Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. The Cellvizio® 100 Series System F400-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.

The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.

The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories.

The CholangioFlex™ series of Confocal Miniprobe™ is intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles).

The CystoFlex™ (F, UHD-R) and UroFlex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

The CelioFlex™ UHD 5 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Device Description

Confocal Miniprobes™ are used with Cellvizio® 100 Series System (F400-v2), which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures.

Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow. Fluorescein Sodium can be used as a contrast agent with Cellvizio® 100 Series system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration; it is delivered independent of Cellvizio® 100 Series system in accordance with Fluorescein Sodium instruction for use.

AI/ML Overview

The provided text describes a submission for 510(k) clearance for the Cellvizio® 100 Series System with Confocal Miniprobes™. This submission seeks to extend the indications for use to include the visualization of blood flow when using Fluorescein Sodium as a contrast agent.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define numerical acceptance criteria in a dedicated table format with specific performance metrics (e.g., sensitivity, specificity, resolution targets met in a study). Instead, the acceptance is based on demonstrating substantial equivalence to previously cleared predicate devices and a reference device, particularly for the extended indication of visualizing blood flow with Fluorescein Sodium.

The "reported device performance" in this context refers to the device's established technical design, operating principle, safety profile, and imaging capabilities, which are asserted to be unchanged from previously cleared versions. For the newly added indication (blood flow visualization with Fluorescein Sodium), the performance is implicitly accepted by demonstrating technical similarity and comparable indications for use with the reference device (Zeiss CONVIVO).

The relevant comparison tables are:

Table 7-2: Comparison of Predicate Device to Cellvizio® 100 Series system with Confocal Miniprobes™ with extended Indications for Use with Fluorescein Sodium contrast agent. This table highlights the technical, biological, and application/usage equivalence to the predicate device.

Aspect	Comparison of Predicate Device to Cellvizio® 100 Series system with Confocal Miniprobes™, with extended Indications for Use with Fluorescein Sodium contrast agent
Technical equivalence	No change of design and performances; Same technical design; Same operating principle; Same safety profile and risk level; Identical technological characteristics; Same reprocessing methods; Same device packaging
Biological equivalence	Same biocompatible patient-contacting materials and same biocompatibility test requirements; Same target tissues to image
Application and usage equivalence	Same intended use of the device; Same environment of use and same intended user; Same instructions for use and operating procedure; Same precautions and safety instructions

Table 7-3: Comparison of Indication for Use between the Subject Device and Previously Cleared Reference Device (Zeiss CONVIVO K181116). This table shows that the subject device has a "Similar Indication for Use for blood flow visualization with Fluorescein Sodium" compared to the reference device.

Attribute	Subject Device Cellvizio® 100 Series System F400-V2 with Confocal Miniprobes™ with Fluorescein	Reference Device CONVIVO K181116	Comparison to Reference
Combination Device	Yes	Yes	Both devices can be used with Fluorescein Sodium as a contrast agent to image blood flow.
Indications for use (relevant part)	Cellvizio® 100 series F400-V2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. ... The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.	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.	Similar Indication for Use for blood flow visualization with Fluorescein Sodium
Visualization of Real-Time images	9 to 12Hz	1 to 3 Hz	Similar/ Real time imaging
Fluorescence Excitation	488 nm	488 nm	Same
Physical Method of Illumination	Laser source (continuous blue light of 488 nm wavelength); Fluorescence	Laser source (continuous blue light of 488 nm wavelength); Fluorescence	Same
Physical Method of Imaging	Confocal Laser Scanning system	Confocal Laser Scanning system	Same

2. Sample size used for the test set and the data provenance:

The document states: "Clinical demonstration based on literature review has been carried out to support this submission, as described in section 13." However, Section 13 is not provided in the input text. Therefore, specific details about the sample size of a test set, if any, and its data provenance (country, retrospective/prospective) are not available in the provided text. The submission primarily relies on demonstrating substantial equivalence rather than presenting new clinical study data with a distinct test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since a specific test set with ground truth established by experts is not detailed in the provided text, this information is not available. The reliance is on existing literature and clinical findings.

4. Adjudication method for the test set:

Again, as a specific test set with expert ground truth is not detailed, the adjudication method is not available.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document does not mention nor describe any MRMC comparative effectiveness study or the use of AI. The device is an imaging system, and the submission is focused on extending its indications based on existing technology and literature.

