The CONVIVO In Vivo Pathology Suite is a system that contains a surgical endo-microscope and a cloud software module. The Suite allows for real-time, remote collaboration between various clinical teams (i.e., neurosurgical and pathology). The device is not intended for diagnostic purposes or to replace standard practices for tumor margin analysis and frozen sections procedures as part of intra-operative consultation.

CONVIVO Surgical Workplace is a surgical endo-microscope that acquires data and creates in-vivo images and image sequences of tissue microstructure. CONVIVO's fiber optic scanner probe is placed in direct contact with tissue during cranial procedures to create in-vivo confocal laser scanning images of the internal microstructure of tissues.

CONVIVO Pathology Workplace (cloud software module) can categorize, archive, and store images created by the acquisition device (such as CONVIVO Surgical Workplace).

Device Description

The CONVIVO Surgical Workplace is a Confocal Laser Endomicroscopy (CEM) system intended to create in vivo confocal laser scanning images of the microvasculature and microstructures of the tissue. The system can be applied during surgical procedures and is to be used in direct contact with the tissue. The system is comprised of a confocal processor, handheld scanner probe, computer, touchscreen monitor, cart, and foot control panel.

Additionally, CONVIVO Surgical Workplace has been configured as a part of a larger CONVIVO In Vivo Pathology Suite which contains the previously cleared system and now includes a cloud-based medical image management and processing system software module (Pathology Workplace) that allows for real-time intraoperative collaboration between surgical teams and pathologists.

AI/ML Overview

The provided FDA 510(k) summary for the CONVIVO In Vivo Pathology Suite focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

The document primarily describes a technical and functional comparison between the subject device and its predicate (CONVIVO, K181116) and a reference device (AI Metrics, K202229), along with verification and validation testing for software and hardware changes.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in terms of numerical performance metrics linked to specific acceptance criteria for diagnostic accuracy or clinical utility. The submission focuses on demonstrating equivalence in intended use and technical characteristics.

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

This information is not available in the provided text. No details are given about a test set or data provenance for a clinical performance study.

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)

This information is not available in the provided text. Ground truth establishment for a test set is not described.

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

This information is not available in the provided text. Adjudication methods are not discussed.

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

There is no indication that an MRMC comparative effectiveness study was done. The device's cloud software module (Pathology Workplace) is described as allowing "real-time, remote collaboration between various clinical teams (i.e., neurosurgical and pathology)," but this is a functionality description, not a claim of AI assistance or improved reader performance that would necessitate an MRMC study.

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

The "CONVIVO Pathology Workplace (cloud software module)" can categorize, archive, and store images. However, the device "is not intended for diagnostic purposes or to replace standard practices for tumor margin analysis and frozen sections procedures as part of intra-operative consultation." Furthermore, "The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. The software is a complement to these standard procedures." This strongly suggests the device is not a standalone diagnostic algorithm requiring standalone performance evaluation. Its role is collaborative and supportive, not AI-driven interpretation.

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

This information is not available in the provided text, as no clinical performance study with defined ground truth is described.

8. The sample size for the training set

This information is not available in the provided text. Since no AI/algorithm for diagnostic purposes is described, a "training set" in the context of machine learning is not mentioned.

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

This information is not available in the provided text.

Summary of available study information:

The document states:

Study Title: "Summarv of the Studies"
Purpose: To ensure that all requirements for proposed changes have been met for the CONVIVO In Vivo Pathology Suite.
Studies Performed:
- Updated Shelf-Life testing for an extension of shelf-life for a system component.
- Updated EMC (Electromagnetic Compatibility) and Electrical Safety Testing for hardware life-cycle changes.
- Updated System and Software Testing for software and interoperability changes.
Methodology: All testing followed internally approved procedures and processes, which are in compliance with referenced standards and FDA guidance documents.
Conclusion: The subject device was deemed substantially equivalent to the predicate and reference devices in terms of safety and effectiveness based on intended use, technological characteristics, and testing methods.

In essence, the "study" described is a series of verification and validation tests for engineering and software changes to demonstrate equivalence, not a clinical performance study with diagnostic accuracy or reader performance as endpoints.

