CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye.

CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

Device Description

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) .

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

AI/ML Overview

The provided text is a 510(k) summary for the Carl Zeiss Meditec AG's CALLISTO eye (Software Version 3.7.2). It primarily focuses on demonstrating substantial equivalence to a predicate device (CALLISTO eye, Software Version 3.6) rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic performance.

The document discusses functional equivalence and safety, but not performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. The device is described as an "assistance system" providing "non-diagnostic video documentation and image capture" and "graphical guidance aid." Therefore, the typical diagnostic performance acceptance criteria and study design (like MRMC studies) are not applicable here.

However, I can extract information related to the device's functional performance and the verification/validation activities performed, which serve as proof that the device meets its functional specifications.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a diagnostic device with performance metrics like sensitivity/specificity, the "acceptance criteria" are related to its functional specifications and safety. The "reported device performance" refers to the successful verification and validation of these functions.

Acceptance Criteria (derived)	Reported Device Performance (Summary from submission)
Functional Equivalence to Predicate Device:
- Identical Indications for Use	Supported by direct comparison tables showing identical IFUs.
- Similar Technological Characteristics	Supported by detailed comparison tables showing identical or equivalent technical characteristics (e.g., software only, accessory, operating system, communication protocols, assistance functions). Differences (e.g., supported surgical microscopes, video format) were assessed and deemed equivalent.
Safety and Effectiveness:
- Risk Management compliance	Risk analysis performed to identify potential hazards and mitigations; controls by design, protection measures, and user instructions. Adheres to ISO 14971.
- Compliance with Software Requirements	Device performance complies with specifications and requirements identified through verification and validation.
- Meets Customer Requirements	Device meets customer's requirements with respect to performance based on validation plan.
- Conformance to applicable standards (e.g., IEC, ISO, NEMA)	Conforms to ISO 14971:2019, IEC 62366-1:2015, IEC 62304:2015, NEMA PS 3.1-3.20.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable or not specified in the context of a "test set" for diagnostic performance. The document describes software verification and validation, which typically involves internal testing against specifications and requirements, often using simulated data, test cases, and potentially real (but de-identified) operational data. The document does not specify a "test set" in the sense of clinical study data with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As a non-diagnostic assistance system, there is no "ground truth" to establish for diagnostic outcomes in the context of the device's stated functions. The validation focuses on whether the software performs its intended functions correctly (e.g., displays images, provides graphical guidance correctly).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there's no diagnostic ground truth being established via expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or mentioned. The device's indications for use emphasize "graphical guidance aid" and "assistance system," not a primary diagnostic tool. The submission states, "Animal and Clinical testing was not conducted."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not directly applicable. The CALLISTO eye software is designed as an "assistance, information system to support ophthalmic surgical procedures" with "graphical guidance aid." Its function is inherently human-in-the-loop, providing information to the surgeon. Standalone performance for a predictive or diagnostic algorithm is not its purpose. The document details "software verification activities" and "validation," which confirm the software's functional correctness.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional validation of this device, the "ground truth" would be the expected correct behavior of the software according to its design specifications and user requirements. This is established through:

Design specifications: The software behaving as programmed.
User requirements: The software meeting the needs of trained clinical personnel for guidance and control.

There is no mention of external clinical ground truth like pathology or outcomes data in this submission for assessing the device's inherent performance.

8. The sample size for the training set

Not applicable. This device is described as software that provides graphical guidance and remote control, not a machine learning or AI algorithm that is "trained" on a dataset for diagnostic or predictive tasks in the conventional sense described by these questions.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI model mentioned in the submission. The "ground truth" for the software's functional correctness is simply its design specifications and user requirements, as verified and validated through software testing.

Summary

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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 PRAStaff@fda.hhs.gov

"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 AGGoeschwizer Strasse 51-52D-07745 JenaGermany
Primary Correspondent	Aditya RaoRegulatory Affairs Specialist - USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 549-9579 Phone (925) 557-4259 FaxE-mail: aditya.rao@zeiss.com (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.

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.

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 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:

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

SUBSTANTIAL EQUIVALENCE

Primary Predicate 6.1.

