CALLISTO eye

K231676 · Carl Zeiss Meditec, AG · NFJ · Aug 28, 2023 · Radiology

Device Facts

• Record ID: K231676
• Device Name: CALLISTO eye
• Applicant: Carl Zeiss Meditec, AG
• Product Code: NFJ · Radiology
• Decision Date: Aug 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

CALLISTO eye is a software-based assistance system for ophthalmic surgery; operates on a dedicated Panel PC with touchscreen. Inputs include video data from ZEISS surgical microscopes (OPMI Lumera family, ARTEVO 800) and OCT B-Scan images from RESCAN 700. System provides graphical guidance overlays (templates) for IOL alignment, capsulorhexis, and incisions; displays device information (cockpits); manages patient data via DICOM. Surgeon operates system via microscope handgrips, foot control panel, or touchscreen to control microscope parameters (zoom, focus, light) and OCT scanning. Output is visual guidance in microscope eyepiece and on Panel PC display. Benefits include improved surgical precision and workflow efficiency during cataract and refractive procedures. Used in OR by surgeons and clinical staff.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation activities confirmed device performance against specifications, including software lifecycle processes (IEC 62304), risk management (ISO 14971), and usability engineering (IEC 62366-1).

Technological Characteristics

Software-only device running on Panel PC (touchscreen, video card). Connectivity via TCP/IP, DICOM, REST, CAN-BUS. Supports OPMI Lumera/ARTEVO microscopes, RESCAN 700, QUATERA 700. OS: Windows 10 Enterprise 2016 LTSB. Standards: ISO 14971:2019, IEC 62366-1:2015, IEC 62304:2015, NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for patients undergoing anterior segment ophthalmic surgical procedures requiring IOL insertion, alignment, positioning, or registration, including toric IOLs, limbal relaxing incisions, and capsulorhexis.

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 3.6) (K180858)

Reference Devices

• RESCAN 700 (K180229)
• QUATERA 700 (K212241)
• FORUM (K213527)

Submission Summary (Full Text)

{0}------------------------------------------------

August 28, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Carl Zeiss Meditec AG % Aditya Rao Regulatory Affairs Specialist - USA Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, California 94568

### Re: K231676

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: June 8, 2023 Received: June 9, 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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K231676

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 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial;"> <svg height="12" width="12"> <path d="M0 0 L12 12 M12 0 L0 12" stroke="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: | August 15, 2023 |

{4}------------------------------------------------

#### DEVICE 2.

| Device Trade Name: | CALLISTO eye (Software Version 3.7.2) |
|--------------------|-----------------------------------------------------------|
| Classification: | 21CFR892.2050 Picture archiving and communications system |
| Regulatory Class: | II |
| Product Code: | NFJ |

#### 3. PREDICATE DEVICE

Predicate Device: CALLISTO eye (Software Version 3.6) - K180858 Classification: 21CFR892.2050 Picture archiving and communications system Regulatory Class: II Product Code: NFJ

#### DEVICE DESCRIPTION 4.

CALLISTO eye software operates as an adjunct to the ZEISS's family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). Specifically, the subject device has the functionality to be connected to an OCT camera (such as in RESCAN 700 (K180229)), a phaco machine (such as in QUATERA 700 (K212241), as well as MIMPS (such as FORUM (K213527).

CALLISTO eye Software must be installed on a computer with a touchscreen; this Panel PC (ORPC) is offered as an accessory. The current model of the ORPC is the CALLISTO eye Panel PC Model II. OPRC function and configuration has been modified since the last CALLISTO eye 510(k) by upgrading electronics components to accommodate lifecycle management needs.

CALLISTO eye 3.7.2 has the same functionalities as CALLISTO eye 3.6 (K180858). These functionalities include patient data management and transmission via DICOM protocol, interfaces to ZEISS's ophthalmic microscopes with/without OCT camera (RESCAN 700) and assists with overlay function for markerless marking to support IOL alignment.