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

The document describes the Cellvizio® 100 Series System as an imaging device that provides visualization. The context implies diagnostic aid for a human operator. There is no mention of a standalone algorithm or its performance.

7. The type of ground truth used:

The submission relies on "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and international independent Health Technology Assessment organizations" as mentioned in the summary. This suggests that the ground truth for the claims of blood flow visualization is derived from broad clinical experience and validated medical knowledge, rather than a single, prospectively established dataset with a specific ground truth method like pathology or expert consensus related to a new study.

8. The sample size for the training set:

As this is a submission for an imaging device and not an AI/ML algorithm that requires a "training set" in the traditional sense, information on a training set sample size is not applicable and not provided.

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

Similarly, as there's no mention of a training set for an AI/ML algorithm, this information is not applicable and not provided. The device's performance is intrinsically linked to its established optical and technical characteristics, as verified in previous clearances and further supported by a literature review for the extended indication.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460

January 24, 2020

Re: K191144

Trade/Device Name: Cellvizio 100 Series System with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN, GCJ, GWG Dated: December 19, 2019 Received: December 20, 2019

Dear Michael Daniel:

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 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

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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 (QS) 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.

Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control 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) K191144

Device Name

Cellvizio® 100 Series system with Confocal Miniprobes™

Indications for Use (Describe)

The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories.

The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K191144

2 Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K191144

Applicant Information:

Date Prepared: January 24, 2020

Manufacturer Contact Person:	Aline Criton
Name:	Mauna Kea Technologies
Address:	9 rue d'EnghienF-75010 Paris, France
Phone:	+33 1 48 24 03 45
Fax:	+33 1 48 24 12 18
Contact Person:	Michael A Daniel, Consultantmadaniel@clinregconsult.com
Phone Number:	(415) 407-0223
Office:	(775) 392-2970
Facsimile Number:	(610) 545-0799

Device Information:

Device Trade Name:	Cellvizio® 100 Series Confocal laser imagingsystems with Confocal Miniprobes™
Common Name:	Endoscope and Accessories Neurological Endoscope
Classification Name(s):	Confocal Optical Imaging
Primary regulation and Product Code:	OWN / GCJ 21 CFR 876.1500
Secondary regulation and ProductCode:	GWG 21 CFR 882.1480
Classification:	Class II

Classification: Predicate Devices:

Previously cleared versions of Cellvizio® 100 Series Confocal laser imaging system with ● Confocal Miniprobe™ (K172844, K180270 and K183640).

Reference Devices:

. The Zeiss CONVIVO (K181116).

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Indications for Use:

The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.

The CystoFlex™ (F, UHD-R) and UroFlex™ B of Confocal Miniprobe™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Device Description:

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Materials, design and intended use of the aforementioned Cellvizio® 100 Series Confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K172844, K180270 and K183640.

Comparison to Predicate Device:

The table below details the difference in Indications for Use between the subject device and the previously cleared predicate device (See Table 7-1).

