(254 days)
No
The summary describes image acquisition, storage, and real-time collaboration features, but there is no mention of AI, ML, or any algorithms that would process images for analysis or interpretation beyond basic management. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device acquires images and facilitates collaboration; it does not directly treat or alleviate a medical condition.
No
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly states that the CONVIVO In Vivo Pathology Suite includes a "surgical endo-microscope" (CONVIVO Surgical Workplace) which is a hardware component comprised of a confocal processor, handheld scanner probe, computer, touchscreen monitor, cart, and foot control panel. While it also includes a software module (CONVIVO Pathology Workplace), the overall system is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "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." This directly contradicts the definition of an IVD, which is used for diagnostic purposes.
- Device Description: The device is described as a system that acquires in-vivo images of tissue microstructure during surgical procedures. IVDs typically analyze samples taken from the body (in vitro), not directly image tissue within the body (in vivo).
- Functionality: The system provides real-time imaging and collaboration tools. While this information might be used by clinicians in their diagnostic process, the device itself is not performing the diagnostic test or analysis on a sample.
The device is an in-vivo imaging system used to visualize tissue during surgery and facilitate collaboration, not to perform diagnostic tests on biological samples.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
GWG, OWN, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Laser Scanning Microscopy
Anatomical Site
cranial procedures, cerebral vascular area, tissues (general)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical and pathology clinical teams; intra-operative consultation.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Maria Golovina
Head of Regulatory Affairs - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 216-1078 Phone (925) 557-4259 Fax
E-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 AG |
| 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 |
| 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
(K181116) | Equivalency
Analysis |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device name | CONVIVO In Vivo Pathology
Suite | CONVIVO | Updated |
| Manufacturer | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany | Identical |
| 510(k) | K211156 | K181116 | Identical |
| | | | K211156 |
| Attribute | Subject Device | Predicate Device
(K181116) | Equivalency
Analysis |
| Classification Product
Code | 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 Advisory
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.
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) | Equivalency
Analysis |
| Patient Population | Patients undergoing
neurological procedures. | Patients undergoing
neurological procedures. | Identical |
| Device Description | Standalone
confocal endomicroscope for
intraoperative imaging with
high magnification.
Live transfer and storage of
images to a cloud Medical
image management and
processing system (Pathology
Workplace) via central server. | Standalone
confocal endomicroscope for
intraoperative imaging with
high magnification. | Updated |
| Basic System Function | View, create and replay
fluorescent images of
microvasculature/capillaries in
the cerebral area. | View, create and replay
fluorescent images of
microvasculature/capillaries in
the cerebral area. | Identical |
| Imaging System | Confocal laser scanning
system | Confocal laser scanning
system | Identical |
| Optical Visualization | Fiber scanner
Photo detector | Fiber scanner
Photo detector | Identical |
| Display | Monitor | Monitor | Identical |
| Fluorescent Agent | Fluorescence imaging system
used with: Sodium Fluorescein
AK-FLUOR® produced
by Akorn, Inc. | Fluorescence imaging system
used with: Sodium Fluorescein
AK-FLUOR® produced
by Akorn, Inc. | Identical |
| Activation of the
fluorescence imaging | The press of a single button of
the CONVIVO Surgical
Workplace activates imaging. | The press of a single button of
the CONVIVO activates
imaging. | Identical |
| Invasivity | Invasive probe used with
Sterile Sheath as a sterility
barrier. | Invasive probe used with
Sterile Sheath as a sterility
barrier. | Identical |
| Result | Fluorescent image with very
high magnification of the
distribution of the sodium
fluorescein dye in the imaged
tissue during the
operation. | Fluorescent image with very
high magnification of the
distribution of the sodium
fluorescein dye in the imaged
tissue during the
operation. | Identical |
Table 1. Subject to Predicate Device Comparison Table
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6
7
| Attribute | Subject Device | Predicate Device
(K181116) | Equivalency
Analysis |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Visualization of
Real-Time images | Yes | Yes | Identical |
| Fluorescence Excitation | 488 nm | 488 nm | Identical |
| K211156 | | | |
| Attribute | Subject Device | Predicate Device
(K181116) | Equivalency
Analysis |
| 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 of
Illumination | Laser source (continuous blue light of 488 nm wavelength);
Fluorescence | Laser source (continuous blue light of 488 nm wavelength);
Fluorescence | Identical |
| Physical Method of
Imaging | Confocal Laser Scanning
Microscopy | Confocal Laser Scanning
Microscopy | Identical |
| Distance of Imaging Head
to Patient | Direct contact to tissue | Direct contact to tissue | Identical |
| Auto detection
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.
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 based
web application | Thin client | Equivalent |
| Software only medical device deployed
within a customer's IT infrastructure or on
virtualized server technology * | Yes | Yes | Equivalent |
| Application supports anatomical datasets,
such as CT and MR. | Yes, endoscopy | Yes | Equivalent, different
image type (MR vs.
endoscopy image) |
| To be used for viewing, manipulation,
communication, storage, 3D-visualization
and comparison of medical images from
multiple imaging modalities and/or
multiple time points. | Yes, but for
singular modality
(neuroendoscopic
image generated
by CONVIVO
acquisition
system) | Yes | Equivalent, lesser
capability |
| Provides tools to help the user assess and
document the extent of a disease and/or the
response to therapy in accordance with
user selected standards* | Yes | Yes | Identical |
| Supports the interpretation and evaluation
of examinations and follow up
documentation of findings within
healthcare institutions, for example, in
Radiology, Oncology, and other Medical
Imaging environments * | Yes | Yes | Identical |
| 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. | Yes | Yes | Identical |
| Not be used in mammography. | Yes | Yes | Identical |
8
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.
9
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) | Equivalency | ||
| Analysis | |||
| Device before the update in regulation) | |||
| Operating system / Run environment* | Microsoft Azure | Windows 64 / native or | |
| virtualized Microsoft | |||
| Windows platform. | Equivalent | ||
| Software delivery method * | Browser based | ||
| web application | Internet software | ||
| download | Equivalent | ||
| Image navigation tools (pan, zoom, scroll, | |||
| window/level) * | Yes: Contrast, | ||
| brightness | |||
| No: Pan, zoom, | |||
| scroll, | |||
| window/level | Yes | Equivalent, | |
| lesser | |||
| functionality | |||
| Measurement tools (linear, ROI, HU) | Scale bar only | Yes | Equivalent, |
| lesser | |||
| functionality | |||
| Automatic long and short axis calculations | No | Yes | Not relevant |
| for intended | |||
| use of subject | |||
| device | |||
| User controls functions with a system of | |||
| interactive menus and tools * | Yes | Yes | Identical |
| Semi-automatic lesion segmentation tools | No | Yes | Not relevant |
| for intended | |||
| use of subject | |||
| device | |||
| Anatomical location labelling tools | Yes | Yes | Equivalent |
| Display output of measurements and | |||
| anatomical location information* | Yes | Yes | Equivalent |
| Tabulation and summation of | |||
| measurements, lesion categorization and | |||
| standard evaluation in accordance with | |||
| selected criteria | No | Yes | Not relevant |
| for intended | |||
| use of subject | |||
| device | |||
| Longitudinal lesion analysis | No | Yes | Not relevant |
| for intended | |||
| use of subject | |||
| device | |||
| Image co-registration for viewing images | |||
| from different time points | No | Yes | Not relevant |
| for intended | |||
| use of subject | |||
| device | |||
| Report generation* | Yes | Yes | Identical |
10
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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.