Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes software for remote control, image display, and graphical guidance, but does not mention any AI or ML capabilities. The performance studies focus on verification and validation against specifications, not AI/ML model performance metrics.

Therapeutic

No.
This device is software that provides remote control, displays images, and offers graphical guidance during surgical procedures; it does not directly treat or diagnose a disease or condition.

Diagnostic

No

The device is described as a software intended for remote control of ophthalmic surgical microscopes and display of images, providing graphical guidance aid to insert, align, position, and register an intraocular lens during anterior segment surgical procedures. Its functionality is primarily to assist in surgical procedures and manage data from other devices, rather than diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the software "must be installed on a computer with a touchscreen; this Panel PC (ORPC) is offered as an accessory." While the software is the core component, it requires specific hardware (the ORPC) to function as intended, making it a system that includes hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the CALLISTO eye Software is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
CALLISTO eye's Function: The CALLISTO eye Software's primary function is to control ophthalmic surgical microscopes, display images of the eye (anterior and posterior segments), and provide graphical guidance during surgical procedures. It processes live video and OCT data acquired directly from the patient's eye during surgery.
No Specimen Analysis: The software does not analyze any biological specimens taken from the patient's body. It works with images and data acquired in vivo (within the living body) during the surgical procedure.

Therefore, the CALLISTO eye Software falls under the category of a surgical guidance or imaging system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

Product codes

NFJ

Device Description

CALLISTO eye software 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 QUATERA 700 phacoemulsification and vitrectomy 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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Image and video data from ophthalmic surgical microscopes (OPMI Lumera family, ARTEVO 800), and OCT data (B-Scan images) from RESCAN 700.

Anatomical Site

Anterior and posterior segment of the eye.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained clinical personnel.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing: Risk management via risk analysis, verification of requirements and standards, and validation of clinical workflow according to ISO 14971. Software verification activities were divided into three phases: Tests accompanying development (including code inspections), Integration test phase stabilization phase, and System verification. Validation was also conducted according to the Validation Plan to ensure that the device meets customer requirements.
Animal/Clinical Performance Testing: Not conducted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180858

Reference Device(s)

K180229, K212241, K213527

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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.

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

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

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

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3

In accordance with 21 CFR 807.92 the 510(k) Summary for the CALLISTO eye is provided below.

SUBMITTER 1.

| Applicant: | Carl Zeiss Meditec AG
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Aditya Rao
Regulatory Affairs Specialist - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 549-9579 Phone (925) 557-4259 Fax
E-mail: aditya.rao@zeiss.com (preferred) |
| Date Prepared: | 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)
Proposed Device | CALLISTO eye (Version 3.6)
Predicate (K180858) | Equivalency Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| CALLISTO eye Software is an
assistance system that provides non-
diagnostic video documentation and
image capture for ophthalmic
surgeries. The system allows the
remote control of the surgical
microscope and RESCAN 700. | CALLISTO eye Software is an
assistance system that provides
non-diagnostic video
documentation and image
capture for ophthalmic surgeries.
The system allows the remote
control of the surgical
microscope and RESCAN 700. | Identical |
| The assistance system relays data of
connected devices and provide this
information to the surgeon. It
visualizes the anterior and posterior
segment image data of the eye in
combination with a surgical
microscope and RESCAN 700. | The assistance system relays
data of connected devices and
provide this information to the
surgeon. It visualizes the anterior
and posterior segment image
data of the eye in combination
with a surgical microscope and
RESCAN 700. | Identical |
| The graphical guidance tools, as
displayed on the CALLISTO eye
Panel PC or microscope eyepiece,
aid the surgeon to insert, align,
position, and register an artificial
lens. These tools are intended for
anterior segment ophthalmic surgical
procedures, including positioning
and angular alignment of toric
intraocular lenses, limbal relaxing
incisions, and capsulorhexis. | The graphical guidance tools, as
displayed on the CALLISTO eye
Panel PC or microscope
eyepiece, aid the surgeon to
insert, align, position, and
register an artificial lens. These
tools are intended for anterior
segment ophthalmic surgical
procedures, including
positioning and angular
alignment of toric intraocular
lenses, limbal relaxing incisions,
and capsulorhexis. | Identical |
| The system utilizes surgeon
information for positioning of
graphical guidance tools. For | The system utilizes surgeon
information for positioning of
graphical guidance tools. | Identical |
| Rx-only / Prescription Use ONLY. | Rx-only / Prescription Use
ONLY. | Identical |