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Aspect	Subject DeviceCellvizio® 100 Series System F400-V2with Confocal Miniprobes™ withFluorescein	Predicate DeviceCellvizio® 100 Series System F400-V2with Confocal Miniprobes™	Comparisonto predicate
Device Name	Cellvizio® 100 Series System withConfocal Miniprobes™	Cellvizio® 100 Series System withConfocal Miniprobes™	Unchanged
Manufacturer	Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France	Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France	Unchanged
Model	Cellvizio® 100 Series F400-V2 withConfocal Miniprobes™	Cellvizio® 100 Series F400-V2 withConfocal Miniprobes™	Unchanged
510 (k)#	Not Assigned	K172844, K180270, and K183640	/
RegulationNumber	21 CFR 876.150021 CFR 882.1480	21 CFR 876.150021 CFR 882.1480	Unchanged
Class	II	II	Unchanged
ClassificationAdvisoryCommittee	General & Plastic Surgery and NeurologicalDevices Panel	General & Plastic Surgery and NeurologicalDevices Panel	Unchanged
Device Class /Name	Confocal Optical Imaging	Confocal Optical Imaging	Unchanged
Product Code	OWN/GCJ/GWG	OWN/GCJ/GWG	Unchanged
CombinationDevice	Yes	No	Extension oftheIndicationsfor Use withFluoresceinSodium dye
Indication ForUse	The Cellvizio® 100 Series system withConfocal Miniprobes™ is a confocal lasersystem with fiber optic probes that isintended to allow imaging of the internalmicrostructure of tissues including, but notlimited to, the identification of cells, vesselsand their organization or architecture. TheCellvizio® 100 series system F400-V2 isindicated for imaging blood flow in vascularareas, including microvasculature andcapillaries.The CranioFlex™ Confocal Miniprobe™ isindicated to provide visualization withincentral nervous system during cranialdiagnostic and therapeutic procedures suchas tumor biopsy and resection.The GastroFlex™ UHD and ColoFlex™UHD Confocal Miniprobes™ are intendedto allow imaging of anatomical tracts, i.e.,gastrointestinal systems, accessed by anendoscope or endoscopic accessories.The AlveoFlex™ Confocal Miniprobe™ isintended to allow imaging of anatomicaltracts, i.e., respiratory systems, accessed byan endoscope or endoscopic accessories.The CholangioFlex™ (or GastroFlex™ M)series of Confocal Miniprobes™ is intendedto allow imaging of the uppergastrointestinal tract including biliary andpancreatic ducts, accessed by an endoscopeor endoscopic accessories.The AQ-Flex™ 19 Confocal Miniprobe™ isintended to allow imaging of anatomicaltracts, i.e., gastrointestinal tracts andrespiratory tracts accessed by an endoscopeor endoscopic accessories, includingthrough endoscopic needles.The CystoFlex™ (F, UHD R) andUroFlex™ B Confocal Miniprobes™ areintended to allow imaging of anatomicaltracts, i.e., urinary, including, but not limitedto, urethra, bladder, and ureter, accessedthrough an endoscope or endoscopicaccessories.The CelioFlex™ UHD 5 ConfocalMiniprobe™ is intended to providevisualization of body cavities, organs, andcanals during endoscopic and laparoscopicsurgical procedures, including robot-assistedprocedures.	Cellvizio® 100 Series System withConfocal Miniprobes™ is a confocal lasersystem with fiber optic probes that areintended to allow imaging of the internalmicrostructure of tissues, including, but notlimited to, the identification of cells andvessels and their organization orarchitecture.The CranioFlex™ Confocal Miniprobe™ isindicated to provide visualization withincentral nervous system during cranialdiagnostic and therapeutic procedures suchas tumor biopsy and resection.The GastroFlex™ UHD and ColoFlex™UHD Confocal Miniprobes™ are intendedto allow imaging of anatomical tracts, i.e.,gastrointestinal systems, accessed by anendoscope or endoscopic accessories.The AlveoFlex™ Confocal Miniprobe™ isintended to allow imaging of anatomicaltracts, i.e., respiratory systems, accessed byan endoscope or endoscopic accessories.The CholangioFlex™ (or GastroFlex™ M)series of Confocal Miniprobes™ is intendedto allow imaging of the uppergastrointestinal tract including biliary andpancreatic ducts, accessed by an endoscopeor endoscopic accessories.The AQ-Flex™ 19 Confocal Miniprobe™ isintended to allow imaging of anatomicaltracts, i.e., gastrointestinal tracts andrespiratory tracts accessed by an endoscopeor endoscopic accessories, includingthrough endoscopic needles.The CystoFlex™ (F, UHD R) andUroFlex™ B Confocal Miniprobe™ areintended to allow imaging of anatomicaltracts, i.e., urinary, including, but not limitedto, urethra, bladder, and ureter, accessedthrough an endoscope or endoscopicaccessories.The CelioFlex™ UHD 5 ConfocalMiniprobe™ is intended to providevisualization of body cavities, organs, andcanals during endoscopic and laparoscopicsurgical procedures, including robot-assistedprocedures.	There is anextension ofthe IndicationFor Use of theCellvizio®100 seriessystem F400-V2 tovisualizeblood flowwithFluoresceinSodiumcontrastagent.Theindicationsfor use of thedifferentConfocalMiniprobes™ do notchange.

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Table 7-1: Comparison of Indication for Use between the Subject Device and Previously Cleared Predicate Device

The table below further demonstrates the substantial equivalence of the subject device to the predicate device.

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Aspect	Comparison of Predicate Device to Cellvizio® 100 Series system with ConfocalMiniprobes™, with extended Indications for Use with Fluorescein Sodium contrastagent
Technical equivalence	No change of design and performancesSame technical designSame operating principleSame safety profile and risk levelIdentical technological characteristicsSame reprocessing methodsSame device packaging
Biological equivalence	Same biocompatible patient-contacting materials and same biocompatibility testrequirementsSame target tissues to image
Application and usageequivalence	Same intended use of the deviceSame environment of use and same intended userSame instructions for use and operating procedureSame precautions and safety instructions

Table 7-2: Comparison of Predicate Device to Cellvizio® 100 Series system with Confocal Miniprobes™, with new Indications for Use.

