(92 days)
No
The summary describes image processing and assistance functions based on predefined templates and preoperative data, but there is no mention of AI, ML, or algorithms that learn or adapt.
No.
The device is described as a software for remote control and graphical guidance during surgical procedures, not as a device that directly treats or provides therapy to a patient. Its function is to assist the surgeon, not to deliver a therapeutic intervention itself.
No
The device is an assistance system that processes real-time video images and provides graphical guidance to assist surgeons during ophthalmic surgical procedures. While it can utilize preoperative diagnostic data and exchange patient data with DICOM-compatible diagnostic devices, it does not perform diagnostic functions itself.
No
The device description explicitly states that the software provides connectivity to and remote control of surgical microscopes (ARTEVO 750/850 and RESCAN 700) and OCT cameras. While the submission focuses on the software, its function is intrinsically linked to and controls hardware components, making it a software component of a medical device system, not a standalone software-only medical device.
Based on the provided information, the CALLISTO eye Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CALLISTO eye's Function: The CALLISTO eye Software is a software device that controls surgical microscopes and displays real-time images of the eye during surgery. It provides graphical guidance and assistance to the surgeon during anterior segment procedures.
- No Specimen Analysis: The device does not analyze any specimens derived from the human body. It processes and displays live video images and pre-operative data to aid the surgeon during a surgical procedure.
Therefore, the CALLISTO eye Software falls under the category of a surgical assistance system or image-guided surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 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 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes.
CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks.
Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images, OCT scans
Anatomical Site
anterior and posterior segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinical personnel
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
Non-Clinical Performance Testing: Risk management via risk analysis, verification of requirements and standards, and validation of clinical workflow according to ISO 14971. Software verification activities included tests accompanying development, integration test phase, and system verification. Validation was also conducted to ensure the device meets customer requirements. Cybersecurity assessment performed based on VAST Threat Modeling as described in IEC 81001-5-1 under recommendation C10.
Animal/Clinical Performance Testing: Not conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 21, 2023
Carl Zeiss Meditec AG Aditya Rao Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568
Re: K232944
Trade/Device Name: CALLISTO eye Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: September 15, 2023 Received: September 20, 2023
Dear Aditya Rao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Bennett N. Walker -S. The date of the signature is 2023.12.21, and the time is 10:10:54 -05'00'.
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
3
Indications for Use
510(k) Number (if known)
Device Name
CALLISTO eye
Indications for Use (Describe)
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 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) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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In accordance with 21 CFR 807.92 the 510(k) Summary for the CALLISTO eye is provided below.
SUBMITTER 1.
| Applicant: | Carl Zeiss Meditec AG
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Aditya Rao
Regulatory Affairs Specialist - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 549-9579 Phone (925) 557-4259 Fax
E-mail: aditya.rao@zeiss.com (preferred) |
| Date Prepared: | December 20, 2023 |
| 510((k) Number | K232944 |
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DEVICE 2.
| Device Trade Name: | CALLISTO eye (Software Version 5.0) – K232944 |
|---|---|
| Classification: | 21CFR892.2050 Medical image management and processing system |
| Regulatory Class: | II |
| Product Code: | NFJ |
3. PREDICATE DEVICE
Predicate Device: CALLISTO eye (Software Version 3.7.2) - K231676 21CFR892.2050 Classification: Medical image management and processing system Regulatory Class: II Product Code: NFJ
DEVICE DESCRIPTION 4.
CALLISTO eye software version 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes.
CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks.
Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The
6
DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).
5. INTENDED USE/INDICATIONS FOR USE
The intended use statement for the subject device is as follows:
CALLISTO eye is intended for use by trained clinical personnel. For Prescription Use ONLY.
The Indications for Use (IFU) statement for the subject device is as follows:
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 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.
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SUBSTANTIAL EQUIVALENCE
Primary Predicate 6.1.