Summary

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December 29, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

Carl Zeiss Meditec Inc. Maria Golovina Head of Regulatory Affairs - USA 5300 Central Parkway Dublin, California 94568

Re: K211156

Trade/Device Name: CONVIVO In Vivo Pathology Suite Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN, LLZ Dated: November 23, 2021 Received: November 24, 2021

Dear Maria Golovina:

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

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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 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 (OS) 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 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).

Sincerely,

Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K21156

Device Name CONVIVO In Vivo Pathology Suite

Indications for Use (Describe)

CONVIVO Pathology Workplace (cloud software module) can categorize, archive, and store images created by the acquisition device (such as CONVIVO Surgical Workplace).

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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510(k) Summary

CONVIVO In Vivo Pathology Suite

In accordance with 21 CFR 807.92, the following summary of information is provided in the 510(k) submission.

Applicant	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany
Primary Contact	Maria GolovinaHead of Regulatory Affairs - USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 216-1078 Phone (925) 557-4259 FaxE-mail: maria.golovina@zeiss.com (preferred)
Date Prepared	Dec 17, 2021

2. Identification of the Product

Trade Name	CONVIVO In Vivo Pathology Suite
Classification/Common Name	Neurological Endoscope; 21 CFR 882.1480
Device Class	II
Product Code	GWG; OWN; LLZ

3. Predicate Device to which Equivalence is Claimed

Primary Predicate:

Device Name	CONVIVO
Manufacturer	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52 D-07745 Jena, Germany
510(k) Number	K181116
Product Code	GWG; OWN
Classification	Neurological Endoscope

Reference Device:

Device Name	AI Metrics
Manufacturer	AI Metrics LLC432 Renaissance Dr. Hoover, AL 35226
510(k) Number	K202229
Product Code	LLZ
Classification	Picture Archiving and Communications System per 21CFR892.2050

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4. Summary of Device Description

Sodium fluorescein can be used as contrast agent with CONVIVO without changes to the formulation, mode of action, approved dose, or route of administration; it is systemically administered, and its delivery is independent of CONVIVO. The application of sodium fluorescein in cerebral imaging has been discussed in detail in K 181116. The Suite will be used with the fluorescein agent cleared under K 181116. The mechanism of action, dosing, and method of application of sodium fluorescein to observing tissue microstructure remains the same as K181116.

5. Indications for Use

CONVIVO Pathology Workplace (cloud software module) can categorize, archive, and store images created by the acquisition device (such as CONVIVO Surgical Workplace).