Comparison to Reference Device:

The table below provides the comparison between the subject device and the reference device (Zeiss CONVIVO Confocal Endomicroscopy system K181116).

Attribute	Subject DeviceCellvizio® 100 Series System F400-V2with Confocal Miniprobes™ withFluorescein	Reference DeviceCONVIVO K181116	Comparison toReference
Device name	Cellvizio® 100 Series System withConfocal Miniprobes™	CONVIVO	/
Manufacturer	Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France	Carl Zeiss Meditec AG GoeschwitzerStrasse 51-52 D-07745 Jena, Germany	/
510(k)	Not Assigned	K181116	/
ClassificationProduct Code	GWG (primary product code) OWN(secondary product code)	GWG (primary product code) OWN(secondary product code)	Same
RegulationNo.	21 CFR 882.148021 CFR 876.1500	21 CFR 882.148021 CFR 876.1500	Same
Class	II	II	Same
ClassificationAdv.Committee	General & Plastic Surgery andNeurological Devices Panel	General & Plastic Surgery andNeurological Devices Panel	Same
Device Class /Name	Confocal Optical Imaging	Confocal Optical Imaging	Same
Product Code	OWN/GCJ/GWG	OWN/GCJ/GWG	Same
CombinationDevice	Yes	Yes	Both devicescan be usedwithFluoresceinSodium as acontrastagent toimage bloodflow.
Indications foruse	The Cellvizio® 100 Series system withConfocal Miniprobes™ is a confocal lasersystem with fiber optic probes that is	The ZEISS CONVIVO is a surgicalendomicroscope intended for viewing intra-operative blood flow in the cerebral	SimilarIndication forUse for blood

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	intended to allow imaging of the internalmicrostructure of tissues including, but notlimited to, the identification of cells,vessels and their organization orarchitecture. Cellvizio® 100 series F400-V2 is indicated for imaging blood flow invascular areas, including microvasculatureand capillaries.The CranioFlex™ Confocal Miniprobe™ isindicated to provide visualization withincentral nervous system during cranialdiagnostic and therapeutic procedures suchas tumor biopsy and resection.The GastroFlex™ UHD and ColoFlex™UHD Confocal Miniprobes™ are intendedto allow imaging of anatomical tracts, i.e.,gastrointestinal systems, accessed by anendoscope or endoscopic accessories.The AlveoFlex™ Confocal Miniprobe™ isintended to allow imaging of anatomicaltracts, i.e., respiratory systems, accessed byan endoscope or endoscopic accessories.The CholangioFlex™ (or GastroFlex™ M)series of Confocal Miniprobes™ isintended to allow imaging of the uppergastrointestinal tract including biliary andpancreatic ducts, accessed by an endoscopeor endoscopic accessories.The AQ-Flex™ 19 Confocal Miniprobe™is intended to allow imaging of anatomicaltracts, i.e., gastrointestinal tracts andrespiratory tracts accessed by an endoscopeor endoscopic accessories, includingthrough endoscopic needles.The CystoFlex™ (F, UHD R) andUroFlex™ B Confocal Miniprobes™ areintended to allow imaging of anatomicaltracts, i.e., urinary, including, but notlimited to, urethra, bladder, and ureter,accessed through an endoscope orendoscopic accessories.The CelioFlex™ UHD 5 ConfocalMiniprobe™ is intended to providevisualization of body cavities, organs, andcanals during endoscopic and laparoscopicsurgical procedures, including robot-assisted procedures	vascular area, including microvasculatureand capillaries.The CONVIVO's fiber optic scanner probeis placed in direct contact with tissueduring cranial diagnostic and therapeuticprocedures, such as tumor biopsy andresection, to create in-vivo confocal laserscanning images of the internalmicrostructure of tissues.	flowvisualizationwithFluoresceinSodium
DeviceDescription	Standalone confocal endomicroscope forintraoperative imaging with highmagnification.	Standalone confocal endomicroscope forintraoperative imaging with highmagnification.	Same
Basic SystemFunction	ImagingSystem	Create in-vivo confocal laser scanningimages of the internal microstructure oftissue.	Confocal laser scanning system with fiberoptic probe	Create in-vivo confocal laser scanningimages of the internal microstructure oftissue.	Confocal laser scanning system with fiberoptic probe	Same	Same
OpticalVisualization	Fiber scanner Photo detector	Fiber scanner Photo detector	Same
Display	Monitor	Monitor	Same

