(86 days)
Not Found
No
The summary describes graphical guidance aids and image processing, but does not mention AI, ML, or any related concepts like deep learning or neural networks. The performance studies focus on traditional software verification and validation.
No.
The device is described as a software system that supports ophthalmic surgical procedures by providing graphical guidance and remote control of surgical microscopes; it does not directly treat or prevent a disease.
No
The device is described as an "assistance, information, and documentation system to support ophthalmic surgical procedures" and "graphical guidance aid to insert, align, position, and register an intraocular lens (IOL)". It processes surgery videos and OCT data but does not interpret or diagnose conditions; its primary function is to aid surgical procedures.
No
The device description explicitly states that the software "must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory." This indicates that the device includes a hardware component (the Panel PC) as part of its intended use and configuration, even if the software is the primary focus. Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CALLISTO eye Software's Intended Use: The intended use of CALLISTO eye Software is for remote control of surgical microscopes and providing graphical guidance during ophthalmic surgical procedures. It assists the surgeon during the procedure, not by analyzing specimens outside the body.
- Device Description: The description reinforces its role as an assistance, information, and documentation system for surgical procedures, processing live surgery videos and OCT data. It's a tool used in the operating room, not a laboratory device for analyzing samples.
- Lack of Specimen Analysis: There is no mention of the device collecting, preparing, or analyzing any biological specimens from the patient.
Therefore, the CALLISTO eye Software falls under the category of a surgical assistance or guidance device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye.
CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.
Product codes
NFJ
Device Description
CALLISTO eye Software, version 3.6, is an assistance, information, and documentation system to support ophthalmic surgical procedures. CALLISTO eye software operates as an adjunct to the OPMI Lumera family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). CALLISTO eye Software must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory. The software enables the visualization of the anterior and posterior segments of the eye and allows the connection and remote control of a surgical microscope.
CALLISTO eye software is provided with differing levels of functionality based on the option licensed. Some of these configurations provide a variety of assistant functions (tools) to assist the surgeon with implanting intraocular lenses (IOL), particularly toric intraocular lenses (tIOL). These tools are comprised of graphical templates including Incisions to insert a toric intraocular lens. Rhexis for opening the capsular bag. Z ALIGN for the alignment of toric intraocular lens, and LRI for the planning of limbal relaxing incisions.
Previously, CALLISTO eye offered some common features throughout all software versions; however, functions for some features were separated by software version according to the proposed use, i.e. the visualization of OCT data in conjunction with the OCT camera RESCAN 700 or the cataract surgery assistance. With CALLISTO eye Software, version 3.6, all functions are present in one software version in addition to a few additional functions, as described in the Table 1 below:
Mentions image processing
CALLISTO eye software operates as an adjunct to the OPMI Lumera family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
surgery videos and OCT data (B-Scan images)
Anatomical Site
anterior and posterior segment of the 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)
Verification and validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye Software. A portion of software verification may be considered "bench testing". Each function and/or feature was tested by means of the appropriate test case or test specification. The system verification test report provides the test cases, expected results for each test case and the actual results obtained.
Software verification activities completed were divided into three phases:
- . Tests accompanying development (including code inspections)
- Integration test phase stabilization phase
- System verification
Validation was also conducted for CALLISTO eye according to the Validation Plan to ensure that the device meets the customer's requirements with respect to performance. The objectives defined in the validation plan were achieved according to the validation results.
Verification and validation activities were successfully completed and prove that CALLISTO eye Software, version 3.6, meets the stipulated requirements and performs as intended.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2018
Carl Zeiss Meditec, Inc Mandy Ambrecht Staff Regulatory Affairs Specialist 5160 Hacienda Drive Dublin, CA 94568
Re: K180858
Trade/Device Name: CALLISTO eye Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: March 29, 2018 Received: April 2, 2018
Dear Mandy Ambrecht:
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 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.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley S. Cunningham -A
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
2
Indications for Use
510(k) Number (if known) K180858
Device Name CALLISTO eye
Indications for Use (Describe)
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye.
CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY (per 21 CFR §807.92)
CALLISTO eye
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena, Germany
+49 7364 206985
+49 7364 954432 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mandy Ambrecht
Staff Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, California 94568
(925) 557-4561 (phone)
(925) 557-4259 (fax) |
Date Summary Prepared: 5-25-2018
| CALLISTO eye | ||
|---|---|---|
| Classification name | System, Image Management, Ophthalmic | |
| Classification | 892.2050 | |
| Class | II | |
| Product Code | NFJ | |
| Trade / Proprietary Name | CALLISTO eye | |
| Common Name | Picture archiving and communications system | |
| Primary Predicate Device | ||
| Company: | Carl Zeiss Meditec AG | |
| Device: | CALLISTO eye, K123464 | |
| Secondary Predicate Device | ||
| Company: | Carl Zeiss Meditec AG | |
| Device: | ZEISS Cataract Suite markerless, K141068 | |
| (with CALLISTO eye software 3.5) | ||
| Secondary Predicate Device | ||
| Company: | Carl Zeiss Meditec AG | |
| Device: | RESCAN 700, K141844 | |
| (with CALLISTO eye software 3.2) |
4
INDICATIONS FOR USE (21 CFR §807.92(a)(5))
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye.
CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.
DEVICE DESCRIPTION (21 CFR §807.92(a)(4))
CALLISTO eye Software, version 3.6, is an assistance, information, and documentation system to support ophthalmic surgical procedures. CALLISTO eye software operates as an adjunct to the OPMI Lumera family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). CALLISTO eye Software must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory. The software enables the visualization of the anterior and posterior segments of the eye and allows the connection and remote control of a surgical microscope.
CALLISTO eye software is provided with differing levels of functionality based on the option licensed. Some of these configurations provide a variety of assistant functions (tools) to assist the surgeon with implanting intraocular lenses (IOL), particularly toric intraocular lenses (tIOL). These tools are comprised of graphical templates including Incisions to insert a toric intraocular lens. Rhexis for opening the capsular bag. Z ALIGN for the alignment of toric intraocular lens, and LRI for the planning of limbal relaxing incisions.
Previously, CALLISTO eye offered some common features throughout all software versions; however, functions for some features were separated by software version according to the proposed use, i.e. the visualization of OCT data in conjunction with the OCT camera RESCAN 700 or the cataract surgery assistance. With CALLISTO eye Software, version 3.6, all functions are present in one software version in addition to a few additional functions, as described in the Table 1 below:
5
| CALLISTO eye Functions | SW
Version
3.0 | SW
Version
3.2 | SW
Version
3.5 | SW
Version
3.6 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------|----------------------|----------------------|
| As cleared in premarket notification | K123464 | K141844 | K141068 | |
| Network connectivity | X | X | X | X |
| User management | X | X | X | X |
| Updated
Patient management | X | X | X | X |
| Import of patient and treatment data
from the IOLMaster Models 500 and
700 | | | X | X |
| Surgery documentation (video
recording and still images) | X | X | X | X |
| Ophthalmic surgical microscope
remote control (OPMI LUMERA 700) | X | X | X | X |
| Live video | X | X | X | X |
| Updated
Assistance functionalities:
Reference axis marker-based, Incision,
Rhexis, Z ALIGN, LRI, and Ktrack | X | X | X | X |
| New
Image Quality for Reference Assistant | | | | X |
| Reference axis markerless, utilizing
the IOLMaster Models 500 and 700
reference image | | | X | X |
| CALLISTO eye Functions | SW
Version 3.0 | SW
Version 3.2 | SW
Version 3.5 | SW
Version 3.6 |
| As cleared in premarket notification | K123464 | K141844 | K141068 | |
| Eye tracking | X | | X | X |
| New
Export of OCT data to connected
PACS system (FORUM) | | | | X |
| Updated
Control of the RESCAN 700 (OCT
Camera) connected to the OPMI
LUMERA 700 | | X | | X |
| Visualization of optical coherence
tomography (OCT) data | | X | | X |
| Capture and review of OCT data
(images and B-scans) | | X | | X |
| Support of 1-Line, 2-Line (OCT cube)
and 5-Line OCT data | | X | | X |
| New
XY-tracking support for Scan
Location Marker (for OCT views
based on vessels) | | | | X |
| New
Support for 2.9 mm and 5.8 mm scan
depths | | | | X |
| New
Automatic combination of scan length
and scan depth (user configurable). | | | | X |
| Updated
Combined full screen mode for
microscope live video and OCT live
view | | | | X |
| Ocular overlays provided for the
external data injection system (EDIS)
to display information in the eyepiece
of the microscope (OPMI LUMERA,
OPMI Lumera i and OPMI Lumera T) | | | X | X |
| New
Icon-based ocular overlays to visualize
the provided information (“Cockpits”)
in the data injections system of the
connected microscope | | | | X |
| Import / Export of patient treatment
data to a USB storage device | X | X | X | X |
| CALLISTO eye Functions | SW
Version
3.0 | SW
Version
3.2 | SW
Version
3.5 | SW
Version
3.6 |
| As cleared in premarket notification | K123464 | K141844 | K141068 | |
| Import / Export of patient treatment
data to connected PACS system
(FORUM) | | | x | x |
| New
Import of patient treatment data using
WLAN | | | | x |
| New
USB recording: Surgery
documentation can be recorded in
parallel to a USB hard drive | | | | x |
Table 1 presents the functions offered by the previous and proposed CALLISTO eye.