6. Substantial Equivalence Comparison to the Predicate Device

Attribute	Subject Device	Predicate Device(K181116)	EquivalencyAnalysis
Device name	CONVIVO In Vivo PathologySuite	CONVIVO	Updated
Manufacturer	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany	Identical
510(k)	K211156	K181116	Identical
			K211156
Attribute	Subject Device	Predicate Device(K181116)	EquivalencyAnalysis
Classification ProductCode	GWG; OWN; LLZ	GWG; OWN	Updated
Regulation #	21 CFR 882.1480(Neurological Endoscope)	21CFR882.1480 (Neurological Endoscope)	Identical
Classification Adv.Committee	Radiology	Radiology	Identical
Application	Angiography	Angiography	Identical
Review AdvisoryCommittee	Neurology	Neurology	Identical
Combination Device	Yes	Yes	Identical
Indications for use	The CONVIVO In Vivo Pathology Suite is a system that contains a surgical endo-microscope and a cloud software module. The Suite allows for real-time, remote collaboration between various clinical teams (i.e., neurosurgical and pathology). The device is not intended for diagnostic purposes or to replace standard practices for tumor margin analysis and frozen sections procedures as part of intra-operative consultation.CONVIVO Surgical Workplace is a surgical endo-microscope that acquires data and creates in-vivo images and image sequences of tissue microstructure. CONVIVO's fiber optic scanner probe is placed in direct contact with tissue during cranial procedures to create in-vivo confocal laser scanning images of the internal microstructure of tissues.CONVIVO Pathology Workplace (cloud software module) can categorize, archive, and store images created by the acquisition device (such as CONVIVO	The ZEISS CONVIVO is a surgical endomicroscope intended for viewing intra-operative blood flow in the cerebral vascular area, including microvasculature and capillaries.The CONVIVO's fiber optic scanner probe is placed in direct contact with tissue during cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, to create in-vivo confocal laser scanning images of the internal microstructure of tissues.	Updated
			K211156
Attribute	Subject Device	Predicate Device (K181116)	Equivalency Analysis
	Surgical Workplace).
Attribute	Subject Device	Predicate Device(K181116)	EquivalencyAnalysis
Patient Population	Patients undergoingneurological procedures.	Patients undergoingneurological procedures.	Identical
Device Description	Standaloneconfocal endomicroscope forintraoperative imaging withhigh magnification.Live transfer and storage ofimages to a cloud Medicalimage management andprocessing system (PathologyWorkplace) via central server.	Standaloneconfocal endomicroscope forintraoperative imaging withhigh magnification.	Updated
Basic System Function	View, create and replayfluorescent images ofmicrovasculature/capillaries inthe cerebral area.	View, create and replayfluorescent images ofmicrovasculature/capillaries inthe cerebral area.	Identical
Imaging System	Confocal laser scanningsystem	Confocal laser scanningsystem	Identical
Optical Visualization	Fiber scannerPhoto detector	Fiber scannerPhoto detector	Identical
Display	Monitor	Monitor	Identical
Fluorescent Agent	Fluorescence imaging systemused with: Sodium FluoresceinAK-FLUOR® producedby Akorn, Inc.	Fluorescence imaging systemused with: Sodium FluoresceinAK-FLUOR® producedby Akorn, Inc.	Identical
Activation of thefluorescence imaging	The press of a single button ofthe CONVIVO SurgicalWorkplace activates imaging.	The press of a single button ofthe CONVIVO activatesimaging.	Identical
Invasivity	Invasive probe used withSterile Sheath as a sterilitybarrier.	Invasive probe used withSterile Sheath as a sterilitybarrier.	Identical
Result	Fluorescent image with veryhigh magnification of thedistribution of the sodiumfluorescein dye in the imagedtissue during theoperation.	Fluorescent image with veryhigh magnification of thedistribution of the sodiumfluorescein dye in the imagedtissue during theoperation.	Identical

Table 1. Subject to Predicate Device Comparison Table

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Attribute	Subject Device	Predicate Device(K181116)	EquivalencyAnalysis
Visualization ofReal-Time images	Yes	Yes	Identical
Fluorescence Excitation	488 nm	488 nm	Identical
K211156
Attribute	Subject Device	Predicate Device(K181116)	EquivalencyAnalysis
Observation	Primary filter: Green bandpass filter (515 – 577 nm)Optional filters:Green longpass filter (> 520 nm)Red longpass filter (> 580 nm)Grey filter allows all wavelengths to pass, however, with significantly reduced intensity.	Primary filter: Green bandpass filter (515 – 577 nm)Optional filters:Green longpass filter (> 520 nm)Red longpass filter (> 580 nm)Grey filter allows all wavelengths to pass, however, with significantly reduced intensity.	Identical
Physical Method ofIllumination	Laser source (continuous blue light of 488 nm wavelength);Fluorescence	Laser source (continuous blue light of 488 nm wavelength);Fluorescence	Identical
Physical Method ofImaging	Confocal Laser ScanningMicroscopy	Confocal Laser ScanningMicroscopy	Identical
Distance of Imaging Headto Patient	Direct contact to tissue	Direct contact to tissue	Identical
Auto detectionof fluorescence influx	Yes	Yes	Identical
Controlled System	Embedded CPU	Embedded CPU	Identical
Storage	HDD, SSD (ext. thumb drive) Medical image management and processing system (Pathology Workplace)	HDD, SSD (ext. thumb drive)	Updated
Export	Export from Surgical Workplace: Via DICOM PACS, USB thumb drives and live transfer / storage of images to Pathology Workplace.Export / download from Pathology Workplace to local hard drive (DICOM and JPG).	Export from Surgical Workplace: Via DICOM PACS, USB thumb drives.	Updated
Laser	Class 3R laser product	Class 3R laser product	Identical
Cloud Software	Pathology Workplace	No	New
Attribute	Subject Device(K211156)	Reference Device(K202229)	Equivalency Analysis
Medical image viewer*	Browser basedweb application	Thin client	Equivalent
Software only medical device deployedwithin a customer's IT infrastructure or onvirtualized server technology *	Yes	Yes	Equivalent
Application supports anatomical datasets,such as CT and MR.	Yes, endoscopy	Yes	Equivalent, differentimage type (MR vs.endoscopy image)
To be used for viewing, manipulation,communication, storage, 3D-visualizationand comparison of medical images frommultiple imaging modalities and/ormultiple time points.	Yes, but forsingular modality(neuroendoscopicimage generatedby CONVIVOacquisitionsystem)	Yes	Equivalent, lessercapability
Provides tools to help the user assess anddocument the extent of a disease and/or theresponse to therapy in accordance withuser selected standards*	Yes	Yes	Identical
Supports the interpretation and evaluationof examinations and follow updocumentation of findings withinhealthcare institutions, for example, inRadiology, Oncology, and other MedicalImaging environments *	Yes	Yes	Identical
The medical professional retains theultimate responsibility for making thepertinent diagnosis based on their standardpractices. The software is a complement tothese standard procedures.	Yes	Yes	Identical
Not be used in mammography.	Yes	Yes	Identical