Additional functionalities unique to CALLISTO eye 3.7.2 are inclusion of changes occurring from software version 3.6 to 3.7.1 and additional support of language packages, bug fixes, cybersecurity enhancements and interoperability abilities with a phaco system (OUATERA 700).

The subject device, CALLISTO eye 3.7.2, provides connectivity to the following surgical microscopes from ZEISS:

- . OPMI LUMERA 700 with Integrated Data Injection System (IDIS)
- OPMI LUMERA T with External Data Injection System (EDIS) ●
- OPMI LUMERA I with External Data Injection System (EDIS) .
- OPMI LUMERA 700 with OCT camera (RESCAN700)
- ARTEVO 800 with 3D monitor cart (3DIS) .
- ARTEVO 800 with OCT camera (RESCAN700) .

{5}------------------------------------------------

The software can acquire photo and videos from all surgical microscope listed above and can remote control these microscopes apart from the OPMI LUMERA T and I.

All OPMI LUMERA family surgical microscopes have been covered by the predicate device CALLISTO eye 3.6 (K180858). With the subject device the range of supported surgical microscopes was extended to the ARTEVO 800 with and without RESCAN700 as principal successor of the OPMI LUMERA 700.

The intended use and indications for use of OPMI LUMERA and ARTEVO 800 are identical and the microscopes can be applied for the same surgical procedure.

CALLISTO eye allows the connection and remote control of a surgical microscope with or without OCT Camera and thus operates as an adjunct to the family of ZEISS surgical microscopes. Functionalities such as light intensity, camera parameters, start/stop recording, zoom, focus, diaphragm, start/stop OCT scanning, etc. of the surgical microscope, including the configuration of the foot control panel and handgrips, can be accessed and managed by the user in CALLISTO eye.

CALLISTO eye Software is an assistance, information system to support ophthalmic surgical procedures. It provides an interface to other devices to facilitate the:

- Display and recording of video data provided by ZEISS surgical microscopes (OPMI) .
- Display of assistance functions (graphical guidance templates) and device information (cockpits) to aid the surgeon in the implantation of intra ocular lenses; e.g., used for the alignment for toric intraocular lenses.
- . Display and recording of OCT image data provided by ZEISS RESCAN 700
- Display and exchange data with the ZEISS OUATERA 700 phacoemulsification and vitrectorny system .
- . Retrieval and storage of patient data from and to the FORUM MIMPS system
- . Configuration of ZEISS surgical microscopes, including the assignment of functions to OPMI handgrips and foot control panel

#### 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 OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eve.

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.

{6}------------------------------------------------

# SUBSTANTIAL EQUIVALENCE

#### Primary Predicate 6.1.

Table 1. Subject to Predicate Device Comparison Table – Indications for Use

| CALLISTO eye (Version 3.7.2)<br>Proposed Device | CALLISTO eye (Version 3.6)<br>Predicate (K180858) | Equivalency Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 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. | 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 |

{7}------------------------------------------------

| Item | Proposed Device (This submission) | Primary Predicate Device (K180858) | Equivalency Analysis |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Trade Name | CALLISTO eye | CALLISTO eye | Identical |
| Software version | CALLISTO eye<br>Software version 3.7.2 | CALLISTO eye<br>Software version 3.6 | N/A |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| Device Classification Name | System, Image<br>Management,<br>Ophthalmic | System, Image<br>Management,<br>Ophthalmic | Identical |
| Regulation description | Medical image<br>management and<br>processing system | Picture archiving and<br>communications system | Equivalent<br>(Change in<br>regulation<br>description by<br>FDA) |
| 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<br>Software is a software<br>device intended for<br>remote control of<br>ophthalmic surgical<br>microscopes of OPMI<br>Lumera family and<br>RESCAN 700, and<br>display images of the<br>anterior and posterior<br>segment of the eye.<br><br>CALLISTO eye<br>Software is indicated as<br>graphical guidance aid<br>to insert, align, position,<br>and register an<br>intraocular lens (IOL)<br>including toric IOLs,<br>limbal relaxing<br>incisions, and<br>capsulorhexis during<br>anterior segment<br>surgical procedures. | CALLISTO eye<br>Software is a software<br>device intended for<br>remote control of<br>ophthalmic surgical<br>microscopes of OPMI<br>Lumera family and<br>RESCAN 700, and<br>display images of the<br>anterior and posterior<br>segment of the eye.<br><br>CALLISTO eye<br>Software is indicated as<br>graphical guidance aid<br>to insert, align, position,<br>and register an<br>intraocular lens (IOL)<br>including toric IOLs,<br>limbal relaxing<br>incisions, and<br>capsulorhexis during<br>anterior segment<br>surgical procedures. | Identical |
| Applications | Ophthalmology | Ophthalmology | Identical |
| Patient Contact | No | No | Identical |

# Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics

{8}------------------------------------------------

| age | 6 | of | 12 | |
|-----|---|----|----|--|

| k) Summary | | | Page 6 of 12 |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed<br>Device (This<br>submission) | Primary Predicate<br>Device<br>(K180858) | Equivalency<br>Analysis |
| Key components | Software only | Software only | Identical |
| Accessory | Panel PC with touch<br>screen and video<br>card.<br>The Panel PC can be<br>provided with a Table<br>stand, Cart or<br>Microscope mount | Panel PC with touch<br>screen and video<br>card.<br>The Panel PC can be<br>provided with a Table<br>stand, Cart or<br>Microscope mount | Identical |
| Hardware<br>requirements | Minimum requirements<br>are no longer supported. | Minimum<br>requirements:<br>• Intel® Core i7 620M<br>2.66GHz,<br>• 8 GB memory,<br>• 500 GB hard disc,<br>• Touch panel display<br>22" / 1920 x 1080 | Identical<br>for<br>recommended<br>hardware<br>requirements.<br>Minimum<br>requirements<br>are not anymore<br>supported. |
| | Recommended<br>requirements:<br>• Intel® Core i5<br>6442EQ 1.9GHz –<br>2.7GHz (Turbo<br>mode)<br>• 16 GB memory,<br>• 1000 GB hard disc,<br>Touch panel display<br>23.6" / 1920 x 1080 | Recommended<br>requirements:<br>• Intel® Core i5<br>6442EQ 1.9GHz –<br>2.7GHz (Turbo<br>mode)<br>• 16 GB memory,<br>• 1000 GB hard disc,<br>Touch panel display<br>23.6" / 1920 x 1080 | |
| Operating system | • Microsoft Windows<br>10 Enterprise, 2016<br>LTSB 64-Bit<br>• Oracle Java 8 | • Microsoft Windows<br>10 Enterprise, 2016<br>LTSB 64-Bit<br>• Oracle Java 8 | Identical |
| Device connectivity<br>(Supported data<br>interfaces) | • Compatible ZEISS<br>Surgical operating<br>microscope<br>• RESCAN 700<br>• IOLMaster 500<br>• IOLMaster 700*)<br>• FORUM<br>• QUATERA 700 | • Surgical operating<br>microscope<br>(Carl Zeiss OPMI<br>LUMERA 700,<br>Lumera i, Lumera T)<br>• RESCAN 700<br>• IOLMaster 500<br>• IOLMaster 700*)<br>• FORUM ARCHIVE<br>& VIEWER | Equivalent<br>(Addition of<br>QUATERA 700<br>to device<br>connectivity. All<br>other data<br>interfaces remain<br>the identical) |
| Item | Proposed<br>Device (This<br>submission) | Primary Predicate<br>Device<br>(K180858) | Equivalency<br>Analysis |
| Supported video<br>cameras, video formats,<br>and display<br>connections/interfaces | Digital HD camera Video input to frame<br>grabber card HD-SDI Video Format: MPEG4 2D Video output via<br>HDMI connection to<br>IDIS, EDIS, and 3D<br>monitor card. | Digital HD camera Video input to frame<br>grabber card HD-SDI<br>and S-Video )PAL,<br>NTSC) Video Format: MPEG2 2D Video output via<br>HDMI connection to<br>IDIS and EDIS. | Equivalent<br>(Identical apart<br>from the support<br>for the video<br>format and the<br>removal of the<br>SD camera<br>support) |