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

CALLISTO eye (Version 3.7.2)Proposed Device	CALLISTO eye (Version 3.6)Predicate (K180858)	Equivalency Analysis
CALLISTO eye Software is anassistance system that provides non-diagnostic video documentation andimage capture for ophthalmicsurgeries. The system allows theremote control of the surgicalmicroscope and RESCAN 700.	CALLISTO eye Software is anassistance system that providesnon-diagnostic videodocumentation and imagecapture for ophthalmic surgeries.The system allows the remotecontrol of the surgicalmicroscope and RESCAN 700.	Identical
The assistance system relays data ofconnected devices and provide thisinformation to the surgeon. Itvisualizes the anterior and posteriorsegment image data of the eye incombination with a surgicalmicroscope and RESCAN 700.	The assistance system relaysdata of connected devices andprovide this information to thesurgeon. It visualizes the anteriorand posterior segment imagedata of the eye in combinationwith a surgical microscope andRESCAN 700.	Identical
The graphical guidance tools, asdisplayed on the CALLISTO eyePanel PC or microscope eyepiece,aid the surgeon to insert, align,position, and register an artificiallens. These tools are intended foranterior segment ophthalmic surgicalprocedures, including positioningand angular alignment of toricintraocular lenses, limbal relaxingincisions, and capsulorhexis.	The graphical guidance tools, asdisplayed on the CALLISTO eyePanel PC or microscopeeyepiece, aid the surgeon toinsert, align, position, andregister an artificial lens. Thesetools are intended for anteriorsegment ophthalmic surgicalprocedures, includingpositioning and angularalignment of toric intraocularlenses, limbal relaxing incisions,and capsulorhexis.	Identical
The system utilizes surgeoninformation for positioning ofgraphical guidance tools. For	The system utilizes surgeoninformation for positioning ofgraphical guidance tools.	Identical
Rx-only / Prescription Use ONLY.	Rx-only / Prescription UseONLY.	Identical

