CALLISTO eye

K232944 · Carl Zeiss Meditec, AG · NFJ · Dec 21, 2023 · Radiology

Device Facts

• Record ID: K232944
• Device Name: CALLISTO eye
• Applicant: Carl Zeiss Meditec, AG
• Product Code: NFJ · Radiology
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CALLISTO eye is intended for use by trained clinical personnel. For Prescription Use ONLY.

Device Story

CALLISTO eye is a software-based assistance system for ophthalmic surgery. It processes real-time video from connected surgical microscopes (ARTEVO 750/850, RESCAN 700) and displays it on a Panel PC or through the microscope eyepiece. The system overlays preoperative clinical data (e.g., from Zeiss IOLMaster) as graphical templates to assist surgeons with IOL alignment, limbal relaxing incisions, and capsulorhexis. It supports markerless toric IOL alignment using preoperative diagnostic data. The system is operated by surgeons and surgical staff in the operating room. It facilitates high patient throughput and teaching. By providing visual guidance and remote control of the microscope, it aims to improve surgical precision and efficiency during anterior segment procedures.

Clinical Evidence

No clinical or animal testing was conducted. Substantial equivalence is supported by non-clinical performance testing, including software verification and validation (integration, system, and usability testing) performed in accordance with FDA guidance for software functions and recognized standards (ISO 14971, IEC 62304, IEC 62366-1).

Technological Characteristics

Software-only device; operates on Panel PC. Connectivity via TCP/IP and DICOM. Supports HD-SDI and MPEG 4 video inputs. Features include graphical guidance overlays (2D line graphics), eye tracking, and remote control of surgical microscopes/OCT. Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for remote control of ophthalmic surgical microscopes (ARTEVO 750/850, RESCAN 700) and display of anterior/posterior eye segment images. Serves as a graphical guidance aid for inserting, aligning, positioning, and registering intraocular lenses (IOLs), including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgery.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• CALLISTO eye (Software Version 3.7.2) (K231676)

Reference Devices

• RESCAN 700 (K180229)
• QUATERA 700 (K230858)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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# Indications for Use

510(k) Number (if known)

K232944

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)

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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<br>Goeschwizer Strasse 51-52<br>D-07745 Jena<br>Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Aditya Rao<br>Regulatory Affairs Specialist - USA<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone [phone] Fax<br>E-mail: [e-mail] (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

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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<br>CALLISTO eye Software is an<br>assistance system that provides non-<br>diagnostic video documentation and<br>image capture for ophthalmic<br>surgeries. The system allows the<br>remote control of the surgical<br>microscope and RESCAN 700. | Predicate (K231676)<br>CALLISTO eye Software is an<br>assistance system that provides<br>non-diagnostic video<br>documentation and image<br>capture for ophthalmic surgeries.<br>The system allows the remote<br>control of the surgical<br>microscope and RESCAN 700. | Identical |
| The assistance system relays data of<br>connected devices and provide this<br>information to the surgeon. It<br>visualizes the anterior and posterior<br>segment image data of the eye in<br>combination with a surgical<br>microscope and RESCAN 700. | The assistance system relays<br>data of connected devices and<br>provide this information to the<br>surgeon. It visualizes the anterior<br>and posterior segment image<br>data of the eye in combination<br>with a surgical microscope and<br>RESCAN 700. | Identical |
| The graphical guidance tools, as<br>displayed on the CALLISTO eye<br>Panel PC or microscope eyepiece,<br>aid the surgeon to insert, align,<br>position, and register an artificial<br>lens. These tools are intended for<br>anterior segment ophthalmic surgical<br>procedures, including positioning<br>and angular alignment of toric<br>intraocular lenses, limbal relaxing<br>incisions, and capsulorhexis. | The graphical guidance tools, as<br>displayed on the CALLISTO eye<br>Panel PC or microscope<br>eyepiece, aid the surgeon to<br>insert, align, position, and<br>register an artificial lens. These<br>tools are intended for anterior<br>segment ophthalmic surgical<br>procedures, including<br>positioning and angular<br>alignment of toric intraocular<br>lenses, limbal relaxing incisions,<br>and capsulorhexis. | Identical |
| The system utilizes surgeon<br>information for positioning of<br>graphical guidance tools. For | The system utilizes surgeon<br>information for positioning of<br>graphical guidance tools. | Identical |
| Rx-only / Prescription Use ONLY. | Rx-only / Prescription Use<br>ONLY. | Identical |