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| CALLISTO eye (Version 5.0) | CALLISTO eye (Version 3.7.2) | Equivalency Analysis |
|---|---|---|
| Proposed Device | ||
| CALLISTO eye Software is an | ||
| assistance system that provides non- | ||
| diagnostic video documentation and | ||
| image capture for ophthalmic | ||
| surgeries. The system allows the | ||
| remote control of the surgical | ||
| microscope and RESCAN 700. | Predicate (K231676) | |
| CALLISTO eye Software is an | ||
| assistance system that provides | ||
| non-diagnostic video | ||
| documentation and image | ||
| capture for ophthalmic surgeries. | ||
| The system allows the remote | ||
| control of the surgical | ||
| microscope and RESCAN 700. | Identical | |
| The assistance system relays data of | ||
| connected devices and provide this | ||
| information to the surgeon. It | ||
| visualizes the anterior and posterior | ||
| segment image data of the eye in | ||
| combination with a surgical | ||
| microscope and RESCAN 700. | The assistance system relays | |
| data of connected devices and | ||
| provide this information to the | ||
| surgeon. It visualizes the anterior | ||
| and posterior segment image | ||
| data of the eye in combination | ||
| with a surgical microscope and | ||
| RESCAN 700. | Identical | |
| The graphical guidance tools, as | ||
| displayed on the CALLISTO eye | ||
| Panel PC or microscope eyepiece, | ||
| aid the surgeon to insert, align, | ||
| position, and register an artificial | ||
| lens. These tools are intended for | ||
| anterior segment ophthalmic surgical | ||
| procedures, including positioning | ||
| and angular alignment of toric | ||
| intraocular lenses, limbal relaxing | ||
| incisions, and capsulorhexis. | The graphical guidance tools, as | |
| displayed on the CALLISTO eye | ||
| Panel PC or microscope | ||
| eyepiece, aid the surgeon to | ||
| insert, align, position, and | ||
| register an artificial lens. These | ||
| tools are intended for anterior | ||
| segment ophthalmic surgical | ||
| procedures, including | ||
| positioning and angular | ||
| alignment of toric intraocular | ||
| lenses, limbal relaxing incisions, | ||
| and capsulorhexis. | Identical | |
| The system utilizes surgeon | ||
| information for positioning of | ||
| graphical guidance tools. For | The system utilizes surgeon | |
| information for positioning of | ||
| graphical guidance tools. | Identical | |
| Rx-only / Prescription Use ONLY. | Rx-only / Prescription Use | |
| ONLY. | Identical |
8
| Feature | CALLISTO eye Software
Version 5.0
(Proposed Device) | CALLISTO eye Software
Version 3.7.2
(K231676) | Equivalency
Analysis | |
|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name | CALLISTO eye | CALLISTO eye | Identical | |
| Software version | CALLISTO eye Software version 5.0 | CALLISTO eye
Software version 3.7.2 | N/A | |
| 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 | Medical image management
and processing system | Identical | |
| Regulation medical
specialty | Radiology | Radiology | Identical | |
| Review panel | Ophthalmic | Ophthalmic | Identical | |
| Product code, | NFJ | NFJ | Identical | |
| Regulation number | 892.2050 | 892.2050 | Identical | |
| Device class | II | II | Identical | |
| Indications for use | CALLISTO eye Software is a
software device intended for
remote control of ophthalmic
surgical microscopes ARTEVO
750/850 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. | 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. | Identical
ARTEVO 750/850 are the
successor models of
OPMI Lumera 700 and
ARTEVO 800
respectively which were
referred as OPMI Lumera
family. | |
| Scope of application | Ophthalmology | Ophthalmology | Identical | |
| Patient Contact | No | No | Identical | |
| Key components | Software only | Software only | Identical | |
| Communication protocols | • TCP/IP
• DICOM | • TCP/IP
• DICOM
• CAN-BUS for EDIS | Identical
CAN-BUS interface
has been removed
because all ARTEVO
microscopes do not
support the EDIS
module. | |
| 510(k) Summary | | | Page 6 of 11 | |
| Supported display
interface and displays | • HDMI
• Panel PC
• IDIS (WITH VERSION
5.0 RELABELED AS
ADVISION)
• ARTEVO 3D Display (in 2D
only) | • HDMI
• Panel PC
• IDIS (WITH VERSION
5.0 RELABELED AS
ADVISION)
• ARTEVO 3D Display
(in 2D only)
• EDIS | Equivalent
All display types are
connected via a standard
HDMI interface. | |
| Supported video input
and formats | • HD-SDI
• MPEG 4 | • HD-SDI
• MPEG 4 | Identical | |
| Assistance Functions | | | | |
| Support of Clinical
workflows sequence
(non-mandatory sequence
of the assistant
functions) | Live mode => Reference =>
Incision => Rhexis => Live
mode => Z Align => Live mode
=> LRI | Full screen mode =>
Reference => Incision =>
Rhexis => Full screen mode
=> Z Align => Full screen
mode => | Equivalent
Live mode in version
5.0 is the same as the
full screen mode
without overlays in
version 3.7.2.