| Communication<br>protocols | TCP/IP (LAN)RIMSREST TCP/IP (WLAN)REST via HTTPS DICOMREST CAN-BUS | TCP/IP (LAN)RIMSREST TCP/IP (WLAN)REST via HTTPS DICOMREST CAN-BUS | Identical<br>Note:<br>RMI – Remote<br>Method<br>Invocation (Java<br>communication<br>protocol)<br>REST -<br>Representational<br>State Transfer<br>(programming<br>paradigm for<br>distributed<br>systems) |
| Assistance Functions | | | |
| Support of graphical<br>and text overlays in<br>live video, recorded<br>videos, images, and<br>the eyepiece of the<br>microscope (DIS) | Yes | Yes | Identical |
| Eye tracking | Yes | Yes | Identical |
| Reference Axis,<br>marker-based | Yes | Yes | Identical |
| Reference Axis,<br>markerless using<br>reference images | Yes | Yes | Identical |
| Incisions | Yes | Yes | Identical |
| Capsulorhexis | Yes | Yes | Identical |
| Toric intraocular lens<br>alignment (Z-Align) | Yes | Yes | Identical |
| Limbal relaxing<br>incisions (LRI) | Yes | Yes | Identical |
| Keratoscope support<br>(K-Track) | Yes | Yes | Identical |
| Assistance Functions for OCT support | | | |
| Item | Proposed<br>Device (This<br>submission) | Primary Predicate<br>Device<br>(K180858) | Equivalency<br>Analysis |
| OCT camera<br>RESCAN 700 | | | |
| Live view of OCT<br>scans (B-Scans) | Yes | Yes | Identical |
| Supported scan type<br>1-Line | Yes | Yes | Identical |
| Supported scan type<br>2-Line (OCT cube) | Yes | Yes | Identical |
| Supported scan type<br>5-Line | Yes | Yes | Identical |
| Recording of live<br>OCT scans (OCT<br>videos) | Yes | Yes | Identical |
| OCT Image capture | Yes | Yes | Identical |
| Capture mode for<br>OCT cubes | Yes | Yes | Identical |
| Scan location marker<br>overlay to indicate<br>location, size, angle,<br>and scan type | Yes | Yes | Identical |
| Display of OCT scans<br>in the right eyepiece<br>of the surgical<br>operating microscope<br>OPMI LUMERA 700 | Yes | Yes | Identical |
| Support of single scan<br>depth | Yes | Yes | Identical |
| Support of dual scan<br>depth (2.9 and 5.8<br>mm). | Yes | Yes | Identical |
| Automatic<br>combination of scan<br>length and scan depth<br>(user configurable). | Yes | Yes | Identical |
| OCT XY-tracking | Yes | Yes | Identical |
| OCT Z tracking | Yes | Yes | Identical |
| Support of a fundus<br>viewing system | Yes<br>Non-contact type<br>(Zeiss RESIGHT)<br>Contact type<br>(e.g., contact glass, aka<br>vitrectomy contact lens) | Yes<br>Non-contact type<br>(Zeiss RESIGHT)<br>Contact type<br>(e.g., contact glass, aka<br>vitrectomy contact lens) | Identical |
| Documentation and Data Management Capabilities | | | |
| User management | Yes | Yes | Identical |
| Patient management | Yes | Yes | Identical |