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FluorescentAgent	Tissue autofluorescence and Fluorescenceimaging system used with FluoresceinSodium yields fluorescent image with veryhigh magnification of the distribution of thefluorescein sodium dye in the imaged tissueduring theoperation.	Fluorescence imaging system used withFluorescein Sodium yields fluorescentimage with very high magnification of thedistribution of the fluorescein Sodium dyein the imaged tissue during theoperation.	Same
Visualizationof Real-Timeimages	9 to 12Hz	1 to 3 Hz	Similar/ Realtime imaging
FluorescenceExcitation	488 nm	488 nm	Same
PhysicalMethod ofIllumination	Laser source (continuous blue light of 488nm wavelength); Fluorescence	Laser source (continuous blue light of 488nm wavelength); Fluorescence	Same
PhysicalMethod ofImaging	Confocal Laser Scanning system	Confocal Laser Scanning system	Same
Actionsensured by thesoftware	Control of the laser-scanning unit and ofthe laser emission, reconstruction of imagesprocess, display of images on a screen.	Control of the laser-scanning unit and ofthe laser emission, reconstruction of imagesprocess, display of images on a screen.	Same
Export	Via DICOM PACS, Shared Drive and USBthumb drives.	Via DICOM PACS, Shared Drive and USBthumb drives	Same
Laser	Class 2M laser product	Class 3R laser product	Similar withlower laserpower for thesubjectdevice

Table 7-3: Comparison of Indication for Use between the Subject Device and Previously Cleared Reference Device

The Cellvizio® 100 series system F400-V2 with the CranioFlex™ Confocal Miniprobe and the reference device. CONVIVO (K181116), have the same indication for use. They are both used to examine blood flow in the cerebral vascular area. In both cases, Fluorescein Sodium 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 Fluorescein Sodium as a contrast agent to visualize vascular structures without changes to the formulation, mode of action, approved dose or route of administration. Fluorescein Sodium is used in an identical manner for both devices.

The resolution and optical characteristics of the Confocal Miniprobes™ are identical or similar to the resolution and optical characteristics of the CranioFlex™ Confocal Miniprobes™. Therefore, blood flow can be image with all Confocal MiniprobesTM.

The Cellvizio® 100 series system with F400-V2 with all Confocal Miniprobes™ device, also enables visualization of blood flow with Fluorescein Sodium for a different Indication for Use (imaging of gastrointestinal, respiratory ad urinary tracts, body cavities, organs and canals accessed by an endoscope, or endoscopic accessories, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures) but a generally equivalent intended use (tissue microstructures imaging).

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Testing Completed:

As no change is being made to the devices, all testing required has been provided in previous submissions (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345, K172844, K180270 and K183640).

Clinical demonstration based on literature review has been carried out to support this submission, as described in section 13.

Summary:

The Cellvizio® 100 Series system F400-v2 with its Confocal Miniprobes™ used with Fluorescein Sodium contrast agent remains exactly the same device in terms of design, performance and general intended use (allow imaging of the internal microstructure) as the previously cleared devices.

The subject device (the Cellvizio® 100 Series system (F400-v2) (with Confocal Miniprobes™) used with Fluorescein Sodium Contrast Agent) has the same indications for use as the predicate device (the Cellvizio® 100 Series system (F400-v2) (with Confocal Miniprobes™)) since both devices are intended to be used to image the tissue microstructures.

The objective of this submission is to extend the previously cleared Indications for Use with the visualization of blood flow when using Fluorescein Sodium as a contrast agent with the proven optical resolution and real time imaging capabilities of the system, corresponding anatomical sizes of cells and vessels, Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and international independent Health Technology Assessment organizations.

The subject device and the reference CONVIVO device are intended to visualize both internal microvascularization and microstructure of tissues. 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 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 generated with the scanner probe are displayed on the monitor. Both devices can be used in realtime during procedures.

The subject device, Cellvizio® 100 Series system (F400-v2) with Confocal Miniprobes™ used with Fluorescein Sodium, and the reference device, CONVIVO used with Fluorescein Sodium, have the same Indication for Use. They are both used to examine blood flow in vascular areas.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.