(181 days)
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.
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.
The provided text is a 510(k) summary for the CONVIVO device. While it details various aspects of device testing, it does not contain a specific table of acceptance criteria and reported device performance in the way typically seen for a study proving a device meets acceptance criteria related to a diagnostic or AI-assisted system's performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Cellvizio 100 Series System) and a reference device (YELLOW 560) through engineering and safety testing, rather than a clinical performance study with specific quantitative acceptance criteria for diagnostic efficacy.
Therefore, many of the requested details cannot be extracted directly from this document. However, I can infer some information based on the provided text.
Here's what can be gathered and what is explicitly not available from the provided text, in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
A specific table with quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values is not provided in this document. The document describes various types of testing but not in a format that directly addresses a clinical performance study's acceptance metrics. The performance data mentioned are primarily related to safety and functionality.
| Acceptance Criteria Category | Specific Criteria (not explicitly quantitative performance for clinical efficacy) | Reported Device Performance (not explicitly quantitative performance for clinical efficacy) |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 | Validated according to ISO 11135:2014; Microbiological barrier function, seal strength, dye penetration tested. |
| Biocompatibility | Compliance with ISO 10993 for patient-contacting components. | Materials tested for Cytotoxicity, Irritation, Sensitization, Material mediated pyrogenicity, acute systemic toxicity, Chemical information/characterization. |
| Design Verification | Compliance with established system requirements | Demonstrated compliance. |
| Laser Safety | Conformity with IEC 60825-1 | Assessed for conformity. |
| Thermal Safety | Maximum temperature limits established in IEC 60601-1 not exceeded. | Maximum temperature did not exceed limits when operated in intermittent mode. |
| In Vivo Testing | Ability to view microstructure of tissues and blood flow intraoperatively. | "The ability to view microstructure of tissues and blood flow intraoperatively was confirmed." (Qualitative statement, no quantitative metrics provided) |
| Software Documentation | Sufficiency for a MAJOR Level of Concern device. | Provided. |
| Electrical Safety | Conformance with ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-2-18:2009. | Demonstrated conformance. |
| Electromagnetic Compatibility | Conformance with IEC 60601-1-2 (4th Edition). | Demonstrated conformance. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document mentions "In vivo Testing" was conducted but does not specify the sample size (e.g., number of patients or images) used for this testing.
- Data Provenance: Not explicitly stated. The in-vivo testing likely occurred in a controlled environment as part of the device development, but details regarding country of origin or whether it was retrospective/prospective are not detailed. It's presented as part of design verification, suggesting internal company testing rather than a large-scale clinical trial.
3. Number of Experts and Qualifications for Ground Truth:
- The document mentions "In vivo Testing" confirming the ability to view microstructures. However, it does not specify the number or qualifications of experts used to establish ground truth for this testing. Given it's a device for direct visualization, the "ground truth" is likely the direct observation by the device itself, validated by experts, but the process is not elaborated.
4. Adjudication Method:
- Since a formal clinical performance study with expert reads/assessments is not described in detail, an adjudication method (2+1, 3+1, etc.) for a test set is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC study comparing human readers with and without AI assistance was not conducted or described in this document. This device is a direct imaging tool, not an AI-diagnostic aid in the typical sense that would necessitate an MRMC study to show improvement in human reader performance.
6. Standalone (Algorithm Only) Performance:
- This device is an endomicroscopy system for direct visualization, not an AI algorithm. Therefore, a "standalone algorithm performance" study is not applicable and was not conducted or described. The device's performance is inherently tied to its operation as an imaging system.
7. Type of Ground Truth Used:
- For the "In vivo testing" that "confirmed the ability to view microstructure of tissues and blood flow intraoperatively," the "ground truth" would implicitly be the direct visualization capability of the device itself during the procedure, likely assessed by qualified personnel. However, the document does not specify if this was through pathology confirmation, other imaging modalities, or a consensus of experts retrospectively labeling images.
8. Sample Size for the Training Set:
- This document describes a medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" for machine learning is not applicable, and no sample size for such a set is provided.
9. How Ground Truth for the Training Set was Established:
- As above, the concept of a training set is not applicable here.
In summary, this 510(k) submission primarily focuses on demonstrating substantial equivalence through engineering, safety, and functionality testing. It does not present a clinical performance study with quantitative diagnostic metrics and associated acceptance criteria that would involve detailed information on ground truth establishment, expert reader studies, or AI algorithm training/testing. The "In vivo Testing" mentioned is a high-level confirmation of the device's basic function.
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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
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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/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 AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany |
| Contact: | Mandy AmbrechtSenior Staff Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568(925) 557-4561 Phonemandy.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: | GWGOWN |
| 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
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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, < 24 hours. The materials of the Sterile Sheath were tested in accordance with ISO 10993 including tests for Cytotoxicity, Irritation, Sensitization, Material mediated pyrogenicity, acute systemic toxicity and Chemical information/characterization.