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

Item	Proposed Device (This submission)	Primary Predicate Device (K180858)	Equivalency Analysis
Trade Name	CALLISTO eye	CALLISTO eye	Identical
Software version	CALLISTO eyeSoftware version 3.7.2	CALLISTO eyeSoftware version 3.6	N/A
Manufacturer	Carl Zeiss Meditec AG	Carl Zeiss Meditec AG	Identical
Device Classification Name	System, ImageManagement,Ophthalmic	System, ImageManagement,Ophthalmic	Identical
Regulation description	Medical imagemanagement andprocessing system	Picture archiving andcommunications system	Equivalent(Change inregulationdescription byFDA)
Regulation medicalspecialty	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 eyeSoftware is a softwaredevice intended forremote control ofophthalmic surgicalmicroscopes of OPMILumera family andRESCAN 700, anddisplay images of theanterior and posteriorsegment of the eye.CALLISTO eyeSoftware is indicated asgraphical guidance aidto insert, align, position,and register anintraocular lens (IOL)including toric IOLs,limbal relaxingincisions, andcapsulorhexis duringanterior segmentsurgical procedures.	CALLISTO eyeSoftware is a softwaredevice intended forremote control ofophthalmic surgicalmicroscopes of OPMILumera family andRESCAN 700, anddisplay images of theanterior and posteriorsegment of the eye.CALLISTO eyeSoftware is indicated asgraphical guidance aidto insert, align, position,and register anintraocular lens (IOL)including toric IOLs,limbal relaxingincisions, andcapsulorhexis duringanterior segmentsurgical 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	ProposedDevice (Thissubmission)	Primary PredicateDevice(K180858)	EquivalencyAnalysis
Key components	Software only	Software only	Identical
Accessory	Panel PC with touchscreen and videocard.The Panel PC can beprovided with a Tablestand, Cart orMicroscope mount	Panel PC with touchscreen and videocard.The Panel PC can beprovided with a Tablestand, Cart orMicroscope mount	Identical
Hardwarerequirements	Minimum requirementsare no longer supported.	Minimumrequirements:• Intel® Core i7 620M2.66GHz,• 8 GB memory,• 500 GB hard disc,• Touch panel display22" / 1920 x 1080	Identicalforrecommendedhardwarerequirements.Minimumrequirementsare not anymoresupported.
	Recommendedrequirements:• Intel® Core i56442EQ 1.9GHz –2.7GHz (Turbomode)• 16 GB memory,• 1000 GB hard disc,Touch panel display23.6" / 1920 x 1080	Recommendedrequirements:• Intel® Core i56442EQ 1.9GHz –2.7GHz (Turbomode)• 16 GB memory,• 1000 GB hard disc,Touch panel display23.6" / 1920 x 1080
Operating system	• Microsoft Windows10 Enterprise, 2016LTSB 64-Bit• Oracle Java 8	• Microsoft Windows10 Enterprise, 2016LTSB 64-Bit• Oracle Java 8	Identical
Device connectivity(Supported datainterfaces)	• Compatible ZEISSSurgical operatingmicroscope• RESCAN 700• IOLMaster 500• IOLMaster 700*)• FORUM• QUATERA 700	• Surgical operatingmicroscope(Carl Zeiss OPMILUMERA 700,Lumera i, Lumera T)• RESCAN 700• IOLMaster 500• IOLMaster 700*)• FORUM ARCHIVE& VIEWER	Equivalent(Addition ofQUATERA 700to deviceconnectivity. Allother datainterfaces remainthe identical)
Item	ProposedDevice (Thissubmission)	Primary PredicateDevice(K180858)	EquivalencyAnalysis
Supported videocameras, video formats,and displayconnections/interfaces	Digital HD camera Video input to framegrabber card HD-SDI Video Format: MPEG4 2D Video output viaHDMI connection toIDIS, EDIS, and 3Dmonitor card.	Digital HD camera Video input to framegrabber card HD-SDIand S-Video )PAL,NTSC) Video Format: MPEG2 2D Video output viaHDMI connection toIDIS and EDIS.	Equivalent(Identical apartfrom the supportfor the videoformat and theremoval of theSD camerasupport)
Communicationprotocols	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	IdenticalNote:RMI – RemoteMethodInvocation (Javacommunicationprotocol)REST -RepresentationalState Transfer(programmingparadigm fordistributedsystems)
Assistance Functions
Support of graphicaland text overlays inlive video, recordedvideos, images, andthe eyepiece of themicroscope (DIS)	Yes	Yes	Identical
Eye tracking	Yes	Yes	Identical
Reference Axis,marker-based	Yes	Yes	Identical
Reference Axis,markerless usingreference images	Yes	Yes	Identical
Incisions	Yes	Yes	Identical
Capsulorhexis	Yes	Yes	Identical
Toric intraocular lensalignment (Z-Align)	Yes	Yes	Identical
Limbal relaxingincisions (LRI)	Yes	Yes	Identical
Keratoscope support(K-Track)	Yes	Yes	Identical
Assistance Functions for OCT support
Item	ProposedDevice (Thissubmission)	Primary PredicateDevice(K180858)	EquivalencyAnalysis
OCT cameraRESCAN 700
Live view of OCTscans (B-Scans)	Yes	Yes	Identical
Supported scan type1-Line	Yes	Yes	Identical
Supported scan type2-Line (OCT cube)	Yes	Yes	Identical
Supported scan type5-Line	Yes	Yes	Identical
Recording of liveOCT scans (OCTvideos)	Yes	Yes	Identical
OCT Image capture	Yes	Yes	Identical
Capture mode forOCT cubes	Yes	Yes	Identical
Scan location markeroverlay to indicatelocation, size, angle,and scan type	Yes	Yes	Identical
Display of OCT scansin the right eyepieceof the surgicaloperating microscopeOPMI LUMERA 700	Yes	Yes	Identical
Support of single scandepth	Yes	Yes	Identical
Support of dual scandepth (2.9 and 5.8mm).	Yes	Yes	Identical
Automaticcombination of scanlength and scan depth(user configurable).	Yes	Yes	Identical
OCT XY-tracking	Yes	Yes	Identical
OCT Z tracking	Yes	Yes	Identical
Support of a fundusviewing system	YesNon-contact type(Zeiss RESIGHT)Contact type(e.g., contact glass, akavitrectomy contact lens)	YesNon-contact type(Zeiss RESIGHT)Contact type(e.g., contact glass, akavitrectomy 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	ProposedDevice (Thissubmission)	Primary PredicateDevice(K180858)	EquivalencyAnalysis
profiles and settings
Store & administerpatient data	Yes	Yes	Identical
Search & sortpatients/documents	Yes	Yes	Identical
Surgery recording	Yes	Yes	Identical
Image capture	Yes	Yes	Identical
Live video	Yes	Yes	Identical
Ability to zoom intoimages	Yes	Yes	Identical
Ability to replaysurgery video files	Yes	Yes	Identical
Export patient andtreatment data	Yes	Yes	Identical
Import patient andtreatment data	Yes	Yes	Identical
Cockpits - Display of Devices Data
Display of data fromconnected devicese.g., patient name, lightintensity, zoom, focusof the surgicalmicroscope, etc.	Yes	Yes	Identical
Device Remote Control (Connectivity over the Local Network)(OPMI LUMERA 700, ARTEVO 800, QUATERA 700)
Receive commandsfrom devices HandGrips, Foot ControlPanel (FCP) buttons orrockers. The function ofthese inputs can beconfigured inCALLISTO eyesettings e.g., lightintensity, focus, zoom,workflow stepsforward/backwards	Yes	Yes	Identical
Send commands todevices by using thetouchscreen of thePanel PC e.g., adjustlight intensity, focus,zoom, etc.	Yes	Yes	Identical

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

510(k) Summary

Page 10 of 12

Item	ProposedDevice (Thissubmission)	Primary PredicateDevice(K180858)	EquivalencyAnalysis
------	-----------------------------------------	------------------------------------------	-------------------------

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}------------------------------------------------

CALLISTO eye Software, version 3.7.2, conforms to the applicable FDA recognized and international IEC and ISO standards with regards to performance and safety:

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 3.7.2, consolidate the functions cleared under the previous premarket notifications K180858 (CALLISTO eye 3.6).

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 3.7.2, is substantially equivalent to the predicate devices, CALLISTO eye (K180858).

Regulation Number and Section

§ 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).