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| Feature | CALLISTO eye Software<br>Version 5.0<br>(Proposed Device) | CALLISTO eye Software<br>Version 3.7.2<br>(K231676) | Equivalency<br>Analysis | |
|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name | CALLISTO eye | CALLISTO eye | Identical | |
| Software version | CALLISTO eye Software version 5.0 | CALLISTO eye<br>Software version 3.7.2 | N/A | |
| Manufacturer | Carl ZEISS Meditec AG | Carl ZEISS Meditec AG | Identical | |
| Device Classification<br>Name | System, Image Management,<br>Ophthalmic | System, Image Management,<br>Ophthalmic | Identical | |
| Regulation description | Medical image management and<br>processing system | Medical image management<br>and processing system | Identical | |
| Regulation medical<br>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<br>software device intended for<br>remote control of ophthalmic<br>surgical microscopes ARTEVO<br>750/850 and RESCAN 700, and<br>display images of the anterior and<br>posterior segment of the eye.<br><br>CALLISTO eye Software is<br>indicated as graphical guidance aid<br>to insert, align, position, and<br>register an intraocular lens (IOL)<br>including toric IOLs, limbal<br>relaxing incisions, and<br>capsulorhexis during anterior<br>segment surgical procedures. | CALLISTO eye Software is a<br>software device intended for<br>remote control of ophthalmic<br>surgical microscopes of OPMI<br>Lumera family and RESCAN<br>700, and display images of the<br>anterior and posterior segment<br>of the eye.<br><br>CALLISTO eye Software is<br>indicated as graphical guidance<br>aid to insert, align, position, and<br>register an intraocular lens<br>(IOL) including toric IOLs,<br>limbal relaxing incisions, and<br>capsulorhexis during anterior<br>segment surgical procedures. | Identical<br>ARTEVO 750/850 are the<br>successor models of<br>OPMI Lumera 700 and<br>ARTEVO 800<br>respectively which were<br>referred as OPMI Lumera<br>family. | |
| Scope of application | Ophthalmology | Ophthalmology | Identical | |
| Patient Contact | No | No | Identical | |
| Key components | Software only | Software only | Identical | |
| Communication protocols | • TCP/IP<br>• DICOM | • TCP/IP<br>• DICOM<br>• CAN-BUS for EDIS | Identical<br>CAN-BUS interface<br>has been removed<br>because all ARTEVO<br>microscopes do not<br>support the EDIS<br>module. | |
| 510(k) Summary | | | Page 6 of 11 | |
| Supported display<br>interface and displays | • HDMI<br>• Panel PC<br>• IDIS (WITH VERSION<br>5.0 RELABELED AS<br>ADVISION)<br>• ARTEVO 3D Display (in 2D<br>only) | • HDMI<br>• Panel PC<br>• IDIS (WITH VERSION<br>5.0 RELABELED AS<br>ADVISION)<br>• ARTEVO 3D Display<br>(in 2D only)<br>• EDIS | Equivalent<br>All display types are<br>connected via a standard<br>HDMI interface. | |
| Supported video input<br>and formats | • HD-SDI<br>• MPEG 4 | • HD-SDI<br>• MPEG 4 | Identical | |
| Assistance Functions | | | | |
| Support of Clinical<br>workflows sequence<br>(non-mandatory sequence<br>of the assistant<br>functions) | Live mode => Reference =><br>Incision => Rhexis => Live<br>mode => Z Align => Live mode<br>=> LRI | Full screen mode =><br>Reference => Incision =><br>Rhexis => Full screen mode<br>=> Z Align => Full screen<br>mode => | Equivalent<br>Live mode in version<br>5.0 is the same as the<br>full screen mode<br>without overlays in<br>version 3.7.2.<br>However, the full<br>screen mode has to be<br>activated by the<br>surgeon, whereas the<br>Live mode steps can<br>be preconfigured in<br>the workflow by the<br>user. | |
| Representation of the<br>assistance tools guidance<br>templates | 2D, line graphics | 2D, line graphics | Identical | |
| Support of graphical and<br>text overlays in live<br>video, recorded videos,<br>images, and the eyepiece<br>of the microscope (DIS) | Yes | Yes | Identical | |
| Eye tracking | Yes | Yes | Identical | |
| Reference Axis, marker-<br>based | Yes | Yes | Identical | |
| Reference Axis,<br>markerless using<br>reference images | Yes | Yes | Identical | |
| Incisions | Yes | Yes | Identical | |
| 510(k) Summary | | Page 7 of 11 | | |
| Capsulorhexis | Yes | Yes | Identical | |
| Toric intraocular lens<br>alignment (Z- Align) | Yes | Yes | Identical | |
| Limbal relaxing incisions<br>(LRI) | Yes | Yes | Identical | |
| Surgical Microscopes +<br>Keratoscope support (K-<br>Track) | ARTEVO 750/850 RESCAN 700 (K180229) QUATERA 700 (K230858) | OPMI LUMERA 700 RESCAN 700 (K180229) QUATERA 700 (K230858) | Equivalent.<br>(Connectivity to OPMI<br>LUMERA 700 / ARTEVO<br>800 is no longer supported<br>in CALLISTO eye 5.0)<br>Additional support added<br>for RESCAN 700 and<br>QUATERA 700 for the<br>subject device. | |
| Assistance Functions for OCT support | | | | |
| Remote control of OCT<br>camera RESCAN 700 | Yes | Yes | Identical | |
| Live view of OCT scans<br>(B-Scans) | Yes | Yes | Identical | |
| OCT scan types: 1-Line<br>(1 B-Scan) | Yes | Yes | Identical | |
| OCT scan types: 2-<br>Line (2<br>perpendicular B-<br>Scans of OCT cube) | Yes | Yes | Identical | |
| OCT scan types:<br>5-Line (5 parallel B-<br>Scans) | Yes | Yes | Identical | |
| Recording of live OCT<br>scans (OCT<br>videos) | Yes | Yes | Identical | |
| OCT Image capture | Yes | Yes | Identical | |
| Capture mode for OCT<br>cubes | Yes | Yes | Identical | |
| Scan location marker<br>overlay to indicate<br>location, size, angle,<br>and scan type | Yes | Yes…