7

Item	Proposed Device (This submission)	Primary Predicate Device (K180858)	Equivalency Analysis
Trade Name	CALLISTO eye	CALLISTO eye	Identical
Software version	CALLISTO eye
Software version 3.7.2	CALLISTO eye
Software version 3.6	N/A
Manufacturer	Carl Zeiss Meditec AG	Carl Zeiss Meditec AG	Identical
Device Classification Name	System, Image
Management,
Ophthalmic	System, Image
Management,
Ophthalmic	Identical
Regulation description	Medical image
management and
processing system	Picture archiving and
communications system	Equivalent
(Change in
regulation
description by
FDA)
Regulation medical
specialty	Radiology	Radiology	Identical
Review panel	Ophthalmic	Ophthalmic	Identical
Product code,	NFJ	NFJ	Identical
Regulation number	892.2050	892.2050	Identical
Device class	II	II	Identical
Indications for use	CALLISTO eye
Software is a software
device intended for
remote control of
ophthalmic surgical
microscopes 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. | 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.

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

8

age	6	of	12

k) Summary			Page 6 of 12
Item	Proposed
Device (This
submission)	Primary Predicate
Device
(K180858)	Equivalency
Analysis
Key components	Software only	Software only	Identical
Accessory	Panel PC with touch
screen and video
card.
The Panel PC can be
provided with a Table
stand, Cart or
Microscope mount	Panel PC with touch
screen and video
card.
The Panel PC can be
provided with a Table
stand, Cart or
Microscope mount	Identical
Hardware
requirements	Minimum requirements
are no longer supported.	Minimum
requirements:
• Intel® Core i7 620M
2.66GHz,
• 8 GB memory,
• 500 GB hard disc,
• Touch panel display
22" / 1920 x 1080	Identical
for
recommended
hardware
requirements.
Minimum
requirements
are not anymore
supported.
	Recommended
requirements:
• Intel® Core i5
6442EQ 1.9GHz –
2.7GHz (Turbo
mode)
• 16 GB memory,
• 1000 GB hard disc,
Touch panel display
23.6" / 1920 x 1080	Recommended
requirements:
• Intel® Core i5
6442EQ 1.9GHz –
2.7GHz (Turbo
mode)
• 16 GB memory,
• 1000 GB hard disc,
Touch panel display
23.6" / 1920 x 1080
Operating system	• Microsoft Windows
10 Enterprise, 2016
LTSB 64-Bit
• Oracle Java 8	• Microsoft Windows
10 Enterprise, 2016
LTSB 64-Bit
• Oracle Java 8	Identical
Device connectivity
(Supported data
interfaces)	• Compatible ZEISS
Surgical operating
microscope
• RESCAN 700
• IOLMaster 500
• IOLMaster 700*)
• FORUM
• QUATERA 700	• Surgical operating
microscope
(Carl Zeiss OPMI
LUMERA 700,
Lumera i, Lumera T)
• RESCAN 700
• IOLMaster 500
• IOLMaster 700*)
• FORUM ARCHIVE
& VIEWER	Equivalent
(Addition of
QUATERA 700
to device
connectivity. All
other data
interfaces remain
the identical)
Item	Proposed
Device (This
submission)	Primary Predicate
Device
(K180858)	Equivalency
Analysis
Supported video
cameras, video formats,
and display
connections/interfaces	Digital HD camera Video input to frame
grabber card HD-SDI Video Format: MPEG4 2D Video output via
HDMI connection to
IDIS, EDIS, and 3D
monitor card.	Digital HD camera Video input to frame
grabber card HD-SDI
and S-Video )PAL,
NTSC) Video Format: MPEG2 2D Video output via
HDMI connection to
IDIS and EDIS.	Equivalent
(Identical apart
from the support
for the video
format and the
removal of the
SD camera
support)
Communication
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
Note:
RMI – Remote
Method
