CONVIVO In Vivo Pathology Suite

K211156 · Carl Zeiss Meditec, AG · LLZ · Dec 29, 2021 · Radiology

Device Facts

• Record ID: K211156
• Device Name: CONVIVO In Vivo Pathology Suite
• Applicant: Carl Zeiss Meditec, AG
• Product Code: LLZ · Radiology
• Decision Date: Dec 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended 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 Surgical Workplace).

Device Story

CONVIVO In Vivo Pathology Suite comprises a surgical endo-microscope (Surgical Workplace) and a cloud-based software module (Pathology Workplace). During cranial procedures, a fiber optic scanner probe contacts tissue to acquire confocal laser scanning images of internal microstructure and microvasculature, often using systemically administered sodium fluorescein as a contrast agent. The Surgical Workplace captures and transfers images to the Pathology Workplace via a central server. The Pathology Workplace allows clinical teams (neurosurgical and pathology) to categorize, archive, and store images for real-time, remote intraoperative collaboration. The system provides high-magnification fluorescent images to assist clinicians; however, it is not intended for diagnostic purposes or to replace standard intraoperative consultation practices. Healthcare providers use the output to visualize tissue microstructure during surgery, aiding in surgical decision-making while maintaining standard diagnostic workflows.

Clinical Evidence

Bench testing only. Evidence includes updated shelf-life testing, EMC and electrical safety testing for hardware changes, and system/software verification and validation testing for interoperability and software modifications. No clinical study data was provided.

Technological Characteristics

Confocal laser scanning endomicroscope; 488 nm laser source; fiber optic scanner probe; green bandpass (515-577 nm) and optional longpass/grey filters. System includes embedded CPU, touchscreen, and cloud-based software (Pathology Workplace) hosted on Microsoft Azure. Connectivity via DICOM PACS and cloud transfer. Class 3R laser. Sterile sheath used as barrier.

Indications for Use

Indicated for patients undergoing neurological procedures. Used for intra-operative imaging of tissue microstructure and microvasculature/capillaries in the cerebral area. Not for diagnostic purposes or to replace standard tumor margin analysis/frozen sections.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• CONVIVO (K181116)

Reference Devices

• AI Metrics (K202229)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 AG<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena, Germany |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Maria Golovina<br>Head of Regulatory Affairs - USA<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone [phone] Fax<br>E-mail: [e-mail] (preferred) |
| Date Prepared | 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 AG<br>Goeschwitzer 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 LLC<br>432 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

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.

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.

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.

### 5. 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 Surgical Workplace).

## 6. Substantial Equivalence Comparison to the Predicate Device

| Attribute | Subject Device | Predicate Device<br>(K181116) | Equivalency<br>Analysis |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device name | CONVIVO In Vivo Pathology<br>Suite | CONVIVO | Updated |
| Manufacturer | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena, Germany | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena, Germany | Identical |
| 510(k) | K211156 | K181116 | Identical |
| | | | K211156 |
| Attribute | Subject Device | Predicate Device<br>(K181116) | Equivalency<br>Analysis |
| Classification Product<br>Code | GWG; OWN; LLZ | GWG; OWN | Updated |
| Regulation # | 21 CFR 882.1480<br>(Neurological Endoscope) | 21CFR882.1480 (Neurological Endoscope) | Identical |
| Classification Adv.<br>Committee | Radiology | Radiology | Identical |
| Application | Angiography | Angiography | Identical |
| Review Advisory<br>Committee | 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.<br>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.<br>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.<br>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<br>(K181116) | Equivalency<br>Analysis |
| Patient Population | Patients undergoing<br>neurological procedures. | Patients undergoing<br>neurological procedures. | Identical |
| Device Description | Standalone<br>confocal endomicroscope for<br>intraoperative imaging with<br>high magnification.<br><br>Live transfer and storage of<br>images to a cloud Medical<br>image management and<br>processing system (Pathology<br>Workplace) via central server. | Standalone<br>confocal endomicroscope for<br>intraoperative imaging with<br>high magnification. | Updated |
| Basic System Function | View, create and replay<br>fluorescent images of<br>microvasculature/capillaries in<br>the cerebral area. | View, create and replay<br>fluorescent images of<br>microvasculature/capillaries in<br>the cerebral area. | Identical |
| Imaging System | Confocal laser scanning<br>system | Confocal laser scanning<br>system | Identical |
| Optical Visualization | Fiber scanner<br>Photo detector | Fiber scanner<br>Photo detector | Identical |
| Display | Monitor | Monitor | Identical |
| Fluorescent Agent | Fluorescence imaging system<br>used with: Sodium Fluorescein<br>AK-FLUOR® produced<br>by Akorn, Inc. | Fluorescence imaging system<br>used with: Sodium Fluorescein<br>AK-FLUOR® produced<br>by Akorn, Inc. | Identical |
| Activation of the<br>fluorescence imaging | The press of a single button of<br>the CONVIVO Surgical<br>Workplace activates imaging. | The press of a single button of<br>the CONVIVO activates<br>imaging. | Identical |
| Invasivity | Invasive probe used with<br>Sterile Sheath as a sterility<br>barrier. | Invasive probe used with<br>Sterile Sheath as a sterility<br>barrier. | Identical |
| Result | Fluorescent image with very<br>high magnification of the<br>distribution of the sodium<br>fluorescein dye in the imaged<br>tissue during the<br>operation. | Fluorescent image with very<br>high magnification of the<br>distribution of the sodium<br>fluorescein dye in the imaged<br>tissue during the<br>operation. | Identical |