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Please note since the FDA Regulation updated certain medical device classification regulations to conform with the Medical Software Provisions in the 21st Century Cures Act (Ref. 86FR20278 Effective April 19, 2021, some of the functionalities below do not fall into the definition of a medical device and are marked with (*). Tables were left 'as-is' to facilitate submission review.

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Table 2. Subject Device to Reference Device Comparison (Intended Use)

Table 3. Subject Device to Reference Device Comparison (Technical Characteristics)

Attribute	Subject Device (K211156)	Reference Device (K202229)	Equivalency Analysis
Software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware. (Please note that “PACS” has not been changed as this was the original table submitted to the FDA by the Reference	Yes	Yes	Identical
Attribute	Subject Device(K211156)	Reference Device(K202229)	EquivalencyAnalysis
Device before the update in regulation)
Operating system / Run environment*	Microsoft Azure	Windows 64 / native orvirtualized MicrosoftWindows platform.	Equivalent
Software delivery method *	Browser basedweb application	Internet softwaredownload	Equivalent
Image navigation tools (pan, zoom, scroll,window/level) *	Yes: Contrast,brightnessNo: Pan, zoom,scroll,window/level	Yes	Equivalent,lesserfunctionality
Measurement tools (linear, ROI, HU)	Scale bar only	Yes	Equivalent,lesserfunctionality
Automatic long and short axis calculations	No	Yes	Not relevantfor intendeduse of subjectdevice
User controls functions with a system ofinteractive menus and tools *	Yes	Yes	Identical
Semi-automatic lesion segmentation tools	No	Yes	Not relevantfor intendeduse of subjectdevice
Anatomical location labelling tools	Yes	Yes	Equivalent
Display output of measurements andanatomical location information*	Yes	Yes	Equivalent
Tabulation and summation ofmeasurements, lesion categorization andstandard evaluation in accordance withselected criteria	No	Yes	Not relevantfor intendeduse of subjectdevice
Longitudinal lesion analysis	No	Yes	Not relevantfor intendeduse of subjectdevice
Image co-registration for viewing imagesfrom different time points	No	Yes	Not relevantfor intendeduse of subjectdevice
Report generation*	Yes	Yes	Identical

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7. Summarv of the Studies

CONVIVO In Vivo Pathology Suite has successfully undergone extensive verification and validation testing to ensure that all requirements for proposed changes have been met.

These included:

. Updated Shelf-Life testing for an extension of shelf-life for a system component
Updated EMC and Electrical Safety Testing for hardware life-cycle changes
Updated System and Software Testing for software and interoperability changes

All testing followed internally approved procedures and processes. These procedures and processes are in compliance with referenced standards and FDA guidance documents.

8. Conclusion

The intended use of the subject CONVIVO In Vivo Pathology Suite are the intended use of the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness. An update to interoperability, software modifications, and inclusion of a new accessory (Pathology Workplace) does not change the objective intent of the system.

The technological characteristics and risk profile of the subject device are equivalent to the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

Testing methods are equivalent to those of the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

Therefore, the subject device meets the requirements for substantial equivalence.

Regulation Number and Section

N/A