Invocation (Java
communication
protocol)
REST -
Representational
State Transfer
(programming
paradigm for
distributed
systems)
Assistance Functions
Support of graphical
and text overlays in
live video, recorded
videos, images, and
the eyepiece of the
microscope (DIS)	Yes	Yes	Identical
Eye tracking	Yes	Yes	Identical
Reference Axis,
marker-based	Yes	Yes	Identical
Reference Axis,
markerless using
reference images	Yes	Yes	Identical
Incisions	Yes	Yes	Identical
Capsulorhexis	Yes	Yes	Identical
Toric intraocular lens
alignment (Z-Align)	Yes	Yes	Identical
Limbal relaxing
incisions (LRI)	Yes	Yes	Identical
Keratoscope support
(K-Track)	Yes	Yes	Identical
Assistance Functions for OCT support
Item	Proposed
Device (This
submission)	Primary Predicate
Device
(K180858)	Equivalency
Analysis
OCT camera
RESCAN 700
Live view of OCT
scans (B-Scans)	Yes	Yes	Identical
Supported scan type
1-Line	Yes	Yes	Identical
Supported scan type
2-Line (OCT cube)	Yes	Yes	Identical
Supported scan type
5-Line	Yes	Yes	Identical
Recording of live
OCT scans (OCT
videos)	Yes	Yes	Identical
OCT Image capture	Yes	Yes	Identical
Capture mode for
OCT cubes	Yes	Yes	Identical
Scan location marker
overlay to indicate
location, size, angle,
and scan type	Yes	Yes	Identical
Display of OCT scans
in the right eyepiece
of the surgical
operating microscope
OPMI LUMERA 700	Yes	Yes	Identical
Support of single scan
depth	Yes	Yes	Identical
Support of dual scan
depth (2.9 and 5.8
mm).	Yes	Yes	Identical
Automatic
combination of scan
length and scan depth
(user configurable).	Yes	Yes	Identical
OCT XY-tracking	Yes	Yes	Identical
OCT Z tracking	Yes	Yes	Identical
Support of a fundus
viewing system	Yes
Non-contact type
(Zeiss RESIGHT)
Contact type
(e.g., contact glass, aka
vitrectomy contact lens)	Yes
Non-contact type
(Zeiss RESIGHT)
Contact type
(e.g., contact glass, aka
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
Device (This
submission)	Primary Predicate
Device
(K180858)	Equivalency
Analysis
profiles and settings
Store & administer
patient data	Yes	Yes	Identical
Search & sort
patients/documents	Yes	Yes	Identical
Surgery recording	Yes	Yes	Identical
Image capture	Yes	Yes	Identical
Live video	Yes	Yes	Identical
Ability to zoom into
images	Yes	Yes	Identical
Ability to replay
surgery video files	Yes	Yes	Identical
Export patient and
treatment data	Yes	Yes	Identical
Import patient and
treatment data	Yes	Yes	Identical
Cockpits - Display of Devices Data
Display of data from
connected devices
e.g., patient name, light
intensity, zoom, focus
of the surgical
microscope, etc.	Yes	Yes	Identical
Device Remote Control (Connectivity over the Local Network)
(OPMI LUMERA 700, ARTEVO 800, QUATERA 700)
Receive commands
from devices Hand
Grips, Foot Control
Panel (FCP) buttons or
rockers. The function of
these inputs can be
configured in
CALLISTO eye
settings e.g., light
intensity, focus, zoom,
workflow steps
forward/backwards	Yes	Yes	Identical
Send commands to
devices by using the
touchscreen of the
Panel PC e.g., adjust
light intensity, focus,
zoom, etc.	Yes	Yes	Identical

12

510(k) Summary

Page 10 of 12

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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
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	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.

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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).