(181 days)
No
The summary describes a confocal laser endomicroscopy system for real-time imaging of microvasculature. There is no mention of AI, ML, image processing beyond basic visualization, or any data analysis that would suggest the use of such technologies. The performance studies focus on safety and basic imaging capability.
No.
The device is used for viewing and imaging, and does not directly treat or provide therapeutic effects to the patient.
Yes
The device is intended for "viewing intra-operative blood flow... to create in-vivo confocal laser scanning images of the internal microstructure of tissues" and specifically mentions its use in "cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection." While it supports therapeutic procedures, the primary function described (creating images for viewing tissue microstructure) is diagnostic in nature.
No
The device description explicitly lists multiple hardware components including a confocal processor, handheld scanner probe, computer, touchscreen monitor, cart, and foot control panel. It also mentions a sterile sheath accessory. This is clearly a hardware-based system with associated software, not a software-only medical device.
Based on the provided information, the ZEISS CONVIVO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- CONVIVO's Use: The CONVIVO is used for in-vivo imaging. It is placed in direct contact with tissue during surgical procedures to visualize the internal microstructure and blood flow within the living patient. It does not analyze samples taken from the body.
Therefore, the ZEISS CONVIVO falls under the category of a medical device used for imaging and visualization within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GWG, OWN
Device Description
The CONVIVO 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.
The Sterile Sheath for CONVIVO is a mandatory single use accessory to the system, intended to provide a sterile barrier between the scanner and the patient's tissue. Before the scanner is used on the patient, the Sterile Sheath is fitted to the scanner using sterile techniques.
Sodium fluorescein is used as a fluorescence contrast agent to visualize intraoperative cerebral vascular area, including microvasculature/capillaries. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Laser Scanning System
Anatomical Site
cerebral vascular area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Design Verification Testing - The purpose of the design verification is to demonstrate that the system complies with the established system requirements.
Laser Safety The CONVIVO device was assessed for conformity with the relevant requirements of IEC 60825-1.
Thermal Safety - When operated in intermittent mode, the maximum temperature of the CONVIVO did not exceed the limits established in IEC 60601-1.
In vivo Testing - The ability to view microstructure of tissues and blood flow intraoperatively was confirmed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Carl Zeiss Meditec AG Ms. Mandy Ambrecht Senior Staff Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, California 94568
10/25/2018
Re: K18116
Trade/Device Name: Convivo Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN Dated: April 25, 2018 Received: April 27, 2018
Dear Mandy Ambrecht:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R Ogden -S 2018.10.25 16:58:44 -04'00'
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181116
Device Name CONVIVO
Indications for Use (Describe)
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.
| 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
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for the CONVIVO is provided below.
| 510(k) Number: | K181116 |
|---|---|
| Applicant: | Carl Zeiss Meditec AG |
| Goeschwitzer Strasse 51-52 | |
| D-07745 Jena, Germany | |
| Contact: | Mandy Ambrecht |
| Senior Staff Regulatory Affairs Specialist | |
| Carl Zeiss Meditec, Inc. | |
| 5160 Hacienda Drive | |
| Dublin, CA 94568 | |
| (925) 557-4561 Phone | |
| mandy.ambrecht@zeiss.com | |
| Date prepared: | October 25, 2018 |
| Trade/Proprietary Name: | CONVIVO |
| Common Name: | Neurological Endoscope |
| Regulation Number: | 21 CFR 882.1480 |
| Classification Name: | Neurological Endoscope |
| Regulatory Class: | II |
| Product Code: | |
| Secondary Code: | GWG |
| OWN | |
| Panel: | Neurology |
| Predicate Device: | Cellvizio 100 Series System with Confocal Miniprobes™ |
| (CranioFlex™ (-,-C) type Confocal Miniprobes™) (K180270) | |
| Reference Device: | YELLOW 560 (K162991) |
Indications for Use
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
4
diagnostic and therapeutic procedures, such as tumor biopsy and resection, to create in-vivo confocal laser scanning images of the internal microstructure of tissues.
Device Description
The CONVIVO 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.
The Sterile Sheath for CONVIVO is a mandatory single use accessory to the system, intended to provide a sterile barrier between the scanner and the patient's tissue. Before the scanner is used on the patient, the Sterile Sheath is fitted to the scanner using sterile techniques.
Sodium fluorescein is used as a fluorescence contrast agent to visualize intraoperative cerebral vascular area, including microvasculature/capillaries. 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.
Testing
Sterilization
The CONVIVO's Scanner Probe must be used together with the ZEISS Sterile Sheath for CONVIVO, which is a sterile and single use device. The Sterile Sheath for CONVIVO is sterilized with Ethylene Oxide.
The sterilization cycle was validated to achieve a sterility assurance level (SAL) of 10-6 according to ISO 11135:2014.
In addition, micro-biological barrier function using micro-biological dusting, seal strength, and a dye penetration testing were conducted. The sterility testing after micro-biological dusting was tested according to ASTM F1608.
Biocompatibility
The only patient contacting component of the subject device is the Sterile Sheath for CONVIVO. The contact category for this component is Tissue/Bone/Dentin Communicating, 520 nm)
Red longpass filter (> 580 nm)
Grey filter allows all wavelengths to
pass, however, with significantly
reduced intensity. | Information not available. |
| Physical Method
of Illumination | Laser source (continuous blue light of
488 nm wavelength); Fluorescence | Information not available. |
| Physical Method
of Imaging | Confocal Laser Scanning system | Confocal laser scanning system |
| Export | Via DICOM PACS, Shared Drive and
USB thumb drives | Information not available. |
| Laser | Class 3R laser product | Information not available. |
Table 5-2: Device Comparison Table
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Conclusion
Both the CONVIVO device and the Cellvizio 100 Series System with Confocal Miniprobes (CranioFlex™ (-,-C) type Confocal Miniprobes™) device have the same intended use for imaging the internal microstructure of tissues. The intended use for the CONVIVO and for the reference device, YELLOW 560, is the same as both devices are used to view intraoperative blood flow and the vasculature in the cerebral area.
In addition, both the CONVIVO device and the Cellvizio 100 Series System with Confocal Miniprobes (CranioFlex™ (- - - ) type Confocal Miniprobes™) device employ confocal laser scanning with fiber optic probes to image internal structures.
Performance data demonstrates the CONVIVO can achieve its intended use. Bench testing (including software and electrical/EMC safety), biocompatibility, sterilization and in viyo testing all support the CONVIVO is as safe and effective as the predicate, and is therefore considered substantially equivalent to the predicate device.
510(k) Summary
Based on the successful verification and validation testing. it is Carl Zeiss Mediter AG's opinion that the CONVIVO does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate device.
Additionally, all testing deemed necessary was conducted on the CONVIVO to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate device.