(92 days)
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 and RESCAN 700, and display images of the anterior and posterior segment of the eye.
CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.
CALLISTO eye software version 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes.
CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks.
Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).
The Carl Zeiss Meditec AG's CALLISTO eye Software, version 5.0, did not conduct a clinical study to prove that the device met the acceptance criteria and was substantially equivalent to the predicate device, CALLISTO eye Software, version 3.7.2.
The submission states: "Animal and Clinical testing was not conducted."
Instead, the submission relied on non-clinical performance testing and risk management to demonstrate substantial equivalence.
Here's the information about the acceptance criteria and the study that was not performed in the traditional sense:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" for clinical performance as no clinical testing was performed. However, the basis for equivalence is the identical indications for use and equivalent technological characteristics and risk profile compared to the predicate device. The performance is deemed to be equivalent to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Identical Indications for Use: CALLISTO eye Software 5.0 will perform precisely the same functions as the predicate in aiding ophthalmic surgical procedures for IOLs, limbal relaxing incisions, and capsulorhexis. | The indications for use are identical to the predicate device, K231676. |
| Equivalent Technological Characteristics: The device will operate with similar functional performance and safety as the predicate device, despite software version update and some hardware connectivity changes. | Software verification and validation activities were successfully completed. The device complies with specifications and requirements. Risk management (ISO 14971) and cybersecurity assessment were performed. |
| Equivalent Risk Profile: The changes to the device will not introduce new safety concerns or modify existing risks such that the device is no longer substantially equivalent. | Risk analysis identified potential hazards and mitigations, controlled by design means, protection measures, and user instructions. Cybersecurity assessment based on VAST Threat Modeling was conducted. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test set was used for patient data. The "test set" for non-clinical testing refers to software test cases and system verification, not patient data.
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 no clinical ground truth was established by experts for a test set. Non-clinical software verification relies on defined specifications and requirements as the "ground truth" for expected software behavior.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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
Not applicable. No MRMC comparative effectiveness study was done as no clinical testing was performed. The device is a "graphical guidance aid" and not an AI that independently diagnoses or drives clinical decisions, nor does it quantify human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for clinical performance. The device is intended as an assistance system with human-in-the-loop (the surgeon). The non-clinical testing focused on software functionality and integration, not standalone clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (software verification and validation), the "ground truth" was established by the pre-defined specifications, requirements, and design documents of the software. Compliance with these internal standards and relevant international standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20) was the basis for verifying performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a training set in the conventional sense. It is a software update to an existing medical image management and processing system.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 21, 2023
Carl Zeiss Meditec AG Aditya Rao Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568
Re: K232944
Trade/Device Name: CALLISTO eye Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: September 15, 2023 Received: September 20, 2023
Dear Aditya Rao:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Bennett N. Walker -S. The date of the signature is 2023.12.21, and the time is 10:10:54 -05'00'.
for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
CALLISTO eye
Indications for Use (Describe)
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 and RESCAN 700, and display images of the anterior and posterior segment of the eye.
CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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In accordance with 21 CFR 807.92 the 510(k) Summary for the CALLISTO eye is provided below.
SUBMITTER 1.
| Applicant: | Carl Zeiss Meditec 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: | December 20, 2023 |
| 510((k) Number | K232944 |
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DEVICE 2.
| Device Trade Name: | CALLISTO eye (Software Version 5.0) – K232944 |
|---|---|
| Classification: | 21CFR892.2050 Medical image management and processing system |
| Regulatory Class: | II |
| Product Code: | NFJ |
3. PREDICATE DEVICE
Predicate Device: CALLISTO eye (Software Version 3.7.2) - K231676 21CFR892.2050 Classification: Medical image management and processing system Regulatory Class: II Product Code: NFJ
DEVICE DESCRIPTION 4.
CALLISTO eye software version 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes.
CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks.
Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The
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DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).
5. INTENDED USE/INDICATIONS FOR USE
The intended use statement for the subject device is as follows:
CALLISTO eye is intended for use by trained clinical personnel. For Prescription Use ONLY.
The Indications for Use (IFU) statement for the subject device is as follows:
CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 and RESCAN 700, and display images of the anterior and posterior segment of the eye. CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.
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SUBSTANTIAL EQUIVALENCE
Primary Predicate 6.1.