However, the full
screen mode has to be
activated by the
surgeon, whereas the
Live mode steps can
be preconfigured in
the workflow by the
user. | |
| Representation of the
assistance tools guidance
templates | 2D, line graphics | 2D, line graphics | Identical | |
| Support of graphical and
text overlays in live
video, recorded videos,
images, and the eyepiece
of the microscope (DIS) | Yes | Yes | Identical | |
| Eye tracking | Yes | Yes | Identical | |
| Reference Axis, marker-
based | Yes | Yes | Identical | |
| Reference Axis,
markerless using
reference images | Yes | Yes | Identical | |
| Incisions | Yes | Yes | Identical | |
| 510(k) Summary | | Page 7 of 11 | | |
| Capsulorhexis | Yes | Yes | Identical | |
| Toric intraocular lens
alignment (Z- Align) | Yes | Yes | Identical | |
| Limbal relaxing incisions
(LRI) | Yes | Yes | Identical | |
| Surgical Microscopes +
Keratoscope support (K-
Track) | ARTEVO 750/850 RESCAN 700 (K180229) QUATERA 700 (K230858) | OPMI LUMERA 700 RESCAN 700 (K180229) QUATERA 700 (K230858) | Equivalent.
(Connectivity to OPMI
LUMERA 700 / ARTEVO
800 is no longer supported
in CALLISTO eye 5.0)
Additional support added
for RESCAN 700 and
QUATERA 700 for the
subject device. | |
| Assistance Functions for OCT support | | | | |
| Remote control of OCT
camera RESCAN 700 | Yes | Yes | Identical | |
| Live view of OCT scans
(B-Scans) | Yes | Yes | Identical | |
| OCT scan types: 1-Line
(1 B-Scan) | Yes | Yes | Identical | |
| OCT scan types: 2-
Line (2
perpendicular B-
Scans of OCT cube) | Yes | Yes | Identical | |
| OCT scan types:
5-Line (5 parallel B-
Scans) | Yes | Yes | Identical | |
| Recording of live OCT
scans (OCT
videos) | Yes | Yes | Identical | |
| OCT Image capture | Yes | Yes | Identical | |
| Capture mode for OCT
cubes | Yes | Yes | Identical | |
| Scan location marker
overlay to indicate
location, size, angle,
and scan type | Yes | Yes | Identical | |
| 510(k) Summary | | | Page 8 of 11 | |
| Display of OCT scans in
the right eyepiece of the
surgical microscope or
the 3D monitor as
2D image. | Yes | Yes | Identical | |
| Support of dual scan depth
(2.9 and 5.8
mm). | Yes | Yes | Identical | |
| Automatic combination
of scan length and scan
depth (user
configurable). | Yes scan length of 9mm scan uses a scan depth of 5.8 mm | Yes scan length of 9mm scan uses a scan depth of 5.8 mm | Identical | |
| OCT XY-tracking | Yes | Yes | Identical | |
| OCT Z tracking | Yes | Yes | Identical | |
| Support of a fundus
viewing system | Yes
Non-contact type (ZEISS
RESIGHT)
Contact type | Yes
Non-contact type (ZEISS
RESIGHT)
Contact type | Identical | |
| OCT remote control via
foot panel | Yes | Yes | Equivalent
(Identical function but
different settings to
provide more flexibility
to the user) | |
| Access to Microscope
live setting with an OCT | Yes | Yes | Equivalent
(Identical function but
with a more streamlined
UI for usability) | |
| Non-Medical Device Features (Other Functions) | | | | |
| User management | Yes | Yes | Identical | |
| Patient management | Yes | Yes | Identical | |
| User specific device
profiles and settings | Yes | Yes | Identical | |
| Store & administer
patient data | Yes | Yes | Identical | |
| Search & sort
patients/documents | Yes | Yes | Identical | |
| Surgery recording | Yes | Yes | Identical | |
| Image capture | Yes | Yes | Identical | |
| Live video | Yes | Yes | Identical | |
| 510(k) Summary | | Page 9 of 11 | | |
| Ability to zoom into
images | Yes | Yes | Identical | |
| Ability to replay surgery