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Performance Data
The following performance testing is provided to support the substantial equivalence of the subject device:
- -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.
Software Documentation
Software documentation for a MAJOR Level of Concern device is provided in support of the subject device.
Electrical Safety Testing
The CONVIVO has demonstrated conformance with the relevant requirements of ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012 (Consolidated text - edition 3.1, including the US deviations).
CONVIVO has demonstrated conformance with the relevant requirements of IEC 60601-2-18:2009 (3rd edition): Particular requirements for the basic safety and essential performance of endoscopic equipment.
Electromagnetic Compatibility Testing
The CONVIVO has demonstrated conformance with the relevant requirements of IEC 60601-1-2 (4th Edition).
Standards
Table 5-1 provides the complete list of standards that are used in the 510(k) to establish device performance and support substantial equivalence.
| StandardsOrganization | StandardsNumber | Standard Title | StandardVersion/Date |
|---|---|---|---|
| ISO | 14971 | Medical Devices – Application ofRisk Management to MedicalDevices | 2007 |
| StandardsOrganization | StandardsNumber | Standard Title | StandardVersion/Date |
| AAMI / ANSI | 60601-1 | Electrical equipment -- Part 1:General requirements for basic safetyand essential performance | 2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 |
| IEC | 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance -Collateral standard:Electromagnetic compatibility -Requirements and tests | 2014 |
| IEC | 60601-2-18 | Medical electrical equipment Part 2:Particular requirements for the basicsafety and essential performance ofendoscopic equipment | Ed. 3 / 2009 |
| IEC | 62304 | Medical device software - Softwarelife cycle processes | 2006 |
| IEC | 60825-1 | Safety of laser products - Part 1:equipment classification, andrequirements | 2007 |
| NEMA | PS 3.1-3.20 | Digital Imaging and Communicationsin Medicine (DICOM) | 2016 |
| AAMI ANSIISO | 10993-1 | Biological evaluation of medicaldevices – Part 1: Evaluation andtesting within a risk managementprocess | 2009 |
| AAMI ANSIISO | 10993-5 | Biological evaluation ofmedical devices - Part 5: Tests for invitro cytotoxicity | 2009 |
| AAMI ANSIISO | 10993-7 | Biological evaluation of medicaldevices - Part 7: ethylene oxidesterilization residuals. (Sterility) | 2008 |
| AAMI ANSIISO | 10993-10 | Biological evaluation of medicaldevices – Part 10: Tests for irritationand skin sensitization | 2010 |
| AAMI ANSIISO | 10993-11 | Biological evaluation of medicaldevices – Part 11: Tests for systemictoxicity | 2006 |
| StandardsOrganization | StandardsNumber | Standard Title | StandardVersion/Date |
| AAMI ANSIISO | 11607-1 | Packaging for terminally sterilizedmedical devices – part 1:requirements for materials, sterilebarrier systems and packaging[including: amendment 1 (2014)]. | 2006 |
| AAMI ANSIISO | 11135 | Sterilization of health care products –Ethylene oxide – Requirements fordevelopment, validation and routinecontrol of a sterilization process formedical devices | 2014 |
| ANSI AAMIISO | 11737-1 | Sterilization of health care products -Microbiological methods - Part 1:Determination of the population ofmicroorganisms on product | 2006 |
Table 5-1: Standards used for CONVIVO
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Substantial Equivalence Discussion
The CONVIVO indications for use are equivalent with the Cellvizio 100 Series System with Confocal Miniprobes (CranioFlex™ (-,-C) type Confocal Miniprobes™) predicate device since both are used to image the same tissue and structure. Also, the general intended use of these devices is the same.
CONVIVO and the predicate device are intended to visualize both microvasculature and internal microstructures. The devices are tools that are used to provide imaging information to the physician.
Both devices are intended to be brought into direct contact with the brain tissue to be examined to create in-vivo confocal laser scanning images of the internal microstructure of tissue.
Furthermore, both devices are confocal laser systems with fiber optic probes and have the identical operation principle. Both devices use a laser source which emits a continuous blue light of 488 nm wavelength. With both devices, a monitor is used to view the images the images generated with the scanner probe are displayed on the monitor. Both devices can be used in realtime during surgical procedures.
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The proposed device, CONVIVO, and the reference device, YELLOW 560 (K162991), have the same intended use. They are both used to examine blood flow in the cerebral vascular area. The ZEISS CONVIVO differs only in the scale of the vasculature that can be imaged, and this difference in technology is supported by performance testing.