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| CALLISTO eye (Version 5.0) | CALLISTO eye (Version 3.7.2) | Equivalency Analysis |
|---|---|---|
| Proposed DeviceCALLISTO 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. | Predicate (K231676)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 |
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| Feature | CALLISTO eye SoftwareVersion 5.0(Proposed Device) | CALLISTO eye SoftwareVersion 3.7.2(K231676) | EquivalencyAnalysis | |
|---|---|---|---|---|
| Trade Name | CALLISTO eye | CALLISTO eye | Identical | |
| Software version | CALLISTO eye Software version 5.0 | CALLISTO eyeSoftware version 3.7.2 | N/A | |
| Manufacturer | Carl ZEISS Meditec AG | Carl ZEISS Meditec AG | Identical | |
| Device ClassificationName | System, Image Management,Ophthalmic | System, Image Management,Ophthalmic | Identical | |
| Regulation description | Medical image management andprocessing system | Medical image managementand processing system | Identical | |
| 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 eye Software is asoftware device intended forremote control of ophthalmicsurgical microscopes ARTEVO750/850 and RESCAN 700, anddisplay images of the anterior andposterior segment of the eye.CALLISTO eye Software isindicated as graphical guidance aidto insert, align, position, andregister an intraocular lens (IOL)including toric IOLs, limbalrelaxing incisions, andcapsulorhexis during anteriorsegment surgical procedures. | CALLISTO eye Software is asoftware device intended forremote control of ophthalmicsurgical microscopes of OPMILumera family and RESCAN700, and display images of theanterior and posterior segmentof the eye.CALLISTO eye Software isindicated as graphical guidanceaid to insert, align, position, andregister an intraocular lens(IOL) including toric IOLs,limbal relaxing incisions, andcapsulorhexis during anteriorsegment surgical procedures. | IdenticalARTEVO 750/850 are thesuccessor models ofOPMI Lumera 700 andARTEVO 800respectively which werereferred as OPMI Lumerafamily. | |
| Scope of application | Ophthalmology | Ophthalmology | Identical | |
| Patient Contact | No | No | Identical | |
| Key components | Software only | Software only | Identical | |
| Communication protocols | • TCP/IP• DICOM | • TCP/IP• DICOM• CAN-BUS for EDIS | IdenticalCAN-BUS interfacehas been removedbecause all ARTEVOmicroscopes do notsupport the EDISmodule. | |
| 510(k) Summary | Page 6 of 11 | |||
| Supported displayinterface and displays | • HDMI• Panel PC• IDIS (WITH VERSION5.0 RELABELED ASADVISION)• ARTEVO 3D Display (in 2Donly) | • HDMI• Panel PC• IDIS (WITH VERSION5.0 RELABELED ASADVISION)• ARTEVO 3D Display(in 2D only)• EDIS | EquivalentAll display types areconnected via a standardHDMI interface. | |
| Supported video inputand formats | • HD-SDI• MPEG 4 | • HD-SDI• MPEG 4 | Identical | |
| Assistance Functions | ||||
| Support of Clinicalworkflows sequence(non-mandatory sequenceof the assistantfunctions) | Live mode => Reference =>Incision => Rhexis => Livemode => Z Align => Live mode=> LRI | Full screen mode =>Reference => Incision =>Rhexis => Full screen mode=> Z Align => Full screenmode => | EquivalentLive mode in version5.0 is the same as thefull screen modewithout overlays inversion 3.7.2.However, the fullscreen mode has to beactivated by thesurgeon, whereas theLive mode steps canbe preconfigured inthe workflow by theuser. | |
| Representation of theassistance tools guidancetemplates | 2D, line graphics | 2D, line graphics | Identical | |
| Support of graphical andtext overlays in livevideo, recorded videos,images, and the eyepieceof the microscope (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 | |
| 510(k) Summary | Page 7 of 11 | |||
| Capsulorhexis | Yes | Yes | Identical | |
| Toric intraocular lensalignment (Z- Align) | Yes | Yes | Identical | |
| Limbal relaxing incisions(LRI) | Yes | Yes | Identical | |
| Surgical Microscopes +Keratoscope support (K-Track) | ARTEVO 750/850 RESCAN 700 (K180229) QUATERA 700 (K230858) | OPMI LUMERA 700 RESCAN 700 (K180229) QUATERA 700 (K230858) | Equivalent.(Connectivity to OPMILUMERA 700 / ARTEVO800 is no longer supportedin CALLISTO eye 5.0)Additional support addedfor RESCAN 700 andQUATERA 700 for thesubject device. | |
| Assistance Functions for OCT support | ||||
| Remote control of OCTcamera RESCAN 700 | Yes | Yes | Identical | |
| Live view of OCT scans(B-Scans) | Yes | Yes | Identical | |
| OCT scan types: 1-Line(1 B-Scan) | Yes | Yes | Identical | |
| OCT scan types: 2-Line (2perpendicular B-Scans of OCT cube) | Yes | Yes | Identical | |
| OCT scan types:5-Line (5 parallel B-Scans) | Yes | Yes | Identical | |
| Recording of live OCTscans (OCTvideos) | Yes | Yes | Identical | |
| OCT Image capture | Yes | Yes | Identical | |
| Capture mode for OCTcubes | Yes | Yes | Identical | |
| Scan location markeroverlay to indicatelocation, size, angle,and scan type | Yes | Yes | Identical | |
| 510(k) Summary | Page 8 of 11 | |||
| Display of OCT scans inthe right eyepiece of thesurgical microscope orthe 3D monitor as2D image. | Yes | Yes | Identical | |
| Support of dual scan depth(2.9 and 5.8mm). | Yes | Yes | Identical | |
| Automatic combinationof scan length and scandepth (userconfigurable). | Yes scan length of <9mm scan uses a scan depth of 2.9 mm scan length of >9mm scan uses a scan depth of 5.8 mm | Yes scan length of <9mm scan uses a scan depth of 2.9 mm scan length of >9mm scan uses a scan depth of 5.8 mm | Identical | |
| OCT XY-tracking | Yes | Yes | Identical | |
| OCT Z tracking | Yes | Yes | Identical | |
| Support of a fundusviewing system | YesNon-contact type (ZEISSRESIGHT)Contact type | YesNon-contact type (ZEISSRESIGHT)Contact type | Identical | |
