function | Subject Device
(K213527) | Primary Predicate Device
(K122938) | Equivalency
Analysis |
| | Interface to Electronic
Medical Records (EMRs)
or Practice Management
Systems: Yes | Interface to Electronic
Medical Records (EMRs) or
Practice Management
Systems: Yes | Identical |
| | Cloud Connection: Yes
via ZEISS developed
non-medical device
accessories | Cloud Connection: No | Equivalent. The
addition of the non-
medical accessories
that support cloud
connectivity does not
impact the
indications for use
and do not impact
the functionality of
the medical device. |
| | Data Exchange: Yes,
bidirectional data
exchange between
FORUM Workplaces | Data Exchange: Yes,
unidirectional data exchange
between FORUM
Workplaces | Different; however,
the addition of this
functionality does
not impact the
indications for use,
device risk profile,
and technical
specifications of the
subject device as
demonstrated in risk
documentation and
testing results. |
| Image/Data Transfer
via DICOM | Yes | Yes | Identical |
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*The addition of new and/or modified medical device functions does not impact safety and equivalence of the subject device because risks associated with these functions were mitigated. Appropriate risk analysis and testing documentation was provided to demonstrate that these modifications do not impact the substantial equivalence as compared to the predicate device.
** The addition of new and/or modical functions and accessories does not impact safety and equivalence of the subject device because the functionality they provide does not have an impact to the FORUM medical device. This was demonstrated by providing appropriate risk assessments and testing information.
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7. Summary of the Studies
FORUM (version 4.3) has successfully undergone extensive software verification and validation testing to ensure that all requirements for proposed changes have been met. Software Verification and Validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
All testing followed internally approved procedures and processes. These procedures and processes are in compliance with referenced standards and FDA guidance documents.
8. Conclusion
The indications for use are equivalent to the indications for use of the predicate device; are deemed to be equivalent in their relationship to safety and effectiveness.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Testing methods are equivalent to those of the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Therefore, the subject device meets the requirements for substantial equivalence.