6
7
Table 5.1: CALLISTO eye Functions by Software Version
RISK MANAGEMENT
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means, protection measures and user instructions. To confirm that the measures are effective and that the product meets its intended uses, verification of requirements and standards was performed as well as validation of the clinical workflow. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.
PERFORMANCE DATA & SUMMARY OF VERIFICATION AND VALIDATION ACTIVITY (21 CFR §807.92(B))
Verification and validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye Software. A portion of software verification may be considered "bench testing". Each function and/or feature was tested by means of the appropriate test case or test specification. The system verification test report provides the test cases, expected results for each test case and the actual results obtained.
Software verification activities completed were divided into three phases:
- . Tests accompanying development (including code inspections)
- Integration test phase stabilization phase ●
- System verification
Validation was also conducted for CALLISTO eye according to the Validation Plan to ensure that the device meets the customer's requirements with respect to performance. The objectives defined in the validation plan were achieved according to the validation results.
8
Verification and validation activities were successfully completed and prove that CALLISTO eye Software, version 3.6, meets the stipulated requirements and performs as intended.
| FDA Recognized Standards | |
|---|---|
| Identification | Description |
| ISO 14971: 2007 | Medical Devices – Application of Risk |
| Management to Medical Devices | |
| IEC 62366-1:2015 | Medical devices – Application of |
| usability engineering to medical devices | |
| IEC 62304:2015 | Medical device software - Software life |
| cycle processes | |
| NEMA PS 3.1-3.20 | Digital Imaging and Communications in |
| Medicine (DICOM) |
CALLISTO eye Software, version 3.6, conforms to the applicable FDA recognized and international IEC and ISO standards with regards to performance and safety:
Table 2: FDA Recognized Standards
TECHNOLOGICAL CHARACTERISTICS (21 CFR 5807.92(a)(6)) AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a)(3))
It is the opinion of Carl Zeiss Meditec AG that the proposed device, CALLISTO eye Software, version 3.6, is substantially equivalent to CALLISTO eye, as described in premarket notification K123464, K141068 and K141844, with regards to indications for use. Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate devices as cleared in premarket notifications K123464, K141068, and K141844 provide non-diagnostic video documentation and image capture for ophthalmic surgeries and allow remote control of the surgical microscope.
Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye as described in K123464 inject (displays) information such as light level, zoom and recording into the right ocular; the proposed device uses "Cockpits", an icon-based ocular overlays to visualize the provided information in the data injections system of the connected microscope.
Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye as described in K141068, provides a variety of assistance functions to assist the surgeon with implanting intraocular lenses (IOL), particularly toric intraocular lenses.
Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye as described in K141068, allows patient and treatment data to be imported from the IOLMaster Model 500 and is compatible with the IOLMaster 700; the proposed device also allows IOLMaster patient and treatment data to be imported using WLAN.
9
CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye version 3.2, as employed in the RESCAN 700 (K141844), can visualize OCT data taken by the OCT Camera RESCAN 700. Specifically, both systems can display 1-Line, 2-Line (OCT-Cube), and 5-Line OCT scans, record videos and images of live OCT scans. Both devices offered XY tracking; the proposed device also offers Z tracking.
SUMMARY (21 CFR §807.92(b)(3))
The modifications to the CALLISTO eye Software, version 3.6, consolidate the functions cleared under the previous premarket notifications K123464 (CALLISTO eye 3.0) and K141068 (Zeiss Cataract Suite markerless with CALLISTO eye 3.5) as well as under K141844 (RESCAN 700).
The modifications to the subject device does not raise new issues of safety or effectiveness. Therefore, ZEISS believes that the subject device, CALLISTO eye Software, version 3.6, is substantially equivalent to the predicate devices, CALLISTO eye software version 3.0 (K123464), ZEISS Cataract Suite markerless with CALLISTO eye software version 3.5 (K141068), and RESCAN 700 with CALLISTO eye software version 3.2 (K141844).