| OCT remote control viafoot panel | Yes | Yes | Equivalent(Identical function butdifferent settings toprovide more flexibilityto the user) | |
| Access to Microscopelive setting with an OCT | Yes | Yes | Equivalent(Identical function butwith a more streamlinedUI for usability) | |
| Non-Medical Device Features (Other Functions) | ||||
| User management | Yes | Yes | Identical | |
| Patient management | Yes | Yes | Identical | |
| User specific deviceprofiles and settings | Yes | Yes | Identical | |
| 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 | |
| 510(k) Summary | Page 9 of 11 | |||
| Ability to zoom intoimages | Yes | Yes | Identical | |
| Ability to replay surgeryvideo files | Yes | Yes | Identical | |
| Export patient andtreatment data | Yes | Yes | Identical | |
| Import patient andtreatment data | Yes | Yes | Identical | |
| Display of data fromconnected devices | Yes | Yes | Equivalent(Identical data butdifferent presentationon the display) | |
| Receive commands | Yes | Yes | Equivalent(Updated interfaces) | |
| Send commands | Yes | Yes | Equivalent(Updated interfaces) | |
| Remote service accessvia internet for servicespecialists | Not supported | Yes | N/AFunctionality notprovided. | |
| Post surgery documentmanagement | Yes | Yes | Equivalent(Identical function butwith a more streamlinedUI) |
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
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510(k) Summarv
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It is the opinion of Carl Zeiss Meditec AG that the proposed device, CALLISTO eye Software, version 5.0, is substantially equivalent to CALLISTO eye Software, version 3.7.2 for the following reasons:
o The indications for use are identical to the indications for use of the predicate device; and therefore, are deemed to be identical in their relationship to safety and effectiveness.
- o The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
- . Testing methods are equivalent to those of the predicate; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Therefore, the subject device meets the requirements for substantial equivalence.
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SUMMARY OF STUDIES 7. Non-Clinical Performance Testing
Risk Management
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means, protection measures and user instructions. To confirm that the measures are effective, and that the product meets its intended uses, verification of requirements and standards was performed as well as validation of the clinical workflow according to ISO 14971. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.
Performance Data & Summary of Verification and Validation Activity (21 CFR $807.92(B))
Verification and Validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye Software. The subject device was tested according to the FDA Guidance for the Content of Premarket Submissions for Device Software Functions (June 2023). A portion of software verification may be considered "bench testing." Each function and/or feature was tested by means of the appropriate test case or test specification. The system verification test report provides the test cases, expected results for each test case and the actual results obtained. Software verification activities completed were divided into three phases:
- . Tests accompanying development (including code inspections)
- . Integration test phase – stabilization phase
- . System verification
Validation was also conducted for CALLISTO eye according to the Validation Plan to ensure that the device meets the customer's requirements with respect to performance. The objectives defined in the validation plan were achieved according to the validation results.
Verification and validation activities were successfully completed and prove that CALLISTO eye Software, version 5.0, meets the stipulated requirements and performs as intended.
Cybersecuritv
CALLISTO eye Software version 5.0 is considered a Cyber device per 524B(c) of the Food, Drug, and Cosmetic Act. ZEISS has followed all recommendations in the FDA guidance document " Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov) (September 27, 2023).
ZEISS' methodology to address cybersecurity risks and vulnerabilities was outlined including all assets, threats, vulnerabilities and controls within a Cybersecurity Risk Assessment. ZEISS performed a Cybersecurity Assessment based on VAST Threat Modeling as described in IEC 81001-5-1 under recommendation C10. VAST Threat Modeling was utilized due to its practical nature/approach and is the same threat modeling approach used in the predicate device (K231676).
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CALLISTO eye Software, version 5.0, conforms to the applicable FDA recognized and international IEC and ISO standards with regards to performance and safety:
| FDA Recognized Standards | |
|---|---|
| Identification | Description |
| ISO 14971:2019 | Medical Devices – Application of Risk Management to Medical Devices |
| IEC 62366-1:2015 | Medical devices – Application of usability engineering to medical devices |
| IEC 62304:2015 | Medical device software - Software life cycle processes |
| NEMA PS 3.1-3.20 | Digital Imaging and Communications in Medicine (DICOM) |
| Table: FDA Recognized Standards |
Animal/Clinical Performance Testing
Animal and Clinical testing was not conducted.
8. CONCLUSION
The modifications to the CALLISTO eye Software, version 5.0, consolidate the functions cleared under the previous premarket notifications K231676 (CALLISTO eye 3.7.2).
The modifications to the subject device do not raise new issues of safety or effectiveness. Therefore, ZEISS believes that the subject device, CALLISTO eye Software, version 5.0, is substantially equivalent to the predicate devices, CALLISTO eye (K231676).
§ 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).