{9}------------------------------------------------

# 510(k) Summary

{10}------------------------------------------------

User specific device

Yes

Identical

Yes

{11}------------------------------------------------

# 510(k) Summary

| Page 9 of 12 | |
|--------------|--|
|--------------|--|

| k) Summary | | | Page 9 of 12 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------|-------------------------|
| Item | Proposed<br>Device (This<br>submission) | Primary Predicate<br>Device<br>(K180858) | Equivalency<br>Analysis |
| profiles and settings | | | |
| Store & administer<br>patient data | Yes | Yes | Identical |
| Search & sort<br>patients/documents | Yes | Yes | Identical |
| Surgery recording | Yes | Yes | Identical |
| Image capture | Yes | Yes | Identical |
| Live video | Yes | Yes | Identical |
| Ability to zoom into<br>images | Yes | Yes | Identical |
| Ability to replay<br>surgery video files | Yes | Yes | Identical |
| Export patient and<br>treatment data | Yes | Yes | Identical |
| Import patient and<br>treatment data | Yes | Yes | Identical |
| Cockpits - Display of Devices Data | | | |
| Display of data from<br>connected devices<br>e.g., patient name, light<br>intensity, zoom, focus<br>of the surgical<br>microscope, etc. | Yes | Yes | Identical |
| Device Remote Control (Connectivity over the Local Network)<br>(OPMI LUMERA 700, ARTEVO 800, QUATERA 700) | | | |
| Receive commands<br>from devices Hand<br>Grips, Foot Control<br>Panel (FCP) buttons or<br>rockers. The function of<br>these inputs can be<br>configured in<br>CALLISTO eye<br>settings e.g., light<br>intensity, focus, zoom,<br>workflow steps<br>forward/backwards | Yes | Yes | Identical |
| Send commands to<br>devices by using the<br>touchscreen of the<br>Panel PC e.g., adjust<br>light intensity, focus,<br>zoom, etc. | Yes | Yes | Identical |

{12}------------------------------------------------

## 510(k) Summary

Page 10 of 12

| Item | Proposed<br>Device (This<br>submission) | Primary Predicate<br>Device<br>(K180858) | Equivalency<br>Analysis |
|------|-----------------------------------------|------------------------------------------|-------------------------|
|------|-----------------------------------------|------------------------------------------|-------------------------|

### QUATERA 700 Remote Control Options

Note: The interface that connects CALLISTO eye to surgical microscope OPMI LUMERA 700 is the same that connects CALLISTO eye to QUATERA 700. The remote-control functionality provided by QUATERA 700 is a subset of the functionality of a connected surgical microscope OPMI LUMERA 700 to CALLISTO eye 3.6, the primary predicate device.

| Video recording on/off | Yes | Yes | Identical |
|-------------------------------|-----|-----|-----------|
| Assistant function – previous | Yes | Yes | Identical |
| Assistant function- next | Yes | Yes | Identical |
| Display patient data | Yes | Yes | Identical |

### Remote Access (only for certified service engineers)

Note: CALLISTO eye Software, version 3.6 as well as version 3.7.2, can be services remotely. A trained representative of Carl Zeiss Meditec (CZM) can access the CALLISTO eye Software over the internet to check the configuration and/or download log files. This remote service is facilitated via the service remote tool, symmedia SP/I instant VPN. To establish a remote session, the user needs to acknowledge and confirm the session in the user interface of CALLISTO eye. As transport encryption, symmedia SP/I instant VPN uses a Secure Sockets layer protections (SSL) with Public Key RSA 2048bit and AES 256-bit symmetric encryption.

| Remote service access via internet, User management | Yes | Yes | Identical |
|-----------------------------------------------------|-----|-----|-----------|
|-----------------------------------------------------|-----|-----|-----------|

{13}------------------------------------------------

| | K231676 |
|----------------|---------------|
| 510(k) Summary | Page 11 of 12 |

It is the opinion of Carl Zeiss Meditec AG that the proposed device, CALLISTO eye Software, version 3.7.2, is substantially equivalent to CALLISTO eye Software, version 3.6 for the following reasons:

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.

. 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.

#### 7. SUMMARY OF STUDIES

# 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 Software Contained in Medical Devices (May 2005). 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 3.7.2, meets the stipulated requirements and performs as intended.

{14}--------------------------…