Table 1. Subject to Predicate Device Comparison Table

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| Attribute | Subject Device | Predicate Device<br>(K181116) | Equivalency<br>Analysis |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Visualization of<br>Real-Time images | Yes | Yes | Identical |
| Fluorescence Excitation | 488 nm | 488 nm | Identical |
| K211156 | | | |
| Attribute | Subject Device | Predicate Device<br>(K181116) | Equivalency<br>Analysis |
| Observation | Primary filter: Green bandpass filter (515 – 577 nm)<br>Optional filters:<br>Green longpass filter (> 520 nm)<br>Red longpass filter (> 580 nm)<br>Grey filter allows all wavelengths to pass, however, with significantly reduced intensity. | Primary filter: Green bandpass filter (515 – 577 nm)<br>Optional filters:<br>Green longpass filter (> 520 nm)<br>Red longpass filter (> 580 nm)<br>Grey filter allows all wavelengths to pass, however, with significantly reduced intensity. | Identical |
| Physical Method of<br>Illumination | Laser source (continuous blue light of 488 nm wavelength);<br>Fluorescence | Laser source (continuous blue light of 488 nm wavelength);<br>Fluorescence | Identical |
| Physical Method of<br>Imaging | Confocal Laser Scanning<br>Microscopy | Confocal Laser Scanning<br>Microscopy | Identical |
| Distance of Imaging Head<br>to Patient | Direct contact to tissue | Direct contact to tissue | Identical |
| Auto detection<br>of 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.<br>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<br>(K211156) | Reference Device<br>(K202229) | Equivalency Analysis |
| Medical image viewer* | Browser based<br>web application | Thin client | Equivalent |
| Software only medical device deployed<br>within a customer's IT infrastructure or on<br>virtualized server technology * | Yes | Yes | Equivalent |
| Application supports anatomical datasets,<br>such as CT and MR. | Yes, endoscopy | Yes | Equivalent, different<br>image type (MR vs.<br>endoscopy image) |
| To be used for viewing, manipulation,<br>communication, storage, 3D-visualization<br>and comparison of medical images from<br>multiple imaging modalities and/or<br>multiple time points. | Yes, but for<br>singular modality<br>(neuroendoscopic<br>image generated<br>by CONVIVO<br>acquisition<br>system) | Yes | Equivalent, lesser<br>capability |
| Provides tools to help the user assess and<br>document the extent of a disease and/or the<br>response to therapy in accordance with<br>user selected standards* | Yes | Yes | Identical |
| Supports the interpretation and evaluation<br>of examinations and follow up<br>documentation of findings within<br>healthcare institutions, for example, in<br>Radiology, Oncology, and other Medical<br>Imaging environments * | Yes | Yes | Identical |
| The medical professional retains the<br>ultimate responsibility for making the<br>pertinent diagnosis based on their standard<br>practices. The software is a complement to<br>these 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<br>(K211156) | Reference Device<br>(K202229) | Equivalency<br>Analysis |
| Device before the update in regulation) | | | |
| Operating system / Run environment* | Microsoft Azure | Windows 64 / native or<br>virtualized Microsoft<br>Windows platform. | Equivalent |
| Software delivery method * | Browser based<br>web application | Internet software<br>download | Equivalent |
| Image navigation tools (pan, zoom, scroll,<br>window/level) * | Yes: Contrast,<br>brightness<br>No: Pan, zoom,<br>scroll,<br>window/level | Yes | Equivalent,<br>lesser<br>functionality |
| Measurement tools (linear, ROI, HU) | Scale bar only | Yes | Equivalent,<br>lesser<br>functionality |
| Automatic long and short axis calculations | No | Yes | Not relevant<br>for intended<br>use of subject<br>device |
| User controls functions with a system of<br>interactive menus and tools * | Yes | Yes | Identical |
| Semi-automatic lesion segmentation tools | No | Yes | Not relevant<br>for intended<br>use of subject<br>device |
| Anatomical location labelling tools | Yes | Yes | Equivalent |
| Display output of measurements and<br>anatomical location information* | Yes | Yes | Equivalent |
| Tabulation and summation of<br>measurements, lesion categorization and<br>standard evaluation in accordance with<br>selected criteria | No | Yes | Not relevant<br>for intended<br>use of subject<br>device |
| Longitudinal lesion analysis…