video files | Yes | Yes | Identical | |
| Export patient and
treatment data | Yes | Yes | Identical | |
| Import patient and
treatment data | Yes | Yes | Identical | |
| Display of data from
connected devices | Yes | Yes | Equivalent
(Identical data but
different presentation
on the display) | |
| Receive commands | Yes | Yes | Equivalent
(Updated interfaces) | |
| Send commands | Yes | Yes | Equivalent
(Updated interfaces) | |
| Remote service access
via internet for service
specialists | Not supported | Yes | N/A
Functionality not
provided. | |
| Post surgery document
management | Yes | Yes | Equivalent
(Identical function but
with a more streamlined
UI) | |
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
9
10
510(k) Summarv
11
12
It is the opinion of Carl Zeiss Meditec AG that the proposed device, CALLISTO eye Software, version 5.0, is substantially equivalent to CALLISTO eye Software, version 3.7.2 for the following reasons:
o The indications for use are identical to the indications for use of the predicate device; and therefore, are deemed to be identical in their relationship to safety and effectiveness.
- o The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
- . Testing methods are equivalent to those of the predicate; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Therefore, the subject device meets the requirements for substantial equivalence.
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SUMMARY OF STUDIES 7. Non-Clinical Performance Testing
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 according to ISO 14971. 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. The subject device was tested according to the FDA Guidance for the Content of Premarket Submissions for Device Software Functions (June 2023). 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 5.0, meets the stipulated requirements and performs as intended.
Cybersecuritv
CALLISTO eye Software version 5.0 is considered a Cyber device per 524B(c) of the Food, Drug, and Cosmetic Act. ZEISS has followed all recommendations in the FDA guidance document " Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov) (September 27, 2023).
ZEISS' methodology to address cybersecurity risks and vulnerabilities was outlined including all assets, threats, vulnerabilities and controls within a Cybersecurity Risk Assessment. ZEISS performed a Cybersecurity Assessment based on VAST Threat Modeling as described in IEC 81001-5-1 under recommendation C10. VAST Threat Modeling was utilized due to its practical nature/approach and is the same threat modeling approach used in the predicate device (K231676).
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CALLISTO eye Software, version 5.0, conforms to the applicable FDA recognized and international IEC and ISO standards with regards to performance and safety:
| FDA Recognized Standards | |
|---|---|
| Identification | Description |
| ISO 14971:2019 | 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) |
| Table: FDA Recognized Standards |
Animal/Clinical Performance Testing
Animal and Clinical testing was not conducted.
8. CONCLUSION
The modifications to the CALLISTO eye Software, version 5.0, consolidate the functions cleared under the previous premarket notifications K231676 (CALLISTO eye 3.7.2).
The modifications to the subject device do not raise new issues of safety or effectiveness. Therefore, ZEISS believes that the subject device, CALLISTO eye Software, version 5.0, is substantially equivalent to the predicate devices, CALLISTO eye (K231676).