While CONVIVO uses a confocal laser scanning system and YELLOW 560 utilizes a surgical stereo microscope, the operation principle is similar. In both cases, Sodium Fluorescein is injected into the patient, excitation light is shined onto the tissue and emitted fluorescent light is used to observe the blood flow and the vasculature within the brain. While the systems have differences, they each have the functions for viewing and recording fluorescent images. Both devices use Sodium Fluorescein as a contrast agent to visualize vascular structures without changes to the formulation, mode of action, approved dose or route of administration. Sodium Fluorescein is used in an identical manner for both devices.
A detailed comparison of the subject device to the predicate device is provided in Table 5-2.
| Attribute | Proposed Device, CONVIVOK181116 (Pending) | Predicate Device, Cellvizio 100Series System with ConfocalMiniprobes™ (CranioFlex™ (-,-C)type Confocal Miniprobes™)K180270 |
|---|---|---|
| Device name | CONVIVO | Cellvizio 100 Series System withConfocal Miniprobes™(CranioFlex™ (-,-C) type ConfocalMiniprobes™) |
| Manufacturer | Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany | Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France |
| 510(k) | K181116 (Pending) | K180270 |
| ClassificationProduct Code | GWG (primary product code)OWN (secondary product code) | GWG (primary product code)OWN (secondary product code) |
| Regulation No. | 21 CFR 882.148021 CFR 876.1500 | 21 CFR 882.148021 CFR 876.1500 |
| ClassificationAdv. Committee | Neurological Devices PanelGeneral & Plastic Surgery | Neurological Devices PanelGeneral & Plastic Surgery and |
| Application | Neurosurgery | Neurosurgery |
| Attribute | Proposed Device, CONVIVOK181116 (Pending) | Predicate Device, Cellvizio 100Series System with ConfocalMiniprobes™ (CranioFlex™ (-,-C)type Confocal Miniprobes™)K180270 |
| ReviewAdvisoryCommittee | Neurology | Neurology |
| CombinationDevice | Yes | No |
| Indications foruse | The ZEISS CONVIVO is a surgicalendomicroscope intended for viewingintra-operative blood flow in thecerebral vascular area, includingmicrovasculature and capillaries.The CONVIVO's fiber optic scannerprobe is placed in direct contact withtissue during cranial diagnostic andtherapeutic procedures, such as tumorbiopsy and resection, to create in-vivoconfocal laser scanning images of theinternal microstructure of tissues. | The Cellvizio® 100 Series systemswith Confocal Miniprobes™ areconfocal laser systems with fiberoptic probes that are intended toallow imaging of the internalmicrostructure of tissues including,but not limited to, the identificationof cells and vessels and theirorganization or architecture.The CranioFlex™(-,-C) ConfocalMiniprobes™ are indicated toprovide visualization within centralnervous system during cranialdiagnostic and therapeutic proceduressuch as tumor biopsy and resection. |
| PatientPopulation | Patients undergoing neurologicalprocedures. | Patients undergoing neurologicalprocedures. |
| DeviceDescription | Standalone confocal endomicroscopefor intraoperative imaging with highmagnification. | Standalone confocal endomicroscopefor intraoperative imaging with highmagnification. |
| Basic SystemFunction | Create in-vivo confocal laserscanning images of the internalmicrostructure of tissue. | Create in-vivo confocal laserscanning images of the internalmicrostructure of tissue. |
| Imaging System | Confocal laser scanning system withfiber optic probe | Confocal laser scanning system withfiber optic probe |
| OpticalVisualization | Fiber scannerPhoto detector | Fiber scannerPhoto detector |
| Display | Monitor | Monitor |
| Attribute | Proposed Device, CONVIVOK181116 (Pending) | Predicate Device, Cellvizio 100Series System with ConfocalMiniprobes™ (CranioFlex™ (-,-C)type Confocal MiniprobesTM)K180270 |
| FluorescentAgent | Fluorescence imaging system usedwith Sodium Fluorescein(AK-FLUOR® produced by Akorn,Inc.) yields fluorescent image withvery high magnification of thedistribution of the sodium fluoresceindye in the imaged tissue during theoperation. | Tissue autofluorescence |
| Invasivity | Invasive probe used with single useSterile Sheath as a sterility barrier. | Invasive. The probe needs to besterilized before use. |
| Visualization ofReal-Timeimages | Yes | Yes |
| FluorescenceExcitation | 488 nm | 488 and 800 nm |
| 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 topass, however, with significantlyreduced intensity. | Information not available. |
| Physical Methodof Illumination | Laser source (continuous blue light of488 nm wavelength); Fluorescence | Information not available. |
| Physical Methodof Imaging | Confocal Laser Scanning system | Confocal laser scanning system |
| Export | Via DICOM PACS, Shared Drive andUSB 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.
§ 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).